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Last Updated: July 2, 2020

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FOCALIN XR Drug Profile


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

Focalin Xr is a drug marketed by Novartis 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. Fourteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Drug patent expirations by year for FOCALIN XR
Drug Prices for FOCALIN XR

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Drug Sales Revenue Trends for FOCALIN XR

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Recent Clinical Trials for FOCALIN XR

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SponsorPhase
Cingulate TherapeuticsPhase 1/Phase 2
Matthew O'BrienPhase 4
Massachusetts General HospitalPhase 4

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Pharmacology for FOCALIN XR
Paragraph IV (Patent) Challenges for FOCALIN XR
Tradename Dosage Ingredient NDA Submissiondate
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2011-09-30
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2011-09-29
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2010-12-20
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2010-12-15
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2007-05-14
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 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
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005 AB RX Yes 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

Expired US Patents for FOCALIN XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-005 Oct 23, 2009   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Moodys
Mallinckrodt
AstraZeneca
Baxter

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