BYDUREON Drug Patent Profile
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Which patents cover Bydureon, and what generic alternatives are available?
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-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: | 374 |
US Patents: | 12 |
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 |
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 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 | ||||
Astrazeneca Ab | BYDUREON BCISE | exenatide synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | RX | Yes | Yes | ⤷ 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 |
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 |
---|---|---|---|
Cyprus | 1126112 | ⤷ Sign Up | |
Austria | E531374 | ⤷ Sign Up | |
China | 104382880 | Poly (lactide-co-glycolide)-based sustained release microcapsules comprising a polypeptide and a sugar | ⤷ Sign Up |
Malaysia | 148566 | CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5- ANHYDRO-1 -C-(3-( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES | ⤷ Sign Up |
Canada | 2309356 | NOUVEAUX COMPOSES AGONISTES DE L'EXENDINE (NOVEL EXENDIN AGONIST COMPOUNDS) | ⤷ Sign Up |
Canada | 2388818 | INHIBITEURS DE SGLT2 A BASE DE GLUCOSIDE C-ARYLE (C-ARYL GLUCOSIDE SGLT2 INHIBITORS) | ⤷ 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 | C300677 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121 |
1506211 | 92182 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
1734971 | 16/2012 | Austria | ⤷ Sign Up | PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001-002 (MITTEILUNG) 20110623 |
1506211 | CR 2014 00037 | Denmark | ⤷ Sign Up | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116 |
2139494 | 34/2020 | Austria | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZIN PROPYLENGYLKOL HYDRAT/SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/16/1108 (MITTEILUNG) 20160715 |
1506211 | C01506211/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 65176 19.08.2014 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |