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Serving leading biopharmaceutical companies globally:

Healthtrust
Boehringer Ingelheim
Cipla
US Army
McKinsey
Chinese Patent Office
Daiichi Sankyo
Argus Health
Novartis
Fish and Richardson

Generated: February 19, 2018

DrugPatentWatch Database Preview

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. There are two patents protecting this drug and six Paragraph IV challenges.

This drug has one hundred and forty-two patent family members in thirty-three countries.

The generic ingredient in FOCALIN XR is dexmethylphenidate hydrochloride. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
Summary for FOCALIN XR
International Patents:142
US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: 5
Bulk Api Vendors: 20
Clinical Trials: 10
Patent Applications: 801
Drug Prices:see details
DailyMed Link:FOCALIN XR at DailyMed
Drug patent expirations by year for FOCALIN XR
Pharmacology for FOCALIN XR
Medical Subject Heading (MeSH) Categories for FOCALIN XR

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-005 Oct 23, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-004 Aug 1, 2006 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-004 Aug 1, 2006 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-005 Oct 23, 2009 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for FOCALIN XR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release capsules 25 mg ➤ Subscribe 9/30/2011
➤ Subscribe Extended-release capsules 35 mg ➤ Subscribe 9/29/2011
➤ 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

Non-Orange Book US Patents for FOCALIN XR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,793,936 Multiparticulate modified release composition ➤ Sign Up
8,119,163 Nanoparticulate and controlled release compositions comprising cefditoren ➤ Sign Up
6,902,742 Multiparticulate modified release composition ➤ Sign Up
7,580,712 Wireless high-speed data network planning tool ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for FOCALIN XR

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Covington
Johnson and Johnson
Baxter
Chubb
Mallinckrodt
Fish and Richardson
Chinese Patent Office
AstraZeneca

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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