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STALEVO 100 Drug Profile
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This drug has fifty-two patent family members in forty countries.
The generic ingredient in STALEVO 100 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.
Summary for Tradename: STALEVO 100
| Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: : | see details |
Pharmacology for Tradename: STALEVO 100
Clinical Trials for: STALEVO 100
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Orion Pharma | STALEVO 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | RX | No | 6,500,867 | Jun 29, 2020 | Y | |||||||||||||||||||
Orion Pharma | STALEVO 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | RX | No | 6,797,732 | Jun 29, 2020 | Y | |||||||||||||||||||
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Expired Patents for Tradename: STALEVO 100
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Orion Pharma | STALEVO 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | 4,963,590 | <disabled> | ||||||||||||||||||||||
Orion Pharma | STALEVO 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | 5,446,194 | <disabled> | ||||||||||||||||||||||
Orion Pharma | STALEVO 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | 5,135,950 | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: STALEVO 100
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| carbidopa, levodopa and entacapone | Tablets | 25/100/200 mg and 37.5/150/200 mg | Stalevo 100 | 6/29/2007 |
International Patent Family for Tradename: STALEVO 100
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bulgaria | 65364 | <disabled in preview> | |||||||||||||||||||||||||||
| Japan | 4885896 | <disabled in preview> | |||||||||||||||||||||||||||
| Portugal | 1189608 | <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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