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`1510196
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`UNITED STATES OF AMERICA
`BEFORE THE FEDERAL TRADE COMMISSION
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`COMMISSIONERS:
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`Edith Ramirez, Chairwoman
`Maureen K. Ohlhausen
`Terrell McSweeny
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`________________________________________________
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`
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`In the Matter of
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`) PUBLIC VERSION
`TEVA PHARMACEUTICAL INDUSTRIES LTD.,
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`a corporation;
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`and
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`
`) Docket No. C-4589
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`ALLERGAN PLC,
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`a corporation.
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`________________________________________________)
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`
`COMPLAINT
`
`Pursuant to the Clayton Act and the Federal Trade Commission Act (“FTC Act”), and its
`authority thereunder, the Federal Trade Commission (“Commission”), having reason to believe
`that Teva Pharmaceutical Industries Ltd. (“Teva”), a corporation subject to the jurisdiction of the
`Commission, has made an offer to acquire the voting securities of certain entities and related
`assets from Allergan plc (“Allergan”), a corporation subject to the jurisdiction of the
`Commission, in violation of Section 5 of the FTC Act, as amended, 15 U.S.C. § 45, that such
`acquisition, if consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C.
`§ 18, and Section 5 of the FTC Act, as amended, 15 U.S.C. § 45, and it appearing to the
`Commission that a proceeding in respect thereof would be in the public interest, hereby issues its
`Complaint, stating its charges as follows:
`
`
`I. RESPONDENTS
`
`
`
`Respondent Teva is a corporation organized, existing, and doing business under
`1.
`and by virtue of the laws of Israel with its principal executive offices located at 5 Basel Street,
`P.O. Box 3190, Petach Tikva 4951033, Israel, and its United States address as follows: General
`Counsel, Teva Pharmaceutical Industries Ltd., c/o Teva North America, 425 Privet Road,
`Horsham, Pennsylvania 19044.
`
`Respondent Allergan is a corporation organized, existing, and doing business
`2.
`under and by virtue of the laws of the Republic of Ireland with its principal executive offices
`located at Clonshaugh Business and Technology Park, Coolock Dublin, D17 E400, Ireland, and
`
`
`
`1
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`MonoSol2007-0001
`
`Dr. Reddys v. MonoSol
`IPR2016-01112
`
`

`

`its United States address as follows: Chief Legal Officer, Allergan plc, Morris Corporate Center
`III, 400 Interpace Parkway, Parsippany, New Jersey 07054.
`
`
`II. THE PROPOSED ACQUISITION
`
`
`
`On July 26, 2015, Teva proposed to acquire Allergan’s generic pharmaceutical
`3.
`business for approximately $40.5 billion (the “Acquisition”).
`
`
`III. THE RELEVANT PRODUCT MARKETS
`
`
`U.S. Food and Drug Administration (“FDA”) marketing approvals for generic
`4.
`pharmaceutical products are based on establishing bioequivalence to already approved drugs.
`When such bioequivalence is demonstrated by in vivo or in vitro studies, the FDA designates
`such generic drugs as “AB-rated” to the branded product, which allows for automatic
`substitution of the generic equivalent for the branded drug when the drug is dispensed at the
`pharmacy. Where only one AB-rated generic drug is approved, it competes against the branded
`drug. Where multiple AB-rated generic drugs are approved, they compete against each other in a
`“generic” market, which typically does not include the branded product. Generic drugs that are
`AB-rated to different branded drugs are not substitutable, even if they contain the same active
`ingredients in the same proportions in the same dosage form. For the purposes of this
`Complaint, relevant lines of commerce in which to analyze the effects of the Acquisition are the
`development, license, manufacture, marketing, distribution, and sale of the following finished
`dosage form pharmaceutical products:
`
`a.
`
`generic acitretin capsules;
`
`generic alendronate sodium tablets;
`
`generic amphetamine asparte/amphetamine sulfate/dextroamphetamine
`saccharate/dextroamphetamine sulfate extended release tablets;
`
`armodafinil tablets;
`
`generic aspirin/dipyridamole extended release capsules;
`
`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx;
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`generic benzoyl peroxide/clindamycin phosphate topical gel;
`
`generic budesonide inhalation suspension;
`
`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx;
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`generic buprenorphine HCl/naloxone HCl buccal film;
`
`generic buspirone hydrochloride tablets;
`
`b.
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`c.
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`d.
`
`e.
`
`f.
`
`g.
`
`h.
`
`i.
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`j.
`
`k.
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`2
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`MonoSol2007-0002
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`

