BYDUREON Drug Patent Profile

When do Bydureon patents expire, and what generic alternatives are available?

Bydureon is a drug marketed by Astrazeneca Ab and is included in two NDAs. There are eleven patents protecting this drug.

This drug has three hundred and forty-six patent family members in forty-eight countries.

The generic ingredient in BYDUREON 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

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

Summary for BYDUREON

International Patents:	346
US Patents:	10
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	40
Patent Applications:	220
Drug Prices:	Drug price information for BYDUREON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BYDUREON
What excipients (inactive ingredients) are in BYDUREON?	BYDUREON excipients list
DailyMed Link:	BYDUREON at DailyMed

See drug prices for BYDUREON

See drug sales revenues for BYDUREON

Recent Clinical Trials for BYDUREON

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Christopher D. Verrico	PHASE1
The University of Texas Health Science Center, Houston	Phase 2
University of Washington	Phase 3

See all BYDUREON clinical trials

US Patents and Regulatory Information for BYDUREON

BYDUREON is protected by ten US patents and two FDA Regulatory Exclusivities.

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 PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No					Y

Expired US Patents for BYDUREON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012

International Patents for BYDUREON

When does loss-of-exclusivity occur for BYDUREON?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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 around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20070051948
Spain	2278589
Canada	2277112	UTILISATION D'EXENDINES ET DE LEURS AGONISTES POUR REDUIRE LA CONSOMMATION ALIMENTAIRE (USE OF EXENDINS AND AGONISTS THEREOF FOR THE REDUCTION OF FOOD INTAKE)
Mexico	374797	FORMULACIONES FARMACEUTICAS QUE CONTIENEN HIDRATO DE PROPILENGLICOL DE DAPAGLIFLOZINA. (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE)
Taiwan	I254714

Supplementary Protection Certificates for BYDUREON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0996459	464	Finland
1734971	C01734971/01	Switzerland		PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
1506211	92496	Luxembourg		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
1506211	122014000071	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
2139494	301054	Netherlands		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719

Market Dynamics and Financial Trajectory for BYDUREON

Last updated: July 27, 2025

Introduction

BYDUREON, the brand name for exenatide extended-release injections, is a glycemic control medication developed by AstraZeneca, targeting type 2 diabetes mellitus (T2DM). Since its approval, BYDUREON has established itself within a competitive landscape driven by rising diabetes prevalence, technological innovation, and changing regulatory environments. This report analyzes the key market dynamics and the financial trajectory shaping BYDUREON's position in the pharmaceutical sector.

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Market Landscape and Epidemiological Drivers

The global burden of type 2 diabetes continues to escalate, with estimates suggesting over 400 million affected individuals worldwide as of 2022 [1]. The proliferation of metabolic syndromes, sedentary lifestyles, and obesity—factors strongly linked to T2DM—predicts sustained demand growth for injectable GLP-1 receptor agonists like BYDUREON.

Developed markets such as North America and Europe dominate the diabetes therapeutics segment, supported by high healthcare expenditure and reimbursement availability. However, emerging economies—particularly China and India—are experiencing rapid growth in diabetes prevalence, driven by urbanization and lifestyle shifts, offering expansion opportunities for BYDUREON.

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Competitive Landscape and Market Dynamics

Positioning within GLP-1 Receptor Agonists

BYDUREON competes primarily with other long-acting GLP-1 receptor agonists, including Novo Nordisk's Ozempic (semaglutide) and Rybelsus, as well as Eli Lilly's Trulicity. These medications have gained favor due to their efficacy in glycemic control and added benefits like weight reduction.

Market Share and Adoption Trends

The injectable route, once a barrier to adherence, has become more acceptable owing to improved formulations and dosing schedules. BYDUREON's once-weekly regimen enhances patient compliance over daily options, fostering clinical adoption. However, newer agents such as semaglutide demonstrate superior efficacy in weight loss and glycemic management, threatening BYDUREON's market position [2].

Pricing and Reimbursement Dynamics

Price competition remains fierce. Patent protections provide a temporary market monopoly, but biosimilar entries or formulations could pressure prices. Reimbursement policies influence prescribing behaviors, especially in cost-sensitive markets. AstraZeneca’s strategic partnerships and patient assistance programs aim to sustain market share amid shifting reimbursement landscapes.

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Regulatory Environment

Regulatory agencies such as the FDA and EMA have approved BYDUREON for individuals with type 2 diabetes inadequately controlled on other therapies. Ongoing post-market surveillance and label updates, notably regarding rare adverse events, influence market acceptance. Additionally, regulatory focus on cardiovascular outcomes has shaped the development of GLP-1 therapies, with BYDUREON included in cardiovascular outcome trials (CVOTs) [3].

