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Last Updated: October 25, 2021

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Treprostinil - Generic Drug Details

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What are the generic drug sources for treprostinil and what is the scope of freedom to operate?

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

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

There are nineteen drug master file entries for treprostinil. Five suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for treprostinil

See drug prices for treprostinil

Recent Clinical Trials for treprostinil

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

SponsorPhase
Ohio State UniversityPhase 2
Mardi Gomberg -MaitlandPhase 2
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Phase 2

See all treprostinil clinical trials

Generic filers with tentative approvals for TREPROSTINIL
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free20MG/MLINJECTABLE;IV (INFUSION), SUBCUTANEOUS
⤷  Try it Free⤷  Try it Free10MG/MLINJECTABLE;IV (INFUSION), SUBCUTANEOUS
⤷  Try it Free⤷  Try it Free5MG/MLINJECTABLE;IV (INFUSION), SUBCUTANEOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 AP RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 RX Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-005 Oct 7, 2016 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-004 Jul 30, 2018 DISCN No No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 AP RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 021272-002 May 21, 2002 ⤷  Try it Free ⤷  Try it Free
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 ⤷  Try it Free ⤷  Try it Free
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 ⤷  Try it Free ⤷  Try it Free
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 ⤷  Try it Free ⤷  Try it Free
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 ⤷  Try it Free ⤷  Try it Free
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 ⤷  Try it Free ⤷  Try it Free
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Dow
Merck
Moodys
Boehringer Ingelheim

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