BYSTOLIC Drug Patent Profile

When do Bystolic patents expire, and when can generic versions of Bystolic launch?

Bystolic is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in BYSTOLIC is nebivolol hydrochloride. There are fourteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bystolic

A generic version of BYSTOLIC was approved as nebivolol hydrochloride by ANI PHARMS on April 16^th, 2015.

Summary for BYSTOLIC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	31
Patent Applications:	4,302
Drug Prices:	Drug price information for BYSTOLIC
Drug Sales Revenues:	Drug sales revenues for BYSTOLIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BYSTOLIC
What excipients (inactive ingredients) are in BYSTOLIC?	BYSTOLIC excipients list
DailyMed Link:	BYSTOLIC at DailyMed

See drug prices for BYSTOLIC

See drug sales revenues for BYSTOLIC

Recent Clinical Trials for BYSTOLIC

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Massachusetts General Hospital	Phase 4
Martin M. Miner, MD	Phase 4
State University of New York at Buffalo	Phase 3

See all BYSTOLIC clinical trials

Pharmacology for BYSTOLIC

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Paragraph IV (Patent) Challenges for BYSTOLIC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BYSTOLIC	Tablets	nebivolol hydrochloride	2.5 mg, 5 mg, 10 mg, and 20 mg	021742	7	2011-12-19

US Patents and Regulatory Information for BYSTOLIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-002	Dec 17, 2007	AB	RX	Yes	No
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-005	Oct 8, 2008	AB	RX	Yes	Yes
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-003	Dec 17, 2007	AB	RX	Yes	No
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-004	Dec 17, 2007	AB	RX	Yes	No

Expired US Patents for BYSTOLIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-004	Dec 17, 2007	5,759,580
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-002	Dec 17, 2007	5,759,580
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-005	Oct 8, 2008	6,545,040
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-004	Dec 17, 2007	6,545,040

International Patents for BYSTOLIC

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

Country	Patent Number	Title	Estimated Expiration
Finland	117888
Japan	H09508913
New Zealand	279822	SOLID MICRONIZED FORM OF THE BIS-BENZOPYRAN NEBIVOLOL, PHARMACEUTICAL COMPOSITIONS
Poland	315973

Supplementary Protection Certificates for BYSTOLIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
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
0334429	C950031	Netherlands		PRODUCT NAME: NEVIVOLOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HYDRO - CHLORIDE; REGISTRATION NO/DATE: RVG 19317 19951018

Market Dynamics and Financial Trajectory for BYSTOLIC (Nebivolol)

Last updated: January 14, 2026

Summary

BYSTOLIC (nebivolol) is a beta-adrenergic blocking agent primarily prescribed for hypertension and heart failure. Since its FDA approval in 2013, BYSTOLIC has established a significant position within the beta-blocker market, benefiting from the global rise in cardiovascular disease (CVD) prevalence. This report evaluates the market landscape, key financial factors, competitive dynamics, growth projections, and strategic implications of BYSTOLIC through 2030.

Introduction

BYSTOLIC is a selective beta-1 adrenergic receptor blocker distinguished by its vasodilatory properties mediated via nitric oxide release, setting it apart from traditional beta-blockers. Developed by Forest Laboratories (later acquired by Allergan, now part of AbbVie), BYSTOLIC was initially positioned as a cardiovascular drug targeted at patients intolerant to other beta-blockers due to side effects.

Global cardiovascular disease (CVD) prevalence continues to rise, with an estimated 523 million cases worldwide in 2019 [1]. As a result, the demand for effective antihypertensives like BYSTOLIC has expanded, though market shares are influenced by competition, generic availability, and evolving treatment guidelines.

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Market Landscape of BYSTOLIC

Global Prevalence of Hypertension and Heart Failure

Parameter	2019 Data	2025 Projection	2030 Projection
Global hypertensive adults	1.28 billion	1.5 billion	1.8 billion
Heart failure prevalence	64 million	75 million	90 million
Key regions	North America, Europe, Asia-Pacific	North America, Asia-Pacific, Latin America	Global expansion

Implication: The increasing prevalence boosts demand for antihypertensive agents, including nebivolol, particularly in aging populations.

Competitive Landscape

Market Players	Market Share (2022)	Product Portfolio	Key Differentiators
AbbVie (BYSTOLIC)	~22%	Nebivolol, various antihypertensives	Selectivity, vasodilatory effects
Novartis	~18%	Bisoprolol, others	Range of beta-blockers
Pfizer	~15%	Metoprolol, others	Broad cardiovascular portfolio
Others	~45%	Various	Generic entries, regional brands

Note: The growing patent expirations for older beta-blockers (e.g., propranolol, atenolol) have increased generic competition for BYSTOLIC and similar drugs, pressuring prices and margins.

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Financial Trajectory of BYSTOLIC (2013–2023)

Revenue Trends

Year	U.S. Sales (Millions USD)	Global Sales (Millions USD)	Growth Rate	Comments
2013	350	420	-	Launch year
2014	410	490	+17%	Market penetration
2015	460	550	+12%	Patent exclusivity increased
2016	495	585	+7%	Entry of generics in some markets
2017	480	570	-2%	Market saturation
2018	460	550	-4.2%	Increased competition
2019	430	520	-6.5%	Introduction of generics
2020	400	495	-7%	Pandemic impact
2021	370	470	-7.5%	Continued generic erosion
2022	350	440	-5.4%	Price competition persists
2023	340	430	-2.9%	Stabilization

Source: Company disclosures and IQVIA IMS data.

Insight: Initial robust revenues have declined owing to patent expiration followed by influx of generics, emphasizing importance of lifecycle management.

