PRASUGREL Drug Patent Profile
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Which patents cover Prasugrel, and when can generic versions of Prasugrel launch?
Prasugrel is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Hec Pharm, Mylan, Panacea, and Lupin Ltd. and is included in nine NDAs.
The generic ingredient in PRASUGREL is prasugrel. There are nineteen drug master file entries for this compound. Additional details are available on the prasugrel profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Prasugrel
A generic version of PRASUGREL was approved as prasugrel by MYLAN on July 12th, 2017.
Summary for PRASUGREL
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 127 |
| Clinical Trials: | 224 |
| Patent Applications: | 103 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PRASUGREL |
| DailyMed Link: | PRASUGREL at DailyMed |
Recent Clinical Trials for PRASUGREL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Collegium Medicum w Bydgoszczy | Phase 3 |
| Allgen pharmaceuticals | Phase 2/Phase 3 |
| St. Antonius Hospital | Phase 2/Phase 3 |
Pharmacology for PRASUGREL
| Drug Class | P2Y12 Platelet Inhibitor |
| Mechanism of Action | P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Anatomical Therapeutic Chemical (ATC) Classes for PRASUGREL
US Patents and Regulatory Information for PRASUGREL
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Lupin Ltd | PRASUGREL HYDROCHLORIDE | prasugrel | TABLET;ORAL | 205930-002 | Jan 9, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Chartwell Rx | PRASUGREL | prasugrel hydrochloride | TABLET;ORAL | 205790-001 | Oct 16, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal Pharms | PRASUGREL | prasugrel hydrochloride | TABLET;ORAL | 205913-002 | Jun 19, 2018 | BX | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hec Pharm | PRASUGREL | prasugrel hydrochloride | TABLET;ORAL | 206021-002 | Jan 16, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Chartwell Rx | PRASUGREL | prasugrel hydrochloride | TABLET;ORAL | 205790-002 | Oct 16, 2017 | DISCN | No | No | ⤷ 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 |
EU/EMA Drug Approvals for PRASUGREL
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Mylan Pharmaceuticals Limited | Prasugrel Mylan | prasugrel | EMEA/H/C/004644 Prasugrel Mylan, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI). |
Authorised | yes | no | no | 2018-05-15 | |
| Substipharm | Efient | prasugrel | EMEA/H/C/000984 Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST-segment-elevation myocardial infarction [UA / NSTEMI] or ST-segment-elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI). |
Authorised | no | no | no | 2009-02-24 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
