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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Harvard Business School
Fuji
McKesson
Daiichi Sankyo
UBS
Baxter
Accenture
AstraZeneca

Generated: May 27, 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-seven patents protecting this drug.

This drug has five hundred and twenty-seven patent family members in forty-six 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.
Drug patent expirations by year for BYDUREON
Pharmacology for BYDUREON
Synonyms for BYDUREON
141758-74-9
286014-72-0
335149-21-8
9P1872D4OL
AC 2993
AC002993
AC2993A
AKOS015994651
Bydureon Pen
Byetta
CS-1174
DA 3091
Exenatide
Exenatide [USAN:INN:BAN:JAN]
Exenatide; Exendin-4
Exendin 3 (Heloderma horridum), 2-glycine-3-L-glutamic acid-
Exendin 4
Exendin-4
HS-2012
HSDB 7789
HY-13443
ITCA 650
LY 2148568
MolPort-009-194-177
PT302
SCHEMBL14634818
UNII-9P1872D4OL
Y-100006

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial 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 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 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ➤ 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 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
8,293,871 Poly(lactide-co-glycolide) based sustained release microcapsules comprising a polypeptide and a sugar ➤ Try a Free Trial
7,521,423 Exendin pharmaceutical compositions ➤ Try a Free Trial
7,875,310 Residual solvent extraction method and microparticles produced thereby ➤ Try a Free Trial
7,799,345 Preparation of injectable suspensions having improved injectability ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for BYDUREON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007 00034 Denmark ➤ Try a Free Trial
2012006 Lithuania ➤ Try a Free Trial PRODUCT NAME: EXENATIDUM; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110617
342 Luxembourg ➤ Try a Free Trial 91342, EXPIRES: 20211120
2012000028 Germany ➤ Try a Free Trial 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:

Teva
Boehringer Ingelheim
Accenture
Citi
Covington
Chubb
Medtronic
Merck
Argus Health

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.