Exenatide synthetic - Generic Drug Details

What are the generic sources for exenatide synthetic and what is the scope of freedom to operate?

Exenatide synthetic is the generic ingredient in five branded drugs marketed by Astrazeneca Ab and Amneal, and is included in four NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Exenatide synthetic has three hundred and seventy-eight patent family members in forty-nine countries.

Two suppliers are listed for this compound.

Summary for exenatide synthetic

International Patents:	378
US Patents:	11
Tradenames:	5
Applicants:	2
NDAs:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	7
Patent Applications:	228
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for exenatide synthetic
DailyMed Link:	exenatide synthetic at DailyMed

Recent Clinical Trials for exenatide synthetic

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

Sponsor	Phase
Center for Neurology, Stockholm	Phase 2
Karolinska Institutet	Phase 2
National Health and Medical Research Council, Australia	Phase 2

See all exenatide synthetic clinical trials

Pharmacology for exenatide synthetic

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

Anatomical Therapeutic Chemical (ATC) Classes for exenatide synthetic

A10BJ	Glucagon-like peptide-1 (GLP-1) analogues
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for EXENATIDE SYNTHETIC

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 exenatide synthetic

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
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 BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		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 exenatide synthetic

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

International Patents for exenatide synthetic

Country	Patent Number	Title	Estimated Expiration
Portugal	2508188
South Korea	101502292
Eurasian Patent Organization	202091391
Eurasian Patent Organization	201490902
Eurasian Patent Organization	200900066
Singapore	184730	METHODS FOR TREATING DIABETES AND REDUCING BODY WEIGHT

Supplementary Protection Certificates for exenatide synthetic

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	18/2013	Austria		PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211	CA 2014 00037	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
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
1140145	30/2007	Austria		PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/06/362/001-004 20061120
2139494	C202030045	Spain		PRODUCT NAME: SAXAGLIPTINA + DAPAGLIFOZINA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1108; DATE OF AUTHORISATION: 20160715; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1108; DATE OF FIRST AUTHORISATION IN EEA: 20160715
1506211	C300677	Netherlands		PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Exenatide Synthetic

Last updated: July 28, 2025

Introduction

Exenatide synthetic, a GLP-1 receptor agonist used primarily in the management of type 2 diabetes mellitus (T2DM), has garnered significant attention within the pharmaceutical industry. Since its initial approval in 2005 under the brand name Byetta, and subsequent formulations such as Bydureon, the drug has carved a substantial market niche owing to its efficacy and unique mechanism of action. This article explores the evolving market dynamics, competitive landscape, regulatory considerations, and financial trajectories associated with synthetic exenatide, with insights pertinent for stakeholders—including pharmaceutical companies, investors, and healthcare providers.

Market Overview and Demand Drivers

Prevalence of Type 2 Diabetes

The global burden of T2DM remains a pivotal driver behind the sustained demand for GLP-1 receptor agonists, including synthetic exenatide. The International Diabetes Federation estimates that approximately 537 million adults worldwide had diabetes in 2021, with projections exceeding 700 million by 2045 [[1]]. The chronic nature of the disease, coupled with rising obesity rates, compels healthcare providers to seek innovative, effective treatments, bolstering the adoption of injectable GLP-1 receptor agonists.

Efficacy and Therapeutic Advantages

Synthetic exenatide offers notable benefits over traditional oral hypoglycemics—namely, improved glycemic control, weight loss, and a favorable profile concerning hypoglycemia risk. Its prolonged-release formulations, such as Bydureon, enhance patient adherence by reducing injection frequency, thus increasing market penetration.

Shift Toward Injectable and Combination Therapies

Although oral medications dominate initial therapy, the paradigm is shifting towards injectable GLP-1 receptor agonists for patients with inadequately controlled T2DM. Moreover, the development of combination therapies that incorporate synthetic exenatide with other antidiabetic agents is accelerating, further propelling expansion within the therapeutic landscape.

Competitive Landscape

Market Players and Patent Dynamics

Several pharmaceutical firms manufacture synthetic exenatide or its analogs. Eli Lilly and Co., the original developer, markets Bydureon (extended-release synthetic exenatide). Other competitors include AstraZeneca with its GLP-1 analogs, and newer entrants developing next-generation agents.

Patent expiration presents both challenges and opportunities. The original patents for Byetta and Bydureon expired or are expiring in key markets, paving the way for biosimilar development and intensified competition, which could lead to price erosion but also increased market access through lower-cost alternatives.

Innovation and Pipeline Developments

Research initiatives focus on enhancing efficacy, reducing side effects, and developing oral formulations. The ongoing pipeline includes rapid-onset single-injection formulations and combined therapies. Such innovations could extend market dominance and reinforce the financial trajectory of synthetic exenatide-based drugs.

