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TYVASO Drug Profile

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. Three suppliers are listed for this compound. Additional details are available on the treprostinil profile page.

Summary for TYVASO

International Patents:	27
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	53
Clinical Trials:	16
Patent Applications:	510
Drug Prices:	Drug price information for TYVASO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TYVASO
DailyMed Link:	TYVASO at DailyMed

Drug patent expirations by year for TYVASO

Recent Clinical Trials for TYVASO

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

Sponsor	Phase
United Therapeutics	Phase 1
Bastiaan Driehuys	Phase 2
United Therapeutics	Phase 2/Phase 3

See all TYVASO clinical trials

Recent Litigation for TYVASO

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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

Petitioner	Date
Watson Laboratories, Inc.	2017-06-21
SteadyMed Ltd.	2015-10-02

See all TYVASO litigation

Pharmacology for TYVASO

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

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

US Patents and Regulatory Information for TYVASO

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Glossary

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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	See Pricing	See Pricing				See Pricing
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009		RX	Yes	Yes	See Pricing	See Pricing		Y		See Pricing
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009		RX	Yes	Yes	See Pricing	See Pricing		Y		See Pricing
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009		RX	Yes	Yes	See Pricing	See Pricing		Y	Y	See Pricing
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009		RX	Yes	Yes	See Pricing	See Pricing	Y			See Pricing
>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

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

Paragraph IV (Patent) Challenges for TYVASO

Drugname	Dosage	Strength	RLD	Date
➤ Subscribe	Inhalation Solution	0.6 mg/mL, 2.9 mL ampules	➤ Subscribe	See Pricing

International Patents for TYVASO

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Country	Patent Number	Estimated Expiration
European Patent Office	3287434	See Pricing
Japan	5797376	See Pricing
South Korea	20160048222	See Pricing
South Korea	20090007797	See Pricing
South Korea	101614465	See Pricing
Japan	2014114317	See Pricing
South Korea	20100105852	See Pricing
>Country	>Patent Number	>Estimated Expiration