Details for New Drug Application (NDA): 021272

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NDA 021272 describes REMODULIN, which is a drug marketed by United Therap and is included in two NDAs. It is available from one supplier. There are ten 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. Six suppliers are listed for this compound. Additional details are available on the treprostinil profile page.

Summary for 021272

Tradename:	REMODULIN
Applicant:	United Therap
Ingredient:	treprostinil
Patents:	10

Pharmacology for NDA: 021272

Physiological Effect	Vasodilation

Suppliers and Packaging for NDA: 021272

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272	NDA	United Therapeutics Corporation	66302-101	66302-101-01	1 VIAL in 1 BOX (66302-101-01) / 20 mL in 1 VIAL
REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272	NDA	United Therapeutics Corporation	66302-102	66302-102-01	1 VIAL in 1 BOX (66302-102-01) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;IV (INFUSION), SUBCUTANEOUS			Strength	1MG/ML
Approval Date:	May 21, 2002	TE:	AP	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 16, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Dec 16, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
Patent:	⤷ Sign Up	Patent Expiration:	Dec 15, 2028	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 021272

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-003	May 21, 2002	⤷ Sign Up	⤷ Sign Up
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-006	Sep 28, 2023	⤷ Sign Up	⤷ Sign Up
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-002	May 21, 2002	⤷ Sign Up	⤷ Sign Up
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-008	Sep 28, 2023	⤷ Sign Up	⤷ Sign Up
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-002	May 21, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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