BYETTA Drug Patent Profile

When do Byetta patents expire, and when can generic versions of Byetta launch?

Byetta is a drug marketed by Astrazeneca Ab and is included in one NDA.

The generic ingredient in BYETTA 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 Byetta

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

Summary for BYETTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	124
Patent Applications:	220
Drug Prices:	Drug price information for BYETTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BYETTA
What excipients (inactive ingredients) are in BYETTA?	BYETTA excipients list
DailyMed Link:	BYETTA at DailyMed

See drug prices for BYETTA

See drug sales revenues for BYETTA

Recent Clinical Trials for BYETTA

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

Sponsor	Phase
Consano Clinical Research, LLC	Phase 4
Boston Medical Center	Phase 1
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 1

See all BYETTA clinical trials

Pharmacology for BYETTA

Drug Class	GLP-1 Receptor Agonist
Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists

Paragraph IV (Patent) Challenges for BYETTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BYETTA	Injection	exenatide synthetic	250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe	021773	1	2014-06-11

US Patents and Regulatory Information for BYETTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005		DISCN	Yes	No
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005		DISCN	Yes	No

Expired US Patents for BYETTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005	7,521,423
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005	7,521,423
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005	6,902,744
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005	5,424,286
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005	7,741,269
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005	6,956,026
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005	5,424,286

International Patents for BYETTA

See the table below for patents covering BYETTA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	4426727
Australia	2006225304
Australia	2638001
European Patent Office	1140145	NOUVELLES FORMULATIONS D'AGONISTES DE L'EXENDINE ET MODES D'ADMINISTRATION (NOVEL EXENDIN AGONIST FORMULATIONS AND METHODS OF ADMINISTRATION THEREOF)
Spain	2247676
Norway	2012008
Spain	2293688

Supplementary Protection Certificates for BYETTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0996459	464	Finland
0996459	SZ 31/2007	Austria		PRODUCT NAME: EXENATIDE
0996459	C00996459/01	Switzerland		FORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US
0996459	0790031-9	Sweden		PRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
1734971	C300526	Netherlands		PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1734971	2012C/017	Belgium		PRODUCT NAME: EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617
1734971	122012000028	Germany		PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617

Market Dynamics and Financial Trajectory for BYETTA

Last updated: July 27, 2025

Introduction

BYETTA (exenatide), developed by AstraZeneca and Boehringer Ingelheim, is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for the treatment of type 2 diabetes mellitus (T2DM). Since its approval by the FDA in 2005, BYETTA has played a significant role in the diabetic therapeutics market. This report analyzes the evolving market landscape, key drivers and challenges, competitive positioning, and financial trajectory of BYETTA, providing valuable insights for stakeholders.

Market Overview and Growth Drivers

Global Diabetes Landscape

The global prevalence of T2DM has surged, reaching approximately 537 million adults in 2021, with projections estimating over 700 million cases by 2045 [1]. The escalating burden fuels sustained demand for efficacious therapies like BYETTA. The market’s expansion is driven by increasing awareness, improved diagnostic capabilities, and a shift toward oral and injectable antidiabetics that offer better glycemic control.

Therapeutic Positioning of BYETTA

As an injectable GLP-1 receptor agonist, BYETTA offers robust glycemic regulation, weight loss benefits, and a favorable cardiovascular profile—attributes that align with the evolving therapeutic needs [2]. It positions itself as an alternative to insulin and older agents, targeting T2DM patients requiring injectable therapy with fewer hypoglycemia risks.

Key Market Drivers

• Increasing Prevalence of T2DM: The global burden fuels demand for effective treatments.
• Advancements in GLP-1 Technology: Improved formulations and dosing schedules enhance patient adherence.
• Cardiovascular Benefits: Evidence of cardiovascular risk reduction bolsters BYETTA’s clinical value.
• Shifting Treatment Guidelines: Leading authorities emphasize GLP-1 receptor agonists as preferred options for patients with cardiovascular risks [3].

Market Challenges and Constraints

Manufacturing and Patent Landscape

Though BYETTA entered the market early, patent expirations—particularly in the U.S. and EU—have led to biosimilar or generic entrants, pressuring prices and margins [4].

Competitive Dynamics

The market is crowded with newer GLP-1 receptor agonists like Trulicity (dulaglutide), Ozempic (semaglutide), and Rybelsus (oral semaglutide), which offer longer-acting formulations, improved efficacy, and dosing convenience [5]. These developments challenge BYETTA’s market share, especially as some competitors demonstrate superior efficacy or added benefits.

Pricing and Reimbursement

Cost considerations remain pivotal; payers favor more effective or more convenient therapies when considering reimbursement. BYETTA’s priced higher than some competitors constrains its utilization, especially in price-sensitive markets.

Safety and Tolerability

Common adverse effects, including gastrointestinal disturbances and potential concerns about pancreatitis, influence clinician and patient preferences. The safety profile directly impacts market adoption.

Competitive Landscape

Key Players and Competitive Products

• Eli Lilly’s Trulicity (dulaglutide): A once-weekly GLP-1 receptor agonist with broad market adoption.
• Novo Nordisk’s Ozempic (semaglutide): Demonstrates superior glycemic control and significant weight loss, supported by robust cardiovascular data.
• Rybelsus (oral semaglutide): Offers oral administration, appealing for patient compliance, potentially encroaching on injectable GLP-1 market share.
• Byetta (exenatide): Pioneered early injectable GLP-1 therapy with a pen device formulation, now challenged by longer-acting formulations.

