BEXAGLIFLOZIN - Generic Drug Details

What are the generic drug sources for bexagliflozin and what is the scope of patent protection?

Bexagliflozin is the generic ingredient in one branded drug marketed by Theracosbio and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bexagliflozin has seventy-one patent family members in thirty-two countries.

Two suppliers are listed for this compound.

Summary for BEXAGLIFLOZIN

International Patents:	71
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	16
Patent Applications:	116
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BEXAGLIFLOZIN
What excipients (inactive ingredients) are in BEXAGLIFLOZIN?	BEXAGLIFLOZIN excipients list
DailyMed Link:	BEXAGLIFLOZIN at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

TABLET;ORAL

^*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 BEXAGLIFLOZIN

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

Sponsor	Phase
Theracos	Phase 2/Phase 3
Theracos	Phase 1
Theracos	Phase 3

See all BEXAGLIFLOZIN clinical trials

Pharmacology for BEXAGLIFLOZIN

Drug Class	Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Sodium-Glucose Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for BEXAGLIFLOZIN

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for BEXAGLIFLOZIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Theracosbio	BRENZAVVY	bexagliflozin	TABLET;ORAL	214373-001	Jan 20, 2023		RX	Yes	Yes	7,838,499		Y	Y
Theracosbio	BRENZAVVY	bexagliflozin	TABLET;ORAL	214373-001	Jan 20, 2023		RX	Yes	Yes	8,987,323		Y	Y
Theracosbio	BRENZAVVY	bexagliflozin	TABLET;ORAL	214373-001	Jan 20, 2023		RX	Yes	Yes	10,533,032
Theracosbio	BRENZAVVY	bexagliflozin	TABLET;ORAL	214373-001	Jan 20, 2023		RX	Yes	Yes
Theracosbio	BRENZAVVY	bexagliflozin	TABLET;ORAL	214373-001	Jan 20, 2023		RX	Yes	Yes	8,106,021
Theracosbio	BRENZAVVY	bexagliflozin	TABLET;ORAL	214373-001	Jan 20, 2023		RX	Yes	Yes	10,981,942		Y	Y

International Patents for BEXAGLIFLOZIN

Country	Patent Number	Title	Estimated Expiration
Ukraine	99924	ПОХІДНІ БЕНЗИЛБЕНЗОЛУ ТА ЇХ ЗАСТОСУВАННЯ[ПРОИЗВОДНЫЕ БЕНЗИЛБЕНЗОЛА И ИХ ПРИМЕНЕНИЕ (BENZYLBENZOL DERIVATIVES AND USING THEREOF)
Spain	2683123
South Korea	20100044909	BENZYLBENZENE DERIVATIVES AND METHODS OF USE
World Intellectual Property Organization (WIPO)	2009026537
Brazil	112012031616	forma cristalina do inibidor de benzilbenzeno sglt2
South Korea	101831675

BEXAGLIFLOZIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bexagliflozin

Introduction to Bexagliflozin

Bexagliflozin, marketed under the brand name Brenzavvy, is a sodium-glucose co-transporter 2 (SGLT2) inhibitor developed by TheracosBio. It received FDA approval in January 2023 for the treatment of type 2 diabetes mellitus, marking a significant milestone in the management of this chronic condition[2].

Increasing Demand for SGLT2 Inhibitors

The global demand for SGLT2 inhibitors, including bexagliflozin, is driven by the rising incidence of type 2 diabetes worldwide. The increasing prevalence of diabetes, particularly among the aging population and those with poor dietary habits and disturbed lifestyles, has created a substantial market for antidiabetic medications[1][4].

Market Size and Growth

The global SGLT2 inhibitors market, which includes bexagliflozin, was estimated at USD 15.85 billion in 2023 and is projected to grow at a CAGR of 7.71% from 2024 to 2030. This growth is attributed to the increasing incidence of type 2 diabetes, ongoing research and development, and supportive government policies and insurance coverage for diabetes treatments[4].

North America Oral Anti-Diabetic Drug Market

In the North American market, the oral anti-diabetic drug segment is expected to reach USD 18.76 billion in 2024 and grow at a CAGR of 4.70% to reach USD 23.60 billion by 2029. The United States dominates this market, driven by the robust presence of key market players and strong regulatory backing. Bexagliflozin, as a new entrant in this market, is poised to benefit from these favorable conditions[3].

