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Last Updated: January 25, 2020

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Prasugrel hydrochloride - Generic Drug Details

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What are the generic drug sources for prasugrel hydrochloride and what is the scope of patent protection?

Prasugrel hydrochloride is the generic ingredient in two branded drugs marketed by Eli Lilly And Co, Accord Hlthcare, Amneal Pharms, Aurobindo Pharma Ltd, Hec Pharm, Mylan, Panacea Biotec Ltd, and Uspharma Windlas, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for prasugrel hydrochloride. Twelve suppliers are listed for this compound.

Recent Clinical Trials for prasugrel hydrochloride

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

SponsorPhase
AdvicePharma GroupPhase 4
Federico II UniversityPhase 4
Kyle MarkelPhase 3

See all prasugrel hydrochloride clinical trials

Recent Litigation for prasugrel hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
ELI LILLY AND COMPANY v. ACCORD HEALTHCARE INC., USA2014-03-12
ELI LILLY AND COMPANY v. PAR PHARMACEUTICAL COMPANIES, INC.2014-01-24

See all prasugrel hydrochloride litigation

PTAB Litigation
PetitionerDate
Lupin, Ltd.2015-10-05
Panacea Biotec Ltd.2015-06-26
Accord Healthcare Inc., USA2015-03-13

See all prasugrel hydrochloride litigation

Pharmacology for prasugrel hydrochloride
Medical Subject Heading (MeSH) Categories for prasugrel hydrochloride
Synonyms for prasugrel hydrochloride
[5-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxo-ethyl]-6,7-dihydro-4H-thieno[3,2-c]pyridin-2-yl] acetate hydrochloride
[5-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-6,7-dihydro-4H-thieno[3,2-c]pyridin-2-yl] acetate,hydrochloride
[5-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-6,7-dihydro-4H-thieno[3,2-c]pyridin-2-yl] acetate;hydrochloride
2-[2-(Acetyloxy)-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]-1-cyclopropyl-2-(2-fluorophenyl)ethanone Hydrochloride
2-Acetoxy-5-(alpha-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine hydrochloride
389574-19-0
5-((1RS)-2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl)-4,5,6,7-tetrahydrothieno(3,2-c)pyridin-2-yl acetate hydrochloride
5-(2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride
574C190
AB0009955
AC-24004
ACM389574190
AKOS022185568
AM20090719
AN-6869
AS-35081
BCP16928
CAS-389574-19-0
CHEMBL1201773
CP0133
CS-1785
CTK8E7134
D05597
DSSTox_CID_28993
DSSTox_GSID_49067
DSSTox_RID_83258
DTXSID1049067
EBD36213
Effient (TN)
Effient hydrochloride
Ethanone, 2-(2-(acetyloxy)-6,7-dihydrothieno(3,2-c)pyridin-5(4H)-yl)-1-cyclopropyl-2-(2-fluorophenyl)-, hydrochloride
Ethanone, 2-[2-(acetyloxy)-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]-1-cyclopropyl-2-(2-fluorophenyl)-, hydrochloride (1:1)
EX-A2645
FT-0656362
HY-15284A
JALHGCPDPSNJNY-UHFFFAOYSA-N
LY 640315
MolPort-006-170-137
NCGC00188690-01
NCGC00188690-02
Prasugrel (hydrochloride)
Prasugrel HCl
Prasugrel hydrochloride (JAN/USAN)
Prasugrel Hydrochloride [USAN]
Prasugrel Hydrochloride(Discontinued)
Prasugren hydrochloride
PubChem23807
RT-015128
s4637
SC-20618
SCHEMBL246128
Tox21_113621
Tox21_113621_1
Paragraph IV (Patent) Challenges for PRASUGREL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
EFFIENT TABLET;ORAL prasugrel hydrochloride 022307 2013-07-10

US Patents and Regulatory Information for prasugrel hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare PRASUGREL prasugrel hydrochloride TABLET;ORAL 205987-001 Feb 2, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Hec Pharm PRASUGREL prasugrel hydrochloride TABLET;ORAL 206021-001 Jan 16, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Eli Lilly And Co EFFIENT prasugrel hydrochloride TABLET;ORAL 022307-001 Jul 10, 2009 AB RX Yes No   Start Trial   Start Trial   Start Trial
Amneal Pharms PRASUGREL prasugrel hydrochloride TABLET;ORAL 205913-002 Jun 19, 2018 AB RX No No   Start Trial   Start Trial   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 prasugrel hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eli Lilly And Co EFFIENT prasugrel hydrochloride TABLET;ORAL 022307-001 Jul 10, 2009   Start Trial   Start Trial
Eli Lilly And Co EFFIENT prasugrel hydrochloride TABLET;ORAL 022307-002 Jul 10, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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