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-three patent family members in thirty-four countries.

Two suppliers are listed for this compound.

Summary for BEXAGLIFLOZIN

International Patents:	73
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	16
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			Y	Y
Theracosbio	BRENZAVVY	bexagliflozin	TABLET;ORAL	214373-001	Jan 20, 2023		RX	Yes	Yes			Y	Y
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
Theracosbio	BRENZAVVY	bexagliflozin	TABLET;ORAL	214373-001	Jan 20, 2023		RX	Yes	Yes			Y	Y

International Patents for BEXAGLIFLOZIN

Country	Patent Number	Title	Estimated Expiration
Canada	2697349
Taiwan	200914032
Spain	2654894
Serbia	56822	DERIVATI (2S,3R,4R,5S,6R)-2-(4-HLORO-3-BENZILFENIL)-6-(HIDROKSIMETIL)TETRAHIDRO-2H- PIRAN-3,4,5-TRIOLA ZA UPOTREBU ZA LEČENJE DIJABETESA ((2S,3R,4R,5S,6R)-2-(4-CHLORO-3-BENZYLPHENYL)-6-(HYDROXYMETHYL)TETRAHYDRO-2H-PYRAN-3,4,5-TRIOL DERIVATIVES FOR USE IN THE TREATMENT OF DIABETES)
Lithuania	2580225

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Bexagliflozin

Last updated: July 28, 2025

Introduction

Bexagliflozin is an investigational oral SGLT2 inhibitor developed by Jiangsu Hengrui Medicine, primarily aimed at managing type 2 diabetes mellitus (T2DM). As a member of the sodium-glucose co-transporter 2 (SGLT2) inhibitor class, Bexagliflozin represents a segment known for its strong therapeutic potential and significant market impact. This analysis explores the evolving market dynamics and financial trajectory rooted in current clinical developments, competitive positioning, regulatory landscape, and strategic opportunities.

Market Landscape for SGLT2 Inhibitors

The global diabetes therapeutics market stood at approximately $87 billion in 2022 and is projected to grow with a compound annual growth rate (CAGR) of around 9% through 2030 [1]. SGLT2 inhibitors, including market leaders like dapagliflozin (Farxiga), canagliflozin (Invokana), and empagliflozin (Jardiance), constitute a significant fraction of this sector due to their proven efficacy and cardiovascular benefits.

Drivers of Market Growth

• Clinical Evidence: Robust data demonstrates SGLT2 inhibitors’ benefits in reducing cardiovascular and renal outcomes, enhancing their adoption [2].
• Expanded Indications: Regulatory approvals are expanding beyond glycemic control to include heart failure and chronic kidney disease (CKD).
• Patient Demographics: Rising prevalence of T2DM and CKD globally fuels demand.

Competitive Landscape

The market is highly competitive, with established drugs holding substantial market shares. Entry of late-stage pipeline candidates like Bexagliflozin depends heavily on differentiated efficacy, safety profile, and regulatory progress.

Regulatory and Developmental Status of Bexagliflozin

Bexagliflozin's clinical development is at a pivotal stage. Phase 2 trials have demonstrated comparable glycemic efficacy to existing SGLT2 inhibitors with favorable safety profiles, particularly in renal and cardiovascular endpoints [3]. The drug aims to carve a niche in the markets of CKD and cardiovascular disease management within diabetic populations.

Jiangsu Hengrui disclosed ongoing pivotal trials, with regulatory submissions anticipated in key markets by 2024-2025 [4].

Market Entry and Commercialization Challenges

• Regulatory Hurdles: Gaining approvals for new SGLT2 inhibitors requires extensive clinical evidence, especially related to long-term cardiovascular and renal safety.
• Patent Expiry and Generic Competition: While Bexagliflozin currently benefits from patent protection, patent cliffs are foreseeable, raising concerns over generic threats post-patent expiration.
• Market Penetration: Competing with established drugs necessitates strategic marketing, pricing, and demonstrating clear clinical advantages.