`

`
`l.
`
`m.
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`n.
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`o.
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`p.
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`q.
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`r.
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`s.
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`t.
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`u.
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`v.
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`w.
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`x.
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`y.
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`z.
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`aa.
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`bb.
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`cc.
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`dd.
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`ee.
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`ff.
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`gg.
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`generic carbidopa/levodopa tablets;
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`generic clarithromycin extended release tablets;
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`generic clonidine HCl transdermal film;
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`generic clozapine tablets;
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`generic cyclosporine capsules;
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`generic cyclosporine oral solution;
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`generic desmopressin acetate tablets;
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`generic desogestrel/ethinyl estradiol tablets (AB-rated to Cyclessa);
`
`generic desogestrel/ethinyl estradiol and ethinyl estradiol tablets (AB-rated to
`Mircette);
`
`generic dexmethylphenidate HCl extended release capsules;
`
`generic dextroamphetamine sulfate extended release capsules;
`
`generic diazepam tablets;
`
`generic dienogest/estradiol valerate and estradiol valerate tablets (AB-rated to
`Natazia);
`
`generic disopyramide phosphate capsules;
`
`generic drospirenone/ethinyl estradiol tablets (AB-rated to Yasmin-28);
`
`generic epirubicin injection;
`
`generic estazolam tablets;
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`generic estradiol tablets;
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`generic ethinyl estradiol/ethynodiol diacetate tablets (AB-rated to Demulen 1/35);
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`generic ethinyl estradiol/etonogestrel vaginal rings;
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`generic ethinyl estradiol/levonorgestrel tablets (AB-rated to Alesse-28);
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`generic ethinyl estradiol/levonorgestrel tablets (AB-rated to Levlite-28);
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`3
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`MonoSol2007-0003
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`

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`hh.
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`ii.
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`jj.
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`kk.
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`ll.
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`pp.
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`vv.
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`generic ethinyl estradiol/levonorgestrel tablets (AB-rated to Lo Seasonique);
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`generic ethinyl estradiol/levonorgestrel tablets (AB-rated to Nordette);
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`generic ethinyl estradiol/levonorgestrel tablets (AB-rated to Seasonique);
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`generic ethinyl estradiol/levonorgestrel tablets (AB-rated to Triphasil-28);
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`generic ethinyl estradiol/levonorgestrel tablets (AB-rated to Quartette);
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`mm. generic ethinyl estradiol/norethindrone tablets (AB-rated to Modicon-28);
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`generic ethinyl estradiol/norethindrone tablets (AB-rated to Tri-Norinyl 28-Day);
`
`generic ethinyl estradiol/norethindrone acetate tablets (AB-rated to Loestrin 21
`1/20);
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`generic ethinyl estradiol/norethindrone acetate tablets (AB-rated to Loestrin 21
`1.5/30);
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`generic ethinyl estradiol/norethindrone acetate/ferrous fumarate tablets (AB-rated
`to Estrostep FE);
`
`generic ethinyl estradiol/norethindrone acetate/ferrous fumarate tablets (AB-rated
`to Loestrin FE 1/20);
`
`generic ethinyl estradiol/norethindrone acetate/ferrous fumarate tablets (AB-rated
`to Loestrin FE 1.5/30);
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`generic ethinyl estradiol/norgestrel tablets (AB-rated to Lo/Ovral);
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`generic ezetimibe/simvastatin tablets;
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`generic fentanyl buccal tablets;
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`generic fludarabine injection;
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`generic fluocinonide cream;
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`generic fluocinonide cream, emulsified base;
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`generic flutamide capsules;
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`generic glyburide/metformin HCl tablets;
`
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`ww.
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`xx.
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`yy.
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`zz.
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`aaa.
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`4
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`MonoSol2007-0004
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`

