`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
`f SHARE H'I'I'PS:IIW'WW.FACEBOOK.COWSHARERISHARER. PHP?
`
`
`E UIVALENCE EVALUIA'I'IOI‘ISIBII..IRI.=HTTPS:”WWWACCESSDATA.FDAGOJISCRIPTSICDERIOBIRESULTS PRODUCTCFM‘? APPL TYPE:NEAPPL NO=022381
`
`1 a
`
`EMAIL MAILTO:?5UBJECT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC E UIVALENCE
`UA IONS
`Y=H1TP :IMWWACC SS ATA.F A. OWSCRIPT ICD RI
`IR
`TS FR
`U ICFM?
`V
`APPL TYPE=N8APPL HO=0223BH
`
` H9919... 9.9L?!H't.-.EI.W?'TQ§9W?.IP§EI . I P‘E‘FHP ...€§I‘?.I.‘.§§§E‘I.t§
`
`
`
`Product Details for NBA 022387
`
`TYVASO (TREPROSTINIL)
`0.6MGIML
`
`Marketing Status: Prescription
`
`Active Ingredient: TREPROSTINIL
`
`Proprietary Name: TYVASO
`Dosage Form; Route of Administration: SOLUTION; INHALATION
`Strength: 0.6MGIML
`Reference Listed Drug: Yes
`Reference Standard: Yes
`TE Code:
`
`Application Number: N022387
`Product Number: 001
`
`Approval Date: Jul 30, 2009
`Applicant Holder Full Name: UNITED THERAPEUTICS CORP
`Marketing Status: Prescription
`
`'_ Information aatent info. cfm?
`
`
`htlszMwwaccessdala.l‘da_goviscriptsicderfohlresultswproduc1_cfm?Appl_Type=N&Appl_No=02238T
`
`‘li2
`
`UNITED THERAPEUTICS, EX. 2012
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01622
`Page 1 of4
`
`
`
`10:3.‘201?
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`hflpsflmaucessdata.fda.gowscriplsiodermbiresults_productdm?Appl_Type=N&App1_No=02238?
`
`2!:
`
`UNITED THERAPEUTICS, EX. 2012
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR2017-D1622
`Page 2 0M
`
`
`
`10i3i201?
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
`f SHARE H'I'I'PS:I'MI'WW.FACEBOOK.COWSHARERISHARER. PHP?
`
`
`E UIVALENCE EVALU.A'I'IOI‘ISIB:I..IRI.=HTTPS:”WWWACCESSDATA. FDA. GOWSCRIPTSiCDERlOBiPATENT INFO. CFM. PRODUCT NO=DD18APPL NO=02238?&APPL TYPE=N
`
`1 a
`
`
`EMAIL MAILTO:?5UBJECT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC E UIVALENCE
`UA IONS
`Y=H1TP :iMWW. C
`S
`ATA.F A. OWSCRIPT ICD R.‘
`i'PAT
`T |NFO.CFM?
`PRODUCT NO=OO1&APPL NO=0223B?&APPL TYP§=N1
`
`
`
`H9919... 9.9%!U't.-.Ef.fii?tg§fiffie.'9$f‘i . I 55293.}? REQdLIFIP‘PEaE'?
`
`
`
`Additional Information about Patents
`
`. Patent information is published on or after the submission date as defined in 21 CFR 314.53id)(5).
`
`- Patent listings published prior to August 18, 2003, only identify method-of—use claims. The listed patents may
`include drug substance andfor drug product claims that are not indicated in the listing.
`
`. As of December 5. 2016, an NBA holder submitting information on a patent that claims both the drug
`substance and the drug product (and is eligible for listing on either basis) is required only to specify that it
`claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book
`patent listing. regardless of when first published, to determine the range of patent claims that may be
`asserted by an NBA holder or patent owner.
`
`Patent and Exclusivity for: N022387
`
`Product 001
`
`TREPROSTINIL (TWASO) SOLUTION 0.6MGiML
`
`Patent Data
`
`Product Patent
`
`Patent
`
`Drug
`Drug
`Substance Product
`
`Delist
`
`No
`
`No
`
`Expiration Claim
`
`Claim
`
`Patent Use Code
`
`Requested
`
`httpsflMwa ccessdata.fda.goviscriptsicderiohlpatenLintoclm ?Product_No=001 mppLNo= 02238? Mpplwtype=N
`
`112
`
`UNITED THERAPEUTICS, EX. 2012
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-D1622
`Page 3 of4
`
`
`
`10:3!201?
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Product Patent
`
`Patent
`
`Drug
`Drug
`Substance Product
`
`Delist
`
`No
`
`Expiration Claim
`
`Claim
`
`Patent Use Code
`
`Requested
`
`
`
`
`U-1849
`
`DP
`
`No
`
`001
`
`6521212 Nov 13,
`2018
`
`001
`
`6756033
`
`Novr 13,
`2018
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`6765117 Oct 24,
`2017
`
`8497393 Dec 15,
`2028
`
`9339507 Mar 10,
`2028
`
`9358240 May 5,
`2028
`
`9593066 Dec 15,
`2028
`
`9604901 Dec 15,
`2028
`
`DS
`
`DS
`
`DS
`
`DS
`
`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`001
`
`001
`
`
`
`May 20, 2017
`
`Jul 30, 2016
`
`
`
`httpsflMwwamessdala.fda.gowscriplsfcdermhlpatenLinfo.cfm?Product_No=0018Appl_No=02238?&Applwtype=N
`
`2L2
`
`UNITED THERAPEUTICS, EX. 2012
`WATSON LABORATORIES V. UNlTED THERAPEUTICS, IPR2017—01622
`Page 4 014
`
`
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