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Last Updated: July 8, 2020

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DONEPEZIL HYDROCHLORIDE Drug 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 Heritage Pharma, Hisun Pharm Hangzhou, Macleods Pharms Ltd, Sandoz, Sun Pharm Industries, Unichem Labs Ltd, Zydus Pharms Usa Inc, Accord Hlthcare, Aci Healthcare Ltd, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo, Cadila, Cadila Pharms Ltd, Cipla Ltd, Dexcel Pharma, Dr Reddys, Dr Reddys Labs Ltd, Graviti Pharms, Hetero Labs Ltd V, Hikma Pharms, Indicus Pharma, Jubilant Generics, Lupin Ltd, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Par Pharm, Pliva Hrvatska Doo, Prinston Inc, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Sun Pharm Inds, Sun Pharm Inds Ltd, Torrent Pharms, Twi Pharms, Wockhardt, 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. Forty-four suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Donepezil Hydrochloride

A generic version of DONEPEZIL HYDROCHLORIDE was approved as donepezil hydrochloride by SANDOZ on May 10th, 2011.

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Drug patent expirations by year for DONEPEZIL HYDROCHLORIDE
Recent Clinical Trials for DONEPEZIL HYDROCHLORIDE

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SponsorPhase
Tenth People's Hospital of Tongji UniveristyPhase 4
RenJi HospitalPhase 4
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western MedicinePhase 4

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Pharmacology for DONEPEZIL HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DONEPEZIL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ARICEPT TABLET;ORAL donepezil hydrochloride 022568 2013-07-09
ARICEPT ODT TABLET, ORALLY DISINTEGRATING;ORAL donepezil hydrochloride 021720 2010-06-30
ARICEPT TABLET;ORAL donepezil hydrochloride 020690

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
Sun Pharm Inds Ltd DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 076786-001 Nov 26, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd V DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 203034-002 Jan 30, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Dexcel Pharma DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 203713-001 Feb 19, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Jubilant Generics DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090768-002 May 31, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Pliva Hrvatska Doo DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090425-002 May 31, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
Moodys
Express Scripts
AstraZeneca
Mallinckrodt

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