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Generated: September 23, 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 list2,282
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
Teva Pharms
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
TABLET;ORAL077107-001Jan 29, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL202580-001Aug 28, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
TABLET;ORAL077107-003Jan 29, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Tris Pharma Inc
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
TABLET;ORAL207901-002Aug 26, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL078908-004May 19, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Abhai Inc
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
TABLET;ORAL206931-002Dec 4, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL079108-003May 19, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204266-002Aug 25, 2015ABRXNoNo► Subscribe► Subscribe► 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;ORAL021802-007Apr 21, 2011ABRXYesNo► Subscribe► SubscribeY ► 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
dexmethylphenidate hydrochloride
TABLET;ORAL021278-003Nov 13, 2001► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-008Apr 21, 2011► Subscribe► Subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-003Nov 13, 2001► 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
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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
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 Ingredient: dexmethylphenidate hydrochloride

Country Document Number Estimated Expiration
European Patent Office1905432► Subscribe
Australia2005247019► Subscribe
World Intellectual Property Organization (WIPO)2006130091► Subscribe
Japan2002528485► Subscribe
Norway20076628► Subscribe
South Africa200704744► Subscribe
Mexico2007007942► Subscribe
Norway20090119► Subscribe
World Intellectual Property Organization (WIPO)2007150075► Subscribe
Denmark1126826► 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:

Cipla
Argus Health
Accenture
AstraZeneca
Citi
Farmers Insurance
Federal Trade Commission
Merck
Fish and Richardson
Daiichi Sankyo

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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