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Last Updated: February 22, 2024

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

Treprostinil has one hundred and seventy-nine patent family members in twenty-two countries.

There are nineteen drug master file entries for treprostinil. Six suppliers are listed for this compound. There are two tentative approvals 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
Insmed IncorporatedPhase 2/Phase 3
Mayo ClinicPhase 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 a Trial⤷  Try a Trial0.4MG/MLINJECTABLE;IV (INFUSION), SUBCUTANEOUS
⤷  Try a Trial⤷  Try a Trial0.2MG/MLINJECTABLE;IV (INFUSION), SUBCUTANEOUS
⤷  Try a Trial⤷  Try a Trial0.1MG/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 Strength NDA ANDAs Submitted Submissiondate
TYVASO Inhalation Solution treprostinil 0.6 mg/mL, 2.9 mL ampules 022387 1 2015-04-13
REMODULIN Injection treprostinil 1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial 021272 1 2012-12-07
REMODULIN Injection treprostinil 10 mg/mL, 20 mL vial 021272 1 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 021272-002 May 21, 2002 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-004 Jul 30, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Dr Reddys TREPROSTINIL treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 210214-002 May 22, 2020 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-006 Sep 28, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 021272-004 May 21, 2002 ⤷  Try a Trial ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 ⤷  Try a Trial ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 ⤷  Try a Trial ⤷  Try a Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 ⤷  Try a Trial ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 ⤷  Try a Trial ⤷  Try a Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for treprostinil

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
SciPharm Sàrl Trepulmix treprostinil EMEA/H/C/005207
Treatment of adult patients with WHO Functional Class (FC) III or IV and:inoperable chronic thromboembolic pulmonary hypertension (CTEPH), orpersistent or recurrent CTEPH after surgical treatmentto improve exercise capacity.
Authorised no no yes 2020-04-03
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for treprostinil

Country Patent Number Title Estimated Expiration
European Patent Office 1791542 SELS DE DIKETOPIPERAZINE PERMETTANT L'ADMINISTRATION DE MEDICAMENTS (DIKETOPIPERAZINE SALTS FOR DRUG DELIVERY) ⤷  Try a Trial
Hong Kong 1156551 用於藥物傳遞的包含哌嗪二酮鹽的微粒子 (MICROPARTICLES COMPRISING DIKETOPIPERAZINE SALTS FOR DRUG DELIVERY) ⤷  Try a Trial
China 101647792 Use of treprostinil to treat and prevent ischemic lesions ⤷  Try a Trial
South Korea 101614465 ⤷  Try a Trial
South Korea 20150039211 약물 전달용 디케토피페라진염, 디케토모르포린염 또는 디케토디옥산염 (DIKETOPIPERAZINE SALTS, DIKETOMORPHOLINE SALTS OR DIKETODIOXANE SALTS FOR DRUG DELIVERY) ⤷  Try a Trial
Russian Federation 2012100715 МИКРОЧАСТИЦЫ ДИКЕТОПИПЕРАЗИНА С ОПРЕДЕЛЕННЫМИ УДЕЛЬНЫМИ ПЛОЩАДЯМИ ПОВЕРХНОСТИ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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