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Last Updated: June 24, 2021

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REMODULIN Drug Profile


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When do Remodulin patents expire, and what generic alternatives are available?

Remodulin is a drug marketed by United Therap and is included in two NDAs. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-three patent family members in nine countries.

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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Remodulin

A generic version of REMODULIN was approved as treprostinil by SANDOZ INC on November 30th, 2017.

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Drug patent expirations by year for REMODULIN
Drug Prices for REMODULIN

See drug prices for REMODULIN

Recent Clinical Trials for REMODULIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Rhode Island HospitalPhase 1/Phase 2
United TherapeuticsPhase 1/Phase 2
University of Rhode IslandPhase 1/Phase 2

See all REMODULIN clinical trials

Pharmacology for REMODULIN
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
Paragraph IV (Patent) Challenges for REMODULIN
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

US Patents and Regulatory Information for REMODULIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-002 Jul 30, 2018 RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 AP RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-004 Jul 30, 2018 RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-003 Jul 30, 2018 RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-004 Jul 30, 2018 RX No No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 AP RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for REMODULIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002   Try Before You Buy   Try Before You Buy
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002   Try Before You Buy   Try Before You Buy
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002   Try Before You Buy   Try Before You Buy
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002   Try Before You Buy   Try Before You Buy
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002   Try Before You Buy   Try Before You Buy
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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