DONEPEZIL HYDROCHLORIDE Drug Patent Profile
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Which patents cover Donepezil Hydrochloride, and when can generic versions of Donepezil Hydrochloride launch?
Donepezil Hydrochloride is a drug marketed by Chartwell Rx, Hisun Pharm Hangzhou, Macleods Pharms Ltd, Sandoz, Sun Pharm Industries, Unichem, Zydus Pharms Usa Inc, Accord Hlthcare, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo, Cadila Pharms Ltd, Cipla Ltd, Dexcel, Dr Reddys, Dr Reddys Labs Ltd, Endo Operations, Heritage Pharma, Hetero Labs Ltd V, Hikma Pharms, Indicus Pharma, Jubilant Generics, Lupin Ltd, Natco Pharma, Osmotica Pharm Us, Prinston Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Sun Pharm Inds, Sun Pharm Inds Ltd, Torrent Pharms, Twi Pharms, Wockhardt, Zydus Lifesciences, and Zydus Pharms. and is included in forty-seven NDAs.
The generic ingredient in DONEPEZIL HYDROCHLORIDE is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Donepezil Hydrochloride
A generic version of DONEPEZIL HYDROCHLORIDE was approved as donepezil hydrochloride by AUROBINDO on May 31st, 2011.
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Summary for DONEPEZIL HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 38 |
| NDAs: | 47 |
| Finished Product Suppliers / Packagers: | 36 |
| Raw Ingredient (Bulk) Api Vendors: | 158 |
| Clinical Trials: | 320 |
| Patent Applications: | 4,015 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DONEPEZIL HYDROCHLORIDE |
| What excipients (inactive ingredients) are in DONEPEZIL HYDROCHLORIDE? | DONEPEZIL HYDROCHLORIDE excipients list |
| DailyMed Link: | DONEPEZIL HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for DONEPEZIL HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Duke University | Phase 2 |
| NeuroSense Therapeutics Ltd. | Phase 2 |
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Phase 2 |
Pharmacology for DONEPEZIL HYDROCHLORIDE
| Drug Class | Cholinesterase Inhibitor |
| Mechanism of Action | Cholinesterase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for DONEPEZIL HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DONEPEZIL HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ARICEPT | Tablets | donepezil hydrochloride | 23 mg | 022568 | 2013-07-09 | |
| ARICEPT ODT | Orally Disintegrating Tablets | donepezil hydrochloride | 5 mg and 10 mg | 021720 | 1 | 2010-06-30 |
US Patents and Regulatory Information for DONEPEZIL HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Torrent Pharms | DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 090686-001 | May 31, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma Pharms | DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 090247-002 | May 31, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys | DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 202723-001 | Jul 24, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Macleods Pharms Ltd | DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 201146-002 | Aug 17, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 090290-002 | May 31, 2011 | 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 |
