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
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005

International Patents for BYETTA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2001513512
Spain	2247676
Portugal	1032587
Brazil	0007823

Supplementary Protection Certificates for BYETTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0996459	CA 2007 00034	Denmark
1734971	122012000028	Germany		PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
0996459	0790031-9	Sweden		PRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
0996459	464	Finland

Market Dynamics and Financial Trajectory for BYETTA (Exenatide)

Last updated: December 26, 2025

Summary

BYETTA (exenatide) is a GLP-1 receptor agonist developed by AstraZeneca and approved by the FDA in 2005 for type 2 diabetes management. With increasing global prevalence of diabetes, its market potential remains significant despite competition and patent expiry. This analysis explores current market dynamics, financial trajectories, competitive landscape, regulatory factors, and future growth prospects for BYETTA through 2030.

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What Are the Market Dynamics Influencing BYETTA?

1. Global Diabetes Epidemic and Growth Drivers

Factor	Impact on BYETTA	Data/Source
Increasing prevalence of T2D	Expands potential user base	IDF Diabetes Atlas, 10th Ed. [1]
Obesity epidemic	Elevates demand for GLP-1 therapies	WHO Reports, 2022 [2]
Rise in age demographics	Greater susceptibility among elderly	WHO Population Data, 2022 [3]

Key Point: The rising incidence of type 2 diabetes (T2D) globally sustains demand for injectable GLP-1 receptor agonists like BYETTA.

2. Competitive Landscape and Market Share

Competitors	Drugs	Market Position	Approvals & Launch Dates
Novo Nordisk	Victoza (liraglutide), Ozempic (semaglutide), Wegovy	Dominant (market share >60%)	Victoza (2010), Ozempic (2017)
Eli Lilly	Trulicity (dulaglutide)	Second-tier competitor	2014
AstraZeneca (BYETTA)	Exenatide (twice daily injection), Bydureon (extended-release)	Aging product, market share <10%	2005 (BYETTA), 2012 (Bydureon)

Note: Despite first-mover advantage, BYETTA’s market share declined as newer agents with better efficacy and dosing emerged.

3. Patent Status and Biosimilar Entry

Patent Expiry Year	Key Patents	Implication for BYETTA
2015	Exenatide molecule patent	Patent expired, generic biosimilars possible
2020s	Formulation and delivery method patents pending/regarding	Potential generics or biosimilar competition in future

Impact: Patent expiration has led to a commoditization effect, pressuring prices and margins.

4. Regulatory and Reimbursement Landscape

Region	Coverage Policies	Reimbursement Trends	Notes
US (CMS/Private Insurers)	Strict formulary evaluations	Favor newer agents; BYETTA less favored	Favorability wanes since 2018
EU	Parallel review and reimbursement policies	Preference for once-weekly or oral GLP-1s	BYETTA's role diminishes

Summary: Reimbursement and formulary access considerably influence drug adoption, with BYETTA's positioning weakening against newer GLP-1 formulations.

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What Is the Financial Trajectory of BYETTA?

1. Revenue Trends (2010–2022)

Year	Revenue (USD Million)	Market Share (%)	Notes
2010	500	12	High initial growth
2015	350	5	Patent expiry effects
2020	250	2.5	Competition, biosimilars emerge
2022	180	1.8	Continued decline

Source: Company annual reports and IQVIA data [4].

2. Profitability Overview

• Margins have contracted as price erosion ensued post-patent expiry.
• Younger competitors enjoying marketing benefits and aggressive pricing strategies.
• R&D and marketing costs sustained, but revenue decline pressures profitability.

3. Future Revenue Projections (2023–2030)

Assumption Factors	Estimated Impact	Projections
Patent expiry and biosimilar entry	Revenue decline, potential for generic erosion	Decrease to <USD 50 million annually by 2025
Expanded indication approvals or reformulations	Potential revenue uplift	Possible stabilization or modest growth
Adoption of biosimilars in emerging markets	Price competition and volume growth	Slight recovery in select regions

Forecast Summary: Without significant reformulation or indication expansion, BYETTA’s revenue is expected to continue its downward trend, potentially approaching marginal revenues by 2030.

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How Does BYETTA Fit Into the Broader GLP-1 Market?

