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Serving leading biopharmaceutical companies globally:

Accenture
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Moodys
Queensland Health
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Daiichi Sankyo

Generated: October 22, 2017

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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, 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-one 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 three hundred and eight patent family members in thirty-six countries.

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

Summary for Generic Name: methylphenidate hydrochloride

US Patents:27
Tradenames:12
Applicants:29
NDAs:51
Drug Master File Entries: see list31
Suppliers / Packagers: see list36
Bulk Api Vendors: see list28
Clinical Trials: see list2,569
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
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
Impax Labs Inc
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL208607-004Jul 14, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Rhodes Pharms
APTENSIO XR
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205831-003Apr 17, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Abhai Llc
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
SOLUTION;ORAL207485-001Nov 18, 2016AARXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL208607-001Jul 14, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL206726-004Oct 21, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Cnty Line Pharms
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL204772-001Feb 29, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL078873-003Jul 19, 2012AB2RXNoNo► Subscribe► Subscribe► Subscribe
Pfizer Inc
QUILLICHEW ER
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL207960-001Dec 4, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Rhodes Pharms
APTENSIO XR
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205831-002Apr 17, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Mayne Pharma
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL078458-004Jun 23, 2016RXNoYes► 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;ORAL021121-001Aug 1, 2000► Subscribe► Subscribe
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-003Jun 5, 2002► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000► Subscribe► Subscribe
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-004Apr 10, 2004► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-004Apr 1, 2002► Subscribe► Subscribe
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-003Jun 5, 2002► Subscribe► Subscribe
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-004Apr 10, 2004► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000► Subscribe► Subscribe
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-002Jun 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
8,790,700Modified release formulations containing drug-ion exchange resin complexes► Subscribe
7,580,712Wireless high-speed data network planning tool► Subscribe
8,323,691Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms► Subscribe
6,905,654 Method and apparatus for reducing static charges during polymerization of olefin polymers► Subscribe
6,034,101 United States Patent: 6034101   ( 1► Subscribe
8,337,890Modified release formulations containing drug-ion exchange resin complexes► Subscribe
9,522,191Modified release formulations containing drug--ion exchange resin complexes► Subscribe
6,548,610 Method and apparatus for reducing static charges during polymerization of olefin polymers► Subscribe
9,549,989Modified release formulations containing drug-ion exchange resin complexes► Subscribe
6,673,367 Controlled/modified release oral methylphenidate formulations► 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
Japan4801149► Subscribe
Norway20101070► Subscribe
Cyprus1117845► Subscribe
BrazilPI0705488► Subscribe
Hong Kong1117060► Subscribe
China1233953► Subscribe
Japan2002513392► Subscribe
Spain2396039► Subscribe
Australia2017202955► Subscribe
Japan2010195822► 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:

Argus Health
Federal Trade Commission
Farmers Insurance
Cantor Fitzgerald
Teva
McKesson
Johnson and Johnson
Fish and Richardson
Fuji
Novartis

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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