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Methylphenidate hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for methylphenidate hydrochloride?

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, 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-eight 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.

This ingredient has two hundred and eighty-three patent family members in thirty-six countries.

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

Summary for Generic Name: methylphenidate hydrochloride

Tradenames:12
Patents:28
Applicants:27
NDAs:48
Drug Master File Entries: see list31
Suppliers / Packagers: see list37
Bulk Api Vendors: see list28
Clinical Trials: see list1,135
Patent Applications: see list2,350
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. Form Dosage
► Subscribe► SubscribeTABLET, EXTENDED RELEASE;ORAL18MG
► Subscribe► SubscribeTABLET, EXTENDED RELEASE;ORAL27MG
► Subscribe► SubscribeTABLET, EXTENDED RELEASE;ORAL36MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novel Labs Inc
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET, CHEWABLE;ORAL204115-002Feb 25, 2015RXNoNo► Subscribe► Subscribe
Rhodes Pharms
APTENSIO XR
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205831-005Apr 17, 2015RXYesNo► Subscribe► Subscribe
Nostrum Labs Inc
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET;ORAL207587-003Mar 3, 2017RXNoNo► Subscribe► Subscribe
Mallinckrodt
METHYLIN
methylphenidate hydrochloride
TABLET, CHEWABLE;ORAL021475-001Apr 15, 2003DISCNYesNo► Subscribe► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-002Aug 1, 2000RXYesNo9,144,549► 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;ORAL021121-004Apr 1, 20024,519,801► Subscribe
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-003Jun 5, 20026,635,284► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 20004,519,801► Subscribe
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 20004,612,008*PED► Subscribe
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-001Jun 5, 20025,837,284► 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
8,323,691Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms► Subscribe
8,936,810Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms► Subscribe
9,198,864Modified release formulations containing drug-ion exchange resin complexes► Subscribe
6,673,367 Controlled/modified release oral methylphenidate formulations► Subscribe
6,548,610 Method and apparatus for reducing static charges during polymerization of olefin polymers► 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
Canada2613474► Subscribe
South Korea20090024284► Subscribe
Austria536867► Subscribe
Japan2012184235► Subscribe
World Intellectual Property Organization (WIPO)9823263► 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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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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