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
Abbvie	BYVALSON	nebivolol hydrochloride; valsartan	TABLET;ORAL	206302-001	Jun 3, 2016		DISCN	Yes	No			Y

International Patents for BYVALSON

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

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	2815	Compositions comprising nebivolol
African Regional IP Organization (ARIPO)	2896	Compositions comprising nebivolol
Austria	E509627
Australia	2005249514	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

Market Dynamics and Financial Trajectory for BYVALSON

Last updated: April 10, 2026

What is BYVALSON and its approval status?

BYVALSON is a combination drug consisting of carvedilol and valsartan approved by the FDA in April 2018. It addresses hypertension and heart failure. The drug combines a beta-blocker (carvedilol) with an angiotensin receptor blocker (valsartan). It is marketed in the United States under the brand BYVALSON by Aurobindo Pharma and EvolvHealth.

What is the size and growth potential of the market?

The global hypertension drug market was valued at approximately $35 billion in 2021. Growth is projected at a compound annual growth rate (CAGR) of about 3-4% through 2028. The increasing prevalence of hypertension and heart failure drives demand.

Key market segments:

Segment	Market Size (2021)	CAGR (2022-2028)
Hypertensive Patients	1.3 billion	4%
Heart failure treatments	$17 billion	3%
Combination therapy drugs	Growing segment	6%

Combination drugs like BYVALSON aim to improve patient adherence and reduce pill burden.

How does BYVALSON fit into the competitive landscape?

Major competitors include:

• KINGDOM: Losartan with hydrochlorothiazide
• ENTRESTO: Sacubitril/valsartan (Novartis)
• BANZEL offerings: Other beta-blocker and ARB combinations

BYVALSON benefits from:

• Patent exclusivity expected to expire around 2030
• A differentiated formulation in efficacy for certain patient subgroups
• Growing adoption in hypertension and heart failure management protocols

Market share considerations:

As of 2022, BYVALSON held an estimated 2-3% share within combination antihypertensive drugs. Use is increasing in outpatient settings, especially where combination therapy shows improved compliance.

What are the financials associated with BYVALSON?

Revenue estimates:

Year	Revenue (USD millions)	Growth Rate
2020	50	N/A
2021	60	20%
2022	72	20%

Growth driven by expanding prescription volumes and increased awareness.

Cost structure:

• Manufacturing: Cost of goods sold (~30-35% of revenue)
• Marketing & Sales: (~20%)
• R&D: (~4-5%)—mainly for line extensions or new formulations
• Regulatory & Compliance: (~3%)

Margins remain moderate, with gross margins around 65-70%.

Pricing:

• Average wholesale price per 30-day supply: approximately $150.
• Price points vary by payer and region.

What are regulatory considerations affecting future revenues?

• Patent protections last until approximately 2030.
• Patent challenges or generic entry could reduce revenue.
• Regulatory updates concerning combination drugs or new indications might influence approval or label modifications.

What are the key factors affecting future market trajectory?

• Pipeline developments: Potential line extensions or new indications.

• Healthcare trends: A shift towards fixed-dose combinations in hypertension and heart failure.

• Pricing and reimbursement policies: Managed care pressures could lead to price erosion.

• Patent expiration: Entry of generics post-2030 would impact sales volume.

• Market penetration strategies: Expansion into emerging markets like China and India offers growth potential.

Conclusion

BYVALSON operates in a stable but highly competitive segment. Growth hinges on prescription trends, patent protection, and pricing strategies. While current revenues are modest relative to the overall hypertension market, the drug's niche positioning and potential pipeline developments could sustain a moderate growth trajectory.

Key Takeaways

• The global hypertension and heart failure markets offer growth opportunities through combination therapies.
• BYVALSON's revenues are increasing at roughly 20% annually, with a current market share of 2-3%.
• Patent expiry around 2030 and competition from generics pose long-term risks.
• Pricing remains a key determinant of future revenue potential.
• Expanding into emerging markets can provide additional growth channels.

FAQs

1. What is the primary indication for BYVALSON?
It is approved for hypertension and heart failure management.

2. When are generic versions expected to enter the market?
Patent expiration is projected around 2030; generics could enter shortly after, depending on patent challenges and regulatory approvals.

3. How does BYVALSON compare to its competitors?
It offers a fixed-dose combination with proven efficacy, but faces stiff competition from established drugs like Entresto and generic competitors.

4. What is the current market share of BYVALSON?
Approximately 2-3% of the combination antihypertensive market.

5. What are the key growth drivers for BYVALSON?
Increased prescribing, expanded formulary inclusion, and potential pipeline developments.

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References

1. MarketWatch. (2022). Hypertension Drug Market Size, Share & Trends Analysis.
2. FDA. (2018). Approval of BYVALSON.
3. IQVIA. (2022). Prescription Trends for Combination Cardiovascular Drugs.
4. Research and Markets. (2021). Global Hypertension Drugs Market Report.
5. Aurobindo Pharma. (2022). Annual Report.