Details for New Drug Application (NDA): 203496

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NDA 203496 describes ORENITRAM, which is a drug marketed by United Therap and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ORENITRAM profile page.

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.

Summary for 203496

Tradename:	ORENITRAM
Applicant:	United Therap
Ingredient:	treprostinil diolamine
Patents:	14

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 203496

Generic Entry Date for 203496^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe 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.

Pharmacology for NDA: 203496

Physiological Effect	Vasodilation

Suppliers and Packaging for NDA: 203496

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496	NDA	United Therapeutics Corporation	66302-300	66302-300-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-300-01)
ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496	NDA	United Therapeutics Corporation	66302-300	66302-300-02	1 BLISTER PACK in 1 CARTON (66302-300-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 0.125MG BASE
Approval Date:	Dec 20, 2013	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 18, 2026
Regulatory Exclusivity Use:	INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
Patent:	⤷ Subscribe	Patent Expiration:	Dec 15, 2028	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	Jul 30, 2026	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 203496

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

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