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RITALIN LA Drug Profile

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Ritalin La is a drug marketed by Novartis and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and seventy-four patent family members in thirty-two countries.

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

Summary for Tradename: RITALIN LA

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: RITALIN LA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-004Apr 10, 2004RXNo6,228,398► subscribeY ► subscribe
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-001Jun 5, 2002RXNo5,837,284► subscribeY ► subscribe
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-004Apr 10, 2004RXNo5,837,284► subscribeY ► subscribe
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Expired Patents for Tradename: RITALIN LA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-003Jun 5, 20026,635,284► subscribe
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-003Jun 5, 20025,837,284► subscribe
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-001Jun 5, 20025,837,284► subscribe
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Paragraph IV activity for: RITALIN LA

Drugname Dosage Strength RLD Submissiondate
metformin hydrochlorideExtended-release Capsules10 mgRitalin LA5/21/2007
metformin hydrochlorideExtended-release Capsules20 mg, 30 mg and 40 mgRitalin LA8/21/2006

Premature patent expiration for: RITALIN LA

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
7,431,944
RITALIN LA
October 07, 2016

Non-Orange Book Patents for Tradename: RITALIN LA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,793,936 Multiparticulate modified release composition► subscribe
5,733,756 Lactams and processes for stereoselective enrichment of lactams, amides, and esters► subscribe
6,355,656 Phenidate drug formulations having diminished abuse potential► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: RITALIN LA

Country Document Number Estimated Expiration
Canada2465077► subscribe
South Korea20080047509► subscribe
Peru13222000► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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