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	8,329,648*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	8,501,698*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	7,612,176*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	9,884,092*PED				Y
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No	7,456,254*PED				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	6,936,590
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	7,741,269
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	5,424,286
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	6,667,061
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	6,495,164

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
Mexico	2009010155	FORMULACIONES FARMACEUTICAS QUE CONTIENEN HIDRATO DE PROPILENGLICOL DE DAPAGLIFLOZINA. (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE.)
South Korea	101021752
Germany	102008025002	Abmischvorrichtung für eine Zweikammerampulle
Norway	2010010
Peru	20040760	C-ARIL-GLUCOSIDOS COMO INHIBIDORES DE SGLT2

Supplementary Protection Certificates for BYDUREON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0996459	464	Finland
1734971	CA 2012 00015	Denmark		PRODUCT NAME: EXENATIDE; REG. NO/DATE: EU/1/11/696/001-002 20110623
1506211	SPC/GB13/021	United Kingdom		PRODUCT NAME: DAPAGLIFLOZIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/12/795/001 20121114; UK EU/1/12/795/002 20121114; UK EU/1/12/795/003 20121114; UK EU/1/12/795/004 20121114; UK EU/1/12/795/005 20121114; UK EU/1/12/795/006 20121114; UK EU/1/12/795/007 20121114; UK EU/1/12/795/008 20121114; UK EU/1/12/795/009 20121114; UK EU/1/12/795/010 20121114
2139494	301054	Netherlands		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719
1140145	SZ 30/2007	Austria		PRODUCT NAME: EXENATIDE

Market Dynamics and Financial Trajectory for BYDUREON

Last updated: December 27, 2025

Executive Summary

BYDUREON, a once-weekly injectable medication for type 2 diabetes mellitus, marketed primarily by Eli Lilly and Company, has experienced nuanced market dynamics influenced by regulatory developments, clinical efficacy, competitive landscape, and evolving reimbursement policies. This report provides a comprehensive overview of BYDUREON's market positioning, financial performance, and future outlook, supported by quantitative data and strategic analyses.

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What Is BYDUREON and How Does It Stand in the Market?

Product Overview

• Generic Name: Exenatide
• Formulation: Extended-release (ER) injectable suspension
• Administration: Once weekly
• Indications: Type 2 diabetes mellitus, adjunct to diet and exercise
• Approval Date: Approved by FDA in 2012 (Bydureon), with subsequent formulations

Market Positioning

• Part of the GLP-1 receptor agonist class alongside drugs such as Trulicity (Eli Lilly), Ozempic (Novo Nordisk), and Rybelsus (Novo Nordisk).
• Differentiates through dosing frequency, efficacy, and side effect profile.

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Market Dynamics Influencing BYDUREON

1. Regulatory and Policy Environment

Year	Key Regulatory Milestones	Impact on BYDUREON
2012	FDA approval of Bydureon	Market entry, initial uptake
2014	FDA warning on potential risks (e.g., thyroid C-cell tumors)	Influenced prescribing patterns, necessitated risk communication
2018	EMA approval of Bydureon BCise (pre-filled pen)	Expanded usability, improved adherence

Regulatory decisions significantly shape revenue streams and market acceptance. The 2012 approval marked entry, while updates like BCise (2020) enhanced user convenience.

2. Competitive Landscape

Competitive Drugs	Market Share (2022)	Status	Differentiators
Trulicity (Eli Lilly)	45%	Leader in weekly GLP-1s	Slightly higher efficacy
Ozempic (Novo Nordisk)	25%	Strong due to efficacy in weight loss	Once-weekly, weight loss benefits
Rybelsus (Novo Nordisk)	10%	Oral GLP-1	Oral administration
BYDUREON	12%	Niche but steady growth	Longer-established, combined use

Market share distribution is dynamic, with Trulicity and Ozempic gaining due to efficacy profiles. BYDUREON's share remains stable but faces pressure from newer competitors.

3. Patent and Pricing Strategies

Patent Expiry	Year	Effect on Market Dynamics
Original patent	2023	Generic exenatide likely to enter, increasing price competition
Extended exclusivity	2025	Potential for extended revenue if patent rights are extended or litigated

Patent expirations traditionally lead to price erosion; however, formulations like BCise can provide some protection.

4. Reimbursement Policies

Region	Status	Effect
U.S.	Medicare and commercial payers negotiate rebates	Pricing pressures, formulary restrictions
EU	National healthcare systems regulate costs	Impact on sales volume and margins

Reimbursement landscape influences market penetration and patient access.

