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Serving leading biopharmaceutical companies globally:

Argus Health
Daiichi Sankyo
Fuji
Dow
Cerilliant
UBS
US Department of Justice
Merck
McKesson
Julphar

Generated: November 24, 2017

DrugPatentWatch Database Preview

METHYLIN Drug Profile

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What is the patent landscape for Methylin, and when can generic versions of Methylin launch?

Methylin is a drug marketed by Mallinckrodt and Mallinckrodt Inc and is included in three NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in nine countries.

The generic ingredient in METHYLIN is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt
METHYLIN
methylphenidate hydrochloride
SOLUTION;ORAL021419-001Dec 19, 2002AARXYesYes► Subscribe► SubscribeY ► Subscribe
Mallinckrodt Inc
METHYLIN ER
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL075629-002May 9, 2000ABRXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt
METHYLIN
methylphenidate hydrochloride
TABLET, CHEWABLE;ORAL021475-002Apr 15, 2003DISCNYesNo► Subscribe► Subscribe► Subscribe
Mallinckrodt
METHYLIN
methylphenidate hydrochloride
SOLUTION;ORAL021419-002Dec 19, 2002AARXYesYes► Subscribe► SubscribeY ► Subscribe
Mallinckrodt
METHYLIN
methylphenidate hydrochloride
TABLET, CHEWABLE;ORAL021475-001Apr 15, 2003DISCNYesNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
METHYLIN ER
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL075629-001May 9, 2000ABRXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt
METHYLIN
methylphenidate hydrochloride
TABLET, CHEWABLE;ORAL021475-003Apr 15, 2003DISCNYesNo► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for METHYLIN

Drugname Dosage Strength RLD Submissiondate
methylphenidate hydrochlorideOral Solution5 mg/5 mL and 10 mg/5 mLMethylin4/13/2010

International Patent Family for Tradename: METHYLIN

Country Document Number Estimated Expiration
China1867359► Subscribe
Australia2004280240► Subscribe
Austria526988► Subscribe
Japan2007508313► Subscribe
European Patent Office1680144► Subscribe
Canada2540052► Subscribe
MexicoPA06003725► Subscribe
World Intellectual Property Organization (WIPO)2005035000► Subscribe
Spain2373042► Subscribe
Japan4959335► 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:

Merck
McKinsey
Harvard Business School
Novartis
Fuji
UBS
AstraZeneca
Medtronic
Chinese Patent Office
Chubb

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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