METHYLIN Drug Patent Profile

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-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Methylin

A generic version of METHYLIN was approved as methylphenidate hydrochloride by SPECGX LLC on November 27^th, 1998.

Summary for METHYLIN

International Patents:	10
US Patents:	1
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	3
Patent Applications:	5,033
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for METHYLIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for METHYLIN
What excipients (inactive ingredients) are in METHYLIN?	METHYLIN excipients list
DailyMed Link:	METHYLIN at DailyMed

See drug prices for METHYLIN

See drug sales revenues for METHYLIN

Recent Clinical Trials for METHYLIN

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

Sponsor	Phase
Nicoleta Stoicea	Phase 1
Dana-Farber Cancer Institute	Phase 1
Boston Children’s Hospital	Phase 1

See all METHYLIN clinical trials

Pharmacology for METHYLIN

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Anatomical Therapeutic Chemical (ATC) Classes for METHYLIN

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

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

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			Y
Specgx Llc	METHYLIN ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	075629-002	May 9, 2000	AB	RX	No	No
Specgx Llc	METHYLIN	methylphenidate hydrochloride	TABLET, CHEWABLE;ORAL	021475-002	Apr 15, 2003		DISCN	Yes	No
Specgx Llc	METHYLIN	methylphenidate hydrochloride	SOLUTION;ORAL	021419-002	Dec 19, 2002	AA	RX	Yes	Yes			Y
Specgx Llc	METHYLIN	methylphenidate hydrochloride	TABLET, CHEWABLE;ORAL	021475-001	Apr 15, 2003		DISCN	Yes	No
Specgx Llc	METHYLIN ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	075629-001	May 9, 2000	AB	RX	No	No
Specgx Llc	METHYLIN	methylphenidate hydrochloride	TABLET, CHEWABLE;ORAL	021475-003	Apr 15, 2003		DISCN	Yes	No

International Patents for METHYLIN

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

Country	Patent Number	Title	Estimated Expiration
China	1867359	Methylphenidate solution and associated methods of administration and produciton
Japan	4959335
Spain	2373042
Austria	526988
Mexico	PA06003725	SOLUCION DE FENIDATO DE METILO Y METODOS ASOCIADOS DE ADMINISTRACION Y PRODUCCION. (METHYLPHENIDATE SOLUTION AND ASSOCIATED METHODS OF ADMINISTRATION AND PRODUCTION.)
World Intellectual Property Organization (WIPO)	2005035000
Japan	2007508313