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BRENZAVVY Drug Patent Profile

Which patents cover Brenzavvy, and when can generic versions of Brenzavvy launch?

Brenzavvy is a drug marketed by Theracosbio and is included in one NDA. There are six patents protecting this drug.

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

The generic ingredient in BRENZAVVY is bexagliflozin. Two suppliers are listed for this compound. Additional details are available on the bexagliflozin profile page.

DrugPatentWatch^® Generic Entry Outlook for Brenzavvy

Brenzavvy will be eligible for patent challenges on January 20, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 20, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for BRENZAVVY

International Patents:	71
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	37
Patent Applications:	58
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRENZAVVY
What excipients (inactive ingredients) are in BRENZAVVY?	BRENZAVVY excipients list
DailyMed Link:	BRENZAVVY at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

214373

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.

Pharmacology for BRENZAVVY

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

US Patents and Regulatory Information for BRENZAVVY

BRENZAVVY is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	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	7,838,499		Y	Y
Theracosbio	BRENZAVVY	bexagliflozin	TABLET;ORAL	214373-001	Jan 20, 2023		RX	Yes	Yes	8,802,637		Y	Y

International Patents for BRENZAVVY

See the table below for patents covering BRENZAVVY around the world.

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

BRENZAVVY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BRENZAVVY (Bexagliflozin)

Introduction to BRENZAVVY

BRENZAVVY, or bexagliflozin, is a sodium-glucose cotransporter 2 (SGLT2) inhibitor approved by the FDA in July 2023 for the treatment of type 2 diabetes. This medication has been making significant waves in the pharmaceutical market due to its affordability, efficacy, and streamlined access.

Market Size and Growth Projections

The global SGLT2 inhibitors market, which includes BRENZAVVY, is projected to experience substantial growth. As of 2023, the market size was estimated at USD 15.85 billion, and it is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.71% from 2024 to 2030[1].

Pricing Strategy and Affordability

One of the key factors driving the market dynamics of BRENZAVVY is its pricing strategy. BRENZAVVY is priced significantly lower than other medications in its class, with a list price of $47.85 per 30-tablet bottle. This is approximately 90% lower than comparable medications, making it highly accessible to both insured and uninsured patients[1][4][5].

Distribution and Accessibility

TheracosBio, the manufacturer of BRENZAVVY, has partnered with several entities to enhance the drug's accessibility. Notably, the partnership with Mark Cuban's Cost Plus Drug Company allows BRENZAVVY to be sold directly to healthcare providers through the Cost Plus Drugs Marketplace program. This eliminates the need for prior authorizations and other insurance-related hurdles, making the medication more accessible to a broader patient base[1][4].

Additionally, BRENZAVVY is available through DiRx, an online mail order pharmacy, which further expands its reach across all 50 states and the District of Columbia[3].

Clinical Efficacy and Safety

BRENZAVVY has demonstrated strong clinical efficacy in reducing blood sugar levels and improving overall diabetes control. Phase 3 clinical studies have shown that BRENZAVVY significantly reduces hemoglobin A1c and fasting blood sugar levels, either as a monotherapy or in combination with other treatments. The BEST trial found that participants' A1C levels decreased from 8.3% to 7.45%, a reduction that can significantly lower the risk of diabetes-related complications such as heart disease, kidney disease, and blindness[2][3].

Moreover, BRENZAVVY has been found to have a safe cardiovascular profile, similar to other approved SGLT2 inhibitors. A meta-analysis confirmed that BRENZAVVY poses no safety risk to the heart or blood vessels, even in patients at high risk for future cardiovascular disease[2].

Financial Impact on Patients and Healthcare System

The affordability of BRENZAVVY is expected to have a significant financial impact on both patients and the healthcare system. For patients, the lower cost eliminates financial barriers, making it easier for them to start and stay on the medication. This is particularly beneficial for the uninsured, underinsured, or those on Medicare, who often face high costs for diabetes treatments[5].

For the healthcare system, the reduced cost of BRENZAVVY can lead to lower overall healthcare expenditures. By reducing the need for prior authorizations and other administrative hurdles, healthcare providers can streamline care, reducing both direct and indirect costs associated with managing type 2 diabetes[4].

Market Competition

BRENZAVVY enters a market dominated by other SGLT2 inhibitors such as canagliflozin (Invokana), dapagliflozin (Farxiga), empagliflozin (Jardiance), and ertugliflozin (Steglatro). However, its unique pricing strategy and partnerships set it apart, making it an attractive option for patients and healthcare providers looking for affordable and effective diabetes management[2][4].

Regulatory Environment

The regulatory environment, particularly the Inflation Reduction Act, has played a role in highlighting BRENZAVVY's competitive pricing. The release of negotiated prices under this act has reinforced BRENZAVVY's position as the lowest-priced SGLT2 inhibitor, further solidifying its market position[5].

Patient Outcomes and Quality of Life

The clinical benefits of BRENZAVVY extend beyond just glycemic control. Patients taking BRENZAVVY have experienced modest decreases in body weight and blood pressure, which can further improve their overall quality of life and reduce the risk of diabetes-related complications[2][3].

Future Outlook

Given its strong clinical profile, affordability, and streamlined access, BRENZAVVY is poised for significant market growth. The expansion of its availability through various partnerships and distribution channels is expected to increase its market share within the SGLT2 inhibitors segment. As the global SGLT2 inhibitors market continues to grow, BRENZAVVY is well-positioned to capture a substantial portion of this market due to its unique value proposition.

Key Takeaways

• Affordability: BRENZAVVY is priced significantly lower than other SGLT2 inhibitors, making it highly accessible.
• Clinical Efficacy: BRENZAVVY has demonstrated strong clinical efficacy in reducing blood sugar levels and improving diabetes control.
• Safety Profile: BRENZAVVY has a safe cardiovascular profile, similar to other approved SGLT2 inhibitors.
• Distribution: Available through multiple channels, including Cost Plus Drugs and DiRx, eliminating insurance-related hurdles.
• Market Growth: Expected to contribute to the growth of the global SGLT2 inhibitors market, projected to grow at a CAGR of 7.71% from 2024 to 2030.

FAQs

1. What is BRENZAVVY used for? BRENZAVVY (bexagliflozin) is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

2. How much does BRENZAVVY cost? BRENZAVVY is priced at $47.85 per 30-tablet bottle, significantly lower than other medications in its class.

3. Is BRENZAVVY safe for patients with cardiovascular risks? Yes, BRENZAVVY has been found to have a safe cardiovascular profile, similar to other approved SGLT2 inhibitors, even in patients at high risk for future cardiovascular disease.

4. Where can BRENZAVVY be purchased? BRENZAVVY can be purchased through Mark Cuban's Cost Plus Drugs online pharmacy, DiRx, and other healthcare businesses through the Cost Plus Drugs Marketplace program.

5. What are the clinical benefits of BRENZAVVY? BRENZAVVY significantly reduces hemoglobin A1c and fasting blood sugar levels, and also results in modest decreases in body weight and blood pressure.

Sources

1. Grand View Research - SGLT2 Inhibitors Market Size, Share & Growth Report, 2030
2. Diatribe - Brenzavvy, a Type 2 Diabetes Drug, Available for Less Than $50
3. BioSpace - TheracosBio Announces Availability of BRENZAVVY® (bexagliflozin) through DiRx’s National Online Pharmacy
4. BioSpace - TheracosBio Extends Partnership with Mark Cuban Cost Plus Drug Company
5. Business Wire - Release of Negotiated Prices Under Inflation Reduction Act Reveals that BRENZAVVY® (bexagliflozin) Remains the Lowest Priced SGLT2 Inhibitor