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CONCERTA Drug Profile

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Concerta is a drug marketed by Janssen Pharms and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-eight patent family members in seventeen countries.

The generic ingredient in CONCERTA is methylphenidate hydrochloride. There are twenty-five drug master file entries for this compound. Thirty-two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for Tradename: CONCERTA

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list2

Pharmacology for Tradename: CONCERTA

Clinical Trials for: CONCERTA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000RXYes6,919,373*PED<disabled>Y<disabled>
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000RXYes9,000,038*PED<disabled>Y<disabled>
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000RXYes8,629,179*PED<disabled>Y<disabled>
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Expired Patents for Tradename: CONCERTA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-004Apr 1, 20024,783,337*PED<disabled>
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 20004,612,008*PED<disabled>
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 20004,519,801<disabled>
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Paragraph IV activity for: CONCERTA

Drugname Dosage Strength RLD Submissiondate
methylphenidate hydrochlorideExtended-release Tablets18 mg*, 27 mg, 36 mg and 54 mgConcerta7/19/2005
metformin hydrochlorideExtended-release Tablets18 mg, 27 mg, 36 mg and 54 mgConcerta7/19/2005

Non-Orange Book Patents for Tradename: CONCERTA

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
2,015,125,493<disabled in preview>
7,521,067Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms<disabled in preview>
6,548,610 Method and apparatus for reducing static charges during polymerization of olefin polymers<disabled in preview>
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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: CONCERTA

Country Document Number Estimated Expiration
Norway20130342<disabled in preview>
Australia4319799<disabled in preview>
Norway20006007<disabled in preview>
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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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