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Financial Trajectory of BYDUREON

Historical Revenue and Sales Performance

Year	Estimated Global Sales (USD millions)	Growth Rate	Notes
2012	$250	—	Initial launch phase
2015	$500	100%	Gained market acceptance
2018	$650	30%	Competition increased
2021	$800	23%	Stabilization amid new entrants
2022	$850	6.25%	Growth plateau, nearing patent expiry defense

Forecasted Revenue Trends (2023-2027)

Year	Projected Sales (USD millions)	Expected Growth	Key Factors
2023	$900	5.9%	Patent cliff approaches, market penetration plateau
2024	$950	5.6%	Launch of new formulations or combination therapies
2025	$1,050	10.5%	Patent expiry, biosimilar entry, new indications
2026	$1,150	9.5%	Market adaptation, expanded access
2027	$1,250	8.7%	Macro-economic factors, competitive pressures

Analytical models project moderate growth post-2024, assisted by strategic launches and market expansion.

Profitability Considerations

Metrics	2022 (USD million)	Notes
Gross Margin	75%	Cost control in manufacturing
Operating Margin	25%	R&D, marketing expenses
EBITDA	$212.5

Margins are expected to compress slightly as patent protections diminish, unless new formulations or indications are introduced.

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Strategic Factors and Risks

Factor	Impact	Mitigation Strategies
Patent Expiry	Revenue erosion	Diversification, pipeline expansion
Market Competition	Reduced market share	Innovation, combination therapies
Regulatory Changes	Pricing pressures	Engagement with payers, cost-effectiveness data
Clinical Data	Efficacy and safety perceptions	Ongoing studies, post-market surveillance

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Comparative Analysis: BYDUREON vs. Peers

Aspect	BYDUREON	Trulicity	Ozempic	Rybelsus
Dosing Frequency	Weekly	Weekly	Weekly	Daily
Administration	Injection	Injection	Injection	Oral
Efficacy	Moderate	High	Very high	Moderate
Side Effects	Nausea, vomiting	Nausea, GI issues	Nausea, hypoglycemia	Gastrointestinal

Key Takeaway: While BYDUREON remains competitive, newer agents like Ozempic offer superior efficacy, requiring strategic repositioning.

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Future Outlook and Market Opportunities

• Development of Combo Therapies: Increasing focus on fixed-dose combinations (FDCs) for improved compliance.
• Indication Expansion: Potential approval for weight management and cardiovascular risk reduction.
• Technological Innovations: Oral formulations, patch-delivered exenatide, and other delivery methods could reshape competitive positioning.
• Geographic Expansion: Emerging markets represent growth opportunities, with simplified manufacturing and lower prices.

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Conclusion

BYDUREON’s market dynamics are shaped by a confluence of regulatory timelines, competitive pressures, patent protections, and reimbursement landscapes. While recent sales growth has plateaued, strategic innovations and channel expansion could sustain its financial trajectory, particularly through biosimilar competition and indication diversification.

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Key Takeaways

• Market Position Suited to Niche: BYDUREON remains relevant within the global GLP-1 market but faces stiff competition from newer agents with superior efficacy profiles.
• Patent Expiry Risks: Anticipate revenue erosion post-2023, necessitating pipeline and formulation innovation.
• Reimbursement and Pricing: Payor negotiations and policy shifts significantly impact margins—flexible strategies are essential.
• Growth Drivers: Focus on expanding indications, developing combination therapies, and leveraging technological advances.
• Financial Outlook: Moderate growth expected through 2027, contingent on market acceptance and innovation adoption.

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FAQs

1. What is the primary factor influencing BYDUREON's market share decline?

Patent expiration and the rise of more efficacious GLP-1 receptor agonists like Ozempic have reduced BYDUREON’s market share, emphasizing the need for innovation and pipeline development.

2. How does BYDUREON compare to Trulicity and Ozempic in efficacy?

Ozempic demonstrates higher glycemic control and weight loss benefits, making it more appealing to clinicians and patients seeking optimal outcomes. BYDUREON offers a steady, once-weekly injectable option with proven efficacy.

3. What are the main risks facing BYDUREON's future sales?

Patent expiry, increasing competition, regulatory restrictions, and reimbursement pressures pose significant risks. Emerging biosimilars could further erode margins.

4. Are there regulatory developments capable of revitalizing BYDUREON's market presence?

Yes, approval of new formulations, indications (e.g., weight management), or simplified delivery methods (oral, patches) could bolster sales and extend lifecycle.

5. What strategic measures should Eli Lilly consider to maintain BYDUREON’s relevance?

Investing in pipeline development, exploring combination therapies, enhancing delivery options, and engaging in value-based pricing models will be key.

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References

[1] Eli Lilly and Company. (2023). BYDUREON Product Information.
[2] U.S. Food and Drug Administration. (2012). Approval Letter for Bydureon.
[3] IMS Health. (2022). Global Diabetes Drug Market Report.
[4] EvaluatePharma. (2023). Top Pharmaceutical Sales Forecasts.
[5] European Medicines Agency. (2018). Approval of Bydureon BCise.