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FOCALIN Drug Profile

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Focalin is a drug marketed by Novartis and is included in two NDAs. It is available from two suppliers. 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. Twenty suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Summary for Tradename: FOCALIN

Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list2
Bulk Api Vendors: see list15
Clinical Trials: see list7
Patent Applications: see list683
Drug Prices:see details
DailyMed Link:FOCALIN at DailyMed

Pharmacology for Tradename: FOCALIN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-001Nov 13, 2001RXYesNo► subscribe► subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-006Aug 11, 2010RXYesYes6,228,398► subscribeY ► subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 2005RXYesNo6,730,325► subscribeY ► 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;ORAL021278-003Nov 13, 20016,355,656► subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-001Nov 13, 20015,908,850► subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-001Nov 13, 20016,355,656► subscribe
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Paragraph IV activity 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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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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