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-six 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:	4,193
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	021742-005	Oct 8, 2008	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
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-003	Dec 17, 2007	6,545,040
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-004	Dec 17, 2007	5,759,580

International Patents for BYSTOLIC

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

Country	Patent Number	Title	Estimated Expiration
Hungary	221848	Mikronizált nebivololt tartalmazó gyógyászati készítmények (PHARMACEUTICALS CONTAINING MICRONIZED NEBIVOLOL)
Portugal	744946
Netherlands	950031
Norway	314712
Germany	68903516
Singapore	118694

Supplementary Protection Certificates for BYSTOLIC

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
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
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: December 9, 2025

Executive Summary

BYSTOLIC (nebivolol) is a selective beta-1 adrenergic receptor blocker indicated primarily for hypertension management. Since its launch in 2013 by Forest Laboratories (a subsidiary of Allergan, now part of AbbVie), BYSTOLIC has carved a notable niche within cardiac care, particularly among patients intolerant to other beta-blockers. This analysis examines the drug's market environment, competitive landscape, revenue trends, regulatory influences, and future growth prospects in the context of evolving healthcare policies, patient populations, and innovation trajectories. Current data suggests a cautiously optimistic outlook, with potential incremental gains driven by differentiated pharmacology and expanding indications.

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1. What Are the Key Market Drivers for BYSTOLIC?

a. Patient Population and Therapy Adoption

• Hypertension Prevalence: In 2022, approximately 1.28 billion adults globally have hypertension, representing a significant market (~30% prevalence). In the U.S., nearly 47% of adults have high blood pressure, creating a substantial target market for antihypertensive agents.

• Subpopulation for Nebivolol: Patients with beta-blocker intolerance, particularly those sensitive to side effects such as fatigue and sexual dysfunction, are primary beneficiaries of BYSTOLIC's selective profile.

b. Pharmacologic Differentiation

• Unique Pharmacology: Nebivolol offers beta-1 selectivity with nitric oxide-mediated vasodilation, potentially reducing side effects associated with traditional beta-blockers.

• Clinical Advantages: Studies suggest improved tolerability, which enhances adherence in hypertensive and heart failure populations.

c. Healthcare Policy and Guidelines

• Guideline Endorsements: The 2017 American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommend beta-blockers as first-line in certain populations, with personalized choices based on tolerability and side effect profile.

• Insurance Coverage and Formularies: Favorable inclusion in formularies bolsters market penetration.

d. Competitive Environment & Market Share

Agent	Market Share (2022)	Notes
BYSTOLIC (Nebivolol)	~10-15%	Differentiated due to tolerability and unique pharmacology
Metoprolol	~35-40%	Largest share, generic, cost-effective
Atenolol	~15-20%	Widely used, though declining due to side effects
Others (Bisoprolol, Carvedilol)	Remaining	Niche or combination therapies

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2. How Has BYSTOLIC's Revenue Trajectory Evolved Over Time?

a. Initial Launch and Early Growth (2013-2018)

• Peak Sales: Reported peak U.S. sales of approximately $240 million in 2015-2016 (per IQVIA data).

• Market Penetration: Gained initial acceptance among cardiologists and primary care providers, especially in patients intolerant of other beta-blockers.

b. Competitive Pressures and Patent Expiry

• Generic Entrants: In 2018, the patent exclusivity expiry for nebivolol led to the entry of generic versions, significantly impacting brand sales.

Year	U.S. Brand Sales (Million USD)	Notes
2013	$50	Launch year, initial uptake
2015	$240	Peak sales
2018	$180	Post-generics introduction, decline begins
2022	$80	Stabilization at reduced levels

c. Post-Patent and Market Share Trends

• Market Share Decline: Generic competition cut into BYSTOLIC’s exclusivity, leading to decreased revenue.

• Repositioning Strategies: AbbVie and partner AstraZeneca have explored expanding indications (e.g., heart failure) and increasing prescriber awareness.

d. Current and Future Revenue Outlook

• Projected Revenues (2023-2025): Estimated to hover between $50-$70 million annually, factoring in market erosion, but with some upside from niche indications and off-label uses.

• Factors Influencing Growth:

  • Increasing prevalence of resistant hypertension.
  • Growing geriatric population with comorbidities.
  • Potential expansion into new markets (EU, Asia) with localized regulatory approval.

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3. What Are the Regulatory and Policy Influences on BYSTOLIC?

a. FDA Approvals & Labeling

• Original Approval (2013): For hypertension treatment based on pivotal trials demonstrating efficacy and tolerability.