Market Share Dynamics

While BYETTA maintains a role, especially in specific regions or among certain patient populations, its market share diminishes in the face of competition from the more convenient, longer-acting, and efficacy-validated agents [6].

Financial Trajectory Analysis

Revenue Trends

From peak revenues exceeding $800 million annually in the late 2000s, BYETTA’s revenue has declined due to patent expirations and market competition [7]. In recent fiscal reports, AstraZeneca disclosed revenues in the hundreds of millions, illustrating a downward trend consistent with market share erosion.

Impact of Patent Expiry and Biosimilar Entry

Patent losses in key markets beginning around 2015 have led to generic or biosimilar competition, notably reducing pricing power. This commoditization contributed to revenue declines and limited growth.

R&D Investment and Lifecycle Management Strategies

AstraZeneca has explored combination therapies and next-generation GLP-1 analogs. For example, use in fixed-dose combinations aims to extend product lifecycle and diversify revenue streams [8].

Market Expansion Opportunities

Emerging markets, where newer therapies face barriers, still present growth opportunities for BYETTA, particularly with strategic pricing and local manufacturing. Additionally, indications for obesity management—given the weight loss benefits—may unlock new revenue streams, subject to regulatory approvals.

Forecasting

Given current trends, BYETTA’s revenue is projected to stabilize at a lower level in the near term, with potential modest growth in niches or emerging markets. The global shift toward once-weekly, orally administered GLP-1 agents compresses volume and pricing prospects.

Regulatory and Patent Outlook

Patent cliffs and biosimilar approvals are anticipated to continue influencing BYETTA’s financial trajectory. However, patent litigation or exclusivity extensions in select jurisdictions could provide intermittent revenue boosts [9]. Future regulatory initiatives targeting delivery devices or combination treatments may open new avenues.

Strategic Implications

• Lifecycle Extension: Focusing on formulation improvements, fixed-dose combinations, and indications like obesity or NASH could prolong relevance.
• Market Expansion: Prioritizing emerging markets with tailored pricing and distribution strategies.
• Differentiation: Emphasizing unique clinical benefits, safety profile, and patient compliance advantages in marketing.

Conclusion

The market dynamics and financial trajectory for BYETTA reflect a maturing product within a highly competitive landscape. While initial growth fueled by unmet needs in T2DM management has plateaued, niche opportunities and strategic lifecycle management may sustain its relevance. Market share erosion from improved alternatives underscores the importance of innovation, positioning, and geographic expansion for continued profitability.

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Key Takeaways

• Evolving Competition: Longer-acting, convenient GLP-1 agonists have diminished BYETTA’s market share, emphasizing the need for product innovation and differentiation.
• Market Growth Factors: The rising prevalence of T2DM and cardiovascular benefits of GLP-1 therapies sustain demand, though price pressures challenge revenue stability.
• Patent & Biosimilar Impact: Patent expirations and biosimilar entries significantly influence BYETTA’s revenue, necessitating strategic adaptations.
• Expansion Opportunities: Emerging markets and indications like obesity management offer potential growth avenues.
• Strategic Focus: Developing fixed-dose combinations and focusing on niche patient populations can prolong product lifecycle and revenue generation.

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FAQs

1. How has patent expiration affected BYETTA’s market position?
Patent expirations have enabled biosimilar and generic competitors to enter major markets, leading to reduced pricing power and declining revenues for BYETTA.

2. What are the main competitors to BYETTA in the GLP-1 receptor agonist market?
Key competitors include Eli Lilly’s Trulicity (dulaglutide), Novo Nordisk’s Ozempic (semaglutide), and Rybelsus (oral semaglutide), which offer longer dosing intervals and superior efficacy.

3. Are there any new formulations or indications that could extend BYETTA’s lifecycle?
Yes, fixed-dose combination therapies and potential approval for obesity treatment could extend its market relevance, contingent upon regulatory and clinical success.

4. How has the rise of oral GLP-1 therapies impacted BYETTA’s market share?
Oral options like Rybelsus provide a patient-preferred administration route, reducing the reliance on injectable therapies like BYETTA and challenging its market share.

5. What strategies can AstraZeneca adopt to sustain BYETTA’s market performance?
Focusing on emerging markets, developing combination products, leveraging clinical data for cardiovascular and weight-loss benefits, and exploring new indications are vital tactics.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 2021.
[2] European Medicines Agency. BYETTA (exenatide) summary of product characteristics.
[3] American Diabetes Association. Standards of Medical Care in Diabetes—2022.
[4] U.S. Patent and Trademark Office. Patent timelines and expirations for exenatide.
[5] EvaluatePharma. Market analysis on GLP-1 receptor agonists, 2022.
[6] IQVIA Medical Data. Market share reports, 2022.
[7] AstraZeneca Annual Reports, 2010–2022.
[8] Press releases—AstraZeneca’s pipeline and partnership announcements.
[9] European Medicines Agency. Regulatory updates on biosimilars.