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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

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 eight 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 021272
Tradename:REMODULIN
Applicant:United Therap
Ingredient:treprostinil
Patents:8
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
Paragraph IV (Patent) Challenges for 021272
Tradename Dosage Ingredient NDA Submissiondate
REMODULIN INJECTABLE;IV (INFUSION), SUBCUTANEOUS treprostinil 021272 2012-12-07
REMODULIN INJECTABLE;IV (INFUSION), SUBCUTANEOUS treprostinil 021272 2011-12-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION), SUBCUTANEOUSStrength1MG/ML
Approval Date:May 21, 2002TE:APRLD:Yes
Patent:  Start TrialPatent Expiration:Dec 16, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 29, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
Patent:  Start TrialPatent Expiration:Sep 5, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION

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 021272-002 May 21, 2002   Start Trial   Start Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002   Start Trial   Start Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002   Start Trial   Start Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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