TREPROSTINIL DIOLAMINE - Generic Drug Details

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What are the generic sources for treprostinil diolamine and what is the scope of freedom to operate?

Treprostinil diolamine is the generic ingredient in one branded drug marketed by United Therap and is included in one NDA. There are fourteen 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 two drug master file entries for treprostinil diolamine. One supplier is listed for this compound.

Summary for TREPROSTINIL DIOLAMINE

International Patents:	59
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	4
Patent Applications:	15
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TREPROSTINIL DIOLAMINE
DailyMed Link:	TREPROSTINIL DIOLAMINE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TREPROSTINIL DIOLAMINE

Generic Entry Date for TREPROSTINIL DIOLAMINE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TREPROSTINIL DIOLAMINE

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

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

See all TREPROSTINIL DIOLAMINE clinical trials

Pharmacology for TREPROSTINIL DIOLAMINE

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Anatomical Therapeutic Chemical (ATC) Classes for TREPROSTINIL DIOLAMINE

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for TREPROSTINIL DIOLAMINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORENITRAM	Extended-release Tablets	treprostinil diolamine	0.125 mg and 5 mg	203496	1	2020-12-28
ORENITRAM	Extended-release Tablets	treprostinil diolamine	0.25 mg and 1 mg	203496	1	2016-05-19
ORENITRAM	Extended-release Tablets	treprostinil diolamine	2.5 mg	203496	1	2015-12-24

US Patents and Regulatory Information for TREPROSTINIL DIOLAMINE

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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	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-005	Oct 7, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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 TREPROSTINIL DIOLAMINE

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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	⤷ Sign Up	⤷ Sign Up
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013	⤷ Sign Up	⤷ Sign Up
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for TREPROSTINIL DIOLAMINE

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Country	Patent Number	Title	Estimated Expiration
South Korea	20140075805	OSMOTIC DRUG DELIVERY SYSTEM COMPRISING RELEASE ENHANCING AGENT	⤷ Sign Up
Japan	2011506599		⤷ Sign Up
Japan	2012162539	COMPOUND AND METHOD FOR DELIVERY OF PROSTACYCLIN ANALOG	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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