Last Updated: August 2, 2026

FOCALIN Drug Patent Profile

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When do Focalin patents expire, and what generic alternatives are available?

Focalin is a drug marketed by Sandoz and is included in two NDAs.

The generic ingredient in FOCALIN is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Focalin

A generic version of FOCALIN was approved as dexmethylphenidate hydrochloride by PLATINUM on November 18^th, 2013.

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Summary for FOCALIN

US Patents:	0
Applicants:	1
NDAs:	2

Paragraph IV (Patent) Challenges for FOCALIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FOCALIN	Tablets	dexmethylphenidate hydrochloride	2.5 mg	021278	1	2004-07-27
FOCALIN	Tablets	dexmethylphenidate hydrochloride	5 mg and 10 mg	021278	1	2004-05-27

US Patents and Regulatory Information for FOCALIN

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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
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-001	Nov 13, 2001	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-003	May 26, 2005	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-001	May 26, 2005	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-008	Apr 21, 2011	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-002	Nov 13, 2001	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-003	Nov 13, 2001	AB	RX	Yes	Yes	⤷ 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

International Patents for FOCALIN

See the table below for patents covering FOCALIN around the world.

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Country	Patent Number	Title	Estimated Expiration
Austria	306266		⤷ Start Trial
Austria	368458		⤷ Start Trial
Australia	2002318302		⤷ Start Trial
Australia	738521		⤷ Start Trial
Australia	738744		⤷ Start Trial
Australia	7834398		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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