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`bbb. generic griseofulvin microcrystalline liquid suspension;
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`generic hydroxyzine pamoate capsules;
`
`eee.
`
`fff.
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`ccc.
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`ddd. generic imiquimod topical cream;
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`generic levalbuterol HCl inhalation solution;
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`generic metformin HCl/saxagliptin extended release tablets;
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`ggg. generic methotrexate injection;
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`hhh. generic methylphenidate HCl extended release tablets;
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`generic methylphenidate HCl extended release capsules;
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`generic metoclopramide HCl tablets;
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`kkk. generic minocycline capsules;
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`generic mirtazapine oral disintegrating tablets;
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`mmm. generic NAB paclitaxel injection;
`
`nnn. generic nabumetone tablets;
`
`ooo. generic nitrofurantoin capsules;
`
`ppp. generic norethindrone tablets (AB-rated to Micronor 28);
`
`qqq. generic norethindrone tablets (AB-rated to Nor-QD);
`
`generic nortriptyline HCl capsules;
`
`generic phentermine HCl/topiramate extended release capsules;
`
`generic propofol injection emulsion;
`
`uuu. generic propranolol HCl tablets;
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`vvv. generic ramelteon tablets;
`
`www. generic rotigotine transdermal patch;
`
`xxx. generic tamoxifen citrate tablets;
`
`
`iii.
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`jjj.
`
`lll.
`
`rrr.
`
`sss.
`
`ttt.
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`
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`5
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`MonoSol2007-0005
`
`

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`yyy. generic tobramycin inhalation solution;
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`generic trimethoprim tablets; and
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`trimipramine maleate capsules.
`
`aaaa.
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`zzz.
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`Additional relevant lines of commerce in which to analyze the effects of the
`5.
`Acquisition, for the purposes of this Complaint, are the development, manufacture, distribution,
`and sale of the following FDA-approved, finished dosage form pharmaceutical products:
`
`
`a.
`
`b.
`
`betamethasone dipropionate augmented ointment;
`
`betamethasone dipropionate cream;
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`c.
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`d.
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`e.
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`f.
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`g.
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`h.
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`i.
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`j.
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`k.
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`l.
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`m.
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`n.
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`o.
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`betamethasone dipropionate lotion;
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`betamethasone dipropionate ointment;
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`betamethasone valerate cream;
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`betamethasone valerate ointment;
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`clobetasol propionate shampoo;
`
`clobetasol propionate ointment;
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`desonide cream;
`
`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx;
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`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx;
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`probenecid tablets;
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`colchicine/probenecid tablets;
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`nystatin/triamcinolone acetonide cream; and
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`nystatin/triamcinolone acetonide ointment.
`
`
`
`6
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`MonoSol2007-0006
`
`

`

`
`
`IV. THE RELEVANT GEOGRAPHIC MARKETS
`
`
`With respect to the lines of commerce set forth in Paragraphs 4 and 5, the United
`6.
`States is the relevant geographic market in which to assess the competitive effects of the
`Acquisition.
`
`
`V. THE STRUCTURE OF THE MARKETS
`
`The structures of the relevant finished dosage form pharmaceutical product
`7.
`markets set forth in Paragraph 4 are described below:
`
`
`a.
`
`Acitretin capsules are retinoids used to treat psoriasis. Three firms—Allergan,
`Teva, and SigmaPharm Laboratories—supply 17.5 mg generic acitretin capsules.
`Mylan Inc. (“Mylan”) is the only other firm that holds an approved Abbreviated
`New Drug Application (“ANDA”) for 17.5 mg generic acitriten capsules. The
`Acquisition would consolidate the 17.5 mg capsule market from four to three
`suppliers. Five firms supply 10 mg and 25 mg generic acitretin capsules:
`Allergan, Teva, Mylan, Prasco Laboratories (“Prasco”), and SigmaPharm
`Laboratories. The Acquisition would reduce the number of suppliers in the 10 mg
`and 25 mg generic acitretin markets from five to four.
`
`b.
`
`
`c.
`
`
`d.
`
`
`e.
`
`Alendronate sodium tablets are used to treat osteoporosis. Five firms supply 35
`mg generic alendronate sodium tablets: Allergan, Teva, Cipla Ltd. (“Cipla”), Sun
`Pharmaceuticals Industries, Inc. (“Sun”), and Virtus Pharmaceuticals. The
`Acquisition would reduce the number of suppliers of 35 mg generic alendronate
`sodium tablets from five to four.
`
`Amphetamine aspartate/amphetamine sulfate/dextroamphetamine
`saccharate/dextroamphetamine sulfate extended release tablets are used to treat
`Attention Deficit Hyperactivity Disorder (“ADHD”). Three firms hold ANDAs
`for 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength tablets: Allergan,
`Teva, and Impax Laboratories, Inc. (“Impax”). Accounting for expected future
`entry, the Acquisition would reduce the number of suppliers from four to three.
`
`Armodafinil tablets are used to treat excessive sleepiness. Teva owns and
`markets the branded product, Nuvigil. Allergan recently entered the 200 mg
`generic armodafinil market as the exclusive first-to-file generic. The Acquisition
`would reduce the number of suppliers for 200 mg armodafinil tablets from two to
`one.
`
`Aspirin/dipyridamole extended release capsules are used to prevent strokes in
`people who have blood flow disorders or a history of blood clots. Teva markets
`an authorized generic and is the only supplier of generic 25 mg/200 mg
`aspirin/dipyridamole extended release capsules. Allergan is one of a limited
`number of suppliers likely to enter the generic 25 mg/200 mg
`
`7
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`MonoSol2007-0007
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`

