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EFFIENT Drug Profile
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Which patents cover Effient, and what generic alternatives are available?
Effient is a drug marketed by Daiichi Sankyo Inc and is included in one NDA.
The generic ingredient in EFFIENT is prasugrel hydrochloride. There are nineteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.
Summary for EFFIENT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 110 |
| Clinical Trials: | 48 |
| Patent Applications: | 2,269 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EFFIENT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EFFIENT |
| What excipients (inactive ingredients) are in EFFIENT? | EFFIENT excipients list |
| DailyMed Link: | EFFIENT at DailyMed |
Recent Clinical Trials for EFFIENT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Gyeongsang National University Hospital | Phase 4 |
| U&I Corporation | Phase 4 |
| Janssen, LP | Phase 4 |
Pharmacology for EFFIENT
| Drug Class | P2Y12 Platelet Inhibitor |
| Mechanism of Action | P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Daiichi Sankyo Inc | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-001 | Jul 10, 2009 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Daiichi Sankyo Inc | 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 |
|---|---|---|---|---|---|---|---|
| Daiichi Sankyo Inc | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-001 | Jul 10, 2009 | Start Trial | Start Trial |
| Daiichi Sankyo Inc | 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 |
|---|---|---|
| South Africa | 200304878 | Start Trial |
| Hong Kong | 1011017 | Start Trial |
| Czech Republic | 287181 | Start Trial |
| Portugal | 1350511 | Start Trial |
| China | 100341506 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EFFIENT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 300397 | Netherlands | Start Trial | 300397, 20120909, EXPIRES: 20170908 |
| 0542411 | CA 2009 00024 | Denmark | Start Trial | |
| 0542411 | 09C0031 | France | Start Trial | PRODUCT NAME: PRASUGREL; NAT. REGISTRATION NO/DATE: EU/1/08/503/001-014 20090225; FIRST REGISTRATION: EU/1/08/503/001/-014 20090225 |
| 0542411 | C00542411/01 | Switzerland | Start Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
