EFFIENT Drug Patent Profile
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Which patents cover Effient, and what generic alternatives are available?
Effient is a drug marketed by Cosette and is included in one NDA.
The generic ingredient in EFFIENT is prasugrel hydrochloride. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Effient
A generic version of EFFIENT was approved as prasugrel hydrochloride by UNICHEM on August 28th, 2023.
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Summary for EFFIENT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 129 |
| Clinical Trials: | 51 |
| Patent Applications: | 1,363 |
| 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 |
|---|---|
| International St. Mary's Hospital | Phase 4 |
| Bucheon St. Mary's Hospital | Phase 4 |
| Yonsei University | 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 | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| EFFIENT | Tablets | prasugrel hydrochloride | 5 mg and 10 mg | 022307 | 17 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-001 | Jul 10, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 |
|---|---|---|---|---|---|---|---|
| Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-001 | Jul 10, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-001 | Jul 10, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-001 | Jul 10, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EFFIENT
See the table below for patents covering EFFIENT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Czech Republic | 200318 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 02051412 | ⤷ Sign Up | |
| Portugal | 1728794 | ⤷ Sign Up | |
| Czech Republic | 287181 | Tetrahydrothienopyridinové deriváty, jejich furo a pyrroloanalogy a jejich příprava a použití pro inhibici agregace krevních destiček (Tetrahydrothienopyridine derivatives, their furo and pyrrolo analogs, process of their preparation and pharmaceutical preparation) | ⤷ Sign Up |
| Hong Kong | 1096684 | ⤷ Sign Up | |
| Israel | 153546 | HYDROCHLORIDE AND MALEATE SALTS OF 2 - ACETOXY - 5 - (?? - CYCLOPROPYL - 2 - FLUOROBENZYL) - 4,5,6,7 - TETRAHYDRO - THIENO [3,2 - c] PYRIDINE, THEIR PREPARATION AND MEDICAMENTS CONTAINING THEM | ⤷ Sign Up |
| Czech Republic | 9202784 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EFFIENT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0542411 | C300397 | Netherlands | ⤷ Sign Up | PRODUCT NAME: PRASUGREL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/08/503/001-014 20090225 |
| 0542411 | SPC021/2009 | Ireland | ⤷ Sign Up | SPC021/2009: 20091119, EXPIRES: 20170908 |
| 0542411 | C00542411/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 0542411 | 09C0031 | France | ⤷ Sign Up | PRODUCT NAME: PRASUGREL; NAT. REGISTRATION NO/DATE: EU/1/08/503/001-014 20090225; FIRST REGISTRATION: EU/1/08/503/001/-014 20090225 |
| 0542411 | 91589 | Luxembourg | ⤷ Sign Up | 91589, EXPIRES: 20170909 |
| 0542411 | 300397 | Netherlands | ⤷ Sign Up | 300397, 20120909, EXPIRES: 20170908 |
| 0542411 | SPC/GB09/032 | United Kingdom | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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.
ISSN: 2162-2639
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