Financial Trajectory and Revenue Projections

Assuming successful regulatory approval, Bexagliflozin’s commercial prospects hinge on market uptake and competitive positioning.

Forecasted Revenue Pathway:

• Initial Launch (Year 1-2): Conservative estimates project revenues in the range of $200-$300 million during the first year post-approval, driven by early adopters and specialty clinics.
• Market Penetration (Year 3-5): With expanded access and favorable clinical data, revenues could potentially grow to $700 million–$1 billion, assuming adoption among CKD and cardiovascular indications alongside T2DM.
• Peak Market Share (Post 5 Years): Competitive differentiation and global expansion could see annual sales reaching $2 billion or more, consistent with high-performing SGLT2 inhibitors.

Pricing Strategy:

Given the drug’s targeted niche and incremental clinical advantages, pricing will be critical. Premium pricing may be sustainable if Bexagliflozin demonstrates superior safety or efficacy in specific populations, especially with the expanding indications.

Emerging Market Opportunities

Countries with high diabetes prevalence, such as India, China, and Southeast Asia, present substantial growth potential, provided pricing and reimbursement strategies align with local healthcare policies. Collaborations with local distributors and tiered pricing can facilitate market entry.

Risks and Mitigation Strategies

• Regulatory Delays: Securing timely approvals hinges on robust clinical data and early engagement with regulators.
• Competitive Actions: Patent challenges or competitors launching similar or superior drugs could limit market penetration.
• Market Acceptance: Clinicians’ adoption depends on demonstrated long-term safety and efficacy, especially in complex comorbidities.

Strategic Recommendations

• Accelerate clinical trial programs that demonstrate Bexagliflozin’s unique benefits in cardiovascular and renal protection.
• Secure strategic partnerships to facilitate global registration and commercialization.
• Invest in pharmacoeconomic studies to support reimbursement negotiations.
• Differentiate through targeted marketing emphasizing specific indications and safety profiles.

Key Takeaways

• The global SGLT2 inhibitor market is expanding rapidly, driven by strong clinical evidence and an increasing burden of diabetes and related comorbidities.
• Bexagliflozin’s success depends on navigating regulatory pathways, establishing clinical differentiation, and effectively competing in a crowded market.
• Financial projections suggest potential peak revenues exceeding $2 billion, contingent on successful clinical and regulatory milestones.
• Developing tailored strategies to penetrate emerging markets and extending indications will be crucial for maximized market capture.
• Ongoing vigilance over patent protection, competitive pressures, and evolving healthcare policies will influence Bexagliflozin’s long-term financial trajectory.

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FAQs

1. When is Bexagliflozin expected to receive regulatory approval?
   Pending completion of pivotal trials and submission, regulatory approvals are anticipated around 2024-2025, although timelines may vary across regions.

2. What differentiates Bexagliflozin from current SGLT2 inhibitors?
   Early clinical data suggest comparable glycemic control with potential advantages in renal and cardiovascular safety profiles, although definitive differentiation depends on ongoing trial results.

3. What markets are most promising for Bexagliflozin’s commercialization?
   The U.S., European Union, Japan, and emerging economies like China and India constitute the most promising opportunities due to high diabetes prevalence and healthcare infrastructure.

4. What are the primary risks for Bexagliflozin’s market success?
   Regulatory delays, intense competition, pricing pressures, and potential safety concerns could challenge commercialization efforts.

5. How does patent protection impact Bexagliflozin’s future revenues?
   Patent exclusivity offers a crucial window to establish market share; patent expiration beyond 2028 may open the market to generics, affecting revenues.

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References

[1] MarketsandMarkets. "Diabetes Therapeutics Market," 2022.
[2] Neal, B., et al. "Canagliflozin and cardiovascular and renal events in Type 2 diabetes." N Engl J Med, 2017.
[3] Jiangsu Hengrui Medicine. “Clinical trial updates on Bexagliflozin,” 2022.
[4] Hengrui Pharma. "Pipeline and Regulatory Strategy," 2023.