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SYMLIN Drug Profile

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Symlin is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug.

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 list2

Pharmacology for Tradename: SYMLIN

Drug ClassAmylin Analog
Mechanism of ActionAmylin 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;SUBCUTANEOUS021332-002Sep 25, 2007RXNo5,686,411<disabled>YY <disabled>
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007RXYes5,686,411<disabled>YY <disabled>
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007RXYes5,814,600<disabled> <disabled>
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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;SUBCUTANEOUS021332-001Mar 16, 20055,175,145<disabled>
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 20077,271,238<disabled>
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-002Sep 25, 20075,814,600<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
6,048,514 Amylin activity assays<disabled in preview>
5,508,260 Methods and compositions for treatment of diabetes mellitus, hypoglycemia, and other conditions<disabled in preview>
5,527,771 Methods and Compositions for treatment of diabetes mellitus, hypoglycemia & 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
Australia648895<disabled in preview>
Canada2171207<disabled in preview>
Singapore98356<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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