RITALIN LA Drug Patent Profile

Which patents cover Ritalin La, and what generic alternatives are available?

Ritalin La is a drug marketed by Novartis and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ritalin La

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

Summary for RITALIN LA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	121
Patent Applications:	3,386
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RITALIN LA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RITALIN LA
DailyMed Link:	RITALIN LA at DailyMed

See drug prices for RITALIN LA

See drug sales revenues for RITALIN LA

Recent Clinical Trials for RITALIN LA

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

Sponsor	Phase
University of Haifa	Phase 2
Ariel University	Phase 2/Phase 3
Maccabi Healthcare Services, Israel	Phase 2/Phase 3

See all RITALIN LA clinical trials

Pharmacology for RITALIN LA

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

Anatomical Therapeutic Chemical (ATC) Classes for RITALIN LA

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

Paragraph IV (Patent) Challenges for RITALIN LA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RITALIN LA	Extended-release Capsules	methylphenidate hydrochloride	10 mg	021284	1	2007-05-21
RITALIN LA	Extended-release Capsules	methylphenidate hydrochloride	20 mg, 30 mg and 40 mg	021284		2006-08-21

US Patents and Regulatory Information for RITALIN LA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-004	Apr 10, 2004	AB1	RX	Yes	No
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-003	Jun 5, 2002	AB1	RX	Yes	No
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-001	Jun 5, 2002	AB1	RX	Yes	No
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-002	Jun 5, 2002	AB1	RX	Yes	No

Expired US Patents for RITALIN LA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-002	Jun 5, 2002
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-002	Jun 5, 2002
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-003	Jun 5, 2002
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-004	Apr 10, 2004

International Patents for RITALIN LA

See the table below for patents covering RITALIN LA around the world.

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	200702595
Australia	1335000
South Korea	20080024206
China	101242813