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Last Updated: February 15, 2025

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. Two suppliers are listed for this compound. Additional details are available on the exenatide synthetic profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Bydureon Bcise

A generic version of BYDUREON BCISE was approved as exenatide synthetic by AMNEAL on November 19th, 2024.

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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 ⤷  Try for Free.

This potential generic entry date is based on patent ⤷  Try for Free.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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 for Free ⤷  Try for Free Y ⤷  Try for Free
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>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 for Free ⤷  Try for Free
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Try for Free ⤷  Try for Free
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Try for Free ⤷  Try for Free
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Try for Free ⤷  Try for Free
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Try for Free ⤷  Try for Free
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Try for Free ⤷  Try for Free
>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: ⤷  Try for Free

Brazil

Patent: 0918904
Patent: formulações de liberação sustentada usando carreadores não aquosos
Estimated Expiration: ⤷  Try for Free

Canada

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

China

Patent: 2164597
Patent: Sustained release formulations using non-aqueous carriers
Estimated Expiration: ⤷  Try for Free

Patent: 4248623
Patent: Sustained release formulations using non-aqueous carriers
Estimated Expiration: ⤷  Try for Free

Croatia

Patent: 0201179
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 23410
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 41905
Estimated Expiration: ⤷  Try for Free

Eurasian Patent Organization

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

Patent: 1170413
Patent: СОСТАВЫ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ, ПОЛУЧЕННЫЕ С ПРИМЕНЕНИЕМ НЕВОДНЫХ НОСИТЕЛЕЙ
Estimated Expiration: ⤷  Try for Free

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: ⤷  Try for Free

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

Finland

Patent: 41905
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 50125
Estimated Expiration: ⤷  Try for Free

Israel

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

Japan

Patent: 44735
Estimated Expiration: ⤷  Try for Free

Patent: 51243
Estimated Expiration: ⤷  Try for Free

Patent: 12502056
Estimated Expiration: ⤷  Try for Free

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: ⤷  Try for Free

Lithuania

Patent: 41905
Estimated Expiration: ⤷  Try for Free

Mexico

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

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

New Zealand

Patent: 4997
Patent: Sustained release formulations using non-aqueous carriers
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 41905
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 41905
Estimated Expiration: ⤷  Try for Free

Singapore

Patent: 201703039S
Patent: SUSTAINED RELEASE FORMULATIONS USING NON-AQUEOUS CARRIERS
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 41905
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 1760953
Estimated Expiration: ⤷  Try for Free

Patent: 110050540
Patent: SUSTAINED RELEASE FORMULATIONS USING NON-AQUEOUS CARRIERS
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 09178
Estimated Expiration: ⤷  Try for Free

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
Poland 2508188 ⤷  Try for Free
World Intellectual Property Organization (WIPO) 0213783 ⤷  Try for Free
South Korea 20070051948 ⤷  Try for Free
South Korea 101532188 ⤷  Try for Free
Peru 20040760 C-ARIL-GLUCOSIDOS COMO INHIBIDORES DE SGLT2 ⤷  Try for Free
Brazil 122017021516 processo de preparação de uma estrutura de cristal de solvato de (s)-propileno glicol de fórmula ia ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BYDUREON BCISE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2139494 C20200028 00358 Estonia ⤷  Try for Free PRODUCT NAME: SAKSAGLIPTIIN JA DAPAGLIFLOSIIN;REG NO/DATE: EU/1/16/1108; 19.07.2016
1734971 91989 Luxembourg ⤷  Try for Free 91989, EXPIRES: 20260617
1140145 CA 2007 00033 Denmark ⤷  Try for Free PRODUCT NAME: EXENATID, EXENDIN, EXENDINAGONISTER; REG. NO/DATE: EU/1/06/362/001-004 20061120
1506211 132014902277722 Italy ⤷  Try for Free PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
1506211 DO 136; 5005-2013 Slovakia ⤷  Try for Free PRODUCT NAME: DAPAGLIFOZIN:REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112; FORMER OWNER: BRISTOL
0996459 91342 Luxembourg ⤷  Try for Free 91342, EXPIRES: 20211120
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for BYDUREON BCise

Introduction

BYDUREON BCise, an exenatide extended-release formulation, is a significant player in the incretin mimetics market, particularly for the treatment of type 2 diabetes. This article delves into the market dynamics and financial trajectory of BYDUREON BCise, highlighting its performance, challenges, and future prospects.

Market Context: Incretin Mimetics

The global incretin mimetics market is projected to grow from $21.8 billion in 2023 to $35.2 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 4.9%[3].