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`aspirin/dipyridamole extended release capsule market in the near future. The
`Acquisition would reduce the number of likely future suppliers for generic 25
`mg/200 mg aspirin/dipyridamole extended release capsule in the near future.
`
`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
`
`Benzoyl peroxide/clindamycin phosphate topical gel is a combination
`antiseptic/antibiotic used to treat acne. There are two suppliers of 5%/1%
`strength benzoyl peroxide/clindamycin phosphate gel, Mylan and Perrigo
`Company plc (“Perrigo”). Teva participates in the market through a partnership
`agreement with Perrigo. Allergan is one of a limited number of suppliers likely to
`enter the generic benzoyl peroxide/clindamycin phosphate topical gel market in
`the near future. The Acquisition would reduce the number of likely future
`suppliers for generic benzoyl peroxide/clindamycin phosphate topical gel in the
`near future.
`
`Budesonide inhalation suspension is a steroid inhalant used for the maintenance
`treatment of asthma and as prophylactic therapy in children. Only three firms
`supply 0.25 mg/2 mL and 0.5 mg/2 mL dosage strengths: Allergan, Teva, and
`Sandoz, Inc. (“Sandoz”). The Acquisition would reduce the number of firms
`supplying 0.25 mg/2 mL and 0.5 mg/2 mL dosage strengths of generic budesonide
`inhalation suspensions from three to two. Teva and Sandoz hold approved
`ANDAs for 1 mg/2 mL generic budesonide inhalant suspension. Allergan is the
`only supplier entering the 1 mg/2 mL generic budesonide inhalation suspension
`market in the near future. The acquisition would reduce the number of likely
`future suppliers of generic budesonide inhalation suspension from three to two in
`the 1 mg/2 mL strength.
`
`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
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`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
`
`Buprenorphine HCl/naloxone HCl buccal film is used to treat opioid dependence.
`Teva and Allergan are two of a limited number of suppliers likely to enter the
`market for generic buprenorphine HCl/naloxone HCl buccal film in the near
`future. The Acquisition would reduce the number of likely future suppliers for
`generic buprenorphine HCl/naloxone HCl buccal film.
`
`
`f.
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`g.
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`h.
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`i.
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`j.
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`8
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`MonoSol2007-0008
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`

