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Serving hundreds of leading biopharmaceutical companies globally:

Teva
McKinsey
Federal Trade Commission
Cerilliant
Covington
Queensland Health
QuintilesIMS
McKesson
AstraZeneca

Generated: July 21, 2018

DrugPatentWatch Database Preview

BYDUREON BCISE Drug Profile

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Which patents cover Bydureon Bcise, and when can generic versions of Bydureon Bcise launch?

Bydureon Bcise is a drug marketed by Astrazeneca Ab and is included in one NDA. There are seventeen patents protecting this drug.

This drug has three hundred and thirty-eight patent family members in thirty-two countries.

The generic ingredient in BYDUREON BCISE is exenatide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the exenatide profile page.
Drug patent expirations by year for BYDUREON BCISE
Generic Entry Opportunity Date for BYDUREON BCISE
Generic Entry Date for BYDUREON BCISE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
SUSPENSION, EXTENDED RELEASE;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.

US Patents and Regulatory Information for BYDUREON BCISE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 BYDUREON BCISE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ➤ Sign Up ➤ Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for BYDUREON BCISE

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
7,906,146 Lyophilized formulations of exendins and exendin agonist analogs ➤ Sign Up
7,297,761 Pharmaceutical compositions containing exendins ➤ Sign Up
7,524,530 Residual solvent extraction method and microparticles produced thereby ➤ Sign Up
7,696,161 Exendin agonist compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for BYDUREON BCISE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
342 Luxembourg ➤ Sign Up 91342, EXPIRES: 20211120
31/2007 Austria ➤ Sign Up PRODUCT NAME: EXENATIDE
989 Luxembourg ➤ Sign Up 91989, EXPIRES: 20260617
2012000028 Germany ➤ Sign Up PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Teva
US Department of Justice
Harvard Business School
Boehringer Ingelheim
Baxter
Covington
Mallinckrodt
McKesson

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.