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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 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-nine 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:	59
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	3
Patent Applications:	15
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for treprostinil diolamine
DailyMed Link:	treprostinil diolamine at DailyMed

Recent Clinical Trials for treprostinil diolamine

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

Sponsor	Phase
Ohio State University	Phase 2
Mardi Gomberg -Maitland	Phase 2
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Phase 2

See all treprostinil diolamine clinical trials

Pharmacology for treprostinil diolamine

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Paragraph IV (Patent) Challenges for TREPROSTINIL DIOLAMINE

Tradename	Dosage	Ingredient	NDA	Submissiondate
ORENITRAM	TABLET, EXTENDED RELEASE;ORAL	treprostinil diolamine	203496	2020-12-28
ORENITRAM	TABLET, EXTENDED RELEASE;ORAL	treprostinil diolamine	203496	2016-05-19

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	203496-004	Dec 20, 2013		RX	Yes	No				Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013		RX	Yes	No			Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-005	Oct 7, 2016		RX	Yes	No
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013		RX	Yes	Yes			Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013		RX	Yes	Yes				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	203496-002	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	203496-005	Oct 7, 2016
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	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
Canada	2760499
China	100558351
Austria	532520
European Patent Office	2792353
South Korea	20120017058
South Korea	20170081292