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Serving leading biopharmaceutical companies globally:

Deloitte
Moodys
Express Scripts
Dow
Covington
US Department of Justice
Baxter
Boehringer Ingelheim
Citi
Harvard Business School

Generated: October 23, 2017

DrugPatentWatch Database Preview

FOCALIN Drug Profile

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Which patents cover Focalin, and what generic Focalin 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. Nineteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Summary for Tradename: FOCALIN

US Patents:0
Applicants:1
NDAs:2
Suppliers / Packagers: see list2
Bulk Api Vendors: see list15
Clinical Trials: see list10
Patent Applications: see list732
Drug Prices:see details
DailyMed Link:FOCALIN at DailyMed

Pharmacology for Tradename: 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;ORAL021278-001Nov 13, 2001ABRXYesNo► Subscribe► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-006Aug 11, 2010ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 2005ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-001May 26, 2005ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-008Apr 21, 2011ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-004Aug 1, 2006ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-006Aug 11, 2010ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-007Apr 21, 2011ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-005Oct 23, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-002Nov 13, 2001ABRXYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: FOCALIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-001Nov 13, 2001► Subscribe► Subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-002Nov 13, 2001► Subscribe► Subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-003Nov 13, 2001► Subscribe► Subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-003Nov 13, 2001► Subscribe► Subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-002Nov 13, 2001► Subscribe► Subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-003Nov 13, 2001► Subscribe► Subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-001Nov 13, 2001► Subscribe► Subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-003Nov 13, 2001► Subscribe► Subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-003Nov 13, 2001► Subscribe► Subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-001Nov 13, 2001► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for FOCALIN

Drugname Dosage Strength RLD Submissiondate
dexmethylphenidateExtended-release capsules25 mgFocalin XR9/30/2011
dexmethylphenidateExtended-release capsules35 mgFocalin XR9/29/2011
dexmethyphenidate hydrochlorideExtended-release Capsule40 mgFocalin XR12/20/2010
dexmethylphenidate hydrochlorideExtended-release Capsule30 mgFocalin XR12/15/2010
dexmethylphenidate hydrochlorideExtended-release Capsules15 mgFocalin XR5/14/2007
dexmethylphenidate hydrochlorideExtended-release Capsules5mg, 10mg and 20 mgFocalin XR3/30/2007
dexmethylphenidate hydrochlorideTablets2.5 mgFocalin7/27/2004
dexmethylphenidate hydrochlorideTablets5 mg and 10 mgFocalin5/27/2004
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Teva
Accenture
Deloitte
Merck
AstraZeneca
Julphar
Cipla
Express Scripts
Baxter
Cantor Fitzgerald

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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