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Last Updated: March 19, 2024

FOCALIN XR Drug Patent Profile


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

Focalin Xr is a drug marketed by Sandoz and is included in one NDA.

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

Paragraph IV (Patent) Challenges for FOCALIN XR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FOCALIN XR Extended-release Capsules dexmethylphenidate hydrochloride 25 mg 021802 1 2011-09-30
FOCALIN XR Extended-release Capsules dexmethylphenidate hydrochloride 35 mg 021802 1 2011-09-29
FOCALIN XR Extended-release Capsules dexmethylphenidate hydrochloride 40 mg 021802 1 2010-12-20
FOCALIN XR Extended-release Capsules dexmethylphenidate hydrochloride 30 mg 021802 1 2010-12-15
FOCALIN XR Extended-release Capsules dexmethylphenidate hydrochloride 15 mg 021802 1 2007-05-14
FOCALIN XR Extended-release Capsules dexmethylphenidate hydrochloride 5 mg, 10 mg and 20 mg 021802 1 2007-03-30

US Patents and Regulatory Information for FOCALIN XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-004 Aug 1, 2006 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-005 Oct 23, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for FOCALIN XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011 ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-005 Oct 23, 2009 ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-004 Aug 1, 2006 ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011 ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010 ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FOCALIN XR

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

Country Patent Number Title Estimated Expiration
Australia 2002318302 ⤷  Try a Trial
Spain 2153338 ⤷  Try a Trial
Israel 187567 ⤷  Try a Trial
Malaysia 122159 A MULTIPARTICULATE MODIFIED RELEASE COMPOSITION ⤷  Try a Trial
Poland 348633 ⤷  Try a Trial
Australia 2005247019 ⤷  Try a Trial
Japan 2010265299 IMPROVED DELIVERY OF MULTIPLE DOSES OF MEDICATION ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.