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`k.
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`n.
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`p.
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`q.
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`Buspirone hydrochloride tablets are used to treat anxiety. Four suppliers provide
`15 mg generic buspirone hydrochloride tablets: Allergan, Teva, Mylan, and
`Zydus Pharmaceuticals, Inc. (“Zydus”). Accounting for expected entry in the
`near future, the Acquisition would reduce the number of likely future suppliers of
`15 mg generic buspirone hydrochloride tablets from five to four.
`
`Carbidopa/levodopa tablets are used to treat Parkinson’s disease. Four firms hold
`approved ANDAs for generic carbidopa/levodopa tablets in the 10 mg/100 mg, 25
`mg/100 mg, and 25 mg/250 mg strengths: Allergan, Teva, Mylan, and Sun. The
`Acquisition would reduce the number of suppliers from four to three.
`
`Clarithromycin extended release tablets are used to treat various bacterial
`infections. Allergan and Teva are the only firms that supply generic
`clarithromycin extended release tablets in the 500 mg strength. Accounting for
`expected entry in the near future, the Acquisition would reduce the number of
`likely future suppliers of generic clarithromycin 500 mg tablets from three to two.
`
`Clonidine HCl transdermal film is an alpha-agonist hypotensive agent used to
`treat high blood pressure. Allergan, Teva, and Mylan are the only three firms
`supplying generic clonidine HCl transdermal film in the 0.1 mg, 0.2 mg, and 0.3
`mg per 24-hour strengths. The Acquisition would reduce the number of firms
`supplying generic clonidine HCl transdermal film from three to two.
`
`Clozapine tablets are used to treat schizophrenia. Four firms supply 25 mg and
`100 mg generic clozapine tablets: Allergan, Teva, Mylan, and Sun. Accounting
`for expected entry, the Acquisition would reduce the number of suppliers for 25
`mg and 100 mg generic clozapine tablets from five to four. Teva and Mylan are
`the only FDA-approved suppliers of 200 mg generic clozapine tablets. Allergan
`is one of a limited number of suppliers likely to enter the 200 mg generic
`clozapine tablet market in the near future. The Acquisition would reduce the
`number of likely future suppliers of generic clozapine tablets in the 200 mg
`strength market in the near future.
`
`Cyclosporine capsules are used to prevent organ rejection after a transplant. Four
`firms supply generic cyclosporine oral capsules in the 25 mg and 100 mg
`strengths: Allergan, Teva, AbbVie, Inc. (“AbbVie”), and Sandoz. The
`Acquisition would reduce the number of suppliers of generic cyclosporine
`capsules from four to three in the 25 mg and 100 mg strength markets.
`
`Cyclosporine oral solution is used to prevent organ rejection after a transplant.
`Only three firms hold ANDAs for 100 mg/mL generic cyclosporine oral solution:
`Allergan, Teva, and AbbVie. The Acquisition would reduce the number of
`suppliers of 100 mg/mL generic cyclosporine oral solution from three to two.
`
`
`
`9
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`MonoSol2007-0009
`
`

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`r.
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`u.
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`w.
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`Desmopressin acetate tablets are used to treat bedwetting, clotting disorders, and a
`form of diabetes that causes excessive urination. Three firms supply 0.1 mg
`generic desmopressin acetate tablets: Allergan, Teva, and Glenmark
`Pharmaceuticals Ltd. (“Glenmark”). The Acquisition would reduce the number of
`firms supplying the 0.1 mg strength market from three to two. Four firms supply
`0.2 mg generic desmopressin acetate tablets: Allergan, Teva, Glenmark, and
`Mylan. The Acquisition would reduce the number of suppliers of the 0.2 mg
`strength tablet from four to three.
`
`Desogestrel/ethinyl estradiol tablets (AB-rated to Cyclessa) are oral
`contraceptives used to prevent pregnancy. Allergan and Teva are the only firms
`that have approved ANDAs. Allergan sells its product as a branded generic under
`the name Caziant. The Acquisition would create a monopoly in the market for
`generic desogestrel/ethinyl estradiol tablets.
`
`Desogestrel/ethinyl estradiol and ethinyl estradiol tablets (AB-rated to Mircette)
`are oral contraceptives used to prevent pregnancy. There are three competitively
`significant generic suppliers: Teva, Allergan, and Glenmark. Other firms
`approved to market the product have negligible sales and market presence.
`Allergan sells its product as a branded generic under the name Azurette. The
`Acquisition would reduce the number of competitively significant suppliers from
`three to two.
`
`Dexmethylphenidate HCl extended release capsules are used to treat ADHD.
`Four firms—Allergan, Teva, Sandoz, and Mylan—market 5 mg, 10 mg, and 20
`mg strength generic dexmethylphenidate HCl extended release capsules. The
`Acquisition would reduce the number of suppliers of 5 mg, 10 mg, and 20 mg
`strength generic dexmethylphenidate HCl extended release capsules from four to
`three. Teva and Allergan are two of a limited number of suppliers likely to enter
`the market for 25 mg and 35 mg strength generic dexmethylphenidate HCl
`extended release capsules in the near future. The Acquisition would reduce the
`number of likely future suppliers for 25 mg and 35 mg strength generic
`dexmethylphenidate HCl extended release capsules.
`
`Dextroamphetamine sulfate extended release capsules are used to treat ADHD.
`Four companies supply generic dextroamphetamine sulfate extended release
`capsules: Allergan, Teva, Mallinckrodt, LLC, and Impax. The Acquisition would
`reduce the number of suppliers from four to three.
`
`Diazepam tablets are used to treat anxiety. Four firms hold ANDAs for 2 mg, 5
`mg, and 10 mg generic diazepam tablets: Allergan, Teva, Endo International plc
`(“Endo”), and Mylan. The Acquisition would reduce the number of suppliers
`from four to three.
`
`
`
`10
`
`
`
`
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`MonoSol2007-0010
`
`

