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Serving 500+ biopharmaceutical companies globally:

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Generated: September 22, 2017

DrugPatentWatch Database Preview

FOCALIN XR Drug Profile

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What is the patent landscape for Focalin Xr, and what generic Focalin Xr 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 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. Nineteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Summary for Tradename: FOCALIN XR

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list6
Bulk Api Vendors: see list14
Clinical Trials: see list7
Patent Applications: see list732
Drug Prices:see details
DailyMed Link:FOCALIN XR at DailyMed

Pharmacology for Tradename: 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;ORAL021802-001May 26, 2005ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-003May 26, 2005ABRXYesNo► 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;ORAL021802-005Oct 23, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-003May 26, 2005ABRXYesNo► 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;ORAL021802-001May 26, 2005ABRXYesNo► 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;ORAL021802-004Aug 1, 2006ABRXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: FOCALIN XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-008Apr 21, 2011► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-008Apr 21, 2011► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 2005► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-003May 26, 2005► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-006Aug 11, 2010► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-007Apr 21, 2011► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-003May 26, 2005► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-004Aug 1, 2006► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 2005► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-005Oct 23, 2009► Subscribe► Subscribe
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Paragraph IV activity for: FOCALIN XR

Drugname Dosage Strength RLD Submissiondate
dexmethylphenidateExtended-release capsules35 mgFocalin XR9/29/2011
dexmethylphenidateExtended-release capsules25 mgFocalin XR9/30/2011
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

Non-Orange Book Patents for Tradename: 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► Subscribe
8,119,163Nanoparticulate and controlled release compositions comprising cefditoren► Subscribe
7,580,712Wireless high-speed data network planning tool► Subscribe
6,902,742 Multiparticulate modified release composition► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: FOCALIN XR

Country Document Number Estimated Expiration
Hungary230454► Subscribe
China100444830► Subscribe
European Patent Office1126826► Subscribe
Mexico2007007942► Subscribe
Australia2004202078► Subscribe
Japan2008545808► Subscribe
Canada2611938► Subscribe
Australia2006343445► Subscribe
Portugal1126826► Subscribe
Hong Kong1117060► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Teva
Cerilliant
Medtronic
Harvard Business School
Accenture
Queensland Health
Daiichi Sankyo
Fish and Richardson
Fuji

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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