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Last Updated: December 6, 2019

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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-eight patent family members in eight countries.

There are nineteen 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
United TherapeuticsPhase 2
Stanford UniversityPhase 2
United TherapeuticsPhase 1

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Recent Litigation for treprostinil diolamine

Identify potential future generic entrants

District Court Litigation
Case NameDate
Supernus Pharmaceuticals, Inc. v. Lee2016-03-28
UNITED THERAPEUTICS CORPORATION v. WATSON LABORATORIES, INC.2015-07-22
UNITED THERAPEUTICS CORPORATION v. TEVA PHARMACEUTICALS USA, INC.2014-09-02

See all treprostinil diolamine litigation

PTAB Litigation
PetitionerDate
SteadyMed Ltd.2015-10-02

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Pharmacology for treprostinil diolamine
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
Synonyms for treprostinil diolamine
2-(((1R,2R,3aS,9aS)-2-hydroxy-1-((S)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl)oxy)acetic acid diethanolamine salt
2-((1R,2R,3aS,9aS)-2-Hydroxy-1-(3(S)-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta(b)naphthalen-5-yloxy)acetic acid diethanolamine salt
830354-48-8
Acetic acid, 2-(((1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-((3S)-3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)-, compd. with 2,2'-iminobis(ethanol) (1:1)
AKOS030524397
CHEMBL2107815
D10430
DTXSID50232132
EX-A1418
H1FKG90039
Orenitram
RHWRWEUCEXUUAV-ZSESPEEFSA-N
SCHEMBL17222566
Treprostinil diethanolamine
Treprostinil diolamine (USAN)
Treprostinil diolamine [USAN]
UNII-H1FKG90039
UT-15C
Paragraph IV (Patent) Challenges for TREPROSTINIL DIOLAMINE
Tradename Dosage Ingredient NDA Submissiondate
ORENITRAM TABLET, EXTENDED RELEASE;ORAL treprostinil diolamine 203496 2016-05-19

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   Start Trial   Start Trial Y   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-005 Oct 7, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 RX Yes No   Start Trial   Start Trial Y   Start 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 203496-002 Dec 20, 2013   Start Trial   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013   Start Trial   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-005 Oct 7, 2016   Start Trial   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013   Start Trial   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013   Start Trial   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013   Start Trial   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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