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Generated: October 16, 2018

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Treprostinil - Generic Drug Details

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What are the generic drug sources for treprostinil and what is the scope of treprostinil freedom to operate?

Treprostinil is the generic ingredient in four branded drugs marketed by United Therap and Sandoz Inc, and is included in five NDAs. There are twenty-two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for treprostinil. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for treprostinil
Ingredient-typeProstaglandins I
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
Synonyms for treprostinil
((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-[(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
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))-
AKOS027470173
BRD-K19706299-001-01-4
BW 15AU
C23H33O5.Na
CHEBI:50861
CHEMBL1237119
CS-7872
CTK8G3571
D01WUA
D06213
DB00374
EX-A1414
GTPL5820
HMS3648G07
HY-100441
LRX 15
LRX-15
MolPort-027-720-928
Orenitram
PAJMKGZZBBTTOY-ZFORQUDYSA-N
Remodulin
Remodulin (TN)
RP17714
RUM6K67ESG
SCHEMBL4349618
SR-01000946210
SR-01000946210-1
treprost
Treprostinil (JAN/USAN/INN)
Treprostinil (USAN/INN)
Treprostinil [USAN:INN]
Treprostinil pound>>UT-15
Treprostinil sodium
treprostinilo
treprostinilum
Tresprostinil
Trevyent
Tyvaso
U 62840
U-62,840
UNII-RUM6K67ESG
Uniprost
UT-15
Viveta
Y0243
ZINC3800475
Tentative approvals for TREPROSTINIL
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial1MG/MLINJECTABLE;INJECTION

US Patents and Regulatory Information for treprostinil

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 ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 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 203496-004 Dec 20, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-001 Jul 30, 2018 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Baxter
Cerilliant
Queensland Health
US Army
Moodys
Deloitte
Cipla
Federal Trade Commission

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.