Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
McKesson
Medtronic
Mallinckrodt
AstraZeneca

Last Updated: August 10, 2022

BYDUREON Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 twenty-three patents protecting this drug.

This drug has three hundred and seventy-one patent family members in forty-six countries.

The generic ingredient in BYDUREON is exenatide synthetic. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the exenatide synthetic profile page.

DrugPatentWatch® Generic Entry Outlook for Bydureon

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 20, 2027. This may change due to patent challenges or generic licensing.

There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

< Available with Subscription >

  Sign up for a Free Trial

Drug patent expirations by year for BYDUREON
Drug Prices for BYDUREON

See drug prices for BYDUREON

Drug Sales Revenue Trends for BYDUREON

See drug sales revenues for BYDUREON

DrugPatentWatch® Estimated Generic Entry Opportunity Date for BYDUREON
Generic Entry Date for BYDUREON*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR 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.

Recent Clinical Trials for BYDUREON

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of WashingtonPhase 3
Dasman Diabetes InstitutePhase 4
Peking Union Medical College HospitalPhase 4

See all BYDUREON clinical trials

Pharmacology for BYDUREON

US Patents and Regulatory Information for BYDUREON

BYDUREON is protected by fourteen US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BYDUREON is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BYDUREON

C-aryl glucoside SGLT2 inhibitors and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Residual solvent extraction method and microparticles produced thereby
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Residual solvent extraction method and microparticles produced thereby
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating diabetes and reducing body weight
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for treating diabetes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating diabetes and reducing body weight
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting BYDUREON

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

INFORMATION ADDED TO LABELING REGARDING A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE CARDIOVASCULAR OUTCOMES AFTER TREATMENT WITH EXENATIDE ONCE WEEKLY IN PATIENTS WITH TYPE 2 DIABETES MELLITES
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

International Patents for BYDUREON

When does loss-of-exclusivity occur for BYDUREON?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1730
Estimated Expiration: See Plans and Pricing

Australia

Patent: 07265246
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0713544
Estimated Expiration: See Plans and Pricing

Patent: 2017015106
Estimated Expiration: See Plans and Pricing

Patent: 2017021516
Estimated Expiration: See Plans and Pricing

Canada

Patent: 53344
Estimated Expiration: See Plans and Pricing

Patent: 24318
Estimated Expiration: See Plans and Pricing

Patent: 85797
Estimated Expiration: See Plans and Pricing

Chile

Patent: 07001915
Estimated Expiration: See Plans and Pricing

China

Patent: 1479287
Estimated Expiration: See Plans and Pricing

Patent: 3145773
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 60299
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0141007
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 15738
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 69374
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8229
Estimated Expiration: See Plans and Pricing

Patent: 0428
Estimated Expiration: See Plans and Pricing

Patent: 8259
Estimated Expiration: See Plans and Pricing

Patent: 5999
Estimated Expiration: See Plans and Pricing

Patent: 0900066
Estimated Expiration: See Plans and Pricing

Patent: 1171333
Estimated Expiration: See Plans and Pricing

Patent: 1490902
Estimated Expiration: See Plans and Pricing

Patent: 1791254
Estimated Expiration: See Plans and Pricing

Patent: 2091391
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 69374
Estimated Expiration: See Plans and Pricing

Patent: 57918
Estimated Expiration: See Plans and Pricing

Patent: 45466
Estimated Expiration: See Plans and Pricing

Patent: 63807
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 27359
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5882
Estimated Expiration: See Plans and Pricing

Patent: 4180
Estimated Expiration: See Plans and Pricing

Patent: 4181
Estimated Expiration: See Plans and Pricing

Patent: 4182
Estimated Expiration: See Plans and Pricing

Patent: 5688
Estimated Expiration: See Plans and Pricing

Japan

Patent: 13889
Estimated Expiration: See Plans and Pricing

Patent: 66651
Estimated Expiration: See Plans and Pricing

Patent: 37187
Estimated Expiration: See Plans and Pricing

Patent: 09545525
Estimated Expiration: See Plans and Pricing

Patent: 13209394
Estimated Expiration: See Plans and Pricing

Patent: 15071636
Estimated Expiration: See Plans and Pricing

Patent: 16172758
Estimated Expiration: See Plans and Pricing

Patent: 17222681
Estimated Expiration: See Plans and Pricing

Patent: 19059779
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 8566
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 9143
Estimated Expiration: See Plans and Pricing

Patent: 7155
Estimated Expiration: See Plans and Pricing

Patent: 08015377
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4346
Estimated Expiration: See Plans and Pricing

Patent: 9190
Estimated Expiration: See Plans and Pricing

Patent: 9195
Estimated Expiration: See Plans and Pricing

Patent: 9202
Estimated Expiration: See Plans and Pricing

Norway

Patent: 085169
Estimated Expiration: See Plans and Pricing

Peru

Patent: 080349
Estimated Expiration: See Plans and Pricing

Patent: 120776
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 012500168
Estimated Expiration: See Plans and Pricing

Poland

Patent: 69374
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 69374
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 638
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 2741
Estimated Expiration: See Plans and Pricing

Patent: 201402181S
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 69374
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0810475
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1493102
Estimated Expiration: See Plans and Pricing

Patent: 090023643
Estimated Expiration: See Plans and Pricing

Spain

Patent: 21665
Estimated Expiration: See Plans and Pricing

Patent: 59862
Estimated Expiration: See Plans and Pricing

Patent: 69130
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 21245
Estimated Expiration: See Plans and Pricing

Patent: 66876
Estimated Expiration: See Plans and Pricing

Patent: 19528
Estimated Expiration: See Plans and Pricing

Patent: 0811127
Estimated Expiration: See Plans and Pricing

Patent: 1406743
Estimated Expiration: See Plans and Pricing

Patent: 1509927
Estimated Expiration: See Plans and Pricing

Patent: 1546054
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 765
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BYDUREON around the world.

Country Patent Number Title Estimated Expiration
Japan 2010523181 See Plans and Pricing
Eurasian Patent Organization 200900066 КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ) -D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА See Plans and Pricing
Australia 757748 See Plans and Pricing
Cyprus 1117734 See Plans and Pricing
Israel 230632 מיקרורפסולות לשחרור משוהה של חומר פעיל המבוסס על פולי (לקטיד-קו-גליקוליד) המכילות פוליפפטיד וסוכר (Poly (lactide-co-glycolide)-based sustained release microcapsules comprising a polypeptide and a sugar) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BYDUREON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1734971 C300526 Netherlands See Plans and Pricing PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1506211 PA2013008 Lithuania See Plans and Pricing PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211 C20130006 00074 Estonia See Plans and Pricing PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012
1506211 179 5017-2014 Slovakia See Plans and Pricing PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
1140145 CA 2007 00033 Denmark See Plans and Pricing PRODUCT NAME: EXENATID, EXENDIN, EXENDINAGONISTER; REG. NO/DATE: EU/1/06/362/001-004 20061120
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Medtronic
Moodys
Dow
AstraZeneca
McKinsey

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 verification 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.