.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Methylphenidate - Generic Drug Details

« Back to Dashboard
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, Mayne Pharma, Pfizer Inc, Nostrum Labs Inc, Cnty Line Pharms, 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
Drug Prices:see low prices

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;ORAL205831-003Apr 17, 2015RXNo7,438,930Dec 16, 2019YY
Actavis Labs Fl Inc
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET;ORAL040220-002Aug 29, 1997RXNo
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-004Apr 1, 2002RXNo8,629,179*PEDJan 31, 2018Y
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: methylphenidate

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

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<disabled>
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-002Apr 6, 20065,958,446<disabled>
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-004Apr 6, 20065,958,446<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: methylphenidate

Country Document Number Estimated Expiration
Spain2452517<disabled in preview>
Hong Kong1156872<disabled in preview>
China1368876<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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.

`abc