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Last Updated: May 26, 2022

METHYLIN Drug Patent 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-four suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Drug patent expirations by year for METHYLIN
Drug Prices for METHYLIN

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Drug Sales Revenue Trends for METHYLIN

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Recent Clinical Trials for METHYLIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Nicoleta StoiceaPhase 1
Boston Children's HospitalPhase 1
Dana-Farber Cancer InstitutePhase 1

See all METHYLIN clinical trials

Paragraph IV (Patent) Challenges for METHYLIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
METHYLIN Oral Solution methylphenidate hydrochloride 5 mg/5 mL 10 mg/5 mL 021419 1 2010-04-13

US Patents and Regulatory Information for METHYLIN

METHYLIN is protected by one US patents.

Patents protecting METHYLIN

Methylphenidate solution and associated methods of administration and production
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Specgx Llc METHYLIN ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 075629-002 May 9, 2000 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Specgx Llc METHYLIN methylphenidate hydrochloride TABLET, CHEWABLE;ORAL 021475-002 Apr 15, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Specgx Llc METHYLIN methylphenidate hydrochloride SOLUTION;ORAL 021419-002 Dec 19, 2002 AA RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Specgx Llc METHYLIN methylphenidate hydrochloride TABLET, CHEWABLE;ORAL 021475-001 Apr 15, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Specgx Llc METHYLIN ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 075629-001 May 9, 2000 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Specgx Llc METHYLIN methylphenidate hydrochloride TABLET, CHEWABLE;ORAL 021475-003 Apr 15, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for METHYLIN

See the table below for patents covering METHYLIN around the world.

Country Patent Number Title Estimated Expiration
Canada 2540052 SOLUTION DE METHYLPHENIDATE ET PROCEDES ASSOCIES D'ADMINISTRATION ET DE PRODUCTION (METHYLPHENIDATE SOLUTION AND ASSOCIATED METHODS OF ADMINISTRATION AND PRODUCTION) See Plans and Pricing
Japan 2007508313 See Plans and Pricing
Japan 4959335 See Plans and Pricing
Spain 2373042 See Plans and Pricing
Austria 526988 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2005035000 See Plans and Pricing
China 1867359 Methylphenidate solution and associated methods of administration and produciton See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
McKinsey
Mallinckrodt
Baxter
Merck

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 verification 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.