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Treprostinil diolamine - Generic Drug Details

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What are the generic drug sources for treprostinil diolamine and what is the scope of treprostinil diolamine patent protection?

Treprostinil diolamine is the generic ingredient in one branded drug marketed by United Therap and is included in one NDA. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Treprostinil diolamine has fifty-eight patent family members in eight countries.

There are nineteen drug master file entries for treprostinil diolamine. One supplier is listed for this compound.

Summary for treprostinil diolamine

International Patents:	58
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	19
Suppliers / Packagers:	1
Bulk Api Vendors:	2
Clinical Trials:	2
Patent Applications:	15
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for treprostinil diolamine
DailyMed Link:	treprostinil diolamine at DailyMed

Pharmacology for treprostinil diolamine

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Synonyms for treprostinil diolamine

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 diethanolamine salt

2-((1R,2R,3aS,9aS)-2-Hydroxy-1-(3(S)-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta(b)naphthalen-5-yloxy)acetic acid diethanolamine salt

830354-48-8

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)-, compd. with 2,2'-iminobis(ethanol) (1:1)

AKOS030524397

CHEMBL2107815

D10430

DTXSID50232132

EX-A1418

H1FKG90039

Orenitram

RHWRWEUCEXUUAV-ZSESPEEFSA-N

SCHEMBL17222566

Treprostinil diethanolamine

Treprostinil diolamine (USAN)

Treprostinil diolamine [USAN]

UNII-H1FKG90039

UT-15C

US Patents and Regulatory Information for treprostinil diolamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-004	Dec 20, 2013		RX	Yes	No			Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-005	Oct 7, 2016		RX	Yes	No				Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-004	Dec 20, 2013		RX	Yes	No			Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013		RX	Yes	Yes
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-004	Dec 20, 2013		RX	Yes	No				Y	Y

Expired US Patents for treprostinil diolamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-004	Dec 20, 2013
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-004	Dec 20, 2013

International Patents for treprostinil diolamine

Country	Patent Number	Estimated Expiration
China	103274926
Japan	5851691
World Intellectual Property Organization (WIPO)	2007127216
China	101903324
Austria	532520