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Generated: September 23, 2018

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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.

The generic ingredient in METHYLIN is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Specgx Llc METHYLIN ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 075629-002 May 9, 2000 AB RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Specgx Llc METHYLIN methylphenidate hydrochloride TABLET, CHEWABLE;ORAL 021475-002 Apr 15, 2003 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Specgx Llc METHYLIN methylphenidate hydrochloride SOLUTION;ORAL 021419-002 Dec 19, 2002 AA RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Paragraph IV (Patent) Challenges for METHYLIN
Drugname Dosage Strength RLD Date
➤ Subscribe Oral Solution 5 mg/5 mL and 10 mg/5 mL ➤ Subscribe ➤ Sign Up

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Healthtrust
Teva
US Department of Justice
Mallinckrodt
Fuji
Boehringer Ingelheim
Cipla
Argus Health

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