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Last Updated: January 30, 2023

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 Inc, and Teva Pharms Usa, and is included in ten NDAs. There are twenty-seven 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-two patent family members in twenty-two 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
Mayo ClinicPhase 2
Ohio State UniversityPhase 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
See Plans and PricingSee Plans and Pricing20MG/MLINJECTABLE;IV (INFUSION), SUBCUTANEOUS
See Plans and PricingSee Plans and Pricing10MG/MLINJECTABLE;IV (INFUSION), SUBCUTANEOUS
See Plans and PricingSee Plans and Pricing5MG/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 Effect Vasodilation
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 ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 021272-001 May 21, 2002 See Plans and Pricing See Plans and Pricing
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 See Plans and Pricing See Plans and Pricing
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 See Plans and Pricing See Plans and Pricing
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 See Plans and Pricing See Plans and Pricing
>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
World Intellectual Property Organization (WIPO) 2009033039 See Plans and Pricing
Japan 5859433 See Plans and Pricing
South Korea 102246914 See Plans and Pricing
Australia 2005277041 Diketopiperazine salts, diketomorpholine salts or diketodioxane salts for drug delivery See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Dow
Merck
Moodys
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.