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Generated: August 19, 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 treprostinil diolamine 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.

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

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 203496-004 Dec 20, 2013 RX Yes No   Try a Free Trial   Try a Free Trial Y   Try a Free Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-005 Oct 7, 2016 RX Yes No   Try a Free Trial   Try a Free Trial Y   Try a Free Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes No   Try a Free Trial   Try a Free Trial Y   Try a Free Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes Yes   Try a Free Trial   Try a Free Trial   Try a Free Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes No   Try a Free Trial   Try a Free Trial Y Y   Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 203496-004 Dec 20, 2013   Try a Free Trial   Try a Free Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013   Try a Free Trial   Try a Free Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013   Try a Free Trial   Try a Free Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013   Try a Free Trial   Try a Free Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013   Try a Free Trial   Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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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 verifification 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.