Last Updated: August 28, 2026

Done - Generic Drug Details

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Generic filers with tentative approvals for DONE

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	10MG	TABLET; ORAL
⤷ Start Trial	⤷ Start Trial	5MG	TABLET; ORAL
⤷ Start Trial	⤷ Start Trial	10MG;21MG	CAPSULE, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for done

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic Pharms Ltd	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	201724-002	Feb 25, 2013	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-001	Mar 11, 2022		DISCN	Yes	No	10,307,379	⤷ Start Trial	Y			⤷ Start Trial
Cipla Ltd	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	077518-002	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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