`

`x.
`
`
`y.
`
`
`z.
`
`
`aa.
`
`
`bb.
`
`
`cc.
`
`
`dd.
`
`
`ee.
`
`Dienogest/estradiol valerate and estradiol valerate tablets (AB-rated to Natazia)
`are oral contraceptives used to prevent pregnancy. Teva and Allergan are two of
`a limited number of suppliers likely to enter the market for generic
`dienogest/estradiol valerate and estradiol valerate tablets in the near future. The
`Acquisition would reduce the number of likely future suppliers.
`
`Disopyramide phosphate capsules are used to treat abnormal heart rhythms.
`Allergan and Teva are the only two firms that hold ANDAs for 100 mg and 150
`mg generic disopyramide phosphate capsules. Accounting for expected generic
`entry, the Acquisition would reduce the number of likely future suppliers from
`three to two.
`
`Drospirenone/ethinyl estradiol tablets (AB-rated to Yasmin-28) are oral
`contraceptives used to prevent pregnancy. There are five competitively
`significant suppliers of Drospirenone/ethinyl estradiol tablets: Allergan, Teva,
`Lupin Ltd. (“Lupin”), Sandoz, and Glenmark. Other firms approved to market the
`product have negligible sales and market presence. Allergan sells its product as a
`branded generic under the name Zarah. The Acquisition would reduce the
`number of competitively significant competitors from five to four.
`
`Epirubicin injection is an anthracycline drug used in chemotherapy for the
`treatment of breast cancer. There are four suppliers of generic epirubicin
`injection in the 50 mg/25mL and 200 mg/100mL size vials: Allergan, Teva, Cipla
`and Hospira, Inc. (“Hospira”), the generic injectable division of Pfizer Inc. The
`Acquisition would reduce the number of suppliers from four to three.
`
`Estazolam tablets are used for the short-term treatment of sleep disorders. Teva
`and Allergan are the only two suppliers for 1 mg and 2 mg generic estazolam
`tablets. The Acquisition would create a monopoly in the market for generic
`estazolam tablets.
`
`Estradiol tablets are used to treat symptoms caused by menopause or removal of
`the ovaries. Three firms sell 0.5 mg, 1 mg, and 2 mg generic estradiol tablets:
`Allergan, Teva, and Mylan. The Acquisition would reduce the number of
`suppliers from three to two.
`
`Ethinyl estradiol/ethynodiol diacetate tablets (AB-rated to Demulen 1/35) are oral
`contraceptives used to prevent pregnancy. Teva and Allergan are the only generic
`suppliers. Allergan sells its product as a branded generic under the name Zovia.
`The Acquisition would create a monopoly in the market for generic ethinyl
`estradiol/ethynodiol diacetate tablets.
`
`Ethinyl estradiol/etonogestrel vaginal rings are contraceptives used to prevent
`pregnancy. Teva and Allergan are two of a limited number of suppliers likely to
`enter the market in the near future. The Acquisition would reduce the number of
`likely future suppliers for generic ethinyl estradiol/etonogestrel vaginal rings.
`
`
`
`11
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`MonoSol2007-0011
`
`

