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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for Patent: 6,858,576

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Which drugs does patent 6,858,576 protect, and when does it expire?


Patent 6,858,576 protects BYDUREON, BYDUREON PEN, and BYETTA, and is included in two NDAs. There has been one Paragraph IV challenge on Byetta.

This patent has seventy-five patent family members in seventeen countries.

Summary for Patent: 6,858,576

Title: Methods for regulating gastrointestinal motility
Abstract:Methods for reducing gastric motility and delaying gastric emptying for therapeutic and diagnostic purposes are disclosed which comprise administration of an effective amount of an exendin or an exendin agonist. Methods for treating conditions associated with elevated, inappropriate, or undesired post-prandial blood glucose levels are disclosed which comprise administration of an effective amount of an exendin or an exendin agonist alone or in conjunction with other anti-gastric emptying agents.
Inventor(s): Young; Andrew A. (San Diego, CA), Gedulin; Bronislava (San Diego, CA), Beeley; Nigel Robert Arnold (Solana Beach, CA), Prickett; Kathryn S. (San Diego, CA)
Assignee: Amylin Pharmaceuticals, Inc. (San Diego, CA)
Application Number:08/908,867
Patent Claim Types:
see list of patent claims
Use; Compound;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
Astrazeneca AbBYDUREONexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012RXYesYes► Subscribe► Subscribe► SubscribeREDUCING GASTRIC MOTILITY OR DELAYING GASTRIC EMPTYING BY ADMINISTERING AN EXENDIN, SUCH AS EXENDIN-4
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe► SubscribeREDUCING GASTRIC MOTILITY OR DELAYING GASTRIC EMPTYING BY ADMINISTERING AN EXENDIN, SUCH AS EXENDIN-4
Astrazeneca AbBYETTAexenatide syntheticINJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005RXYesYes► Subscribe► Subscribe► SubscribeREDUCING GASTRIC MOTILITY OR DELAYING GASTRIC EMPTYING BY ADMINISTERING AN EXENDIN, SUCH AS EXENDIN-4
Astrazeneca AbBYETTAexenatide syntheticINJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005RXYesYes► Subscribe► Subscribe► SubscribeTREATING TYPE 2 DIABETES MELLITUS WITH EXENATIDE BY STIMULATING INSULIN RELEASE
Astrazeneca AbBYETTAexenatide syntheticINJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes► Subscribe► Subscribe► SubscribeTREATING TYPE 2 DIABETES MELLITUS WITH EXENATIDE BY STIMULATING INSULIN RELEASE
Astrazeneca AbBYETTAexenatide syntheticINJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes► Subscribe► Subscribe► SubscribeREDUCING GASTRIC MOTILITY OR DELAYING GASTRIC EMPTYING BY ADMINISTERING AN EXENDIN, SUCH AS EXENDIN-4
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Non-Orange Book Patents for Patent: 6,858,576

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
8,288,338Exendin and exendin agonists for eating disorders► Subscribe
7,223,725Exendin agonist compounds► Subscribe
8,026,210Exendins and exendin agonist analogs to regulate gastrointestinal motility► Subscribe
7,700,549Exendin agonist analogs to treat diabetes► Subscribe
6,956,026 Use of exendins for the reduction of food intake► Subscribe
7,297,761Pharmaceutical compositions containing exendins► Subscribe
7,741,269Exendins and exendin agonists for weight reduction and obesity► Subscribe
7,419,952Use of exendins and agonists thereof to treat diabetes► Subscribe
7,220,721Exendin agonist peptides► Subscribe
7,138,375Use of exendins and agonists thereof for lowering plasma lipid► Subscribe
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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 Patent: 6,858,576

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria304864► Subscribe
Austria381939► Subscribe
Austria383867► Subscribe
Austria417622► Subscribe
Austria493998► Subscribe
Australia1404699► Subscribe
Australia1458899► Subscribe
Australia2003200129► Subscribe
Australia2003203955► Subscribe
Australia2006225176► Subscribe
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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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Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
McKinsey
Dow
Federal Trade Commission
AstraZeneca
McKesson
Baxter
Julphar
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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