`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
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`
`
`Product Details for NDA 022387
`
`TYVASO (TREPROSTINIL)
`
`0.6MGIML
`
`Marketing Status: Prescription
`
`Active Ingredient: TREPROSTINIL
`
`Proprietary Name: TYVASO
`Dosage Form; Route of Administration: SOLUTION; INHALATION
`
`Strength: 0.6MGI‘ML
`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 TH ERAPEUTICS CORP
`
`Marketing Status: Prescription
`
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`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01621
`Page 1 of4
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`Orange Book: Approved Drug Products with Therapeuh'c Equivalence Evaluations
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
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`
`
`
`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 mayr
`include drug substance andior 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 NDA 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
`
`https:iiwwaccessdata_fda_goviscriptsrcd eriobipatent_info.cim ?Prod uct_No= 001&Appl_No= 02 23 8?&Appl_typ e=N
`
`1i'2
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`Page 3 of4
`
`
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`10133201?
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Patent
`
`Drug
`Drug
`Substance Product
`
`Delist
`
`Expiration Claim
`
`Claim
`
`Patent Use Code
`
`Requested
`
`Nov 13,
`2018
`
`Nov 13,
`2018
`
`Oct 24,
`2017
`
`Dec 15,
`2028
`
`Mar 10,
`2028
`
`May 5,
`2028
`
`Dec 15,
`2028
`
`Dec 15,
`2028
`
`DS
`
`DS
`
`DS
`
`DS
`
`DP
`
`
`
`[ghow code.cfm?
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`
`Product Patent
`No
`No
`
`001
`
`6521212
`
`001
`
`6756033
`
`001
`
`6765117
`
`001
`
`8497393
`
`001
`
`9339507
`
`001
`
`9358240
`
`001
`
`9593066
`
`001
`
`9604901
`
`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`001
`
`001
`
`
`
`May 20, 2017
`
`Jul 30, 2016
`
`. atent.cfm
`
`[Low 3 list of all explusivi
`
`
`
`https:lewaccessdata.fda.gowscriptsrcder!ob.‘patent_info.dm?Product_No=001&Appl_No=02238?&App1_1ype=N
`
`24'2
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