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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. One supplier is listed for this compound. Additional details are available on the exenatide synthetic profile page.

Summary for BYETTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	124
Patent Applications:	1
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

BYETTA is protected by zero US patents and one FDA Regulatory Exclusivity.

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

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	7,741,269
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005	6,902,744
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	6,858,576
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	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
Canada	2299425
Brazil	9815670
China	1384755
Hong Kong	1031120
Austria	493998

Supplementary Protection Certificates for BYETTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1734971	300526	Netherlands		PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1140145	CA 2007 00033	Denmark		PRODUCT NAME: EXENATID, EXENDIN, EXENDINAGONISTER; REG. NO/DATE: EU/1/06/362/001-004 20061120
0996459	0790031-9	Sweden		PRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
0996459	C00996459/01	Switzerland		FORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US
0996459	464	Finland

BYETTA Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of BYETTA (Exenatide)

Introduction to BYETTA

BYETTA, also known as exenatide, is a glucagon-like peptide-1 (GLP-1) receptor agonist used primarily in the treatment of type 2 diabetes. Developed by Amylin Pharmaceuticals and later acquired by AstraZeneca, BYETTA has been a significant player in the diabetes management market since its approval.

Market Size and Growth

The market for GLP-1 receptor agonists, including BYETTA, has been growing steadily. The global GLP-1 receptor agonist market was estimated at USD 53.46 billion in 2024 and is projected to grow at a CAGR of 17.46% from 2025 to 2030[4].

Key Drivers of Growth

• Increasing Prevalence of Diabetes: The rising incidence of type 2 diabetes globally, driven by factors such as increasing obesity and inactivity, is a major driver for the growth of the GLP-1 agonist market, including BYETTA[1][4].
• Technological Advancements: Improvements in the efficiency and delivery mechanisms of GLP-1 agonists have enhanced their appeal and usability, contributing to market growth[1].
• Demographic Factors: The aging population and increasing life expectancy in many countries are also driving the demand for diabetes treatments[1].

Financial Performance of BYETTA

Historical Sales Data

• In 2008, BYETTA generated net product sales of $678.5 million, which was a 9% increase over 2007. This was part of Amylin Pharmaceuticals' total revenue of $840.1 million for the year[5].
• By the third quarter of 2010, BYETTA sales had reached $422.9 million, down from $503.9 million in the same period in 2009, reflecting a decline in market share due to competition from other GLP-1 agonists[2].

Revenue Trends

• Declining Market Share: Despite its initial success, BYETTA's market share has declined over the years. By the fourth quarter of 2012, BYETTA's market share had dropped to 20%, largely due to the introduction of other GLP-1 agonists like Victoza (liraglutide) and Bydureon (exenatide extended-release)[3].
• Geographical Performance: BYETTA has seen varying levels of success in different regions. North America has been a significant market, but the drug has also faced competition in international markets, particularly with the launch of other GLP-1 agonists[3].

Competitive Landscape

Market Competition

• Other GLP-1 Agonists: The market for GLP-1 agonists is highly competitive, with drugs like Victoza (liraglutide), Bydureon (exenatide extended-release), and more recently, semaglutide (Ozempic and Rybelsus), gaining significant market share. Victoza, in particular, has dominated the market, holding around 70% of the GLP-1 agonist market share in 2012[3][4].
• New Entrants: The approval and launch of new GLP-1 agonists, such as Zepbound, are expected to further intensify competition in the market[4].

Distribution and Application

Channels of Distribution

• BYETTA is distributed through various channels, including hospitals and drug stores. The drug store segment has been a major contributor to its sales due to its consumer-friendly nature and ease of use[1].

Clinical Applications

• BYETTA is primarily used in the management of type 2 diabetes. It is administered via injection, either twice daily or once weekly in its extended-release form (Bydureon)[1][4].

Financial Challenges and Restructuring

Cost Structure and Expenses

• Amylin Pharmaceuticals, the original developer of BYETTA, faced significant financial challenges, including high selling, general, and administrative expenses. The company implemented cost-reduction measures, such as workforce reductions, to manage these expenses[2].

Collaborative Agreements

• The company also generated revenue through collaborative agreements, particularly with Eli Lilly, which included cost-sharing payments for BYETTA and exenatide once weekly development expenses[2][5].

Future Outlook

Market Projections

• Despite the decline in BYETTA's market share, the overall GLP-1 agonist market is expected to continue growing. The increasing prevalence of type 2 diabetes and the expanding approval of new GLP-1 agonists are key factors driving this growth[1][4].

Innovations and New Formulations

• Innovations such as the launch of single-dose vials of Zepbound and other cost-effective formulations are expected to impact the market dynamics and potentially revitalize interest in existing drugs like BYETTA[4].

Key Takeaways

• BYETTA has been a significant player in the GLP-1 agonist market but has faced declining market share due to competition.
• The global GLP-1 agonist market is expected to grow significantly, driven by the increasing prevalence of type 2 diabetes and technological advancements.
• Distribution channels, including drug stores, remain crucial for BYETTA's sales.
• Financial performance has been impacted by competitive pressures and high operational costs.

FAQs

What is BYETTA used for?

BYETTA (exenatide) is used primarily in the treatment of type 2 diabetes.

How is BYETTA administered?

BYETTA is administered via injection, either twice daily or once weekly in its extended-release form (Bydureon).

What are the main drivers of the GLP-1 agonist market growth?

The main drivers include the increasing prevalence of type 2 diabetes, technological advancements, and demographic factors such as aging populations.

Which regions contribute the most to BYETTA's sales?

North America has been a significant market for BYETTA, although the Asia Pacific region, particularly countries like China and India, has a high diabetic population and potential for growth.

How has BYETTA's market share changed over the years?

BYETTA's market share has declined over the years, from around 31% in 2011 to 20% in 2012, due to competition from other GLP-1 agonists.

Sources

1. Verified Market Research: Exenatide Market Size, Trends, Scope, Opportunities, Share ...
2. BioSpace: Amylin Pharmaceuticals, Inc. Reports Third Quarter Financial Results
3. Close Concerns: 2013-04-11 CC - 4Q12 Diabetes and Obesity Industry Roundup
4. Grand View Research: GLP-1 Receptor Agonist Market Size & Share Report, 2030
5. Fierce Biotech: Amylin Pharmaceuticals, Inc. Q4 Loss Widens on Charges, Falling BYETTA Sales