Donepezil Hydrochloride Patent Expiration

Donepezil Hydrochloride was first introduced by Eisai Inc in its drug Aricept on Nov 25, 1996. Other drugs containing Donepezil Hydrochloride are Adlarity, Aricept Odt. 41 different companies have introduced drugs containing Donepezil Hydrochloride.


Donepezil Hydrochloride Patents

Given below is the list of patents protecting Donepezil Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Adlarity US10016372 Transdermal delivery systems with pharmacokinetics bioequivalent to oral delivery Jul 26, 2037 Corium
Adlarity US10300025 Donepezil transdermal delivery system Jul 26, 2037 Corium
Adlarity US10307379 Donepezil transdermal delivery system Jul 26, 2037 Corium
Adlarity US10835499 Systems and methods for long term transdermal administration May 20, 2038 Corium
Adlarity US10966936 Systems comprising a composite backing and methods for long term transdermal administration Aug 11, 2038 Corium
Adlarity US11103463 Methods for treating alzheimer's disease with donepezil transdermal system Jul 26, 2037 Corium
Adlarity US11648214 Systems and methods for long term transdermal administration Sep 23, 2037 Corium
Adlarity US11679086 Systems comprising a composite backing and methods for long term transdermal administration May 26, 2037 Corium
Adlarity US9993466 Donepezil transdermal delivery system Jul 26, 2037 Corium
Aricept US5985864 Polymorphs of donepezil hydrochloride and process for production Dec 30, 2016

(Expired)

Eisai Inc
Aricept US6140321 Polymorphs of donepezil hydrochloride and process for production Dec 30, 2016

(Expired)

Eisai Inc
Aricept US6245911 Donepezil polycrystals and process for producing the same Dec 01, 2018

(Expired)

Eisai Inc
Aricept US8481565 Method for stabilizing anti-dementia drug Oct 04, 2026 Eisai Inc
Aricept Odt US7727548 Rapidly disintegrable tablet containing polyvinyl alcohol Jun 23, 2022

(Expired)

Eisai Inc
Aricept Odt US7727552 Oral pharmaceutical preparations decreased in bitterness by masking Mar 26, 2018

(Expired)

Eisai Inc


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Donepezil Hydrochloride Generics

Several generic applications have been filed for Donepezil Hydrochloride. The first generic version for Donepezil Hydrochloride was by Sun Pharmaceutical Industries Inc and was approved on Dec 11, 2009. And the latest generic version is by Hisun Pharmaceutical Hangzhou Co Ltd and was approved on Jul 27, 2018.

Given below is the list of companies who have filed for Donepezil Hydrochloride generic.


1. HERITAGE PHARMA

Heritage Pharma Labs Inc has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Heritage Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A May 31, 2011
10MG tablet Discontinued ORAL N/A May 31, 2011


2. DEXCEL

Dexcel Pharma Technologies Ltd has filed for 1 generic for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Dexcel.

Strength Dosage Form Availability Application Pathway TE code Launch Date
23MG tablet Prescription ORAL AB Feb 19, 2016


3. CADILA PHARMS LTD

Cadila Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Cadila Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Sep 19, 2017
10MG tablet Prescription ORAL AB Sep 19, 2017


4. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB May 31, 2011
10MG tablet Prescription ORAL AB May 31, 2011


5. CIPLA LTD

Cipla Ltd has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Cipla Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB May 31, 2011
5MG tablet Prescription ORAL AB May 31, 2011


6. UNICHEM

Unichem Laboratories Ltd has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Unichem.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet, orally disintegrating Discontinued ORAL N/A Nov 10, 2016
10MG tablet, orally disintegrating Discontinued ORAL N/A Nov 10, 2016


7. HISUN PHARM HANGZHOU

Hisun Pharmaceutical Hangzhou Co Ltd has filed for 3 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Hisun Pharm Hangzhou.

Strength Dosage Form Availability Application Pathway TE code Launch Date
23MG tablet Discontinued ORAL N/A Mar 24, 2017
5MG tablet, orally disintegrating Prescription ORAL AB Jul 27, 2018
10MG tablet, orally disintegrating Prescription ORAL AB Jul 27, 2018


8. APOTEX

Apotex Inc has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Discontinued ORAL N/A Jun 2, 2011
5MG tablet Discontinued ORAL N/A Jun 2, 2011


9. HIKMA PHARMS

Hikma Pharmaceuticals has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Hikma Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A May 31, 2011
10MG tablet Discontinued ORAL N/A May 31, 2011


10. OSMOTICA PHARM US

Osmotica Pharmaceutical Us Llc has filed for 1 generic for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Osmotica Pharm Us.