`

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`Ethinyl estradiol/levonorgestrel tablets (AB-rated to Alesse-28) are oral
`contraceptives used to prevent pregnancy. Five firms supply generic Alesse-28:
`Allergan, Teva, Endo, Lupin, and Sandoz. Allergan sells its product as a branded
`generic under the name Lutera. The Acquisition would reduce the number of
`suppliers from five to four.
`
`Ethinyl estradiol/levonorgestrel tablets (AB-rated to Levlite-28) are oral
`contraceptives used to prevent pregnancy. Three firms have ANDAs approved
`for generic Levlite-28: Allergan, Teva, and Mylan. Allergan sells its product as a
`branded generic under the name Sronyx. The Acquisition would reduce the
`number of suppliers from three to two.
`
`Ethinyl estradiol/levonorgestrel tablets (AB-rated to Lo Seasonique) are oral
`contraceptives used to prevent pregnancy. Teva owns the branded product and
`markets an authorized generic. Allergan and Lupin market generic products,
`which compete directly with Teva’s authorized generic. Allergan sells its product
`as a branded generic under the name Amethia Lo. Accounting for expected entry,
`the Acquisition would reduce the number of suppliers from four to three.
`
`Ethinyl estradiol/levonorgestrel tablets (AB-rated to Nordette) are oral
`contraceptives used to prevent pregnancy. There are five competitively
`significant suppliers of generic Nordette: Allergan, Teva, Sandoz, Glenmark, and
`Mylan. Allergan sells its product as a branded generic under the name Levora.
`The Acquisition would reduce the number of suppliers from five to four.
`
`Ethinyl estradiol/levonorgestrel tablets (AB-rated to Seasonique) are oral
`contraceptives used to prevent pregnancy. Teva owns the branded product and
`markets an authorized generic. Four additional firms supply generic Seasonique:
`Allergan, Glenmark, Lupin, and Mylan. Allergan sells its product as a branded
`generic under the name Amethia. The Acquisition would reduce the number of
`suppliers from five to four.
`
`Ethinyl estradiol/levonorgestrel tablets (AB-rated to Triphasil-28) are oral
`contraceptives used to prevent pregnancy. Three firms supply generic Triphasil-
`28: Allergan, Teva, and Endo. Allergan sells its product as a branded generic
`under the name Trivora. The Acquisition would reduce the number of suppliers
`from three to two.
`
`Ethinyl estradiol/levonorgestrel tablets (AB-rated to Quartette) are oral
`contraceptives used to prevent pregnancy. Teva and Allergan are two of a limited
`number of suppliers likely to enter the market for generic Quartette in the near
`future. The Acquisition would reduce the number of likely future suppliers for
`generic Quartette.
`
`
`
`12
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`MonoSol2007-0012
`
`

`

`mm. Ethinyl estradiol/norethindrone tablets (AB-rated to Modicon-28) are oral
`contraceptives used to prevent pregnancy. Allergan, Teva, and Mylan market
`generic Modicon-28. Allergan sells its product as a branded generic under the
`name Necon. The Acquisition would reduce the number of suppliers from three
`to two.
`
`Ethinyl estradiol/norethindrone tablets (AB-rated to Tri-Norinyl 28-Day) are oral
`contraceptives used to prevent pregnancy. Allergan markets branded Tri-Norinyl
`28-Day and an authorized generic, which Allergan sells under the name Leena,
`and Teva markets the only generic version. The Acquisition would reduce the
`number of suppliers from two to one.
`
`Ethinyl estradiol/norethindrone acetate tablets (AB-rated to Loestrin 21 1/20) are
`oral contraceptives used to prevent pregnancy. There are four suppliers of generic
`Loestrin 21 1/20: Allergan, Teva, Mylan, and Endo. Allergan sells its product as
`a branded generic under the name Microgestin 1/20. The Acquisition would
`reduce the number of suppliers from four to three.
`
`Ethinyl estradiol/norethindrone acetate tablets (AB-rated to Loestrin 21 1.5/30)
`are oral contraceptives used to prevent pregnancy. Four firms market generic
`Loestrin 21 1.5/30: Allergan, Teva, Mylan, and Endo. Allergan sells its product
`as a branded generic under the name Microgestin 1.5/30. The Acquisition would
`reduce the number of suppliers from four to three.
`
`Ethinyl estradiol/norethindrone acetate/ferrous fumarate tablets (AB-rated to
`Estrostep FE) are oral contraceptives used to prevent pregnancy. Teva and
`Allergan, which markets branded Estrostep FE and an authorized generic, are the
`only suppliers of generic Estrostep FE. Allergan sells its product as a branded
`generic under the name Tilia Fe. Thus, the Acquisition would create a monopoly
`in the generic Estrostep FE market.
`
`Ethinyl estradiol/norethindrone acetate/ferrous fumarate tablets (AB-rated to
`Loestrin FE 1/20) are oral contraceptives used to prevent pregnancy. Five firms
`supply generic Loestrin FE 1/20: Allergan, Teva, Endo, Mylan, and Lupin.
`Allergan sells its product as a branded generic under the name Microgestin Fe
`1/20. The Acquisition would reduce the number of suppliers from five to four.
`
`Ethinyl estradiol/norethindrone acetate/ferrous fumarate tablets (AB-rated to
`Loestrin FE 1.5/30) are oral contraceptives used to prevent pregnancy. Five firms
`supply generic Loestrin FE 1.5/30: Allergan, Teva, Endo, Lupin, and Mylan.
`Allergan sells its product as a branded generic under the name Microgestin Fe
`1.5/30. The Acquisition would reduce the number of suppliers from five to four.
`
`Ethinyl estradiol/norgestrel tablets (AB-rated to Lo/Ovral) are an oral
`contraceptive drug used to prevent pregnancy. Allergan and Teva are the only
`current suppliers of generic ethinyl estradiol/norgestrel tablets. Allergan sells its
`
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`13
`
`MonoSol2007-0013
`
`

