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
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			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

International Patents for BEXAGLIFLOZIN

Country	Patent Number	Title	Estimated Expiration
South Korea	101831675
Denmark	2187742
Hungary	E035947
Hungary	E040355
Ukraine	108887	КРИСТАЛІЧНА ФОРМА БЕНЗИЛ-БЕНЗОЛЬНОГО ІНГІБІТОРА SGLT2
Russian Federation	2013101580	КРИСТАЛЛИЧЕСКАЯ ФОРМА БЕНЗИЛ-БЕНЗОЛЬНОГО ИНГИБИТОРА SGLT

Market Dynamics and Financial Trajectory for Bexagliflozin

Last updated: March 4, 2026

What is Bexagliflozin?

Bexagliflozin is an SGLT2 inhibitor developed to treat type 2 diabetes mellitus (T2DM). It functions by reducing renal glucose reabsorption, thereby increasing urinary glucose excretion. Developed by AbbVie, it entered clinical trials in multiple regions. Its chemical name is (1S,2S,3S,4R,5S,6R)-6-(4-chlorophenyl)-2-((4-methylpiperazin-1-yl)methyl)-4-(3-methyl-3-oxobutan-2-yl)-2,3,4,5-tetrahydro-1H-pyrrolo[3,4-b]pyridin-1-one.

How does Bexagliflozin compare within the SGLT2 inhibitor class?

Drug	Marketed Status	Indications	Market Launch	Estimated Peak Revenue (USD millions)
Dapagliflozin (Farxiga)	Approved	T2DM, heart failure, CKD	2014	3,500+
Empagliflozin (Jardiance)	Approved	T2DM, heart failure, CKD	2014	4,200+
Canagliflozin (Invokana)	Approved	T2DM, CKD	2013	2,700+
Bexagliflozin	Under Development	T2DM	Phase 3	N/A

Bexagliflozin is in late-stage development, with Phase 3 trials completed as of 2022. It aims to differentiate by improving selectivity and reducing adverse events associated with existing treatments.

Market Drivers for Bexagliflozin

• Increasing T2DM prevalence: Projected to reach 700 million globally by 2045 (IDF Diabetes Atlas, 9th Edition 2019).
• Shift toward SGLT2 inhibitors: Proven benefits in cardiovascular and renal outcomes boost adoption.
• Patient preference: Oral administration and favorable safety profiles contribute to higher compliance.
• Expanding indications: Potential to treat heart failure and chronic kidney disease beyond T2DM.

Barriers to Market Entry

• Established competitors: Dapagliflozin, empagliflozin, and canagliflozin dominate market share.
• Regulatory hurdles: Need for long-term safety data.
• Pricing pressures: Payers favor cost-effective options.
• Patent landscape: Existing patents on key formulations may delay generic entry.

Financial Projections and Trajectory

Revenue Estimates

Year	Projected Revenue (USD millions)	Assumptions
Year 1	50-100	Initial launch, limited market penetration
Year 2	200-300	Growing prescriber awareness
Year 3	500-700	Broader insurance coverage, expanded indications

Key Factors Influencing Revenue

• Market penetration rate: A conservative estimate places it at 10-15% of the SGLT2 class share in initial years.
• Pricing strategy: Premium pricing aligned with clinical benefits; potential discounts as generic competition arises.
• Regulatory approvals: Successful completion of trials and timely FDA/EU approval serve as critical milestones.
• Partnerships: Collaborations with healthcare providers and payers influence adoption rates.

R&D and Launch Costs

• Estimated $500-700 million to complete Phase 3 trials, secure regulatory approval, and launch.
• Marketing and commercialization expenses could comprise 20-25% of annual revenues upon launch.

Competitive Position and Opportunities

• Differentiation: Bexagliflozin may gain market share through superior selectivity for SGLT2, reduced adverse effects, and additional indications.
• Partnership potential: Licensing agreements with regional players could accelerate market access.
• Pipeline expansion: Development of combination therapies may amplify revenue streams.

Risks and Uncertainties

• Delays in regulatory approvals due to safety concerns.
• Lower-than-expected market penetration owing to entrenched competitors.
• Regulatory changes or reimbursement policies that limit pricing flexibility.
• Patent disputes or challenges to proprietary formulations.

Summary of Market Outlook

Bexagliflozin’s trajectory hinges upon clinical trial success, regulatory approval, and strategic commercialization. With a crowded class and high R&D costs, its market share growth will be incremental unless it demonstrates significant clinical advantages. Revenue potential remains promising, contingent on overcoming barriers and capturing unmet needs in T2DM and related comorbidities.

---

Key Takeaways

• Bexagliflozin is in late-stage development with expectations to enter the global T2DM market.
• It faces significant competition from established SGLT2 inhibitors, with dominant brands generating annual revenues exceeding $3 billion.
• Financial trajectory forecasts suggest modest initial revenues with potential for growth as indications expand.
• Barriers include regulatory hurdles, patent landscapes, and market adoption challenges.
• Successful differentiation and strategic partnerships may elevate its market share and revenue potential.

---

FAQs

1. What distinguishes Bexagliflozin from other SGLT2 inhibitors?
   It aims to offer higher selectivity and fewer side effects, but definitive clinical advantages remain unproven pending trial results.

2. When is Bexagliflozin expected to launch commercially?
   Regulatory approval deadlines projected for 2023-2024, with market entry shortly thereafter.

3. What are the primary markets for Bexagliflozin?
   The initial focus is the U.S. and European markets, with potential expansion into Asia and emerging markets.

4. What are the major hurdles for Bexagliflozin’s commercialization?
   Achieving regulatory approval, gaining prescriber acceptance, and establishing a competitive pricing model.

5. Could Bexagliflozin replace existing SGLT2 drugs?
   Not immediately. Adoption depends on demonstrable clinical benefits, safety profile, and cost-effectiveness.

---

References

[1] International Diabetes Federation. (2019). IDF Diabetes Atlas, 9th edition.
[2] Bloomberg Intelligence. (2022). Global Market for SGLT2 Inhibitors.
[3] AbbVie. (2022). Bexagliflozin clinical trial summaries and development pipeline.