Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

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TYVASO Drug Profile

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Which patents cover Tyvaso, and when can generic versions of Tyvaso launch?

Tyvaso is a drug marketed by United Therap and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-seven patent family members in seven countries.

The generic ingredient in TYVASO is treprostinil. There are nineteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the treprostinil profile page.

US ANDA Litigation and Generic Entry Outlook for Tyvaso

A generic version of TYVASO was launched as treprostinil by SANDOZ INC on December 14th, 2019.

Drug patent expirations by year for TYVASO
Drug Prices for TYVASO

See drug prices for TYVASO

Recent Clinical Trials for TYVASO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
United TherapeuticsPhase 1
Bastiaan DriehuysPhase 2
United TherapeuticsPhase 2/Phase 3

See all TYVASO clinical trials

Recent Litigation for TYVASO

Identify potential future generic entrants

District Court Litigation
Case NameDate
UNITED THERAPEUTICS CORPORATION v. WATSON LABORATORIES, INC.2015-07-22
UNITED THERAPEUTICS CORPORATION v. TEVA PHARMACEUTICALS USA, INC.2014-09-02
UNITED THERAPEUTICS CORPORATION v. SANDOZ, INC.2012-03-14

See all TYVASO litigation

PTAB Litigation
PetitionerDate
Watson Laboratories, Inc.2017-06-21
SteadyMed Ltd.2015-10-02

See all TYVASO litigation

Pharmacology for TYVASO
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
Synonyms for TYVASO
((1R,2R,3aS,9aS)-2-hydroxy-1-((3S)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cylopent(b)naphthalen-5-yl)oxy)acetate
({(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl}oxy)acetic acid
(1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy- 1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl] oxy]acetic acid
[[(1R,2R,3aS,9aS)-2-Hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphtalen-5-yl]oxy]acetic acid
[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-Hexahydro-2-hydroxy-1-[(S)-3-hydroxyoctyl]-1H-benzo[f]indene-5-yl]oxy]acetic acid
[[(1R,2R,3aS,9aS)-2,3,4,9,9a-Hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid
[1R-[1|A(S*),2|A,3a|A,9a|A]]-[[2,3,3a,4,9,9a-| section signexahydro-2-hydroxy-1-(3-hydroxyoctyl)-1H-benz[f]inden-5-yl]oxy]acetic Acid
15AU
15AU81
2-(((1R,2R,3aS,9aS)-2-hydroxy-1-((S)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl)oxy)acetic acid
2-((1r,2r,3as,9as)-2-hydroxy-1-((s)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1h-cyclopenta[b]naphthalen-5-yloxy)acetic acid
2-[[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[g]naphthalen-5-yl]oxy]acetic acid
2-[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-Hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic Acid
2-[[(2R,3R,3aS,9aS)-2-hydroxy-3-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[g]naphthalen-8-yl]oxy]acetic acid
2-{[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H,2H,3H,3aH,4H,9H,9aH-cyclopenta[b]naphthalen-5-yl]oxy}acetic acid
2025AH
289480-64-4
289480-64-4 (Sodium salt)
7JZ75N2NT6
81846-19-7
81846-19-7 (Parent)
AC-30205
AC-30207
AC1OCF2J
Acetic acid, (((1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-((3S)-3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)-
Acetic acid, (((1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-((3S)-3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)-, monosodium salt
Acetic acid, ((2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-(3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)-, (1R-(1alpha(S*),2beta,3aalpha,9aalpha))-
AKOS027470173
AKOS030524396
API0005768
ARD-1550
BCP10253
BRD-K19706299-001-01-4
BW 15AU
BW-15AU
C23H33O5.Na
CHEBI:50861
CHEBI:50863
CHEMBL1237119
CS-6170
CS-7872
CTK8G3571
D06213
D08628
DB00374
EX-A1414
EX-A1416
GTPL5820
HMS3648G07
HY-100441
HY-16504
LRX 15
LRX-15
MolPort-027-720-928
Orenitram
PAJMKGZZBBTTOY-ZFORQUDYSA-N
Remodulin
Remodulin (TN)
RP17714
RUM6K67ESG
Rumodolin
SCHEMBL4349618
SCHEMBL61996
sodium ({(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl}oxy)acetate
sodium 2-(((1R,2R,3aS,9aS)-2-hydroxy-1-((S)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl)oxy)acetate
SR-01000946210
SR-01000946210-1
Treprostinil
Treprostinil (JAN/USAN/INN)
Treprostinil (sodium)
Treprostinil [USAN:INN]
Treprostinil monosodium salt
Treprostinil pound>>UT-15
Treprostinil sodium
treprostinilo
treprostinilum
Tresprostinil
Trevyent
U 62840
U-62,840
U-62840
UNII-7JZ75N2NT6
UNII-RUM6K67ESG
Uniprost
UT-15
Viveta
Y0243
ZINC3800475
Paragraph IV (Patent) Challenges for TYVASO
Tradename Dosage Ingredient NDA Submissiondate
TYVASO SOLUTION;INHALATION treprostinil 022387 2015-04-13

US Patents and Regulatory Information for TYVASO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TYVASO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009   Start Trial   Start Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009   Start Trial   Start Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009   Start Trial   Start Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.