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Last Updated: October 31, 2024

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 EffectVasodilation
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:RXDosage:INJECTABLE;IV (INFUSION), SUBCUTANEOUSStrength1MG/ML
Approval Date:May 21, 2002TE:APRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Dec 16, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Dec 16, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
Patent:⤷  Sign UpPatent Expiration:Dec 15, 2028Product Flag?Substance Flag?YDelist Request?

Expired US Patents for NDA 021272

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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