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
Patent Applications:	3
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
Israel	179999	תכשירים המכילים נביבולול ואנטגוניסט של קולטן אנגיוטנסין ii ושימושים שלהם (Compositions comprising nebivolol and an angiotensin ii receptor antagonist and uses thereof)
Hong Kong	1204570	含奈必洛爾的組合物 (COMPOSITIONS COMPRISING NEBIVOLOL)
European Patent Office	2808015	Compositions comportant du nebivolol (Compositions comprising nebivolol)
European Patent Office	2174658	Compositions comportant du nebivolol (Compositions comprising nebivolol)
Russian Federation	2006147220	КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ В СЕБЯ НЕБИВОЛОЛ
Canada	2610694	COMPOSITIONS A BASE DE NEBIVOLOL (COMPOSITIONS COMRISING NEBIVOLOL)
Russian Federation	2010130950	КОМПОЗИЦИИ, СОДЕРЖАЩИЕ НЕБИВОЛОЛ

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

Market Dynamics and Financial Trajectory for BYVALSON: Analyzing the Current Landscape and Future Outlook

Last updated: July 31, 2025

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Introduction

BYVALSON, a combination medication comprising valsartan and amlodipine, has emerged as a significant player in the antihypertensive drug market. Approved by the U.S. Food and Drug Administration (FDA) in 2020, BYVALSON addresses hypertension management by combining two widely used classes of medication—angiotensin receptor blockers (ARBs) and calcium channel blockers (CCBs)—to improve patient outcomes. This analysis explores the evolving market dynamics, competitive landscape, and financial trajectory underpinning BYVALSON, offering strategic insights for stakeholders.

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Market Overview

The global hypertension drug market was valued at approximately $30 billion in 2022, with steady growth projected at a compounded annual rate (CAGR) of 4-6% over the next five years [1]. The increase is driven by rising prevalence of hypertension, aging populations, and investments in cardiovascular disease management.

Within this market, fixed-dose combination (FDC) therapies like BYVALSON have gained popularity. FDCs enhance adherence, simplify treatment regimens, and potentially improve clinical outcomes. As hypertension treatment guidelines increasingly advocate for combination therapy in early stages, the demand for drugs like BYVALSON is expected to rise.

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Market Dynamics Affecting BYVALSON

1. Rising Hypertension Prevalence

Globally, an estimated 1.39 billion adults suffer from hypertension, with projections indicating a steady increase due to lifestyle factors and aging demographics [2]. The U.S. alone reports a prevalence rate nearing 45% among adults [3]. This persistent growth sustains the need for effective treatment options, including combination therapies.

2. Regulatory and Reimbursement Policies

Regulatory agencies actively support innovation within cardiovascular therapeutics. The FDA’s expedited review pathways and favorable labeling for certain combination drugs amplify BYVALSON’s market prospects. Additionally, reimbursement policies favor cost-effective and adherence-improving medications, positioning BYVALSON favorably in payers' formularies.

3. Competitive Landscape

BYVALSON faces competition from both branded and generic formulations. While competitor products include other FDCs such as Amlodipine/valsartan from different manufacturers, patent expirations and the increasing availability of generics are intensifying price competition.

4. Patent Status and Lifecycle

The original patent protecting BYVALSON's formulation is anticipated to expire by 2028, opening avenues for generic entry. Generics are likely to exert downward pressure on prices, impacting the revenue trajectory of the branded drug.

5. Clinical Efficacy and Patient Adherence

Clinical trials demonstrate that BYVALSON’s fixed-dose approach improves blood pressure control and reduces pill burden, factors correlated with better adherence. Enhanced adherence translates into better long-term management, fostering sustained demand.

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Financial Trajectory Analysis

1. Revenue Drivers

• Market Penetration: As prescribers increasingly adopt BYVALSON for its combined efficacy, market penetration is expected to expand, particularly in the U.S. and Europe.
• Expanding Indications: Potential approval for additional indications such as resistant hypertension or specific hypertensive subpopulations could broaden revenue streams.
• Generic Competition: Entry of generics post-patent expiration will likely lead to significant price erosion, impacting margins, but can also create a subsidy effect by expanding overall market volume.

