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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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-nine patent family members in twelve countries.

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

Summary for TYVASO

International Patents:	39
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	33
Clinical Trials:	14
Patent Applications:	412
Drug Prices:	see details
DailyMed Link:	TYVASO at DailyMed

Pharmacology for TYVASO

Ingredient-type	Prostaglandins I
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

15 AU81

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-[(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)

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

BRD-K19706299-001-01-4

BW 15AU

BW-15AU

C23H33O5.Na

CHEBI:50861

CHEBI:50863

CHEMBL1237119

CS-6170

CS-7872

CTK8G3571

D01WUA

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

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

treprost

Treprostinil

Treprostinil (JAN/USAN/INN)

Treprostinil (sodium)

Treprostinil (USAN/INN)

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

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
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

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

Paragraph IV (Patent) Challenges for TYVASO

Drugname	Dosage	Strength	RLD	Submissiondate
	Inhalation Solution	0.6 mg/mL, 2.9 mL ampules		2015-04-13

Non-Orange Book US Patents for TYVASO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,156,786	Process to prepare treprostinil, the active ingredient in remodulin.RTM.
8,242,305	Process to prepare treprostinil, the active ingredient in remodulin
8,748,657	Process to prepare treprostinil

International Patents for TYVASO

Country	Document Number	Estimated Expiration
China	103274926
Spain	2630407
South Korea	20090007797
Denmark	1161234