EFFIENT Drug Patent Profile
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Which patents cover Effient, and when can generic versions of Effient launch?
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.
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: | 103 |
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 |
---|---|
Bucheon St. Mary's Hospital | Phase 4 |
Yonsei University | Phase 4 |
Gangnam Severance Hospital | Phase 4 |
Pharmacology for EFFIENT
Drug Class | P2Y12 Platelet Inhibitor |
Mechanism of Action | P2Y12 Receptor Antagonists |
Physiological Effect | Decreased Platelet Aggregation |
Anatomical Therapeutic Chemical (ATC) Classes for EFFIENT
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 |
---|---|---|---|---|---|---|---|
Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-001 | Jul 10, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
European Patent Office | 0542411 | DERIVES DE TETRAHYDROTHIENO-, FURO ET PYRROLOPYRIDINE, LEUR PREPARATION ET LEUR UTILISATION COMME INHIBITEURS DE L'AGREGATION DES PLAQUETTES SANGUINES (TETRAHYDROTHIENOPYRIDINE DERIVATIVES, FURO AND PYRROLO ANALOGS THEREOF AND THEIR PREPARATION AND USES FOR INHIBITING BLOOD PLATELET AGGREGATION) | ⤷ Try a Trial |
Taiwan | I293249 | ⤷ Try a Trial | |
Canada | 2432644 | COMPOSITION PHARMACEUTIQUE COMPORTANT DE L'ASPIRINEMC ET DU CS-747 (PHARMACEUTICAL COMPOSITION COMPRISING ASPIRINTM AND CS-747) | ⤷ Try a Trial |
Finland | 924002 | ⤷ Try a Trial | |
Czech Republic | 9202784 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EFFIENT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0542411 | SPC021/2009 | Ireland | ⤷ Try a Trial | SPC021/2009: 20091119, EXPIRES: 20170908 |
0542411 | C300397 | Netherlands | ⤷ Try a 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 | ⤷ Try a Trial | 300397, 20120909, EXPIRES: 20170908 |
0542411 | 09C0031 | France | ⤷ Try a 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 | CA 2009 00024 | Denmark | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |