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METHYLIN Drug Profile

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Methylin is a drug marketed by Mallinckrodt and Mallinckrodt Inc and is included in three NDAs. It is available from two suppliers. 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-seven suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for Tradename: METHYLIN

Suppliers / Packagers: see list2
Bulk Api Vendors: see list15
Clinical Trials: see list1
Patent Applications: see list5,673
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:METHYLIN at DailyMed

Pharmacology for Tradename: METHYLIN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
methylphenidate hydrochloride
SOLUTION;ORAL021419-001Dec 19, 2002RXYesYes7,691,880► subscribeY ► subscribe
Mallinckrodt Inc
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL075629-002May 9, 2000RXNoNo► subscribe► subscribe
methylphenidate hydrochloride
TABLET, CHEWABLE;ORAL021475-002Apr 15, 2003DISCNYesNo► subscribe► subscribe
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Paragraph IV activity 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
Australia2004280240► subscribe
China1867359► subscribe
Japan2007508313► 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.