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Serving leading biopharmaceutical companies globally:

Fuji
Accenture
Johnson and Johnson
McKinsey
Chubb
Covington
Colorcon
Teva
Baxter
Merck

Generated: January 17, 2018

DrugPatentWatch Database Preview

FOCALIN Drug Profile

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Which patents cover Focalin, and what generic alternatives are available?

Focalin is a drug marketed by Novartis and is included in two NDAs. There are two patents protecting this drug and eight Paragraph IV challenges.

The generic ingredient in FOCALIN is dexmethylphenidate hydrochloride. There are five drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
Summary for FOCALIN
Drug patent expirations by year for FOCALIN
Pharmacology for FOCALIN
Medical Subject Heading (MeSH) Categories for FOCALIN

US Patents and Regulatory Information for FOCALIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-001 Nov 13, 2001 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-004 Aug 1, 2006 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-005 Oct 23, 2009 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-002 Nov 13, 2001 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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Expired US Patents for FOCALIN

Paragraph IV (Patent) Challenges for FOCALIN
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release capsules 35 mg ➤ Subscribe 9/29/2011
➤ Subscribe Extended-release capsules 25 mg ➤ Subscribe 9/30/2011
➤ Subscribe Extended-release Capsule 40 mg ➤ Subscribe 12/20/2010
➤ Subscribe Extended-release Capsule 30 mg ➤ Subscribe 12/15/2010
➤ Subscribe Extended-release Capsules 15 mg ➤ Subscribe 5/14/2007
➤ Subscribe Extended-release Capsules 5mg, 10mg and 20 mg ➤ Subscribe 3/30/2007
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 7/27/2004
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 5/27/2004

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Serving leading biopharmaceutical companies globally:

Deloitte
Baxter
Moodys
Farmers Insurance
Novartis
US Department of Justice
Fish and Richardson
Cipla
Argus Health

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 verifification 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.

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