BYDUREON Drug Patent 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 twenty-two patents protecting this drug.
This drug has three hundred and eighty-four 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
Summary for BYDUREON
International Patents: | 384 |
US Patents: | 13 |
Applicants: | 1 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 31 |
Clinical Trials: | 39 |
Patent Applications: | 8 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for BYDUREON |
Drug Sales Revenues: | Drug sales revenues for BYDUREON |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BYDUREON |
What excipients (inactive ingredients) are in BYDUREON? | BYDUREON excipients list |
DailyMed Link: | BYDUREON at DailyMed |



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
Sponsor | Phase |
---|---|
The University of Texas Health Science Center, Houston | Phase 2 |
University of Washington | Phase 3 |
Dasman Diabetes Institute | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for BYDUREON
US Patents and Regulatory Information for BYDUREON
BYDUREON is protected by thirteen US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BYDUREON is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Residual solvent extraction method and microparticles produced thereby
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Polymer-based sustained release device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Polymer-based sustained release device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Polymer-based sustained release device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for treating diabetes and reducing body weight
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Polymer-based sustained release device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Polymer-based sustained release device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method for treating diabetes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Polymer-based sustained release device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for treating diabetes and reducing body weight
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting BYDUREON
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Astrazeneca Ab | BYDUREON BCISE | exenatide synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | BYDUREON | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-001 | Jan 27, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | BYDUREON | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-001 | Jan 27, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | BYDUREON | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-001 | Jan 27, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>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: ⤷ Try a Trial
Australia
Patent: 07265246
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0713544
Estimated Expiration: ⤷ Try a Trial
Patent: 2017015106
Estimated Expiration: ⤷ Try a Trial
Patent: 2017021516
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 53344
Estimated Expiration: ⤷ Try a Trial
Patent: 24318
Estimated Expiration: ⤷ Try a Trial
Patent: 85797
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 07001915
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1479287
Estimated Expiration: ⤷ Try a Trial
Patent: 3145773
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 60299
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0141007
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 15738
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 69374
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 8229
Estimated Expiration: ⤷ Try a Trial
Patent: 0428
Estimated Expiration: ⤷ Try a Trial
Patent: 8259
Estimated Expiration: ⤷ Try a Trial
Patent: 5999
Estimated Expiration: ⤷ Try a Trial
Patent: 0900066
Estimated Expiration: ⤷ Try a Trial
Patent: 1171333
Estimated Expiration: ⤷ Try a Trial
Patent: 1490902
Estimated Expiration: ⤷ Try a Trial
Patent: 1791254
Estimated Expiration: ⤷ Try a Trial
Patent: 2091391
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 69374
Estimated Expiration: ⤷ Try a Trial
Patent: 57918
Estimated Expiration: ⤷ Try a Trial
Patent: 45466
Estimated Expiration: ⤷ Try a Trial
Patent: 63807
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 27359
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 5882
Estimated Expiration: ⤷ Try a Trial
Patent: 4180
Estimated Expiration: ⤷ Try a Trial
Patent: 4181
Estimated Expiration: ⤷ Try a Trial
Patent: 4182
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 13889
Estimated Expiration: ⤷ Try a Trial
Patent: 66651
Estimated Expiration: ⤷ Try a Trial
Patent: 37187
Estimated Expiration: ⤷ Try a Trial
Patent: 09545525
Estimated Expiration: ⤷ Try a Trial
Patent: 13209394
Estimated Expiration: ⤷ Try a Trial
Patent: 15071636
Estimated Expiration: ⤷ Try a Trial
Patent: 16172758
Estimated Expiration: ⤷ Try a Trial
Patent: 17222681
Estimated Expiration: ⤷ Try a Trial
Patent: 19059779
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 8566
Estimated Expiration: ⤷ Try a Trial
Patent: 3930
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 9143
Estimated Expiration: ⤷ Try a Trial
Patent: 7155
Estimated Expiration: ⤷ Try a Trial
Patent: 08015377
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 4346
Estimated Expiration: ⤷ Try a Trial
Patent: 9190
Estimated Expiration: ⤷ Try a Trial
Patent: 9195
Estimated Expiration: ⤷ Try a Trial
Patent: 9202
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 6828
Estimated Expiration: ⤷ Try a Trial
Patent: 085169
Estimated Expiration: ⤷ Try a Trial
Patent: 221233
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 080349
Estimated Expiration: ⤷ Try a Trial
Patent: 120776
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 012500168
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 69374
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 69374
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 638
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 2741
Estimated Expiration: ⤷ Try a Trial
Patent: 201402181S
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 69374
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0810475
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1493102
Estimated Expiration: ⤷ Try a Trial
Patent: 090023643
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 21665
Estimated Expiration: ⤷ Try a Trial
Patent: 59862
Estimated Expiration: ⤷ Try a Trial
Patent: 69130
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 21245
Estimated Expiration: ⤷ Try a Trial
Patent: 66876
Estimated Expiration: ⤷ Try a Trial
Patent: 19528
Estimated Expiration: ⤷ Try a Trial
Patent: 0811127
Estimated Expiration: ⤷ Try a Trial
Patent: 1406743
Estimated Expiration: ⤷ Try a Trial
Patent: 1509927
Estimated Expiration: ⤷ Try a Trial
Patent: 1546054
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 765
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Slovenia | 2069374 | ⤷ Try a Trial | |
China | 101065116 | Poly (lactide-co-glycolide)-based sustained release microcapsules comprising a polypeptide and a sugar | ⤷ Try a Trial |
Serbia | 60258 | FARMACEUTSKE FORMULACIJE KOJE SADRŽE HIDRAT PROPILEN GLIKOL DAPAGLIFLOZINA (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE) | ⤷ Try a Trial |
Taiwan | I411453 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BYDUREON
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1734971 | C01734971/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012 |
2139494 | 2020C/533 | Belgium | ⤷ Try a Trial | PRODUCT NAME: QTERN -SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719 |
1506211 | 122014000070 | Germany | ⤷ Try a Trial | 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 | PA 2013 008, C 1506211 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |