PRASUGREL HYDROCHLORIDE Drug Patent Profile
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When do Prasugrel Hydrochloride patents expire, and when can generic versions of Prasugrel Hydrochloride launch?
Prasugrel Hydrochloride is a drug marketed by Unichem and is included in one NDA.
The generic ingredient in PRASUGREL HYDROCHLORIDE 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 Prasugrel Hydrochloride
A generic version of PRASUGREL HYDROCHLORIDE was approved as prasugrel hydrochloride by UNICHEM on August 28th, 2023.
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Summary for PRASUGREL HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 79 |
| Clinical Trials: | 226 |
| Patent Applications: | 58 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PRASUGREL HYDROCHLORIDE |
| DailyMed Link: | PRASUGREL HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for PRASUGREL HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Gianluca Di Bella | Phase 3 |
| Antonio Micari | Phase 3 |
| Greca Zanda | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Unichem | PRASUGREL HYDROCHLORIDE | prasugrel hydrochloride | TABLET;ORAL | 213315-001 | Aug 28, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Unichem | PRASUGREL HYDROCHLORIDE | prasugrel hydrochloride | TABLET;ORAL | 213315-002 | Aug 28, 2023 | AB | RX | 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 |
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 |
