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DAYTRANA Drug Profile
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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 list | 1 |
| Drug Prices: : | see details |
Pharmacology for Tradename: DAYTRANA
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
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;TRANSDERMAL | 021514-001 | Apr 6, 2006 | RX | No | 6,210,705 | Sep 30, 2018 | Y | |||||||||||||||||||
Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-002 | Apr 6, 2006 | RX | No | 8,632,802 | Oct 7, 2025 | Y | |||||||||||||||||||
Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-001 | Apr 6, 2006 | RX | No | 9,034,370 | Oct 7, 2025 | Y | |||||||||||||||||||
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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;TRANSDERMAL | 021514-001 | Apr 6, 2006 | 5,958,446 | <disabled> | ||||||||||||||||||||||
Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-003 | Apr 6, 2006 | 5,958,446 | <disabled> | ||||||||||||||||||||||
Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-002 | Apr 6, 2006 | 5,958,446 | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: DAYTRANA
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| methylphenidate | Transdermal System | 10 mg/9 hrs, 15 mg/9 hrs, 20 mg/9 hrs and 30 mg/9 hrs | Daytrana | 4/13/2011 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,916,191 | Device for transdermal administration of drugs including acrylic polymers | <disabled in preview> | |||||||||||||||||||||||||||
| 9,333,263 | Device 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hungary | 226615 | <disabled in preview> | |||||||||||||||||||||||||||
| Japan | 4316800 | <disabled in preview> | |||||||||||||||||||||||||||
| Taiwan | I242452 | <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.
Export unavailable in trial.
Subscribe for complete access.
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