Pricing and Accessibility

TheracosBio has taken a significant step to enhance the accessibility of bexagliflozin by partnering with the Mark Cuban Cost Plus Drug Company. This partnership allows healthcare providers to purchase bexagliflozin at a list price 90% lower than comparable medications, making it more affordable for both the uninsured and insured patients. This initiative is expected to boost the market growth of SGLT2 inhibitors over the forecast period[4].

Clinical Efficacy and Safety

Bexagliflozin has demonstrated strong clinical efficacy and safety in various trials. The Bexagliflozin Efficacy and Safety Trial (BEST) showed that bexagliflozin significantly reduced HbA1c levels, systolic blood pressure, and weight in patients with type 2 diabetes at high risk of cardiovascular events. The trial also demonstrated non-inferiority for the composite outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina[2][5].

Competitive Landscape

The SGLT2 inhibitors market is competitive, with other notable drugs like Jardiance (empagliflozin), Farxiga (dapagliflozin), and Invokana (canagliflozin). However, bexagliflozin's unique positioning, particularly its cost-efficiency and expanded accessibility through the Cost Plus Drug Company partnership, sets it apart in the market[4].

Regulatory Approvals and Support

Bexagliflozin's FDA approval in January 2023 was a crucial milestone. Additionally, initiatives by government organizations, such as the inclusion of Jardiance in the “Drug Price Negotiation Program” as part of the Inflation Reduction Act, indicate a supportive regulatory environment that can drive market growth for SGLT2 inhibitors[4].

Distribution Channels

The distribution of bexagliflozin is expected to be robust, with availability through hospital pharmacies, retail pharmacies, and online pharmacies. This multi-channel approach ensures widespread accessibility, further contributing to its market growth[4].

Regional Outlook

The market for SGLT2 inhibitors, including bexagliflozin, is not limited to North America but has a global reach. Regions such as Europe, Asia Pacific, and Latin America are also expected to contribute significantly to the market growth, driven by the increasing prevalence of diabetes and supportive healthcare policies[4].

Financial Projections

Given the favorable market conditions, bexagliflozin is expected to contribute substantially to the financial growth of the SGLT2 inhibitors market. With a projected CAGR of 7.71% from 2024 to 2030, the market is poised for significant expansion. The cost-efficiency and expanded accessibility of bexagliflozin are key factors that will drive its financial trajectory positively[4].

Key Takeaways

• Increasing Demand: Rising cases of type 2 diabetes and aging population drive demand.
• Market Growth: Projected CAGR of 7.71% from 2024 to 2030 for the global SGLT2 inhibitors market.
• Clinical Efficacy: Significant reduction in HbA1c, systolic blood pressure, and weight.
• Accessibility: Partnered with Mark Cuban Cost Plus Drug Company to offer at a lower price.
• Regulatory Support: FDA approval and inclusion in government programs.
• Distribution: Available through multiple channels including hospital, retail, and online pharmacies.

FAQs

What is the current market size of the global SGLT2 inhibitors market?

The global SGLT2 inhibitors market size was estimated at USD 15.85 billion in 2023[4].

How is bexagliflozin priced compared to other SGLT2 inhibitors?

Bexagliflozin is priced 90% lower than comparable medications through the Mark Cuban Cost Plus Drug Company partnership[4].

What are the primary benefits of bexagliflozin in treating type 2 diabetes?

Bexagliflozin reduces HbA1c levels, systolic blood pressure, and weight, and demonstrates non-inferiority for cardiovascular outcomes[2][5].

Which regions are expected to contribute significantly to the market growth of SGLT2 inhibitors?

North America, Europe, Asia Pacific, and Latin America are expected to contribute significantly to the market growth[4].

What is the projected CAGR for the global SGLT2 inhibitors market from 2024 to 2030?

The projected CAGR is 7.71% from 2024 to 2030[4].

Sources

1. Procurement Resource: Bexagliflozin Production Cost Reports[1].
2. Pharmacy Times: Bexagliflozin (Brenzavvy): Advancing Diabetes Management With SGLT-2 Inhibition[2].
3. Mordor Intelligence: North America Oral Anti-Diabetic Drug Market Size & Share Analysis[3].
4. Grand View Research: SGLT2 Inhibitors Market Size, Share & Growth Report, 2030[4].
5. Diabetes Journal: The Bexagliflozin Efficacy and Safety Trial (BEST)[5].