Details for New Drug Application (NDA): 021272

✉ Email this page to a colleague

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 nine 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:	9

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;INTRAVENOUS, 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	66302-101	66302-101-01	1 VIAL in 1 BOX (66302-101-01) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS			Strength	1MG/ML
Approval Date:	May 21, 2002	TE:	AP	RLD:	Yes
Patent:	10,076,505	Patent Expiration:	Dec 16, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,695,308	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:	11,723,887	Patent Expiration:	Dec 15, 2028	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 021272

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-001	May 21, 2002	9,199,908	⤷ Subscribe
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-004	May 21, 2002	9,199,908	⤷ Subscribe
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-004	May 21, 2002	10,076,505	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.