`

`product as a branded generic under the name Low-Ogestrel. Accounting for
`future entry, the Acquisition would reduce the number of current and likely future
`suppliers from three to two.
`
`Ezetimibe/simvastatin tablets are used to treat high cholesterol. Teva and
`Allergan are among a limited number of likely future suppliers of generic
`ezetimibe/simvastatin tablets in the 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg,
`and 10 mg/80 mg strengths. The Acquisition would reduce the number of likely
`future suppliers for generic ezetimibe/simvastatin tablets.
`
`Fentanyl buccal tablets are used to treat severe pain. Teva markets the branded
`product, Fentora, and plans to launch an authorized generic product. Allergan is
`one of a limited number of future generic fentanyl buccal tablet suppliers. The
`Acquisition would reduce the number of likely future suppliers for generic
`fentanyl buccal tablets.
`
`
`ww. Fludarabine injection is a chemotherapy drug used to treat chronic lymphocytic
`leukemia. There are only three independent suppliers of 50 mg lyophilized vials:
`Allergan, Teva, and Hospira. The Acquisition would reduce the number of
`independent suppliers from three to two.
`
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`Fluocinonide cream is a steroid used as an anti-inflammatory for the treatment of
`skin disorders. Three firms market 0.05% generic fluocinonide cream: Teva,
`Allergan, and Sun, owner of the branded product, which sells an authorized
`generic. The Acquisition would reduce the number of suppliers from three to
`two.
`
`Fluocinonide cream, emulsified base is a steroid used as an anti-inflammatory for
`the treatment of skin disorders. Only two firms market 0.05% generic
`fluocinonide emulsified base cream: Teva and Taro, which sells an authorized
`generic. Allergan is the only supplier likely to enter the market in the near future.
`The acquisition would reduce the number of likely future suppliers of 0.05%
`generic fluocinonide emulsified base cream from three to two.
`
`Flutamide capsules are used in hormone-based chemotherapy for the treatment of
`prostate cancer. Three firms supply 125 mg generic flutamide capsules:
`Allergan, Teva, and Endo. The Acquisition would reduce the number of suppliers
`from three to two.
`
`
`aaa. Glyburide/metformin HCl tablets are used to treat high blood sugar levels caused
`by type-2 diabetes. There are four independent suppliers of 1.25/250 mg, 2.5/500
`mg, and 5/500 mg generic glyburide/metformin HCl tablets: Allergan, Teva,
`Aurobindo Pharma Ltd. (“Aurobindo”), and Heritage Pharmaceuticals Inc.
`(“Heritage”). The Acquisition would reduce the number of suppliers from four to
`three.
`
`
`
`
`
`14
`
`MonoSol2007-0014
`
`

`

`bbb. Griseofulvin microcrystalline liquid suspension is used to treat fungal infections
`of the skin, hair, and nails. Allergan, Teva, and Endo supply 125 mg/5mL generic
`griseofulvi