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RITALIN LA Drug Profile

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

US ANDA 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
Suppliers / Packagers:	2
Bulk Api Vendors:	47
Clinical Trials:	108
Patent Applications:	3,048
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
Wingate Institute	Phase 4
Loewenstein Hospital	Phase 4
Tel Aviv University	Phase 4

See all RITALIN LA clinical trials

Pharmacology for RITALIN LA

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

Paragraph IV (Patent) Challenges for RITALIN LA

Tradename	Dosage	Ingredient	NDA	Submissiondate
RITALIN LA	CAPSULE, EXTENDED RELEASE;ORAL	methylphenidate hydrochloride	021284	2007-05-21
RITALIN LA	CAPSULE, EXTENDED RELEASE;ORAL	methylphenidate hydrochloride	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
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-005	Oct 27, 2014		DISCN	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	021284-003	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	021284-001	Jun 5, 2002
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-004	Apr 10, 2004
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-003	Jun 5, 2002

International Patents for RITALIN LA

Country	Patent Number	Estimated Expiration
Japan	2002510318
Indonesia	29852
Israel	142896
Hungary	230454
Australia	2007260822