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 four branded drugs marketed by Astrazeneca Ab and is included in three NDAs. There are twenty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Exenatide synthetic has four hundred and thirty-nine patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for EXENATIDE SYNTHETIC

International Patents:	439
US Patents:	21
Tradenames:	4
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	7
Patent Applications:	6,452
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXENATIDE SYNTHETIC
DailyMed Link:	EXENATIDE SYNTHETIC at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EXENATIDE SYNTHETIC

Dosage:

FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
Neuroscience Trials 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 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
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		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	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	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
Poland	2139494
Spain	2809178
Russian Federation	2421237	СПОСОБЫ ЛЕЧЕНИЯ ДИАБЕТА И СНИЖЕНИЯ МАССЫ ТЕЛА (METHODS OF DIABETES TREATMENT AND BODY WEIGHT REDUCTION)

Supplementary Protection Certificates for EXENATIDE SYNTHETIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	PA2014026	Lithuania		PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	PA 2013 008, C 1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211	C20130006 00074	Estonia		PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012

EXENATIDE SYNTHETIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Exenatide Synthetic

Introduction to Exenatide Synthetic

Exenatide synthetic, commonly known by its brand name BYETTA, is a glucagon-like peptide-1 (GLP-1) receptor agonist used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The exenatide market has been growing at a rapid pace over the last few years and is expected to continue this trend through the forecast period of 2022 to 2030. This growth is driven by several key factors, including the increasing prevalence of diabetes, particularly in established and emerging countries, and the improved efficiency of GLP-1 agonists[1].

Key Drivers of Market Growth

Increasing Diabetes Prevalence

The rise in the diabetic population, attributed to factors such as increasing median age, obesity, and inactivity levels, is a significant driver. Countries with high percentages of geriatric populations, like Japan, Italy, Germany, and France, are expected to contribute substantially to this growth[1].

Technological Advancements and Healthcare Infrastructure

Advancements in healthcare technology and the availability of skilled medical professionals are also crucial. The increasing health awareness among consumers and the ease of access to medical knowledge via the internet further boost the market[1].

Geographical Contributions

The global exenatide market is segmented geographically, with North America expected to contribute the most due to its high per capita income. However, the Asia Pacific region, particularly China and India, has the highest number of diabetic patients, making it a significant market as well[1].

Market Segmentation

By Type

The market is segmented into extended-release injectable suspension and fast-release injectable suspension. The fast-release injectable suspension is more popular due to its lesser side effects and its ability to help patients lower their body weight, which is crucial for treating obese type 2 diabetes mellitus patients[1].

By Application

The market is segmented into hospital and drug store applications, with the drug store segment contributing more significantly. This is because exenatide is consumer-friendly and easy to use, requiring administration twice a day or once a week[1].

Competitive Landscape

The competitive landscape of the exenatide market includes major players such as Novo Nordisk, Sanofi, Eli Lilly, AstraZeneca, Teva Pharmaceuticals Industries, Bachem AG, and Ranbaxy Laboratories Limited. These companies are engaged in various development strategies to maintain and expand their market share[1].

Financial Trajectory

Revenue Projections

While exenatide is part of the older generation of GLP-1 agonists, its market share is expected to decline as newer, more effective drugs like Mounjaro and Ozempic gain traction. However, the overall GLP-1 agonist market is projected to grow significantly. For instance, Visible Alpha consensus revenue estimates for 2030 show substantial revenues for newer GLP-1 agonists, with Mounjaro leading at $20.6 billion and Ozempic at $18.1 billion[3].

Generic Market Entry

The recent FDA approval of Amneal’s generic exenatide injectable marks a significant milestone. This is one of the first generic GLP-1 injectables approved in the U.S., reflecting Amneal’s innovation and regulatory capabilities in complex pharmaceuticals. The entry of generics is expected to impact the pricing and market dynamics, potentially increasing accessibility and reducing costs for patients[5].

Challenges and Restraints

Despite the growth potential, the exenatide market faces several challenges. These include the rise in treatment costs, side effects such as low blood sugar, nausea, dizziness, and more serious conditions like medullary thyroid cancer and pancreatitis. Additionally, the increasing competition from newer, more effective GLP-1 agonists could reduce the market share of exenatide[1].

Impact of Newer GLP-1 Agonists

Newer GLP-1 agonists like Mounjaro and Ozempic have significantly improved drug profiles, offering better efficacy, safety, and dosing frequency. These drugs are also associated with cardiovascular benefits and more meaningful weight loss, which is likely to shift market preference away from older drugs like exenatide[3].

Off-Label Use and Supply Issues

The high demand for newer GLP-1 agonists, such as Wegovy and Ozempic, for weight loss has led to supply issues. This has resulted in off-label use of these drugs, further complicating the market dynamics for traditional GLP-1 agonists like exenatide[3].

Key Takeaways

• The exenatide market is growing due to increasing diabetes prevalence and technological advancements.
• The market is segmented by type and application, with fast-release injectable suspension and drug store segments being more prominent.
• Major players are engaged in competitive strategies to maintain market share.
• The entry of generic exenatide is expected to impact pricing and accessibility.
• Newer GLP-1 agonists pose a significant challenge to the market share of exenatide.
• Off-label use and supply issues of newer drugs affect the traditional GLP-1 agonist market.

FAQs

1. What is exenatide synthetic used for?

Exenatide synthetic, known by its brand name BYETTA, is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus[5].

2. What are the key drivers of the exenatide market growth?

Key drivers include the increasing prevalence of diabetes, technological advancements, and the availability of skilled medical professionals. Geographical factors, such as high per capita income in North America and a large diabetic population in the Asia Pacific, also play a role[1].

3. How is the exenatide market segmented?

The market is segmented by type (extended-release and fast-release injectable suspensions) and application (hospital and drug store)[1].

4. What are the challenges faced by the exenatide market?

Challenges include the rise in treatment costs, side effects, and increasing competition from newer, more effective GLP-1 agonists[1].

5. How does the entry of generic exenatide impact the market?

The entry of generic exenatide is expected to increase accessibility and reduce costs for patients, potentially impacting the pricing and market dynamics of the drug[5].

Cited Sources:

1. Verified Market Research: Exenatide Market Size, Trends, Scope, Opportunities, Share.
2. Drug Patent Watch: Byetta.
3. Visible Alpha: Analysts Forecast Revenues for Drugs Treating Type 2 Diabetes.
4. ACS Publications: Synthesis, Optimization, and Biological Evaluation of Corrinated GLP-1R Agonist.
5. Amneal Pharmaceuticals: Amneal Resubmits DHE Autoinjector New Drug Application and Receives U.S. FDA Approval of Exenatide.