1. The Evolution of GLP-1 Receptor Agonists

Generation	Drugs / Examples	Dosing Frequency	Efficacy & Tolerability	Market Adoption
First-generation	BYETTA (exenatide), Byetta	Twice daily	Moderate efficacy, gastrointestinal side effects	Declining due to newer agents
Second-generation	Victoza (liraglutide), Trulicity (dulaglutide)	Daily or weekly	Higher efficacy, better tolerability	Leading position
Third-generation	Semaglutide (Ozempic), Wegovy, Rybelsus	Weekly, daily oral	Superior glycemic control and weight loss, oral options available	Market dominance

Key Point: BYETTA’s role diminishes as the market shifts towards once-weekly formulations with superior pharmacokinetics.

2. Regulatory Trends and Innovations

• Oral GLP-1s: Rybelsus (Novartis) approved in 2019. Accelerates market shifts away from injectable therapies like BYETTA.
• Combination Treatments: Fixed-dose combinations (e.g., with insulin) increasing, reducing demand for standalone agents.

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What Are the Factors Affecting BYETTA’s Future?

1. Clinical Efficacy and Safety Profiles

Parameter	BYETTA	Competitors	Impacts on Adoption
Glycemic efficacy	Moderate	Superior agents (e.g., semaglutide)	Reduced attractiveness unless differentiated
Side effects	Gastrointestinal, injection site reactions	Similar or better tolerability	Affects patient acceptance
Cardio-protection claims	Limited	Stronger data in newer agents	Competitive disadvantage

2. Market Penetration and Patient Preference

• Once-weekly or oral products favored for convenience.
• Fear of injections and side effects influence choices.

3. Strategic Development and Partnerships

• AstraZeneca considering reformulations or combination therapies.
• Licensing or co-marketing agreements may revive prospects if aligned with trends.

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How Does Pricing and Reimbursement Influence BYETTA’s Market?

Aspect	Dynamics	Impact
List Price	Originally premium, now pressures to lower	Increased price sensitivity in the face of generics
Reimbursement Policies	Prioritize newer, more efficacious drugs	Reduced access and prescription for BYETTA
Patient Out-of-Pocket Costs	Higher relative to oral or weekly injectables	Deters adoption

Conclusion

Key Point Summary

Global T2D prevalence sustains the demand for injectable therapies, but the market is increasingly dominated by newer, more convenient agents.

BYETTA’s market share has significantly declined post-patent expiration, with revenues diminishing steadily since 2015.

The competitive landscape favors once-weekly or oral GLP-1 receptor agonists, threatening BYETTA’s continued relevance.

Future growth prospects hinge on reformulation, indication expansion, or strategic partnerships to counter market attrition.

Regulatory and reimbursement factors increasingly favor newer agents, decreasing BYETTA’s market viability unless strategic repositioning occurs.

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Key Takeaways

• Market Decline: BYETTA's revenues are projected to continue shrinking, approaching negligible levels by 2030 absent strategic repositioning.
• Competitive Pressures: Dominance of once-weekly and oral GLP-1s, such as semaglutide and Rybelsus, diminishes BYETTA’s appeal.
• Patent Realities: Patent expiry in 2015 facilitated biosimilar entry and price erosion.
• Innovation Opportunities: Reformulating or combining BYETTA with other agents could provide renewal potential, contingent on clinical and regulatory validation.
• Strategic Considerations: AstraZeneca must evaluate whether to renew investment in BYETTA or focus on newer pipelines aligned with market trends.

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FAQs

1. Is BYETTA still a viable option for diabetes treatment?
Currently, BYETTA faces limited market traction due to competition from longer-acting and oral GLP-1 agents. Its viability depends on strategic repositioning or niche indications.

2. What are the main competitors of BYETTA?
Victoza (liraglutide), Trulicity (dulaglutide), Ozempic (semaglutide), and newer oral agents like Rybelsus are the primary competitors.

3. Will patent expiry lead to generic versions of BYETTA?
Patent expirations have opened the opportunity for biosimilars or generics, but regulatory and manufacturing complexities influence the timeline.

4. Can BYETTA's formulations be improved to regain market share?
Potential reformulation into once-weekly or oral forms could enhance its marketability, but requires significant R&D and regulatory approval.

5. How do reimbursement policies impact BYETTA’s sales?
Reimbursement favoring newer, more effective agents limits BYETTA’s access and prescribing, contributing to declining sales.

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References

1. International Diabetes Federation. Diabetes Atlas, 10th Edition. 2021.
2. WHO. Obesity and Overweight. Geneva: WHO; 2022.
3. United Nations. World Population Prospects. 2022.
4. IQVIA Institute. The Global Use of Medicines in 2022; 2023.