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Last Updated: July 10, 2020

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METHYLIN Drug Profile


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When do Methylin patents expire, and what generic alternatives are available?

Methylin is a drug marketed by Specgx Llc 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-two drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Paragraph IV (Patent) Challenges for METHYLIN
Tradename Dosage Ingredient NDA Submissiondate
METHYLIN SOLUTION;ORAL methylphenidate hydrochloride 021419 2010-04-13

US Patents and Regulatory Information for METHYLIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Specgx Llc METHYLIN methylphenidate hydrochloride SOLUTION;ORAL 021419-001 Dec 19, 2002 AA RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Specgx Llc METHYLIN ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 075629-002 May 9, 2000 AB RX No No   Start Trial   Start Trial   Start Trial
Specgx Llc METHYLIN methylphenidate hydrochloride TABLET, CHEWABLE;ORAL 021475-002 Apr 15, 2003 DISCN Yes No   Start Trial   Start Trial   Start Trial
Specgx Llc METHYLIN methylphenidate hydrochloride SOLUTION;ORAL 021419-002 Dec 19, 2002 AA RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Specgx Llc METHYLIN methylphenidate hydrochloride TABLET, CHEWABLE;ORAL 021475-001 Apr 15, 2003 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
McKinsey
Mallinckrodt
Baxter
Merck

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