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ORENITRAM Drug Patent Profile

Which patents cover Orenitram, and when can generic versions of Orenitram launch?

Orenitram is a drug marketed by United Therap and is included in one NDA. There are fourteen patents protecting this drug and three Paragraph IV challenges.

This drug has fifty-nine patent family members in eight countries.

The generic ingredient in ORENITRAM is treprostinil diolamine. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the treprostinil diolamine profile page.

DrugPatentWatch^® Generic Entry Outlook for Orenitram

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 11, 2031. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ORENITRAM

International Patents:	59
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	7
Patent Applications:	73
Drug Prices:	Drug price information for ORENITRAM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ORENITRAM
What excipients (inactive ingredients) are in ORENITRAM?	ORENITRAM excipients list
DailyMed Link:	ORENITRAM at DailyMed

See drug prices for ORENITRAM

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

NDA:

203496

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 ORENITRAM

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

Sponsor	Phase
Lung Biotechnology PBC	Phase 4
United Therapeutics	Phase 4
Bial - Portela C S.A.	Phase 1

See all ORENITRAM clinical trials

Pharmacology for ORENITRAM

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Paragraph IV (Patent) Challenges for ORENITRAM

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 ORENITRAM

ORENITRAM is protected by fifteen US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ORENITRAM

FDA Regulatory Exclusivity protecting ORENITRAM

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				Y
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
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	203496-003	Dec 20, 2013		RX	Yes	Yes				Y

Expired US Patents for ORENITRAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	203496-002	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	203496-005	Oct 7, 2016
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013

International Patents for ORENITRAM

When does loss-of-exclusivity occur for ORENITRAM?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Austria

Canada

China

European Patent Office

Japan

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ORENITRAM around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2198760
Denmark	299089
World Intellectual Property Organization (WIPO)	2005007081
China	1264819
European Patent Office	2427054	COMPOSITIONS SOLIDES À BASE D'ANALOGUES DE PROSTACYCLINE (SOLID FORMULATIONS OF PROSTACYCLIN ANALOGS)
European Patent Office	2252570	PROCEDE AMELIORE DE PREPARATION DE TREPROSTINIL, L'INGREDIENT ACTIF DANS LE REMODULIN ® (AN IMPROVED PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN REMODULIN ®)