Details for New Drug Application (NDA): 208276

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NDA 208276 describes REMODULIN, which is a drug marketed by United Therap and is included in two NDAs. It is available from one supplier. There are five patents protecting this drug and two Paragraph IV challenges. Additional details are available on the REMODULIN profile page.

The generic ingredient in REMODULIN is treprostinil. There are nineteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the treprostinil profile page.

Summary for 208276

Tradename:	REMODULIN
Applicant:	United Therap
Ingredient:	treprostinil
Patents:	1

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS, SUBCUTANEOUS			Strength	20MG/20ML (1MG/ML)
Approval Date:	Jul 30, 2018	TE:		RLD:	No
Patent:	9,593,066	Patent Expiration:	Dec 15, 2028	Product Flag?		Substance Flag?	Y	Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS, SUBCUTANEOUS			Strength	50MG/20ML (2.5MG/ML)
Approval Date:	Jul 30, 2018	TE:		RLD:	No
Patent:	9,593,066	Patent Expiration:	Dec 15, 2028	Product Flag?		Substance Flag?	Y	Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS, SUBCUTANEOUS			Strength	100MG/20ML (5MG/ML)
Approval Date:	Jul 30, 2018	TE:		RLD:	No
Patent:	9,593,066	Patent Expiration:	Dec 15, 2028	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 208276

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-004	Jul 30, 2018	9,713,599	⤷ Get Started Free
United Therap	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-001	Jul 30, 2018	10,076,505	⤷ Get Started Free
United Therap	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-003	Jul 30, 2018	10,076,505	⤷ Get Started Free
United Therap	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-003	Jul 30, 2018	9,713,599	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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