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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, Mylan Pharms Inc, Novartis, Rhodes Pharms, Barr Labs Inc, Cnty Line Pharms, Nostrum Labs Inc, Tedor Pharma Inc, Mayne Pharma, Pfizer Inc, Abhai, Vintage Pharms, and Kremers Urban Pharms, and is included in forty-eight NDAs. There are thirty-one 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 thirty-one drug master file entries for methylphenidate. One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: methylphenidate

Tradenames:13
Patents:31
Applicants:28
NDAs:48
Drug Master File Entries: see list31
Suppliers / Packagers: see list1
Bulk Api Vendors: see list16
Clinical Trials: see list180
Patent Applications: see list5,673
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:methylphenidate at DailyMed

Pharmacology for Ingredient: methylphenidate

Tentative approvals for METHYLPHENIDATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL18MG
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL27MG
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL36MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Fl Inc
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET;ORAL040220-002Aug 29, 1997RXNoNo► subscribe► subscribe
Abhai
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL207488-002Jun 9, 2015RXNoNo► subscribe► subscribe
Novel Labs Inc
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET;ORAL207884-002Nov 13, 2015RXNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: methylphenidate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-001Apr 6, 20065,958,446► subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-003Apr 6, 20065,958,446► subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-004Apr 6, 20065,958,446► subscribe
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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► subscribe
9,333,263Device for transdermal administration of drugs including acrylic based polymers► 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: methylphenidate

Country Document Number Estimated Expiration
Germany69822199► subscribe
World Intellectual Property Organization (WIPO)2006041911► subscribe
Colombia4970785► 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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