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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
US Department of Justice
Chubb
Harvard Business School
AstraZeneca
Merck
QuintilesIMS
Farmers Insurance
Moodys

Generated: June 21, 2018

DrugPatentWatch Database Preview

ORENITRAM Drug Profile

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Which patents cover Orenitram, and what generic alternatives are available?

Orenitram is a drug marketed by United Therap and is included in one NDA. There are thirteen patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-six patent family members in eight countries.

The generic ingredient in ORENITRAM is treprostinil diolamine. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the treprostinil diolamine profile page.
Drug patent expirations by year for ORENITRAM
Pharmacology for ORENITRAM
Ingredient-typeProstaglandins I
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
Synonyms for ORENITRAM
((1R,2R,3aS,9aS)-2-hydroxy-1-((3S)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cylopent(b)naphthalen-5-yl)oxy)acetate
({(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl}oxy)acetic acid
(1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy- 1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl] oxy]acetic acid
[[(1R,2R,3aS,9aS)-2-Hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphtalen-5-yl]oxy]acetic acid
[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-Hexahydro-2-hydroxy-1-[(S)-3-hydroxyoctyl]-1H-benzo[f]indene-5-yl]oxy]acetic acid
[[(1R,2R,3aS,9aS)-2,3,4,9,9a-Hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid
[1R-[1|A(S*),2|A,3a|A,9a|A]]-[[2,3,3a,4,9,9a-| section signexahydro-2-hydroxy-1-(3-hydroxyoctyl)-1H-benz[f]inden-5-yl]oxy]acetic Acid
15 AU81
15AU
15AU81
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
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
2-[[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a
2-[[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[g]naphthalen-5-yl]oxy]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]acetic Acid
2-[[(2R,3R,3aS,9aS)-2-hydroxy-3-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[g]naphthalen-8-yl]oxy]acetic acid
2-{[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H,2H,3H,3aH,4H,9H,9aH-cyclopenta[b]naphthalen-5-yl]oxy}acetic acid
2025AH
289480-64-4
289480-64-4 (Sodium salt)
81846-19-7
830354-48-8
AC1OCF2J
Acetic acid, (((1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-((3S)-3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)-
Acetic acid, ((2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-(3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)-, (1R-(1alpha(S*),2beta,3aalpha,9aalpha))-
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)
AKOS027470173
AKOS030524397
BRD-K19706299-001-01-4
BW 15AU
C23H33O5.Na
CHEBI:50861
CHEMBL1237119
CHEMBL2107815
CS-7872
CTK8G3571
D01WUA
D06213
D10430
DB00374
DTXSID50232132
EX-A1414
EX-A1418
GTPL5820
H1FKG90039
HMS3648G07
HY-100441
LRX 15
LRX-15
MolPort-027-720-928
PAJMKGZZBBTTOY-ZFORQUDYSA-N
Remodulin
Remodulin (TN)
RHWRWEUCEXUUAV-ZSESPEEFSA-N
RP17714
RUM6K67ESG
SCHEMBL17222566
SCHEMBL4349618
SR-01000946210
SR-01000946210-1
treprost
Treprostinil
Treprostinil (JAN/USAN/INN)
Treprostinil (USAN/INN)
Treprostinil [USAN:INN]
Treprostinil diethanolamine
TREPROSTINIL DIOLAMINE
Treprostinil diolamine (USAN)
Treprostinil diolamine [USAN]
Treprostinil pound>>UT-15
Treprostinil sodium
treprostinilo
treprostinilum
Tresprostinil
Trevyent
Tyvaso
U 62840
U-62,840
UNII-H1FKG90039
UNII-RUM6K67ESG
Uniprost
UT-15
UT-15C
Viveta
Y0243
ZINC3800475

US Patents and Regulatory Information for ORENITRAM

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 203496-005 Oct 7, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 ORENITRAM

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

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Paragraph IV (Patent) Challenges for ORENITRAM
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 0.25 mg and 1 mg ➤ Subscribe 2016-05-19
➤ Subscribe Extended-release Tablets 2.5 mg ➤ Subscribe 2015-12-24

Non-Orange Book US Patents for ORENITRAM

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,199,908 Compounds and methods for delivery of prostacyclin analogs ➤ Sign Up
9,878,972 Compounds and methods for delivery of prostacyclin analogs ➤ Sign Up
7,384,978 Compounds and methods for delivery of prostacyclin analogs ➤ Sign Up
9,624,156 Compounds and methods for delivery of prostacyclin analogs ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Deloitte
Citi
McKinsey
Teva
Daiichi Sankyo
Chubb
Farmers Insurance

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