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Dexmethylphenidate hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for dexmethylphenidate hydrochloride?

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 fourteen NDAs. There are three 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 thirty-eight patent family members in thirty-two countries.

There are five drug master file entries for dexmethylphenidate hydrochloride. Twenty suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: dexmethylphenidate hydrochloride

Tradenames:3
Patents:3
Applicants:11
NDAs:14
Drug Master File Entries: see list5
Suppliers / Packagers: see list20
Bulk Api Vendors: see list16
Clinical Trials: see list990
Patent Applications: see list1,136
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. Form Dosage
► Subscribe► SubscribeCAPSULE, EXTENDED RELEASE; ORAL5MG
► Subscribe► SubscribeCAPSULE, EXTENDED RELEASE; ORAL10MG
► Subscribe► SubscribeCAPSULE, EXTENDED RELEASE; ORAL20MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL078908-004May 19, 2014RXNoNo► Subscribe► Subscribe
Impax Labs Inc
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL079108-004Dec 21, 2015RXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204266-002Aug 25, 2015RXNoNo► Subscribe► Subscribe
Teva Pharms Usa
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL078908-001Nov 19, 2013RXNoNo► Subscribe► Subscribe
Teva Pharms
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
TABLET;ORAL077107-003Jan 29, 2007RXNoNo► 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;ORAL021802-005Oct 23, 20095,837,284► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 20056,528,530► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-006Aug 11, 20105,837,284► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-005Oct 23, 20096,355,656► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-008Apr 21, 20116,635,284► 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
6,902,742 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
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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
BrazilPI0713447► Subscribe
European Patent Office2197448► Subscribe
Israel179379► Subscribe
European Patent Office2020229► Subscribe
China1403076► 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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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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