• Additional Indications: Efforts to expand into heart failure management were unsuccessful, limiting pipeline growth.

b. Patent and Exclusivity

Patent Expiry Date	Impact
2018 (or earlier for formulations)	Entry of generics, substantial revenue decline

c. Healthcare Policies

• Pricing & Reimbursement: Cost-effectiveness remains crucial; however, price pressure from generics influences revenue.

• MARE (Medicaid/Medicare Access & Reconciliation): Policies favor generic utilization, reducing brand sales.

d. International Regulatory Landscape

• EU & Asia: Regulatory approvals are limited or pending; market expansion depends on local health authority policies.

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4. How Does BYSTOLIC Compare with Its Competitors?

Pharmacologic and Market Competitor Analysis

Agent	Type	Mechanism	Unique Features	Market Share (2022)	Main Indications
Nebivolol (BYSTOLIC)	Selective beta-1 blocker	Vasodilation via NO pathway	Tolerability, compliance	10-15%	Hypertension, off-label heart failure
Metoprolol	Selective beta-1 blocker	Heart rate reduction	Cost-effective, generic	35-40%	Hypertension, angina, MI
Atenolol	Selective beta-1 blocker	Heart rate reduction	Cost-effective, generic	15-20%	Hypertension, angina
Bisoprolol & Carvedilol	Beta-blockers with additional alpha blockade	Additional vasodilation	Niche, heart failure	Remainder	Heart failure

Distinguishing Features of BYSTOLIC

• Favorable side effect profile
• Potential for better adherence
• Limited widespread adoption compared to generics

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5. What Are the Future Growth Opportunities and Challenges?

Opportunities

Opportunity Area	Description	Potential Impact
Expanding Indications	Focus on heart failure where beta-blockers are cornerstone	New revenue streams
Market Expansion	Entry into emerging markets with unmet needs	Increased sales volume
Formulation Innovation	Extended-release, combination therapies	Competitive differentiation
Biomarker & Personalized Medicine	Tailored therapy for resistant hypertension	Market advantage

Challenges

Challenge	Details	Mitigation Strategies
Generic Competition	Pricing pressure	Emphasize pharmacology benefits, patient adherence
Limited Patent Exclusivity	Reduced pricing power	Focus on niche indications, formulations
Market Saturation	Decline after initial uptake	Diversification into combination therapies and indications
Regulatory Hurdles	Slower approvals in new markets	Strategic partnerships and local clinical trials

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Key Takeaways

Aspect	Insight
Market Position	BYSTOLIC holds a niche in hypertension management, especially among patients intolerant to other beta-blockers, but faces stiff generic competition.
Revenue Trend	Peak revenues (~$240 million in 2015) declined significantly post-patent expiry; current sales hover around $50-$70 million annually.
Growth Outlook	Moderate growth potential based on expanding indications, new markets, and formulary positioning, but limited by generic erosion.
Competitive Edge	Differentiated pharmacology and tolerability offer advantages in select patient segments.
Future Focus	Strategic emphasis on expanding indications, formulating combination therapies, and international market entry to sustain profitability.

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FAQs

Q1: Will BYSTOLIC regain market share with new indications?
While expanding to additional indications like heart failure could bolster sales, regulatory and clinical trial hurdles make significant growth challenging. Its niche positioning and differentiators remain its primary advantage.

Q2: How does nebivolol's pharmacology influence its market acceptance?
Its selective beta-1 blockade with nitric oxide-mediated vasodilation provides a tolerability advantage, especially in patients experiencing side effects with traditional beta-blockers, fostering adherence.

Q3: Is BYSTOLIC likely to face further generic price erosion?
Yes. The expiration of key patents in 2018 opened the market to generics, resulting in substantial price and revenue declines, expected to continue unless new formulations or indications are developed.

Q4: What are the regulatory hurdles for expanding BYSTOLIC's indications globally?
Different health authorities require local clinical trials, evidence of efficacy and safety, and regulatory review processes, which can be time-consuming and costly.

Q5: How does BYSTOLIC compare cost-wise to its competitors?
Brand-name nebivolol is generally more expensive than generic metoprolol and atenolol. Its value proposition centers on tolerability rather than cost, limiting its competitiveness in price-sensitive markets.

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References

1. IQVIA. (2022). United States Prescription Data.
2. American College of Cardiology/American Heart Association. (2017). 2017 ACC/AHA Hypertension Guidelines.
3. FDA. (2013-2022). Drug Approval and Patent Information.
4. AbbVie. (2022). BYSTOLIC Product Data.
5. Global Hypertension Market Report. (2022). MarketResearch.com.

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This comprehensive review underscores BYSTOLIC's position as a differentiated yet challenged antihypertensive agent. Its future hinges on indications expansion, market penetration strategies, and navigating intense generic competition.