Prasugrel hydrochloride - Generic Drug Details
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What are the generic drug sources for prasugrel hydrochloride and what is the scope of freedom to operate?
Prasugrel hydrochloride
is the generic ingredient in three branded drugs marketed by Cosette, Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Hec Pharm, Lupin Ltd, Mylan, Panacea, and Unichem, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.There are seventeen drug master file entries for prasugrel hydrochloride. Nine suppliers are listed for this compound.
Summary for prasugrel hydrochloride
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 11 |
NDAs: | 11 |
Drug Master File Entries: | 17 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 79 |
Clinical Trials: | 226 |
Patent Applications: | 121 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for prasugrel hydrochloride |
What excipients (inactive ingredients) are in prasugrel hydrochloride? | prasugrel hydrochloride excipients list |
DailyMed Link: | prasugrel hydrochloride at DailyMed |
Recent Clinical Trials for prasugrel hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Antonio Micari | Phase 3 |
Greca Zanda | Phase 3 |
Giampiero Vizzari | Phase 3 |
Pharmacology for prasugrel hydrochloride
Drug Class | P2Y12 Platelet Inhibitor |
Mechanism of Action | P2Y12 Receptor Antagonists |
Physiological Effect | Decreased Platelet Aggregation |
Medical Subject Heading (MeSH) Categories for prasugrel hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for prasugrel hydrochloride
Paragraph IV (Patent) Challenges for PRASUGREL HYDROCHLORIDE
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 prasugrel hydrochloride
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lupin Ltd | PRASUGREL | prasugrel hydrochloride | TABLET;ORAL | 205930-002 | Jan 9, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Chartwell Rx | PRASUGREL | prasugrel hydrochloride | TABLET;ORAL | 205790-001 | Oct 16, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Dr Reddys | PRASUGREL | prasugrel hydrochloride | TABLET;ORAL | 205926-001 | Jul 7, 2020 | DISCN | No | No | ⤷ 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 prasugrel hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for prasugrel hydrochloride
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 |
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