BYVALSON Drug Patent Profile

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

Byvalson is a drug marketed by Abbvie and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in fifteen countries.

The generic ingredient in BYVALSON is nebivolol hydrochloride; valsartan. There are fourteen drug master file entries for this compound. Additional details are available on the nebivolol hydrochloride; valsartan profile page.

DrugPatentWatch^® Generic Entry Outlook for Byvalson

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for BYVALSON

International Patents:	37
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Drug Prices:	Drug price information for BYVALSON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BYVALSON
DailyMed Link:	BYVALSON at DailyMed

See drug prices for BYVALSON

Paragraph IV (Patent) Challenges for BYVALSON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BYVALSON	Tablets	nebivolol hydrochloride; valsartan	5 mg/80 mg	206302	1	2017-06-09

US Patents and Regulatory Information for BYVALSON

BYVALSON is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	BYVALSON	nebivolol hydrochloride; valsartan	TABLET;ORAL	206302-001	Jun 3, 2016		DISCN	Yes	No	7,838,552
Abbvie	BYVALSON	nebivolol hydrochloride; valsartan	TABLET;ORAL	206302-001	Jun 3, 2016		DISCN	Yes	No	7,803,838		Y

International Patents for BYVALSON

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1753418	COMPOSITIONS COMPRENANT DU NÉBIVOLOL (COMPOSITIONS COMPRISING NEBIVOLOL)
Australia	2005249514	Compositions comprising nebivolol
Israel	179999	תכשירים המכילים נביבולול ואנטגוניסט של קולטן אנגיוטנסין ii ושימושים שלהם (Compositions comprising nebivolol and an angiotensin ii receptor antagonist and uses thereof)
China	102188708	Compositions comprising nebivolol
South Africa	200610708	Compositions comprising nebivolol
South Korea	20070044833	COMPOSITIONS COMPRISING NEBIVOLOL

Supplementary Protection Certificates for BYVALSON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0334429	SPC/GB96/048	United Kingdom		PRODUCT NAME: NEBIVOLOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE; REGISTERED: NL RVG/19317 19951018; UK 00242/0309 19960509

BYVALSON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BYVALSON

Introduction to BYVALSON

BYVALSON, a fixed-dose combination (FDC) of the beta blocker nebivolol and the angiotensin II receptor blocker (ARB) valsartan, was approved by the U.S. Food and Drug Administration (FDA) in June 2016 for the treatment of hypertension to lower blood pressure. This approval marked a significant milestone as BYVALSON became the first and only FDC of a beta blocker and an ARB available in the U.S.[1][4].

Market Need and Demand

Hypertension is a significant public health issue, with nearly half of the patients in the U.S. remaining uncontrolled. The need for new and effective therapies is paramount, as uncontrolled hypertension is associated with serious cardiovascular risks such as stroke, heart failure, and myocardial infarction. BYVALSON addresses this need by offering a dual-mechanism approach to blood pressure reduction, which is particularly beneficial since most patients with hypertension require two or more medications to achieve their blood pressure goals[1][4].

Clinical Efficacy and Safety

The FDA approval of BYVALSON was based on a Phase III, double-blind, placebo-controlled, dose-escalating, 8-week efficacy and safety study. This study, which randomized approximately 4,100 patients with Stage 1 or 2 hypertension, demonstrated statistically significant reductions in both diastolic and systolic blood pressure compared to either nebivolol alone or valsartan alone. The overall rate of adverse events was similar across treatment groups and placebo during the study period[1][4].

Market Positioning

BYVALSON's unique combination of nebivolol and valsartan provides a competitive edge in the antihypertensive market. Both nebivolol and valsartan are widely used and effective drugs in the management of hypertension. The FDC offers the convenience of a single tablet, which can enhance patient compliance and simplify treatment regimens. This positioning is crucial in a market where patient adherence to medication is a significant challenge[1][4].

