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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Cerilliant
Covington
Merck
McKesson
Novartis
Chinese Patent Office
Cantor Fitzgerald
AstraZeneca
US Department of Justice

Generated: August 23, 2017

DrugPatentWatch Database Preview

Methylphenidate hydrochloride - Generic Drug Details

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What are the generic drug sources for methylphenidate hydrochloride and what is the scope of methylphenidate hydrochloride patent protection?

Methylphenidate hydrochloride
is the generic ingredient in twelve branded drugs marketed by 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, Novartis, Rhodes Pharms, Barr Labs Inc, Abhai Inc, Cnty Line Pharms, Nostrum Labs Inc, Tedor Pharma Inc, Mayne Pharma, Pfizer Inc, Abhai Llc, Vintage Pharms, and Kremers Urban Pharms, and is included in forty-nine NDAs. There are twenty-seven patents protecting this compound and twelve Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Methylphenidate hydrochloride has two hundred and eighty-six patent family members in thirty-six countries.

There are thirty-one drug master file entries for methylphenidate hydrochloride. Thirty-four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: methylphenidate hydrochloride

Tradenames:12
Patents:27
Applicants:28
NDAs:49
Drug Master File Entries: see list31
Suppliers / Packagers: see list34
Bulk Api Vendors: see list28
Clinical Trials: see list2,540
Patent Applications: see list3,603
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:methylphenidate hydrochloride at DailyMed

Pharmacology for Ingredient: methylphenidate hydrochloride

Tentative approvals for METHYLPHENIDATE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe10MGCAPSULE, EXTENDED RELEASE; ORAL
► Subscribe► Subscribe60MGCAPSULE, EXTENDED RELEASE;ORAL
► Subscribe► 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
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000ABRXYesNo► Subscribe► Subscribe ► Subscribe
Pfizer Inc
QUILLICHEW ER
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL207960-002Dec 4, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
Rhodes Pharms
APTENSIO XR
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205831-006Apr 17, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
RITALIN
methylphenidate hydrochloride
TABLET;ORAL010187-006Approved Prior to Jan 1, 1982ABRXYesNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: methylphenidate hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000► Subscribe► Subscribe
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-001Jun 5, 2002► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: methylphenidate hydrochloride

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
9,675,704Modified release formulations containing drug-ion exchange resin complexes► Subscribe
9,180,100Methylphenidate extended release chewable tablet► Subscribe
6,905,654 Method and apparatus for reducing static charges during polymerization of olefin polymers► Subscribe
9,522,191Modified release formulations containing drug--ion exchange resin complexes► Subscribe
9,549,989Modified release formulations containing drug-ion exchange resin complexes► 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 hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2005035000► Subscribe
European Patent Office1126826► Subscribe
Austria325606► Subscribe
European Patent Office2103307► Subscribe
European Patent Office1905432► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cerilliant
McKinsey
Chubb
Johnson and Johnson
Fuji
US Army
Dow
Accenture
Mallinckrodt
Baxter

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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