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Serving leading biopharmaceutical companies globally:

Chubb
McKesson
Fish and Richardson
Daiichi Sankyo
Accenture
Julphar
Federal Trade Commission
Harvard Business School
AstraZeneca
UBS

Generated: January 23, 2018

DrugPatentWatch Database Preview

Methylphenidate - Generic Drug Details

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What are the generic sources for methylphenidate and what is the scope of methylphenidate freedom to operate?

Methylphenidate
is the generic ingredient in fourteen branded drugs marketed by Noven Pharms Inc, Neos Theraps Inc, Rhodes Pharms, Ucb Inc, Barr Labs Inc, Impax Labs Inc, Mallinckrodt Inc, Mayne Pharma, Teva Pharms, Novartis, Nextwave Pharms, Mallinckrodt, Abhai Llc, Breckenridge Pharm, Novel Labs Inc, Tris Pharma Inc, Tedor Pharma Inc, Pfizer Inc, Janssen Pharms, Able, Actavis Elizabeth, Cnty Line Pharms, Kremers Urban Pharms, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Actavis Labs Fl Inc, Ascent Pharms Inc, Sun Pharm Inds Inc, and Vintage Pharms, and is included in fifty-three NDAs. There are thirty-five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Methylphenidate has forty-nine patent family members in twenty-nine countries.

There are thirty-one drug master file entries for methylphenidate. Two suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for methylphenidate
Pharmacology for methylphenidate
Medical Subject Heading (MeSH) Categories for methylphenidate
Tentative approvals for METHYLPHENIDATE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe10MGCAPSULE, EXTENDED RELEASE; ORAL
➤ Subscribe➤ Subscribe60MGCAPSULE, EXTENDED RELEASE;ORAL
➤ Subscribe➤ Subscribe50MGCAPSULE, EXTENDED RELEASE;ORAL

US Patents and Regulatory Information for methylphenidate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Osmotica METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 205327-001 Jul 28, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Neos Theraps Inc COTEMPLA XR-ODT methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489-003 Jun 19, 2017 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis RITALIN methylphenidate hydrochloride TABLET;ORAL 010187-010 Approved Prior to Jan 1, 1982 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Abhai Llc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride SOLUTION;ORAL 207485-001 Nov 18, 2016 AA RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mallinckrodt Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 202608-001 Dec 28, 2012 BX RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Breckenridge Pharm METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 207587-002 Mar 3, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-006 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-002 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-005 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for methylphenidate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-004 Apr 6, 2006 ➤ Subscribe ➤ Subscribe
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-001 Apr 6, 2006 ➤ Subscribe ➤ Subscribe
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-002 Apr 6, 2006 ➤ Subscribe ➤ Subscribe
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-003 Apr 6, 2006 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
8,916,191 Device for transdermal administration of drugs including acrylic polymers ➤ Subscribe
9,265,737 Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles ➤ Subscribe
9,017,731 Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles ➤ Subscribe
8,709,491 Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles ➤ Subscribe
9,333,263 Device for transdermal administration of drugs including acrylic based polymers ➤ Subscribe
9,839,619 Method for treating ADD or ADHD comprising administering amphetamine complexed with ion-exchange resin particles ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for methylphenidate

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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Farmers Insurance
UBS
US Department of Justice
Baxter
Fish and Richardson
Healthtrust
Moodys
Accenture

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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