Regulatory and Reimbursement Influences

Regulatory Approvals and Guidelines

Regulatory bodies such as the FDA and EMA have continually evaluated the safety and efficacy profiles of synthetic exenatide. The approval of newer formulations and the broadening of indications—including cardiovascular benefits—bolster commercial prospects [[2]].

Reimbursement Policies

Government and private payers influence market trajectory through formulary decisions. The increasing demonstration of cardiovascular risk reduction associated with GLP-1 receptor agonists has led to favorable reimbursement policies in several regions, enhancing market accessibility.

Market Size and Revenue Projections

Historical Market Performance

From an initial estimate of $1.2 billion in 2011, the GLP-1 receptor agonist class, including synthetic exenatide, has experienced robust growth, reaching an estimated $21 billion globally in 2022 [[3]]. Synthetic exenatide’s contribution constitutes a significant share within this class.

Future Financial Trajectory

Analysts project compounded annual growth rates (CAGR) of approximately 10-12% for the GLP-1 segment until 2030, driven by expanded indications, biosimilar entries, and increased adoption [[4]]. Synthetic exenatide’s revenue is expected to follow this trend, though the expansion may be tempered by patent expiries and new competitors.

Market Challenges and Risks

• Patent cliff: As patents expire, biosimilar competition intensifies, risking revenue erosion.
• Pricing pressures: Payers push for cost containment, potentially limiting reimbursement and profit margins.
• Adverse events and safety concerns: Long-term safety profiles influence market acceptance.
• Patient adherence: Injectable regimens may hinder long-term adherence, impacting real-world effectiveness and revenue.

Strategic Implications

Pharmaceutical firms must navigate patent landscapes, invest in innovative formulations, and consider strategic partnerships for biosimilar development. Enhancing clinical evidence, especially regarding cardiovascular and renal benefits, will be crucial for market expansion. Additionally, global markets present varied opportunities and challenges, requiring tailored go-to-market strategies.

Conclusion

Synthetic exenatide’s market dynamics are shaped by evolving clinical needs, regulatory landscapes, competitive pressures, and technological innovations. While its current financial trajectory demonstrates strong growth, future expansion hinges on intellectual property strategies, pipeline differentiation, and adoption of combination therapies. Stakeholders must remain vigilant to regulatory shifts, reimbursement policies, and competitive innovations to optimize market positioning.

Key Takeaways

• The global rise in T2DM prevalence sustains demand for synthetic exenatide, reinforced by its efficacy and patient adherence advantages.
• Patent expiries and biosimilar development threaten revenue streams but open opportunities for market penetration through cost-effective alternatives.
• Innovations in formulations and indications (e.g., cardiovascular benefits) are critical to maintaining competitive advantage.
• Reimbursement policies driven by real-world evidence significantly influence market access and revenue potential.
• Strategic investments in pipeline development, collaborations, and global expansion are essential for maximizing long-term financial prospects.

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FAQs

1. How does patent expiration impact the market for synthetic exenatide?
Patent expirations enable biosimilar competitors to enter the market, increasing price competition and potentially reducing profits for original manufacturers. However, they also create opportunities for market expansion through lower-cost options, making therapies accessible to broader populations.

2. What are the main therapeutic advantages of synthetic exenatide over other diabetic medications?
Synthetic exenatide offers superior glycemic control, significant weight loss benefits, and a reduced risk of hypoglycemia compared to some oral agents. Its cardiovascular and renal benefits further distinguish it within the therapeutic landscape.

3. Are there ongoing advancements in the formulation of synthetic exenatide?
Yes. Research focuses on oral formulations, rapid-onset injections, and combination therapies, aimed at enhancing patient compliance, efficacy, and safety.

4. What role do regulatory agencies play in shaping the market trajectory of synthetic exenatide?
Regulatory bodies approve new formulations and expanded indications, influence reimbursement policies, and assess safety profiles. Their decisions directly impact market access and financial prospects.

5. How does the global prevalence of T2DM influence the future outlook for synthetic exenatide?
The rising global burden of T2DM sustains demand but also invites increased competition. Market expansion depends on successful regulatory approvals, reimbursement, and adaptation to regional healthcare systems.

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Sources

[1] International Diabetes Federation. IDF Diabetes Atlas, 2021.
[2] U.S. Food and Drug Administration. FDA Approvals and Labeling.
[3] GlobalData. GLP-1 receptor agonists market analysis, 2022.
[4] Grand View Research. Diabetes Drugs Market Forecast, 2022-2030.