Pricing and Market Penetration

• Average Wholesale Price (AWP): Approx. $5.50 per 40 mg tablet in the U.S.
• Market Penetration: Estimated to be around 15-20% of the beta-blocker prescription market in North America, with rising penetration in Asia due to increasing hypertension awareness.

Cost Structure and Profitability

Metric	Estimated Range	Comments
Manufacturing Cost per Unit	$0.50–$1.00	Economies of scale in generics
R&D Investment	$200 million (pre-launch & post-market)	Recovered via sales, though revenue decline hits profitability
Gross Margin	60–70% (patented period), declining with generics	Margins decrease with increased price competition

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Drivers and Restraints Shaping Market Dynamics

Drivers

• Rising CVD Burden: Aging populations increasing hypertension and heart failure prevalence.
• Advances in Pharmacology: Nebivolol's vasodilatory properties favor its use in specific patient subsets.
• Guideline Endorsements: Updated hypertension guidelines (e.g., American Heart Association 2017) recommend beta-blockers in certain scenarios, expanding potential indication.
• Reimbursement Policies: Favorability towards branded drugs in certain markets enhances profitability temporarily.

Restraints

• Generic Competition: Entry of multiple generic nebivolol formulations erodes sales.
• Pricing Pressures: Managed-care organizations and payers push for cost-effective generics.
• Limited Indications: Primarily approved for hypertension and heart failure, constraining market scope.
• Alternative Therapies: ACE inhibitors, ARBs, calcium channel blockers, and novel agents like SGLT2 inhibitors gain market share.

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Market Forecasts and Growth Projections

Scenario	CAGR (2023–2030)	Assumptions	Key Factors
Conservative	1.5%	Market saturation, generic erosion	Continued competition, moderate population growth
Moderate	3%	Growing hypertension prevalence, incremental regulatory support	Expanded indications, better adherence
Aggressive	5%+	New patent extensions, combination therapies	Marketing innovations, orphan drug pathways

Summary: The global nebivolol market for BYSTOLIC is expected to decline modestly in revenue terms, primarily due to generic competition, but ongoing demographic and clinical factors maintain a baseline demand.

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Strategic Considerations for Stakeholders

Aspect	Recommendations
Lifecycle Management	Develop combination therapies (e.g., nebivolol + diuretic) or new formulations to extend patent life.
Geographic Expansion	Focus on emerging markets with increasing CVD burdens.
Pricing Strategies	Adopt value-based pricing in regions with high acceptance of branded medications.
Pipeline Development	Innovate with nebivolol derivatives or delivery systems to differentiate products.
Partnerships & Alliances	Collaborate with regional pharmaceutical firms to bolster market reach.

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Comparison with Similar Beta-Blockers

Drug	Selectivity	Vasodilatory Effect	Patent Status	Major Competitors	Clinical Advantage
Nebivolol (BYSTOLIC)	Beta-1 selective	YES	Patent expired (2017 in US)	Metoprolol, atenolol	Fewer side effects, nitric oxide release
Metoprolol	Beta-1 selective	NO	Expired	Atenolol	Widely used, cost-effective
Carvedilol	Non-selective	YES	Existing	Labetalol	Additional alpha-blockade
Bisoprolol	Beta-1 selective	NO	Existing	Atenolol	Cardioselective, tolerability

Takeaway: Nebivolol offers unique vasodilatory benefits but faces stiff generic competition, necessitating strategic positioning.

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Key Regulatory and Policy Environment

• FDA (US): Approved in 2013; subsequent generic approvals started around 2017.
• EMA (Europe): Similar approval timeline; market dynamics mirror US trends.
• Pricing and Reimbursement: Varies; high-income countries favor branded medications initially, shifting to generics.

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Conclusion

BYSTOLIC's market trajectory is characterized by early growth, subsequent decline fueled by patent expiry and generic competition, and a modest expected stabilization aligned with demographic trends. Strategic initiatives such as pipeline diversification, geographic expansion, and innovative formulations could mitigate revenue erosion. The overall market remains promising due to the persistent global burden of hypertension and heart failure, but stakeholders must adapt swiftly to competitive pressures.

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Key Takeaways

• Market maturity and patent expirations have led to declining revenues for BYSTOLIC since 2017.
• Growing global CVD prevalence sustains baseline demand, especially in aging populations.
• Generic competition is the primary market challenge, demanding strategic innovation.
• Regional expansion in emerging markets offers growth opportunities.
• Differentiation through combination therapies and new formulations could extend product lifecycle and profitability.

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Frequently Asked Questions (FAQs)

1. What are the main factors influencing BYSTOLIC’s market share decline?
Patent expiration, generic entry, pricing pressures, and competition from newer antihypertensive agents have significantly eroded BYSTOLIC's market share.

2. How does nebivolol compare to other beta-blockers in clinical efficacy?
Nebivolol is cardioselective with vasodilatory effects, potentially leading to fewer side effects like fatigue and sexual dysfunction, giving it an advantage in specific patient populations.

3. What regions are emerging as pivotal for BYSTOLIC’s future growth?
Asia-Pacific, Latin America, and parts of Eastern Europe are crucial due to rising hypertension rates and expanding healthcare infrastructure.

4. Are there ongoing efforts to extend BYSTOLIC’s patent or develop new formulations?
While no recent patent extensions have been announced, development of combination products or new delivery systems remains a strategic focus.

5. How do regulatory policies influence BYSTOLIC’s market prospects?
Regulatory approvals and reimbursement policies impact access and pricing, with stricter pricing controls in certain countries affecting profitability.

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References

[1] World Health Organization. (2019). "Cardiovascular Diseases (CVDs)."
[2] IQVIA. (2022). Global Prescription Data Reports.
[3] American Heart Association. (2017). "2017 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure."
[4] Clinical Pharmacology Database. (2023). Nebivolol Profile.