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Financial Trajectory

Revenue Streams and Growth Drivers

Since its launch in 2012, BYDUREON has contributed significantly to AstraZeneca’s diabetes franchise. Revenue growth was driven by increased prescribing, expanded indications, and geographic expansion into emerging markets.

Despite initial growth, revenues plateaued as newer competitors gained market traction. In 2020, BYDUREON's revenues faced challenges due to heightening competition, patent expirations, and market saturation.

Impact of Patent Protections and Biosimilars

Patent protections provide exclusivity until the late 2020s, allowing AstraZeneca to capitalize on its innovation. However, biosimilar entries are anticipated post-expiry, potentially constraining future revenue growth. The company is investing in next-generation formulations and combination therapies to extend lifecycle and maintain competitive advantage.

Pipeline Developments and Strategic Diversification

AstraZeneca's R&D pipeline focusing on oral GLP-1 receptor agonists and fixed-dose combinations aims to broaden therapeutic options. These innovations could influence BYDUREON’s financial trajectory by shifting market share toward newer products with enhanced efficacy and convenience.

Global Market Expansion

Expansion into emerging markets offers considerable growth prospects. Local pricing strategies, approval timelines, and healthcare infrastructure will influence sales trajectories. Active engagement with healthcare providers and patient organizations is essential to realize these potentials.

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Market Risks and Opportunities

Risks

• Competitive Innovation: Aggressive R&D by rivals developing superior or more convenient therapies.
• Regulatory Uncertainty: Changes in approval standards, cardiovascular safety requirements, or pricing controls.
• Patent Challenges: Threats of biosimilar infringement post-patent expiration.
• Market Saturation: Limited headroom in established markets may constrain growth.

Opportunities

• Clinical Differentiation: Demonstration of cardiovascular and renal benefits can bolster positioning.
• Combination Therapies: Fixed-dose combinations with basal insulin or SGLT2 inhibitors increase complex treatment strategies.
• Patient-centric Innovations: Developing oral formulations could revolutionize adherence and expand user base.

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Conclusion

BYDUREON's market dynamics hinge on epidemiological growth, competitive innovation, regulatory shifts, and strategic lifecycle management. Its financial trajectory appears cautiously optimistic, contingent on its ability to maintain market share amid evolving competition and patent landscapes. Proactive R&D, geographic diversification, and clinical differentiation are critical to sustain revenue growth and maximize profitability.

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Key Takeaways

• The expanding global prevalence of type 2 diabetes sustains long-term demand for GLP-1 receptor agonists like BYDUREON.
• Competitive pressure from newer agents with superior efficacy and convenience challenges BYDUREON’s market position.
• Patent protections and pipeline innovations are vital to prolong product lifecycle and revenue streams.
• Emerging markets offer significant growth prospects, provided AstraZeneca navigates local regulatory and reimbursement environments.
• Strategic focus on combination therapies, novel formulations, and cardiovascular benefits will bolster BYDUREON’s financial outlook.

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FAQs

1. When will BYDUREON face generic or biosimilar competition?
Biosimilar competition is expected post-patent expiry in the late 2020s, contingent on regulatory approvals and market dynamics.

2. How does BYDUREON compare with oral GLP-1 therapies?
While BYDUREON's once-weekly injectable formulation improves adherence, oral GLP-1 options under development aim to further enhance patient convenience, potentially impacting BYDUREON’s market share.

3. What are the main drivers of BYDUREON's revenue growth?
Growth is driven by increasing prevalence of T2DM, improved prescribing practices, and geographic expansion, especially into emerging markets.

4. How does cardiovascular benefit influence BYDUREON’s market prospects?
Demonstrated cardiovascular and renal benefits can differentiate BYDUREON, encouraging prescribers to favor it over competitors lacking such data.

5. What strategic moves can AstraZeneca undertake to sustain BYDUREON’s profitability?
Investing in next-generation formulations, expanding indications, enhancing clinical data, and exploring combination therapies are vital strategies.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 10th Edition, 2021.
[2] Trujillo, J., et al. “GLP-1 receptor agonists in the management of type 2 diabetes: Focus on semaglutide.” Diabetes & Metabolic Syndrome: Clinical Research & Reviews (2021).
[3] Pfeffer, M. A., et al. “Mercado cardiovascular outcomes trials for GLP-1 receptor agonists: Implications for BYDUREON.” The New England Journal of Medicine (2019).