necEIVEn
`
`n NOV 2 1 2013 U
`
`r&P -.. J.
`
`Bt
`Par Pharmaceutical, !no.
`One Rarn Ridge Road
`Sprin{J Valley, NY 10977
`tel 845-425-7100
`fax 845-573-6795
`www.p~lrpharm.com
`
`CONFIDENTIAL
`
`November 20, 2013
`
`Jazz Pharmaceuticals, Inc.
`3180 Porter Drive
`PRlo Alto, California 94304
`
`Jazz Pharmaceuticals International Limited
`2 Church Street
`lTamilton HM 11
`Bennuda
`
`EUSA Pharrna (USA), Inc.
`1717 Langhorne Newtovm Rd #20 1
`Langhothe, PA 19047-1085
`
`EUSA Phat·ma (Europe), Ltd.
`The Magdalen Ce1\tre
`Oxford Science Park
`Oxford OX4 4GA
`England
`
`VIA REGISTERED EXPRESS MAIL
`RETURN RECEIPT REQUESTED
`
`Re:
`
`Sodium Oxybate500 rnglmt Oral Solutioil. (XYREM®)
`United States Patent Nos. 6,780,889; 7,262,219; 7,668,730; 7,765,106; 7,765,107; 7,851,506;
`7,895,059; 8,263)650; 8,324,275;and 8,457,988
`Notice of Pa.rAgr.!Uili IV Certifiqgtion -------·--·-.. -............ --.. ·----·-·-................ _ .. ____ ,_
`
`Dear Sirs:
`
`This is a notice of certification letter on behalf of Par Pharmaceutical, Inc., (''Par") pursuant to §
`505G)(2)(B)(ii) of the Federal Food, Drug and Cosmetic Act ("the Act") and 21 U.S.C. § 355(j)(2)(B)(ii)
`·
`and§ 314.95 of Title 21 of the Code of Federal Regulations:
`
`1.
`
`An Abbreviated New Drug Application ("AND A'') containing any required bioavailability or
`bioequivalence data or information has been submitted under § 505(j) of the Act for the drug with
`respect to which the certification is made to obtain approval to engage in the commercial
`manufacture, nse, or sale ofthe drug before the expiration date of United States Patent Nos.
`6,780,889; 7,262,219; 7,668,730; 7,765,106;7,765,107; 7,851,506; 7,895,059; 8,263,650;
`8,324,275; and 8,457,988, listed in the Approved Drug Products with Therapeutic Equivalence
`
`1
`
`JAZZ EXHIBIT 2022
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00547
`
`Page 1 of 3
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`Page 2 of 3
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`2.
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`3.
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`4.
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`5.
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`Evaluations (the "Orange Book"). The Food and Drug Administration ("FDA") has received this
`ANDA for substantive review.
`
`The ANDA number is 205403.
`
`The established name of Par's proposed drug product is: Sodium Oxybate Oral Solution.
`
`The active iqgredient, strength, and dosage form of the proposed drug product is 500 mg/ml of
`sodium oxybate. The dosage form is an oral. solution.
`
`The Orl;lng~Book lists the following U.S, Pat~;mts for )(YREM® tablets: (1) U.S. Patent No.
`6,780,889 (''the '889 patent"), which is listed as expiring on July 4, 4020; (4) U.S. PatentNo.
`7,462,219 ("the '219 patent"), which is listed as expiring on July 4i 2020; (3) U.S. Patent No.
`7,668,730 (''the '730 patent"), which is listed as expiring on June 16; 2024; (4) U.S. Patent No.
`7,765,106 ('fthe '106 patent"), whichis listed as expiring on June 16,2024; (5) U.S. Patent No.
`7,765;107 ("the '107 patent''), which is listed as expiring on June 16, 2024; (6) U.S. Patent No.
`7,851,506 ("the '506 patent~') which is listed as expiring on December 22, 2019; (7) U.S. Patent
`No. 7,895,059 ("the '059 pat~nt") whic!J is listed as expiring on December 17, 2022; (8) U.S.
`Pate11tNo. 8,2631650 ("the ''6SO patent") which is listed as expidng 911 December 22, 20 19; (9)
`U.S. Patent No. 8,324,275 ("the '275 patent") which is listed as expiring on December 22, 20 19;
`~tnd{lO)U.S. PatentNo.8,457,988 ("thq'988patent")\Yhich is listed as ~x;piring onDecember
`17,.~022. TheANQAdndicates,that Patintend~,tqmal'ket the product before the expiration of the
`'889, '219, '730, '106, '107, '506, '059, '650, '275, and '988 patents, and contains a certification
`pursuantto 21 U.S.C. § 355(j)(2)(A)(vii)([V) that in Par's opinion, these patents are invalid,
`unenforceable, and/or willnot be intHnged by the manufacture; use, or sale of the product for
`which the application is su])mitted.
`
`6.
`
`An Offer ofConfidcrltial Access to the ANDA, pursuant to§ SOS(j)~S)(C)(i)(IH) of the Act
`accompanies this.notice as a separate enclosure.
`
`Attached is a detailed statement of the factualand legal bases of Par's patent certification. This
`information is supplied fonhe. sole purpqse qf complying with the above~referenccd statutes and
`regulations. Neither Par nor its attorneys waive any attorney-clientprivileg~ or work~product immunity
`conqer11ingthe subject iJiatter of' this communicatioii.
`
`Sincerely,
`
`Encl.: Detailed Statementofthe Factual and Legal Bases for Par's Patagraph IV Patent
`Certification and Offer ofCCmfidtmtial Access
`
`Duplicate with enclosure via FEDEX
`
`2
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`Page 3 of 3