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Last Updated: February 23, 2024

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 fourteen patents protecting this drug.

This drug has four hundred and fifteen 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

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Drug patent expirations by year for BYDUREON BCISE
Drug Prices for BYDUREON BCISE

See drug prices for BYDUREON BCISE

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

SponsorPhase
The University of Texas Health Science Center, HoustonPhase 2
University of WashingtonPhase 3
Dasman Diabetes InstitutePhase 4

See all BYDUREON BCISE clinical trials

Pharmacology for BYDUREON BCISE

US Patents and Regulatory Information for BYDUREON BCISE

BYDUREON BCISE is protected by fourteen US patents and three 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

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

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

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 ⤷  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 ⤷  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
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
Germany 60020259 ⤷  Try a Trial
Taiwan I519528 ⤷  Try a Trial
Mexico 2008015377 SOLVATOS Y COMPLEJOS CRISTALINOS DE LOS DERIVADOS DE (1S) - 1,5-ANHIDRO-1-C-(3-((FENIL)METIL)FENIL)-D-GLUCITOL CON AMINOACIDOS COMO INHIBIDORES DE SGLT2 PARA EL TRATAMIENTO DE LA DIABETES. (CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-L-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES.) ⤷  Try a Trial
Australia 2003239910 ⤷  Try a Trial
Peru 20040760 C-ARIL-GLUCOSIDOS COMO INHIBIDORES DE SGLT2 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 03099314 ⤷  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
1734971 C300526 Netherlands ⤷  Try a Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
2139494 301054 Netherlands ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719
1506211 92182 Luxembourg ⤷  Try a Trial PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1140145 SZ 30/2007 Austria ⤷  Try a Trial PRODUCT NAME: EXENATIDE
1734971 16/2012 Austria ⤷  Try a Trial PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001-002 (MITTEILUNG) 20110623
0996459 SZ 31/2007 Austria ⤷  Try a Trial PRODUCT NAME: EXENATIDE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Baxter
Medtronic
Harvard Business School
McKinsey
Boehringer Ingelheim

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.