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Last Updated: August 7, 2020

DrugPatentWatch Database Preview

Treprostinil - Generic Drug Details

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What are the generic sources for treprostinil and what is the scope of patent protection?

Treprostinil is the generic ingredient in four branded drugs marketed by United Therap, Dr Reddys, Par Sterile Products, Sandoz Inc, and Teva Pharms Usa, and is included in eight NDAs. There are twenty-two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Treprostinil has seventy-four patent family members in nine countries.

There are nineteen drug master file entries for treprostinil. Five suppliers are listed for this compound.

Drug Prices for treprostinil

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Recent Clinical Trials for treprostinil

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SponsorPhase
Huilan ZhangPhase 3
United TherapeuticsPhase 1/Phase 2
University of Rhode IslandPhase 1/Phase 2

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Pharmacology for treprostinil
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
Paragraph IV (Patent) Challenges for TREPROSTINIL
Tradename Dosage Ingredient NDA Submissiondate
TYVASO SOLUTION;INHALATION treprostinil 022387 2015-04-13
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 treprostinil

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 208276-001 Jul 30, 2018 RX No No   Start Trial   Start Trial Y   Start Trial
Par Sterile Products TREPROSTINIL treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 209382-002 Sep 24, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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 treprostinil

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   Start Trial   Start Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002   Start Trial   Start Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009   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:

Harvard Business School
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Baxter
Johnson and Johnson
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Medtronic

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