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SYMLIN Drug Profile
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This drug has one hundred and nineteen patent family members in twenty-six countries.
The generic ingredient in SYMLIN is pramlintide acetate. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pramlintide acetate profile page.
Summary for Tradename: SYMLIN
| Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Drug Prices: : | see details |
Pharmacology for Tradename: SYMLIN
| Drug Class | Amylin Analog |
| Mechanism of Action | Amylin Agonists |
Clinical Trials for: SYMLIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-002 | Sep 25, 2007 | RX | No | 5,686,411 | Mar 16, 2019 | Y | Y | ||||||||||||||||||
Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-003 | Sep 25, 2007 | RX | Yes | 5,686,411 | Mar 16, 2019 | Y | Y | ||||||||||||||||||
Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-003 | Sep 25, 2007 | RX | Yes | 5,814,600 | Sep 29, 2015 | ||||||||||||||||||||
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Expired Patents for Tradename: SYMLIN
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-001 | Mar 16, 2005 | 5,175,145 | <disabled> | ||||||||||||||||||||||
Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-003 | Sep 25, 2007 | 7,407,934 | <disabled> | ||||||||||||||||||||||
Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-001 | Mar 16, 2005 | 5,998,367 | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Tradename: SYMLIN
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,407,934 | Methods for regulating postprandial blood glucose | <disabled in preview> | |||||||||||||||||||||||||||
| 5,424,394 | Synthetic preparation of amylin and amylin analogues | <disabled in preview> | |||||||||||||||||||||||||||
| 5,508,260 | Methods and compositions for treatment of diabetes mellitus, hypoglycemia, and other conditions | <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: SYMLIN
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Greece | 3035387 | <disabled in preview> | |||||||||||||||||||||||||||
| Denmark | 0586589 | <disabled in preview> | |||||||||||||||||||||||||||
| Japan | 2818296 | <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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