RITALIN LA Drug Patent Profile
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Which patents cover Ritalin La, and what generic alternatives are available?
Ritalin La is a drug marketed by Sandoz 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-six 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 27th, 1998.
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Questions you can ask:
- What is the 5 year forecast for RITALIN LA?
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Summary for RITALIN LA
Recent Clinical Trials for RITALIN LA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Johns Hopkins University | Phase 4 |
University of Florida | Early Phase 1 |
University of Zurich | Phase 1 |
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 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-004 | Apr 10, 2004 | AB1 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sandoz | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-003 | Jun 5, 2002 | AB1 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sandoz | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-001 | Jun 5, 2002 | AB1 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sandoz | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-002 | Jun 5, 2002 | AB1 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sandoz | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-005 | Oct 27, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for RITALIN LA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-004 | Apr 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-002 | Jun 5, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-004 | Apr 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-003 | Jun 5, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-002 | Jun 5, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-003 | Jun 5, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RITALIN LA
See the table below for patents covering RITALIN LA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5463223 | ⤷ Sign Up | |
Mexico | 2007016151 | COMPOSICIONES DE LIBERACION CONTROLADA Y EN FORMA DE NANO-PARTICULAS QUE COMPRENDEN COMPUESTOS ARIL-HETEROCICLICOS. (NANOPARTICULATE AND CONTROLLED RELEASE COMPOSITIONS COMPRISING ARYL-HETEROCYCLIC COMPOUNDS.) | ⤷ Sign Up |
New Zealand | 511442 | Multiparticulate modified release composition for multiple dosing of ADD patients with methylphenidate HCl | ⤷ Sign Up |
Japan | 2009541359 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2006132752 | ⤷ Sign Up | |
European Patent Office | 1126826 | COMPOSITION DE METHYLPHENIDATE A LIBERATION MODIFIEE MULTIPARTICULAIRE (MULTIPARTICULATE MODIFIED RELEASE COMPOSITION OF METHYLPHENIDATE) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |