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Last Updated: June 21, 2024

bydureon Drug Patent Profile


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When do Bydureon patents expire, and when can generic versions of Bydureon launch?

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

This drug has three hundred and seventy-seven patent family members in forty-eight 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 eight 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

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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 Loss of Exclusivity (LOE) 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
The University of Texas Health Science Center, HoustonPhase 2
University of WashingtonPhase 3
Dasman Diabetes InstitutePhase 4

See all bydureon clinical trials

US Patents and Regulatory Information for bydureon

bydureon is protected by twelve US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of bydureon is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polymer-based sustained release device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polymer-based sustained release device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polymer-based sustained release device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods for treating diabetes and reducing body weight
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polymer-based sustained release device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polymer-based sustained release device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method for treating diabetes
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polymer-based sustained release device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods for treating diabetes and reducing body weight
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting bydureon

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  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

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 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ⤷  Sign Up ⤷  Sign Up
>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: ⤷  Sign Up

Australia

Patent: 07265246
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0713544
Estimated Expiration: ⤷  Sign Up

Patent: 2017015106
Estimated Expiration: ⤷  Sign Up

Patent: 2017021516
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 53344
Estimated Expiration: ⤷  Sign Up

Patent: 24318
Estimated Expiration: ⤷  Sign Up

Patent: 85797
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 07001915
Estimated Expiration: ⤷  Sign Up

China

Patent: 1479287
Estimated Expiration: ⤷  Sign Up

Patent: 3145773
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 60299
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0141007
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 15738
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 69374
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 8229
Estimated Expiration: ⤷  Sign Up

Patent: 0428
Estimated Expiration: ⤷  Sign Up

Patent: 8259
Estimated Expiration: ⤷  Sign Up

Patent: 5999
Estimated Expiration: ⤷  Sign Up

Patent: 0900066
Estimated Expiration: ⤷  Sign Up

Patent: 1171333
Estimated Expiration: ⤷  Sign Up

Patent: 1490902
Estimated Expiration: ⤷  Sign Up

Patent: 1791254
Estimated Expiration: ⤷  Sign Up

Patent: 2091391
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 69374
Estimated Expiration: ⤷  Sign Up

Patent: 57918
Estimated Expiration: ⤷  Sign Up

Patent: 45466
Estimated Expiration: ⤷  Sign Up

Patent: 63807
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 27359
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 5882
Estimated Expiration: ⤷  Sign Up

Patent: 4180
Estimated Expiration: ⤷  Sign Up

Patent: 4181
Estimated Expiration: ⤷  Sign Up

Patent: 4182
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 13889
Estimated Expiration: ⤷  Sign Up

Patent: 66651
Estimated Expiration: ⤷  Sign Up

Patent: 37187
Estimated Expiration: ⤷  Sign Up

Patent: 09545525
Estimated Expiration: ⤷  Sign Up

Patent: 13209394
Estimated Expiration: ⤷  Sign Up

Patent: 15071636
Estimated Expiration: ⤷  Sign Up

Patent: 16172758
Estimated Expiration: ⤷  Sign Up

Patent: 17222681
Estimated Expiration: ⤷  Sign Up

Patent: 19059779
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 8566
Estimated Expiration: ⤷  Sign Up

Patent: 3930
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 9143
Estimated Expiration: ⤷  Sign Up

Patent: 7155
Estimated Expiration: ⤷  Sign Up

Patent: 08015377
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 4346
Estimated Expiration: ⤷  Sign Up

Patent: 9190
Estimated Expiration: ⤷  Sign Up

Patent: 9195
Estimated Expiration: ⤷  Sign Up

Patent: 9202
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 6828
Estimated Expiration: ⤷  Sign Up

Patent: 7770
Estimated Expiration: ⤷  Sign Up

Patent: 085169
Estimated Expiration: ⤷  Sign Up

Patent: 221233
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 080349
Estimated Expiration: ⤷  Sign Up

Patent: 120776
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 012500168
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 69374
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 69374
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 638
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 2741
Estimated Expiration: ⤷  Sign Up

Patent: 201402181S
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 69374
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0810475
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1493102
Estimated Expiration: ⤷  Sign Up

Patent: 090023643
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 21665
Estimated Expiration: ⤷  Sign Up

Patent: 59862
Estimated Expiration: ⤷  Sign Up

Patent: 69130
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 21245
Estimated Expiration: ⤷  Sign Up

Patent: 66876
Estimated Expiration: ⤷  Sign Up

Patent: 19528
Estimated Expiration: ⤷  Sign Up

Patent: 0811127
Estimated Expiration: ⤷  Sign Up

Patent: 1406743
Estimated Expiration: ⤷  Sign Up

Patent: 1509927
Estimated Expiration: ⤷  Sign Up

Patent: 1546054
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 765
Estimated Expiration: ⤷  Sign Up

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
China 102639359 Pseudo-sound control device, pseudo-sound generating device, and electric movable body equipped with said devices ⤷  Sign Up
Austria 304864 ⤷  Sign Up
Hungary E045165 ⤷  Sign Up
Australia 2011200663 Exendin for treating diabetes and reducing body weight ⤷  Sign Up
European Patent Office 2435033 MÉTHODES POUR LE TRAITEMENT DE DIABÈTE DE TYPE 2 CHEZ DES PATIENTS RÉSISTANT À UN TRAITEMENT PRÉCÉDENT AVEC D'AUTRES MÉDICAMENTS ANTI-DIABÉTIQUES EMPLOYANT UN INHIBITEUR SGLT2 ET COMPOSITIONS ASSOCIÉES (METHODS FOR TREATING TYPE 2 DIABETES IN PATIENTS RESISTANT TO PREVIOUS TREATMENT WITH OTHER ANTI-DIABETIC DRUGS EMPLOYING AN SGLT2 INHIBITOR AND COMPOSITIONS THEREOF) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for bydureon

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 C20140021 00131 Estonia ⤷  Sign Up PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014
1506211 13C0022 France ⤷  Sign Up PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
0996459 464 Finland ⤷  Sign Up
1506211 122014000070 Germany ⤷  Sign Up PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211 PA2014026,C1506211 Lithuania ⤷  Sign Up PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.