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Serving 500+ biopharmaceutical companies globally:

McKinsey
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Dow
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Accenture
Citi
Johnson and Johnson
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Generated: July 27, 2017

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Dexmethylphenidate hydrochloride - Generic Drug Details

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What are the generic sources for dexmethylphenidate hydrochloride and what is the scope of dexmethylphenidate hydrochloride freedom to operate?

Dexmethylphenidate hydrochloride
is the generic ingredient in three branded drugs marketed by Tris Pharma Inc, Novartis, Teva Pharms, Impax Labs Inc, Teva Pharms Usa, Abhai Inc, Sun Pharm Inds, Novel Labs Inc, Par Pharm Inc, Mylan Pharms Inc, and Intellipharmaceutics, and is included in fifteen NDAs. There are two patents protecting this compound and eight Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexmethylphenidate hydrochloride has one hundred and forty patent family members in thirty-three countries.

There are five drug master file entries for dexmethylphenidate hydrochloride. Nineteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: dexmethylphenidate hydrochloride

Tradenames:3
Patents:2
Applicants:11
NDAs:15
Drug Master File Entries: see list5
Suppliers / Packagers: see list19
Bulk Api Vendors: see list16
Clinical Trials: see list2,255
Patent Applications: see list1,204
Therapeutic Class:Central Nervous System Agents
Drug Prices:see low prices
DailyMed Link:dexmethylphenidate hydrochloride at DailyMed

Pharmacology for Ingredient: dexmethylphenidate hydrochloride

Tentative approvals for DEXMETHYLPHENIDATE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe5MGCAPSULE, EXTENDED RELEASE;ORAL
► Subscribe► Subscribe40MGCAPSULE, EXTENDED RELEASE;ORAL
► Subscribe► Subscribe35MGCAPSULE, EXTENDED RELEASE;ORAL
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;ORAL021802-003May 26, 2005ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Par Pharm Inc
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL202842-008Nov 30, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-003May 26, 2005ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Teva Pharms Usa
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL202731-001Jul 5, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: dexmethylphenidate hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-004Aug 1, 2006► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-007Apr 21, 2011► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-004Aug 1, 2006► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-001May 26, 2005► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 2005► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: dexmethylphenidate hydrochloride

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
7,580,712Wireless high-speed data network planning tool► Subscribe
8,119,163Nanoparticulate and controlled release compositions comprising cefditoren► 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 Ingredient: dexmethylphenidate hydrochloride

Country Document Number Estimated Expiration
Denmark1126826► Subscribe
Norway20090158► Subscribe
South Africa200810098► Subscribe
Israel187567► Subscribe
South Africa200704744► 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:

Argus Health
Merck
Dow
UBS
US Army
McKesson
Chinese Patent Office
US Department of Justice
Deloitte
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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ISSN: 2162-2639

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