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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Cerilliant
Citi
Cipla
McKinsey
McKesson
Covington
Harvard Business School
Colorcon
Moodys

Generated: January 18, 2018

DrugPatentWatch Database Preview

BYDUREON Drug Profile

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

Bydureon is a drug marketed by Astrazeneca Ab and is included in two NDAs. There are thirty-eight patents protecting this drug.

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

The generic ingredient in BYDUREON 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.
Summary for BYDUREON
Drug patent expirations by year for BYDUREON
Pharmacology for BYDUREON

US Patents and Regulatory Information for BYDUREON

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 PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for BYDUREON

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
7,138,375 Use of exendins and agonists thereof for lowering plasma lipid ➤ Subscribe
7,700,549 Exendin agonist analogs to treat diabetes ➤ Subscribe
6,296,842 Process for the preparation of polymer-based sustained release compositions ➤ Subscribe
8,263,550 Exendin agonist compounds ➤ Subscribe
7,858,740 Exendin agonist compounds ➤ Subscribe
8,187,672 Residual solvent extraction method and microparticles produced thereby ➤ Subscribe
7,297,761 Pharmaceutical compositions containing exendins ➤ Subscribe
8,293,871 Poly(lactide-co-glycolide) based sustained release microcapsules comprising a polypeptide and a sugar ➤ Subscribe
7,223,725 Exendin agonist compounds ➤ Subscribe
7,157,555 Exendin agonist compounds ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for BYDUREON

Supplementary Protection Certificates for BYDUREON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1734971/01 Switzerland ➤ Subscribe PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
0526 Netherlands ➤ Subscribe PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
0996459/01 Switzerland ➤ Subscribe FORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US
30/2007 Austria ➤ Subscribe PRODUCT NAME: EXENATIDE
31/2007 Austria ➤ Subscribe PRODUCT NAME: EXENATIDE
90031-9 Sweden ➤ Subscribe PRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
2007 00034 Denmark ➤ Subscribe
4 Finland ➤ Subscribe
00526 Netherlands ➤ Subscribe PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
2012 00015 Denmark ➤ Subscribe
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Farmers Insurance
Merck
Healthtrust
Cantor Fitzgerald
Julphar
McKinsey
Deloitte
AstraZeneca

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