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Methylphenidate - Generic Drug Details

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Methylphenidate is the generic ingredient in thirteen branded drugs marketed by Noven Pharms Inc, Nextwave Pharms, Mallinckrodt, Tris Pharma Inc, Ucb Inc, Novel Labs Inc, Able, Corepharma, Teva Pharms, Mallinckrodt Inc, Watson Labs, Sun Pharm Inds Inc, Ascent Pharms Inc, Actavis Labs Fl Inc, Janssen Pharms, Actavis Elizabeth, Novartis, Rhodes Pharms, Barr Labs Inc, Watson Labs Inc, Pfizer Inc, Nostrum Labs Inc, Tedor Pharma Inc, Abhai, Vintage Pharms, and Kremers Urban Pharms, and is included in forty-three NDAs. There are thirty-three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-three patent family members in twenty-eight countries.

There are twenty-five drug master file entries for methylphenidate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: methylphenidate

Tradenames:13
Patents:33
Applicants:26
NDAs:43
Drug Master File Entries: see list25
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details

Pharmacology for Ingredient: methylphenidate

Tentative approvals for METHYLPHENIDATE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL10MG

Clinical Trials for: methylphenidate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rhodes Pharms
APTENSIO XR
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205831-005Apr 17, 2015RXNo7,438,930<disabled>YY <disabled>
Tris Pharma Inc
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
SOLUTION;ORAL091601-002Jul 23, 2010RXNo<disabled><disabled>
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000RXYes9,000,038*PED<disabled>Y<disabled>
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Expired Orange Book Patents for Generic Ingredient: methylphenidate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-003Apr 6, 20065,958,446<disabled>
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-001Apr 6, 20065,958,446<disabled>
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-002Apr 6, 20065,958,446<disabled>
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Non-Orange Book Patents for Generic Ingredient: methylphenidate

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
8,916,191Device for transdermal administration of drugs including acrylic polymers<disabled in preview>
9,333,263Device for transdermal administration of drugs including acrylic based polymers<disabled in preview>
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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: methylphenidate

Country Document Number Estimated Expiration
Israel136760<disabled in preview>
Spain2452517<disabled in preview>
Czech Republic305817<disabled in preview>
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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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