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Last Updated: November 24, 2024

TREPROSTINIL Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Treprostinil

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

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Drug patent expirations by year for TREPROSTINIL
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Recent Clinical Trials for TREPROSTINIL

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SponsorPhase
Insmed IncorporatedPhase 2/Phase 3
Mayo ClinicPhase 2
Ohio State UniversityPhase 2

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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
Alembic Global TREPROSTINIL treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 211574-001 Feb 11, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa TREPROSTINIL treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 206648-002 Sep 26, 2019 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys TREPROSTINIL treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 210214-003 May 22, 2020 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic Global TREPROSTINIL treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 211574-004 Feb 11, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Operations TREPROSTINIL treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 209382-004 Sep 24, 2019 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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

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