Strength Dosage Form Availability Application Pathway TE code Launch Date
23MG tablet Discontinued ORAL N/A Jan 26, 2016


11. ZYDUS PHARMS USA INC

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Zydus Pharms Usa Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet, orally disintegrating Discontinued ORAL N/A May 10, 2011
10MG tablet, orally disintegrating Discontinued ORAL N/A May 10, 2011


12. TORRENT PHARMS

Torrent Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Torrent Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB May 31, 2011
10MG tablet Prescription ORAL AB May 31, 2011


13. SUN PHARM INDS

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A May 31, 2011
10MG tablet Discontinued ORAL N/A May 31, 2011


14. LUPIN LTD

Lupin Ltd has filed for 1 generic for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
23MG tablet Prescription ORAL AB Oct 30, 2015


15. SUN PHARM INDS LTD

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A Nov 26, 2010
10MG tablet Discontinued ORAL N/A Nov 26, 2010


16. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
23MG tablet Prescription ORAL AB Aug 31, 2017


17. INDICUS PHARMA

Indicus Pharma Llc has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Indicus Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Jun 13, 2012
10MG tablet Prescription ORAL AB Jun 13, 2012


18. WOCKHARDT

Wockhardt Ltd has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Wockhardt.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A May 31, 2011
10MG tablet Discontinued ORAL N/A May 31, 2011


19. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Discontinued ORAL N/A Aug 29, 2011
5MG tablet Discontinued ORAL N/A Aug 29, 2011


20. ACTAVIS ELIZABETH

Actavis Elizabeth Llc has filed for 1 generic for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Actavis Elizabeth.

Strength Dosage Form Availability Application Pathway TE code Launch Date
23MG tablet Discontinued ORAL N/A Dec 17, 2015


21. TWI PHARMS

Twi Pharmaceuticals Inc has filed for 1 generic for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Twi Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
23MG tablet Prescription ORAL AB Oct 29, 2014


22. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 3 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB May 31, 2011
5MG tablet Prescription ORAL AB May 31, 2011
23MG tablet Discontinued ORAL N/A Apr 12, 2016


23. DR REDDYS LABS LTD

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB May 31, 2011
10MG tablet Prescription ORAL AB May 31, 2011


24. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A May 31, 2011
10MG tablet Discontinued ORAL N/A May 31, 2011


25. ALEMBIC PHARMS LTD

Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Alembic Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Feb 25, 2013
5MG tablet Prescription ORAL AB Feb 25, 2013


26. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Jan 30, 2015
5MG tablet Prescription ORAL AB Jan 30, 2015


27. SCIEGEN PHARMS INC

Sciegen Pharmaceuticals Inc has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Sciegen Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Oct 29, 2014
5MG tablet Prescription ORAL AB Oct 29, 2014


28. SUN PHARM INDUSTRIES

Sun Pharmaceutical Industries Inc has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm Industries.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet, orally disintegrating Discontinued ORAL N/A Dec 11, 2009
10MG tablet, orally disintegrating Discontinued ORAL N/A Dec 11, 2009


29. PRINSTON INC

Prinston Pharmaceutical Inc has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Prinston Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB May 31, 2011
10MG tablet Prescription ORAL AB May 31, 2011


30. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

(reference standard)

tablet, orally disintegrating Prescription ORAL AB Dec 14, 2012
5MG tablet, orally disintegrating Prescription ORAL AB Dec 14, 2012
23MG tablet Prescription ORAL AB Jan 22, 2014


31. AUROBINDO

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Aurobindo.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB May 31, 2011
10MG tablet Prescription ORAL AB May 31, 2011


32. MYLAN PHARMS INC

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Mylan Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A May 31, 2011
10MG tablet Discontinued ORAL N/A May 31, 2011


33. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 1 generic for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
23MG tablet Prescription ORAL AB Jul 24, 2013


34. RISING

Rising Pharma Holding Inc has filed for 3 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Jul 5, 2013
10MG tablet Prescription ORAL AB Jul 5, 2013
23MG tablet Discontinued ORAL N/A Oct 22, 2015


35. ACI

Aci Healthcare Ltd has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Aci.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB May 31, 2011
10MG tablet Prescription ORAL AB May 31, 2011


36. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 1 generic for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
23MG tablet Discontinued ORAL N/A Jun 5, 2015


37. ENDO OPERATIONS

Endo Operations Ltd has filed for 1 generic for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
23MG tablet Discontinued ORAL N/A Jul 24, 2013


38. ZYDUS LIFESCIENCES

Zydus Lifesciences Ltd has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Oct 24, 2012
10MG tablet Prescription ORAL AB Oct 24, 2012


39. JUBILANT GENERICS

Jubilant Generics Ltd has filed for 2 different strengths of generic version for Donepezil Hydrochloride. Given below are the details of the strengths of this generic introduced by Jubilant Generics.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB May 31, 2011
10MG tablet Prescription ORAL AB May 31, 2011