Financial Projections and Market Opportunity

Given the high prevalence of hypertension and the need for effective treatments, BYVALSON has a substantial market opportunity. Here are some key financial and market dynamics:

• Launch and Availability: BYVALSON was expected to be available in the second half of 2016, which allowed Allergan to capitalize on the existing demand for antihypertensive medications[1][4].
• Market Size: The antihypertensive market is vast, with millions of patients requiring blood pressure management. BYVALSON's entry into this market provided Allergan with a significant revenue stream.
• Pricing and Competition: While specific pricing details for BYVALSON are not provided, the drug's unique combination and clinical efficacy could support a competitive pricing strategy. However, the antihypertensive market is highly competitive, with numerous generic and branded options available. This competition could impact BYVALSON's market share and pricing power[1][4].

Regulatory and Legal Considerations

The pharmaceutical industry is heavily regulated, and antitrust laws play a crucial role in shaping market dynamics. For instance, the case of In re Bystolic Antitrust Litigation highlights the complexities surrounding settlement agreements and the potential for antitrust claims. Although BYVALSON's approval did not involve such disputes, the broader regulatory environment is important for understanding the financial trajectory of any pharmaceutical product[2].

Patient and Physician Adoption

The adoption of BYVALSON by both patients and physicians is critical for its financial success. The drug's efficacy, safety profile, and convenience of a single tablet are key factors that influence adoption. Endorsements from medical professionals, such as William B. White, MD, who highlighted the effectiveness of nebivolol and valsartan, can also drive adoption rates[1][4].

Long-Term Financial Trajectory

The long-term financial trajectory of BYVALSON depends on several factors, including market penetration, patient compliance, and the competitive landscape. Here are some considerations:

• Patent Exclusivity: BYVALSON's patent exclusivity period will impact its revenue potential. As patents expire, generic competition can erode market share and revenue.
• Market Penetration: The ability of BYVALSON to penetrate the market and become a preferred treatment option will significantly influence its financial performance.
• Healthcare Policies and Reimbursement: Changes in healthcare policies and reimbursement rates can affect the drug's accessibility and affordability, thereby impacting its financial trajectory[1][4].

Key Takeaways

• Unique Combination: BYVALSON is the first FDC of a beta blocker and an ARB, offering a dual-mechanism approach to blood pressure reduction.
• Clinical Efficacy: Statistically significant reductions in blood pressure were demonstrated in clinical trials.
• Market Opportunity: The antihypertensive market is vast, with a significant need for effective treatments.
• Regulatory Environment: The pharmaceutical industry is heavily regulated, and antitrust laws can impact market dynamics.
• Adoption and Compliance: Patient and physician adoption, influenced by efficacy, safety, and convenience, are crucial for financial success.

FAQs

Q: What is BYVALSON, and how does it work? A: BYVALSON is a fixed-dose combination of the beta blocker nebivolol and the angiotensin II receptor blocker valsartan, designed to lower blood pressure through dual mechanisms of action.

Q: When was BYVALSON approved by the FDA? A: BYVALSON was approved by the FDA in June 2016.

Q: What were the key findings of the clinical trials for BYVALSON? A: Clinical trials demonstrated statistically significant reductions in both diastolic and systolic blood pressure compared to either nebivolol alone or valsartan alone.

Q: How does BYVALSON compare to other antihypertensive medications? A: BYVALSON is the first and only FDC of a beta blocker and an ARB, offering a unique combination that can enhance patient compliance and simplify treatment regimens.

Q: What are the potential long-term financial implications for BYVALSON? A: The long-term financial trajectory of BYVALSON will depend on factors such as market penetration, patient compliance, patent exclusivity, and the competitive landscape.

Cited Sources

1. Allergan Announces FDA Approval of BYVALSON™ (nebivolol and valsartan) 5 mg/ 80 mg tablets - PR Newswire
2. In re Bystolic Antitrust Litigation, No. 23-410 (2d Cir. 2024) - Justia Law
3. A Multi-Billion-Dollar Drug Market - Baron Capital Group
4. FDA approves Allergan's hypertension drug Byvalson - European Pharmaceutical Review