Prasugrel - Generic Drug Details
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Summary for prasugrel
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 10 |
NDAs: | 10 |
Drug Master File Entries: | 19 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 127 |
Clinical Trials: | 225 |
Patent Applications: | 186 |
Drug Prices: | Drug price trends for prasugrel |
What excipients (inactive ingredients) are in prasugrel? | prasugrel excipients list |
DailyMed Link: | prasugrel at DailyMed |
Recent Clinical Trials for prasugrel
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Giorgio Quadri | Phase 3 |
Ferdinando Varbella | Phase 3 |
Azienda Ospedaliera Universitaria Policlinico "G. Martino" | Phase 3 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | |||
Panacea | PRASUGREL | prasugrel hydrochloride | TABLET;ORAL | 205897-001 | Oct 16, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Dr Reddys | PRASUGREL | prasugrel hydrochloride | TABLET;ORAL | 205926-001 | Jul 7, 2020 | DISCN | 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 | ||||
>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 |