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Last Updated: September 25, 2022

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 fifteen patents protecting this drug.

This drug has four hundred and one patent family members in forty-six 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 nine 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 Generic Entry Opportunity 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
University of WashingtonPhase 3
Dasman Diabetes InstitutePhase 4
Peking Union Medical College HospitalPhase 4

See all BYDUREON BCISE clinical trials

Pharmacology for BYDUREON BCISE

US Patents and Regulatory Information for BYDUREON BCISE

BYDUREON BCISE is protected by fifteen US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BYDUREON BCISE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Residual solvent extraction method and microparticles produced thereby
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Residual solvent extraction method and microparticles produced thereby
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating diabetes and reducing body weight
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sustained release formulations using non-aqueous carriers
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for treating diabetes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating diabetes and reducing body weight
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting BYDUREON BCISE

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

INFORMATION ADDED TO LABELING REGARDING A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE CARDIOVASCULAR OUTCOMES AFTER TREATMENT WITH EXENATIDE ONCE WEEKLY IN PATIENTS WITH TYPE 2 DIABETES MELLITES
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 See Plans and Pricing See Plans and Pricing
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 See Plans and Pricing See Plans and Pricing
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 See Plans and Pricing See Plans and Pricing
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 See Plans and Pricing See Plans and Pricing
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 0918904
Estimated Expiration: See Plans and Pricing

Canada

Patent: 34525
Estimated Expiration: See Plans and Pricing

China

Patent: 2164597
Estimated Expiration: See Plans and Pricing

Patent: 4248623
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0201179
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 41905
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0299
Estimated Expiration: See Plans and Pricing

Patent: 1170413
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 41905
Estimated Expiration: See Plans and Pricing

Patent: 85837
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 50125
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1231
Estimated Expiration: See Plans and Pricing

Japan

Patent: 44735
Estimated Expiration: See Plans and Pricing

Patent: 51243
Estimated Expiration: See Plans and Pricing

Patent: 12502056
Estimated Expiration: See Plans and Pricing

Patent: 15110637
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 41905
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 2189
Estimated Expiration: See Plans and Pricing

Patent: 11002398
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4997
Estimated Expiration: See Plans and Pricing

Poland

Patent: 41905
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 41905
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201703039S
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 41905
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1760953
Estimated Expiration: See Plans and Pricing

Patent: 110050540
Estimated Expiration: See Plans and Pricing

Spain

Patent: 09178
Estimated Expiration: See Plans and Pricing

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
Australia 2006202247 See Plans and Pricing
Japan 5030292 See Plans and Pricing
Ukraine 77306 С-АРИЛ ГЛЮКОЗИДНЫЕ ИНГИБИТОРЫ SGLT2 И СПОСОБ ИХ ПРИМЕНЕНИЯ;С-АРИЛ ГЛЮКОЗИДНІ SGLT2 ІНГІБІТОРИ ТА СПОСІБ ЇХ ЗАСТОСУВАННЯ (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD FOR THEIR USE) See Plans and Pricing
Japan 2005531588 See Plans and Pricing
European Patent Office 2508188 Formulations pharmaceutiques contenant un hydrate de propylèneglycol dapagliflozine (Pharmaceutical formulations containing dapagliflozin propylene glycol hydrate) See Plans and Pricing
Montenegro 00091 C-ARIL GLUKOZID SGLT2 INHIBITORI I POSTUPAK ZA NJIHOVU UPOTREBU (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD) See Plans and Pricing
>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 See Plans and Pricing PRODUCT NAME: SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719
0996459 91342 Luxembourg See Plans and Pricing 91342, EXPIRES: 20211120
0996459 C00996459/01 Switzerland See Plans and Pricing FORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US
1506211 SPC/GB14/050 United Kingdom See Plans and Pricing PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121
1506211 588 Finland See Plans and Pricing
1506211 136 5005-2013 Slovakia See Plans and Pricing PRODUCT NAME: DAPAGLIFLOZIN; FIRST REGISTRATION NO/DATE: EU/1/12/795/001, EU/1/12/795/002, EU/1/12/795/003, EU/1/12/795/004, EU/1/12/795/005, EU/1/12/795/006, EU/1/12/795/007, EU/1/12/795/007, EU/1/12/795/008, EU/1/12/795/009, EU/1/12/795/010 20121112
>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.