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 seven 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 thirty-nine patent family members in forty-nine countries.

Two suppliers are listed for this compound.

Summary for EXENATIDE SYNTHETIC

International Patents:	339
US Patents:	7
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
Karolinska Institutet	Phase 2
Center for Neurology, Stockholm	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 BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		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	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No					Y
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005		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

Expired US Patents for EXENATIDE SYNTHETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017
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
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 BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005

International Patents for EXENATIDE SYNTHETIC

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	020428
China	103145773
Slovenia	2341905
Canada	2924318
Mexico	2011002398
China	105056211	Exendin for treating diabetes and reducing body weight
Lithuania	2508188

Supplementary Protection Certificates for EXENATIDE SYNTHETIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2139494	PA2020522	Lithuania		PRODUCT NAME: SASAGLIPTINAS IR DAPAGLIFLOZINAS; REGISTRATION NO/DATE: EU/1/16/1108 20160715
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	122020000043	Germany		PRODUCT NAME: SAXAGLIPTIN UND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160715
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	C 2013 012	Romania		PRODUCT NAME: DAPAGLIFLOZIN SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTUIA (2S, 3R, 4R, 5S, 6R)-2-[4-CLOR-3-(4-ETOXIBENZIL)FENIL]-6-(HIDROXIMETIL)TETRAHIDRO-2H-PIRAN-3,4,5-TRIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/795/001, RO EU/1/12/795/002, RO EU/1/12/795/003, RO EU/1/12/795/004, RO EU/1/12/795/005, RO EU/1/12/795/006, RO EU/1/12/795/007, RO EU/1/12/795/008, RO EU/1/12/795/009, RO EU/1/12/795/001/010; DATE OF NATIONAL AUTHORISATION: 20121112; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/795/001, EMEA EU/1/12/795/002, EMEA EU/1/12/795/003, EMEA EU/1/12/795/004, EMEA EU/1/12/795/005, EMEA EU/1/12/795/006, EMEA EU/1/12/795/007, EMEA EU/1/12/795/008 [...]
1140145	SZ 30/2007	Austria		PRODUCT NAME: EXENATIDE
1506211	PA2013008,C1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112

EXENATIDE SYNTHETIC Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Exenatide Synthetic?

Exenatide synthetic, a glucagon-like peptide-1 (GLP-1) receptor agonist, is primarily used to treat type 2 diabetes mellitus. It is marketed under brand names such as Byetta and Bydureon. The drug competes in a growing sector of incretin-based therapies, which has sustained its market presence over the past decade.

Market Size and Growth Trends

The global market for GLP-1 receptor agonists was valued at approximately $10.2 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 9.5% from 2022 to 2028, driven by increasing prevalence of type 2 diabetes and rising adoption of injectable therapies.

Byetta, launched in 2005, and Bydureon, approved in 2012, dominate sales, but newer agents like semaglutide and dulaglutide threaten market share. An expected transition toward oral GLP-1 medications may influence future growth prospects.

Competitive Landscape

Exenatide competes with drugs such as:

• Semaglutide (Ozempic, Rybelsus)
• Dulaglutide (Trulicity)
• Liraglutide (Victoza)

Semaglutide's approval of an oral formulation in 2019 broadens the market. While exenatide remains relevant, market share shifts toward newer, more convenient formulations could reduce its volume.

Key Market Drivers

• Increasing type 2 diabetes prevalence: 537 million adults affected worldwide in 2021, expected to reach 643 million by 2030 (International Diabetes Federation).
• Evidence supporting cardiovascular benefits: Regulatory updates (e.g., FDA’s 2020 guidance) encourage use in patients with established cardiovascular disease.
• Patient preference for injectable therapies: Despite the advent of oral options, injectable drugs retain a substantial user base due to established efficacy.

Market Challenges

• Competition from oral GLP-1 analogs.
• Drug adherence issues: Injection burdens impact long-term compliance.
• Pricing pressures and biosimilar potential: Although biosimilars are limited for injectable peptides, generic and biosimilar firms are exploring options.

