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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 14^th, 2019.

Summary for TYVASO

International Patents:	27
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	55
Clinical Trials:	16
Patent Applications:	527
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

See drug prices 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

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

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
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009

International Patents for TYVASO

Country	Patent Number	Estimated Expiration
Japan	2014114317
South Korea	20160048222
South Korea	20170081292
World Intellectual Property Organization (WIPO)	2007134292
Japan	5851691