2. Revenue Forecasts

• 2023-2025: Initial moderate growth driven by increased prescribing and formulary inclusion.
• 2026-2028: Peak revenue phase as market reaches saturation and patent protection begins to lapse.
• Post-2028: Revenue decline from generic entry with possible stabilization depending on market share retention strategies.

3. Cost Considerations

• Research and Development (R&D): Ongoing investments in biosimilars, new formulations, or additional indications.
• Manufacturing Costs: Economies of scale and reduced costs from generic manufacturing could reduce margins on branded BYVALSON but lower generic entry barriers.
• Market Access and Promotion: Expenses related to educational campaigns, physician outreach, and payer negotiations significantly influence profit margins.

4. Valuation and Investment Outlook

In light of current market size and growth prospects, BYVALSON’s revenue forecasts position it as a mid-tier product with potential for sustainable profits, especially if a robust market share is maintained pre-generic entry. Pharmaco-economic advantages like improved adherence support value-based pricing strategies.

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Strategic Challenges and Opportunities

Challenges:

• Patent Expiry and Generic Competition: The imminent patent expiration portends revenue decline unless defenses, such as line extensions or combination patents, are secured.
• Market Saturation: The hypertension market’s maturity constrains growth potential in developed markets.
• Pricing Pressure: Heavy competition and cost-containment policies threaten margins.

Opportunities:

• Market Expansion: Growing hypertension prevalence in emerging markets offers potential for geographic expansion.
• Line Extensions: Developing new fixed-dose combinations or pediatric formulations could diversify product offerings.
• Advanced Formulations: Introducing longer-acting or combination therapies with improved safety profiles may differentiate BYVALSON.

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Conclusion

BYVALSON’s market dynamics are characterized by growth driven by rising hypertension prevalence, favorable clinical profiles, and evolving prescribing patterns favoring combination therapies. Financially, the product is positioned for expansion until patent expiration around 2028, after which generic competition is anticipated to reshape its revenue trajectory. Strategic investments in market access, formulation innovation, and geographic expansion can bolster its long-term prospects, even in a competitive, maturation-phase market.

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Key Takeaways

• The global hypertension market provides a strong growth backdrop for BYVALSON, primarily fueled by increased disease prevalence and supportive treatment guidelines.
• Fixed-dose combination therapies like BYVALSON deliver clinical and adherence advantages, driving demand.
• Patent expiration around 2028 poses a significant inflection point, with potential revenue erosion from generics.
• Market expansion into emerging economies and innovation in formulation can extend BYVALSON’s financial trajectory.
• Effective strategic responses to patent cliff challenges, including line extensions and geographic diversification, are critical for sustained profitability.

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FAQs

1. When is BYVALSON’s patent set to expire, and what impacts will this have?
BYVALSON’s patent protection is expected to expire around 2028. Post-expiration, generic manufacturers are likely to enter the market, exerting downward pressure on prices and reducing branded sales revenue.

2. How does BYVALSON compare to other antihypertensive treatments regarding adherence?
BYVALSON’s fixed-dose combination simplifies treatment regimens, enhances patient adherence, and improves blood pressure control outcomes relative to separate component therapies.

3. What opportunities exist for BYVALSON beyond the current indications?
Potential opportunities include approval for resistant hypertension, pediatric use, or additional fixed-dose combinations targeting specific patient populations, thereby diversifying revenue streams.

4. How are regulatory policies influencing BYVALSON’s market growth?
Accelerated approvals and formulary inclusions, especially in major markets like the U.S., positively influence BYVALSON’s market penetration, while reimbursement policies favor cost-effective, adherence-enhancing medications.

5. What strategies can stakeholders adopt to mitigate revenue decline post-patent expiration?
Strategies include developing line extensions or new formulations, expanding geographic reach, engaging in value-based pricing, and fostering clinical research to support broader indications.

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References

[1] MarketsandMarkets, "Hypertension Drugs Market," 2022
[2] World Health Organization, "Hypertension," 2021
[3] CDC, "High Blood Pressure Data," 2022