What Is the Financial Trajectory of Exenatide Synthetic?

Revenue and Sales Performance

AbbVie, the original manufacturer of Byetta and Bydureon, reported peak sales of over $1.2 billion in 2014. Since then, sales have declined, reaching approximately $350 million in 2020, partly due to patent expirations and competition.

Biogen, which licensed exenatide rights in certain markets, reports similar trends of declining revenues over recent years.

Patent and Regulatory Status

Patent expiry timelines influence revenue trajectories:

• Byetta's patent expired in 2013 in the US.
• Bydureon’s patent expired in 2022, prompting potential biosimilar entrance.

Regulatory exclusivity periods limited initial competition, but that protection diminishes as patents expire, opening pathways for generics/biosimilars.

R&D and Pipeline Development

Efforts to improve exenatide formulations include:

• Development of once-weekly versions (e.g., Bydureon)
• Exploration of oral alternatives (though no oral exenatide approved to date)

Investment in next-generation GLP-1 therapies diminishes the focus on exenatide, with companies reallocating R&D to more advanced modalities.

Investment and Industry Outlook

Investors examine the following:

• Market share erosion due to newer therapies.
• Potential for biosimilar competition reducing pricing power.
• Strategic collaborations to develop combination therapies and alternative delivery systems.

In 2022, Pfizer announced plans to develop oral GLP-1 agents, indicating marketing shifts away from injectable exenatide.

How Do the Market and Financial Trends Compare to Other GLP-1 Therapies?

Feature	Exenatide	Semaglutide	Liraglutide
Launch Year	2005	2017 (Ozempic), 2019 (Rybelsus)	2010
Market Valuation (2021)	$350 million	$6 billion (2021 estimate)	$1.4 billion
Administration Frequency	Twice daily / Weekly	Weekly / Daily	Daily
Patent Expiry Year	2022 (Beydureon)	Patents expiring 2030+	Limited; patent expiration in 2027

The shift toward longer-acting, oral formulations signifies a declining trajectory for exenatide. Industry projections favor a transition to semaglutide and similar molecules.

What Are the Key Takeaways?

• Exenatide synthetic’s market share declines as newer GLP-1 therapies dominate.
• Revenue peaked around 2014 and is trending downward amid patent expiration and intensified competition.
• The shift to oral formulations and longer-acting injectables reduces exenatide’s appeal.
• Investment focus is on innovations in oral delivery and combination treatments.
• Biosimilar entrants remain a concern as patent protections lapse.

What Are the Frequently Asked Questions?

1. When will exenatide patents expire?
Patents for exenatide expired in the US in 2013 for Byetta and 2022 for Bydureon. Patent expirations enable biosimilar development, increasing market competition.

2. Are biosimilars for exenatide in development?
Yes. Patent expirations open opportunities for biosimilars, but none have received widespread approval or market presence as of early 2023.

3. How does exenatide compare to newer GLP-1 treatments?
Newer agents like semaglutide have longer dosing intervals, oral formulations, and demonstrated superior cardiovascular benefits, leading to higher market adoption.

4. What is the outlook for exenatide’s sales?
Sales are expected to decline steadily as market share shifts toward longer-acting and oral therapies, with continued competition impacting revenue stability.

5. What regulatory changes impact the exenatide market?
FDA guidance emphasizing cardiovascular safety and the approval of oral GLP-1 drugs influence prescribing trends and R&D priorities.

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References

1. International Diabetes Federation. IDF Diabetes Atlas, 2022.
2. IQVIA. Pharmaceutical Market Data, 2021.
3. U.S. Food and Drug Administration. Guidance for Industry: Diabetes Drugs, 2020.
4. MarketsandMarkets. GLP-1 Receptor Agonists Market, 2022.
5. Biogen Annual Report, 2021.