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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Argus Health
Teva
Express Scripts
US Army
Healthtrust
Fuji
UBS
Covington

Generated: July 16, 2018

DrugPatentWatch Database Preview

SYMLIN Drug Profile

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When do Symlin patents expire, and what generic alternatives are available?

Symlin is a drug marketed by Astrazeneca Ab and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-two patent family members in sixteen countries.

The generic ingredient in SYMLIN is pramlintide acetate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pramlintide acetate profile page.
Summary for SYMLIN
International Patents:32
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 6
Clinical Trials: 17
DailyMed Link:SYMLIN at DailyMed
Drug patent expirations by year for SYMLIN
Generic Entry Opportunity Date for SYMLIN
Generic Entry Date for SYMLIN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
INJECTABLE;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for SYMLIN
Drug ClassAmylin Analog
Mechanism of ActionAmylin Agonists

US Patents and Regulatory Information for SYMLIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-002 Sep 25, 2007 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-003 Sep 25, 2007 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-001 Mar 16, 2005 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for SYMLIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-003 Sep 25, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-001 Mar 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-002 Sep 25, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-001 Mar 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
5,424,394 Synthetic preparation of amylin and amylin analogues ➤ Try a Free Trial
6,610,824 Amylin agonist peptides and uses therefor ➤ Try a Free Trial
7,271,238 Amylin agonist peptides and uses therefor ➤ Try a Free Trial
5,998,367 Pramlintide pro H-amylin salts and compositions ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Chinese Patent Office
US Department of Justice
Farmers Insurance
Federal Trade Commission
Baxter
AstraZeneca
Covington
Teva

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