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EFFIENT Drug Profile
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Effient is a drug marketed by Eli Lilly And Co and is included in one NDA.
The generic ingredient in EFFIENT is prasugrel hydrochloride. There are nineteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.
Summary for EFFIENT
Recent Clinical Trials for EFFIENT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Janssen, LP | Phase 4 |
| HonorHealth Research Institute | Phase 2 |
| Boston Scientific Corporation | Phase 2 |
Recent Litigation for EFFIENT
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ELI LILLY AND COMPANY v. ACCORD HEALTHCARE INC., USA | 2014-03-12 |
| ELI LILLY AND COMPANY v. PAR PHARMACEUTICAL COMPANIES, INC. | 2014-01-24 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Lupin, Ltd. | 2015-10-05 |
| Panacea Biotec Ltd. | 2015-06-26 |
| Accord Healthcare Inc., USA | 2015-03-13 |
Pharmacology for EFFIENT
| Drug Class | P2Y12 Platelet Inhibitor |
| Mechanism of Action | P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Synonyms for EFFIENT
| [5-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxidanylidene-ethyl]-6,7-dihydro-4H-thieno[3,2-c]pyridin-2-yl] ethanoate |
| [5-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-6,7-dihydro-4H-thieno[3,2-c]pyridin-2-yl] acetate |
| [5-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-6,7-dihydro-4H-thieno[4,5-c]pyridin-2-yl] acetate |
| 150322-43-3 |
| 2-[2-(Acetyloxy)-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]-1-cyclopropyl-2-(2-fluorophenyl)ethanone |
| 2-Acetoxy-5-(alpha-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c] pyridine |
| 2-acetoxy-5-(alpha-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine |
| 2-Acetoxy-5-(alpha-cyclopropylcarbonyl-2-fluorobenzyl)4,5,6,7-tetrahydrothieno[3,2-c]pyridine |
| 2-acetyloxy-5-(alpha-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine |
| 2-acetyloxy-5-(alpha-cycloproylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-C]pyridine |
| 322P433 |
| 5-(2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate |
| 5-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate |
| 5-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4H,5H,6H,7H-thieno[3,2-c]pyridin-2-yl acetate |
| A809033 |
| AB0005241 |
| AB01274761_02 |
| AB01274761-01 |
| AB1008453 |
| ABP000379 |
| AC-1640 |
| acetic acid [5-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-6,7-dihydro-4H-thieno[3,2-c]pyridin-2-yl] ester |
| Acetic acid 5-[2-cyclopropyl-1-(2-fluoro-phenyl)-2-oxo-ethyl]-4,5,6,7-tetrahydro-thieno[3,2-c]pyridin-2-yl ester |
| ACN-040194 |
| ACT06208 |
| AK327587 |
| AKOS015841187 |
| AM20090728 |
| API0003912 |
| AR-270/43507998 |
| BCP01882 |
| C-58278 |
| CHEBI:87723 |
| CHEMBL1201772 |
| CP0097 |
| CS 747 |
| CS-0657 |
| CS-747 |
| DB06209 |
| DTGLZDAWLRGWQN-UHFFFAOYSA-N |
| Efient |
| EN002851 |
| ETH051 |
| Ethanone, 2-(2-(acetyloxy)-6,7-dihydrothieno(3,2-c)pyridin-5(4H)-yl)-1-cyclopropyl-2-(2-fluorophenyl)- |
| Ethanone, 2-[2-(acetyloxy)-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]-1-cyclopropyl-2-(2-fluorophenyl)- |
| FD7194 |
| FT-0650150 |
| GTPL7562 |
| HMS3604B09 |
| HMS3654D09 |
| HSDB 7995 |
| HY-15284 |
| KS-00000XJY |
| KS-5301 |
| LY-640315 |
| LY640315 |
| MCULE-1302242257 |
| MLS003882595 |
| MLS006012001 |
| NCGC00188690-01 |
| NCGC00188690-02 |
| P2040 |
| PB23765 |
| Prasita |
| Prasugrel |
| Prasugrel (Effient) |
| Prasugrel [INN:BAN] |
| Prasugrel, >=98% (HPLC) |
| prasugrel, 2-[2-(Acetyloxy)-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]-1-cyclopropyl-2-(2-fluorophenyl)ethanone |
| Prasugrel, 98% |
| Prasugrel/Effient |
| PubChem19523 |
| Q-101872 |
| Q-1607 |
| Q416232 |
| s1258 |
| SB20805 |
| SC-20714 |
| SCHEMBL14112007 |
| SCHEMBL245032 |
| SMR002533665 |
| STL232602 |
| SW219175-1 |
| W0064 |
| ZB0747 |
| ZLA0001 |
| zlchem 1 |
Paragraph IV (Patent) Challenges for EFFIENT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| EFFIENT | TABLET;ORAL | prasugrel hydrochloride | 022307 | 2013-07-10 |
US Patents and Regulatory Information for EFFIENT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eli Lilly And Co | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-001 | Jul 10, 2009 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Eli Lilly And Co | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | AB | RX | Yes | Yes | 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 EFFIENT
| 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 |
International Patents for EFFIENT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 9205160 | Start Trial |
| Norway | 923484 | Start Trial |
| Hungary | 0400644 | Start Trial |
| Czech Republic | 9202784 | Start Trial |
| Germany | 122009000045 | Start Trial |
| Spain | 2122984 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EFFIENT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0542411 | SPC021/2009 | Ireland | Start Trial | SPC021/2009: 20091119, EXPIRES: 20170908 |
| 0542411 | C300397 | Netherlands | Start Trial | PRODUCT NAME: PRASUGREL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/08/503/001-014 20090225 |
| 0542411 | C00542411/01 | Switzerland | Start Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 0542411 | CA 2009 00024 | Denmark | Start Trial | |
| 0542411 | SPC/GB09/032 | United Kingdom | Start Trial | PRODUCT NAME: PRASUGREL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/08/503/001 20090225; UK EU/1/08/503/002 20090225; UK EU/1/08/503/003 20090225; UK EU/1/08/503/004 20090225 |
| 0542411 | 300397 | Netherlands | Start Trial | 300397, 20120909, EXPIRES: 20170908 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
