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Chinese Patent Office
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McKinsey
Healthtrust
Farmers Insurance
Julphar
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Generated: October 23, 2017

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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, Nextwave Pharms, Mallinckrodt, Tris Pharma Inc, Ucb Inc, Novel Labs Inc, Able, Impax Labs Inc, Teva Pharms, Mallinckrodt Inc, Watson Labs, Sun Pharm Inds Inc, Ascent Pharms Inc, Actavis Labs Fl Inc, Janssen Pharms, Actavis Elizabeth, Mylan Pharms Inc, Osmotica, Novartis, Rhodes Pharms, Barr Labs Inc, Abhai Inc, Cnty Line Pharms, Breckenridge Pharm, Tedor Pharma Inc, Mayne Pharma, Pfizer Inc, Abhai Llc, Vintage Pharms, and Kremers Urban 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-seven patent family members in twenty-eight 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 Generic Name: methylphenidate

US Patents:35
Tradenames:14
Applicants:31
NDAs:53
Drug Master File Entries: see list31
Suppliers / Packagers: see list2
Bulk Api Vendors: see list16
Clinical Trials: see list341
Patent Applications: see list5,456
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. Strength Dosage Form
u► Subscribe10MGCAPSULE, EXTENDED RELEASE; ORAL
u► Subscribe60MGCAPSULE, EXTENDED RELEASE;ORAL
u► Subscribe50MGCAPSULE, EXTENDED RELEASE;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rhodes Pharms
APTENSIO XR
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205831-004Apr 17, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Nextwave Pharms
QUILLIVANT XR
methylphenidate hydrochloride
FOR SUSPENSION, EXTENDED RELEASE;ORAL202100-001Sep 27, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Pfizer Inc
QUILLICHEW ER
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL207960-003Dec 4, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Neos Theraps Inc
COTEMPLA XR-ODT
methylphenidate
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL205489-001Jun 19, 2017RXYesNo► Subscribe► SubscribeY ► Subscribe
Rhodes Pharms
APTENSIO XR
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205831-001Apr 17, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Rhodes Pharms
APTENSIO XR
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205831-006Apr 17, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Pfizer Inc
QUILLICHEW ER
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL207960-001Dec 4, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000ABRXYesNo► Subscribe► SubscribeY► Subscribe
Rhodes Pharms
APTENSIO XR
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205831-006Apr 17, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Neos Theraps Inc
COTEMPLA XR-ODT
methylphenidate
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL205489-002Jun 19, 2017RXYesNo► Subscribe► SubscribeY ► 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, 2006► Subscribe► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-004Apr 6, 2006► Subscribe► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-003Apr 6, 2006► Subscribe► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-002Apr 6, 2006► Subscribe► 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
9,017,731Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles► Subscribe
8,916,191Device for transdermal administration of drugs including acrylic polymers► Subscribe
8,709,491Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles► Subscribe
9,333,263Device for transdermal administration of drugs including acrylic based polymers► Subscribe
9,265,737Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles► 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
Norway20003096► Subscribe
Hong Kong1156872► Subscribe
Australia1824999► Subscribe
Japan4316800► Subscribe
Poland195315► Subscribe
European Patent Office2314288► Subscribe
New Zealand505689► Subscribe
Japan2009073856► Subscribe
Czech Republic20002209► Subscribe
China101120934► 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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Serving leading biopharmaceutical companies globally:

Cipla
McKinsey
Boehringer Ingelheim
AstraZeneca
Colorcon
Federal Trade Commission
Argus Health
US Army
Johnson and Johnson
Dow

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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