BYDUREON BCISE Drug Patent Profile
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When do Bydureon Bcise patents expire, and what generic alternatives are available?
Bydureon Bcise is a drug marketed by Astrazeneca Ab and is included in one NDA. There are thirteen patents protecting this drug.
This drug has three hundred and ninety-seven patent family members in forty-eight countries.
The generic ingredient in BYDUREON BCISE 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 Bcise
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 4, 2031. 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 BCISE
International Patents: | 397 |
US Patents: | 13 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 39 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for BYDUREON BCISE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BYDUREON BCISE |
What excipients (inactive ingredients) are in BYDUREON BCISE? | BYDUREON BCISE excipients list |
DailyMed Link: | BYDUREON BCISE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BYDUREON BCISE
Generic Entry Date for BYDUREON BCISE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
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 BCISE
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 |
Pharmacology for BYDUREON BCISE
Drug Class | GLP-1 Receptor Agonist |
Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for BYDUREON BCISE
US Patents and Regulatory Information for BYDUREON BCISE
BYDUREON BCISE is protected by thirteen US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BYDUREON BCISE 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 BCISE
C-aryl glucoside SGLT2 inhibitors and method
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
Sustained release formulations using non-aqueous carriers
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 BCISE
NEW PATIENT POPULATION
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 BCISE | exenatide synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | RX | Yes | Yes | ⤷ 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 | 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 | 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 | 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 | 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 BCISE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca Ab | BYDUREON BCISE | exenatide synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | BYDUREON BCISE | exenatide synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | BYDUREON BCISE | exenatide synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | BYDUREON BCISE | exenatide synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | BYDUREON BCISE | exenatide synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BYDUREON BCISE
When does loss-of-exclusivity occur for BYDUREON BCISE?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 09289529
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0918904
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 34525
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2164597
Estimated Expiration: ⤷ Try a Trial
Patent: 4248623
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0201179
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 23410
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 41905
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 0299
Estimated Expiration: ⤷ Try a Trial
Patent: 1170413
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 41905
Estimated Expiration: ⤷ Try a Trial
Patent: 85837
Estimated Expiration: ⤷ Try a Trial
Finland
Patent: 41905
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 50125
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 1231
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 44735
Estimated Expiration: ⤷ Try a Trial
Patent: 51243
Estimated Expiration: ⤷ Try a Trial
Patent: 12502056
Estimated Expiration: ⤷ Try a Trial
Patent: 15110637
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 41905
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 2189
Estimated Expiration: ⤷ Try a Trial
Patent: 11002398
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 4997
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 41905
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 41905
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201703039S
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 41905
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1760953
Estimated Expiration: ⤷ Try a Trial
Patent: 110050540
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 09178
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 BCISE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1123410 | ⤷ Try a Trial | |
Hong Kong | 1025252 | ⤷ Try a Trial | |
Austria | 304864 | ⤷ Try a Trial | |
Portugal | 1032587 | ⤷ Try a Trial | |
Russian Federation | 2242244 | НОВЫЕ КОМПОЗИЦИИ АГОНИСТОВ ЭКСЕНДИНА И СПОСОБЫ ИХВВЕДЕНИЯ (NEW COMPOSITIONS OF EXENDINE AGONISTS AND METHODS OF THEIR ADMINISTRATION) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BYDUREON BCISE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2139494 | LUC00176 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719 |
1506211 | 300677 | Netherlands | ⤷ Try a Trial | 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 |
1140145 | 91343 | Luxembourg | ⤷ Try a Trial | 91343, EXPIRES: 20211120 |
1506211 | 2014C/041 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LA COMBINAISON DE DAPAGLIFLOZINE (OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE); AUTHORISATION NUMBER AND DATE: EU/1/13/900 20140121 |
1506211 | 13C0022 | France | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |