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Last Updated: January 30, 2023

Treprostinil diolamine - Generic Drug Details


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

Treprostinil diolamine is the generic ingredient in one branded drug marketed by United Therap and is included in one NDA. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Treprostinil diolamine has fifty-nine patent family members in eight countries.

There are two drug master file entries for treprostinil diolamine. One supplier is listed for this compound.

Recent Clinical Trials for treprostinil diolamine

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

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

See all treprostinil diolamine clinical trials

Pharmacology for treprostinil diolamine
Drug ClassProstacycline Vasodilator
Physiological Effect Vasodilation
Paragraph IV (Patent) Challenges for TREPROSTINIL DIOLAMINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ORENITRAM Extended-release Tablets treprostinil diolamine 0.125 mg and 5 mg 203496 1 2020-12-28
ORENITRAM Extended-release Tablets treprostinil diolamine 0.25 mg and 1 mg 203496 1 2016-05-19
ORENITRAM Extended-release Tablets treprostinil diolamine 2.5 mg 203496 1 2015-12-24

US Patents and Regulatory Information for treprostinil diolamine

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 203496-002 Dec 20, 2013 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 RX Yes No See Plans and Pricing See Plans and Pricing Y Y 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 Y See Plans and Pricing
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
>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 diolamine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 See Plans and Pricing See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 See Plans and Pricing See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-005 Oct 7, 2016 See Plans and Pricing See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Mallinckrodt
Express Scripts
Harvard Business School
McKesson

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.