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Dexmethylphenidate hydrochloride - Generic Drug Details

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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, Mylan Pharms Inc, and Intellipharmaceutics, and is included in thirteen NDAs. There are eight patents protecting this compound and eight Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and seventy-four 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:8
Applicants:10
NDAs:13
Drug Master File Entries: see list5
Suppliers / Packaging: see list20
Therapeutic Class:Central Nervous System Agents
Drug Prices:see low prices

Pharmacology for Ingredient: dexmethylphenidate hydrochloride

Tentative approvals for DEXMETHYLPHENIDATE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL5MG
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL10MG
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL20MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 2005RXNo7,431,944► subscribeY ► subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 2005RXNo6,355,656► subscribeY ► subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-006Aug 11, 2010RXYes5,908,850► 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;ORAL021278-002Nov 13, 20016,355,656► subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-001Nov 13, 20016,355,656► subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-001Nov 13, 20016,528,530► 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
8,119,163Nanoparticulate and controlled release compositions comprising cefditoren► subscribe
6,793,936 Multiparticulate modified release composition► subscribe
5,733,756 Lactams and processes for stereoselective enrichment of lactams, amides, and esters► 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
Cyprus1107748► subscribe
Canada2468370► subscribe
Peru13222000► 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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