Dominant Segment

Exenatide, the active ingredient in BYDUREON BCise, held a market share of 27.4% in 2023, making it a leading drug in the incretin mimetics segment[3].

Application and Distribution

Type 2 diabetes mellitus is the dominant application segment, accounting for 62.3% of the market share. Hospital pharmacies are the leading distribution channel, indicating a strong presence in clinical settings[3].

Product Approval and Expansion

Initial Approval

BYDUREON BCise was first approved in the US in October 2017 as a once-weekly single-dose autoinjector device for adults with type 2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines, in addition to diet and exercise[4].

Pediatric Approval

In July 2021, the US FDA approved BYDUREON BCise for pediatric patients aged 10 to 17 with type 2 diabetes, marking a significant expansion of its indication. This approval provided a convenient, once-weekly treatment option for a younger demographic[4].

Financial Performance: Challenges and Impact

Production Constraints

In 2019, AstraZeneca faced production constraints with the new Bydureon Bcise device, leading to a 7% decline in sales over the first nine months of the year. Despite efforts to resolve these constraints, the third quarter saw a 16% drop in global sales, largely due to a downturn in US sales[1].

Regional Performance

The decline in Bydureon sales was more pronounced in Europe and other established markets, with declines of 14% and 25%, respectively, over the first nine months of 2019. However, growth in other parts of AstraZeneca’s biopharmaceuticals business, such as the cardiovascular, renal, and metabolism (CVRM) unit, helped mitigate the impact[1].

Current Financial Trajectory

Overall Revenue

In the full-year 2023 results, AstraZeneca reported total revenue of $45,811 million, up 6% despite a decline from COVID-19 medicines. Excluding COVID-19 medicines, total revenue increased by 15%, and product sales increased by 14%[2].

Segment Performance

The CVRM business, which includes Bydureon Bcise, saw significant growth. Total revenue from the CVRM segment increased by 18%, driven by strong demand for other products like Brilinta and Farxiga in emerging markets[2].

Market Dynamics and Growth Drivers

Macroeconomic and Geopolitical Factors

The incretin mimetics market is influenced by macroeconomic and geopolitical factors. Economic expansion in developed regions increases healthcare spending, while inflationary pressures and trade disruptions can impact production costs and supply chains[3].

Regional Growth

The Asia Pacific region is expected to experience the highest CAGR during the forecast period due to the rising incidence of type 2 diabetes and expanding healthcare infrastructure. Government initiatives and advancements in drug formulation technologies are expected to support market growth[3].

Competitive Landscape

Innovations and Clinical Trials

The market is driven by innovations and clinical trials. For example, Sanofi’s efpeglenatide, a once-weekly GLP-1 receptor agonist, has shown promising results, indicating a competitive landscape where companies are investing heavily in new treatments[3].

Key Takeaways

  • Market Growth: The incretin mimetics market, led by exenatide, is expected to grow significantly, driven by increasing healthcare expenditures and the adoption of advanced diabetes management therapies.
  • Product Expansion: BYDUREON BCise’s approval for pediatric patients has expanded its market reach and addressed a previously unmet need.
  • Financial Performance: Despite initial production constraints, AstraZeneca’s CVRM segment has shown strong growth, driven by other successful products.
  • Regional Dynamics: The Asia Pacific region is poised for the highest growth due to rising diabetes incidence and healthcare infrastructure expansion.

FAQs

  1. What is BYDUREON BCise? BYDUREON BCise is an exenatide extended-release formulation used as a once-weekly single-dose autoinjector device for the treatment of type 2 diabetes.

  2. What were the production constraints faced by BYDUREON BCise? In 2019, AstraZeneca faced production constraints with the new Bydureon Bcise device, leading to a decline in sales.

  3. How has BYDUREON BCise’s indication expanded? BYDUREON BCise was approved for pediatric patients aged 10 to 17 with type 2 diabetes in July 2021, expanding its market reach.

  4. What are the key drivers of the incretin mimetics market? The market is driven by increasing healthcare expenditures, adoption of advanced diabetes management therapies, and government initiatives aimed at improving diabetes management.

  5. Which region is expected to experience the highest CAGR in the incretin mimetics market? The Asia Pacific region is expected to experience the highest CAGR due to the rising incidence of type 2 diabetes and expanding healthcare infrastructure.

Sources

  1. Outsourcing-pharma: AstraZeneca sales hurt by Bydureon Bcise production constraints.
  2. AstraZeneca: Full-year and Q4 2023 results announcement.
  3. Market.us: Incretin Mimetics Market Size, Share | CAGR Of 4.9%.
  4. AstraZeneca-US: BYDUREON BCise (exenatide extended-release) approved in the US for the treatment of type 2 diabetes.

More… ↓

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