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DAYTRANA Drug Profile

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Daytrana is a drug marketed by Noven Pharms Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has forty-three patent family members in twenty-eight countries.

The generic ingredient in DAYTRANA is methylphenidate. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. There is one tentative approval for this compound. Additional details are available on the methylphenidate profile page.

Summary for Tradename: DAYTRANA

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: DAYTRANA

Clinical Trials for: DAYTRANA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-001Apr 6, 2006RXNo6,210,705<disabled>Y <disabled>
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-002Apr 6, 2006RXNo8,632,802<disabled>Y <disabled>
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-001Apr 6, 2006RXNo9,034,370<disabled>Y <disabled>
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Expired Patents for Tradename: DAYTRANA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-003Apr 6, 20065,958,446<disabled>
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-001Apr 6, 20065,958,446<disabled>
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-002Apr 6, 20065,958,446<disabled>
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Paragraph IV activity for: DAYTRANA

Drugname Dosage Strength RLD Submissiondate
methylphenidateTransdermal System10 mg/9 hrs, 15 mg/9 hrs, 20 mg/9 hrs and 30 mg/9 hrsDaytrana4/13/2011

Non-Orange Book Patents for Tradename: DAYTRANA

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
8,916,191Device for transdermal administration of drugs including acrylic polymers<disabled in preview>
9,333,263Device for transdermal administration of drugs including acrylic based 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: DAYTRANA

Country Document Number Estimated Expiration
Poland341596<disabled in preview>
Slovenia20360<disabled in preview>
Austria260652<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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