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Last Updated: February 28, 2024

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 fourteen 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.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for treprostinil diolamine
Generic Entry Date for treprostinil diolamine*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for treprostinil diolamine

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

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

See all treprostinil diolamine clinical trials

Pharmacology for treprostinil diolamine
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
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 203496-003 Dec 20, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-005 Oct 7, 2016 RX Yes No ⤷  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 Y 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 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 Y ⤷  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 diolamine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-005 Oct 7, 2016 ⤷  Try a Trial ⤷  Try a Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 ⤷  Try a Trial ⤷  Try a Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 ⤷  Try a Trial ⤷  Try a Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 ⤷  Try a Trial ⤷  Try a Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 ⤷  Try a Trial ⤷  Try a Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for treprostinil diolamine

Country Patent Number Title Estimated Expiration
Spain 2377387 ⤷  Try a Trial
Japan 5043433 ⤷  Try a Trial
Japan 5851691 ⤷  Try a Trial
Japan 2013139468 OSMOTIC PRESSURE DRUG DELIVERY SYSTEM ⤷  Try a Trial
South Korea 20100105852 AN IMPROVED PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN REMODULIN® ⤷  Try a Trial
Japan 6242371 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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