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Last Updated: November 13, 2024

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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 four hundred and eight 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 eleven 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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Summary for BYDUREON BCISE
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 thirteen US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BYDUREON BCISE 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 BCISE

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

Sustained release formulations using non-aqueous carriers
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 BCISE

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 BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  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
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  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 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 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Sign Up ⤷  Sign Up
>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
Patent: Sustained release formulations using non-aqueous carriers
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0918904
Patent: formulações de liberação sustentada usando carreadores não aquosos
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 34525
Patent: FORMULATIONS A LIBERATION PROLONGEE A BASE DE SUPPORTS NON AQUEUX (SUSTAINED RELEASE FORMULATIONS USING NON-AQUEOUS CARRIERS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 2164597
Patent: Sustained release formulations using non-aqueous carriers
Estimated Expiration: ⤷  Sign Up

Patent: 4248623
Patent: Sustained release formulations using non-aqueous carriers
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0201179
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 23410
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 41905
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 0299
Patent: СОСТАВЫ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ, ПОЛУЧЕННЫЕ С ПРИМЕНЕНИЕМ НЕВОДНЫХ НОСИТЕЛЕЙ (SUSTAINED RELEASE FORMULATIONS USING NON-AQUEOUS CARRIERS)
Estimated Expiration: ⤷  Sign Up

Patent: 1170413
Patent: СОСТАВЫ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ, ПОЛУЧЕННЫЕ С ПРИМЕНЕНИЕМ НЕВОДНЫХ НОСИТЕЛЕЙ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 41905
Patent: FORMULATIONS À LIBÉRATION PROLONGÉE À BASE DE SUPPORTS NON AQUEUX (SUSTAINED RELEASE FORMULATIONS USING NON-AQUEOUS CARRIERS)
Estimated Expiration: ⤷  Sign Up

Patent: 85837
Patent: FORMULATIONS À LIBÉRATION PROLONGÉE À BASE DE SUPPORTS NON AQUEUX (SUSTAINED RELEASE FORMULATIONS USING NON-AQUEOUS CARRIERS)
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 41905
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 50125
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 1231
Patent: הרכבים בעלי שחרור מושהה עם נשאים שאינם מימיים (Sustained release formulations using non-aqueous carriers)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 44735
Estimated Expiration: ⤷  Sign Up

Patent: 51243
Estimated Expiration: ⤷  Sign Up

Patent: 12502056
Estimated Expiration: ⤷  Sign Up

Patent: 15110637
Patent: 非水性担体を用いた徐放性製剤 (SUSTAINED RELEASE FORMULATION USING NON-AQUEOUS CARRIER)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 41905
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 2189
Patent: FORMULACIONES DE LIBERACIÓN SOSTENIDA USANDO PORTADORES NO ACUOSOS. (SUSTAINED RELEASE FORMULATIONS USING NON-AQUEOUS CARRIERS.)
Estimated Expiration: ⤷  Sign Up

Patent: 11002398
Patent: FORMULACIONES DE LIBERACION SOSTENIDA USANDO PORTADORES NO ACUOSOS. (SUSTAINED RELEASE FORMULATIONS USING NON-AQUEOUS CARRIERS.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 4997
Patent: Sustained release formulations using non-aqueous carriers
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 41905
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 41905
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201703039S
Patent: SUSTAINED RELEASE FORMULATIONS USING NON-AQUEOUS CARRIERS
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 41905
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1760953
Estimated Expiration: ⤷  Sign Up

Patent: 110050540
Patent: SUSTAINED RELEASE FORMULATIONS USING NON-AQUEOUS CARRIERS
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 09178
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 BCISE around the world.

Country Patent Number Title Estimated Expiration
Cyprus 1112348 ⤷  Sign Up
Israel 178335 מיקרוקפסולות לשחרור מושהה של חומר פעיל המבוסס על פולי (לקטיד-קו-גליקוליד) המכילות פוליפפטיד וסוכר (Poly (lactide-co-glycolide)-based sustained release microcapsules comprising a polypeptide and a sugar) ⤷  Sign Up
European Patent Office 1246638 UTILISATION D'EXENDINES ET D'AGONISTES DE CES DERNIERES POUR TRAITER L'HYPERTRIGLYCERIDEMIE (USE OF EXENDINS AND AGONISTS THEREOF FOR THE TREATMENT OF HYPERTRIGLYCERIDEMIA) ⤷  Sign Up
Slovenia 1283699 ⤷  Sign Up
Portugal 1283699 ⤷  Sign Up
European Patent Office 1658856 Exendines destinés à la suppression du glucagon (Exendins for glucagon suppression) ⤷  Sign Up
Eurasian Patent Organization 028259 КРИСТАЛЛИЧЕСКИЙ СОЛЬВАТ ПРОИЗВОДНОГО (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТОЙ И СПОСОБ ЕГО ПОЛУЧЕНИЯ (CRYSTALLINE SOLVATE OF (1S)-1,5-ANHYDRO-L-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVE WITH AMINO ACID AND PROCESS FOR PREPARING THE SAME) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BYDUREON BCISE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1734971 C01734971/01 Switzerland ⤷  Sign Up PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
2139494 C202030045 Spain ⤷  Sign Up PRODUCT NAME: SAXAGLIPTINA + DAPAGLIFOZINA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1108; DATE OF AUTHORISATION: 20160715; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1108; DATE OF FIRST AUTHORISATION IN EEA: 20160715
0996459 91342 Luxembourg ⤷  Sign Up 91342, EXPIRES: 20211120
2139494 C20200028 00358 Estonia ⤷  Sign Up PRODUCT NAME: SAKSAGLIPTIIN JA DAPAGLIFLOSIIN;REG NO/DATE: EU/1/16/1108; 19.07.2016
1506211 PA2013008 Lithuania ⤷  Sign Up PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211 92496 Luxembourg ⤷  Sign Up PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
1734971 PA2012006 Lithuania ⤷  Sign Up PRODUCT NAME: EXENATIDUM; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110617
>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.