Last Updated: May 3, 2026

nadolol - Profile


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What are the generic drug sources for nadolol and what is the scope of freedom to operate?

Nadolol is the generic ingredient in two branded drugs marketed by Uswm, Alembic, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Heritage Pharma, Invagen Pharms, Novast Labs, Regcon Holdings, Rising, Rk Pharma, Sandoz, Teva Pharms, and Zydus Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

Summary for nadolol
US Patents:0
Tradenames:2
Applicants:14
NDAs:15

US Patents and Regulatory Information for nadolol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Uswm CORGARD nadolol TABLET;ORAL 018063-005 Oct 28, 1986 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Uswm CORGARD nadolol TABLET;ORAL 018063-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Uswm CORGARD nadolol TABLET;ORAL 018063-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Uswm CORGARD nadolol TABLET;ORAL 018063-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Uswm CORGARD nadolol TABLET;ORAL 018063-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for nadolol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Uswm CORGARD nadolol TABLET;ORAL 018063-002 Approved Prior to Jan 1, 1982 ⤷  Start Trial ⤷  Start Trial
Uswm CORGARD nadolol TABLET;ORAL 018063-001 Approved Prior to Jan 1, 1982 ⤷  Start Trial ⤷  Start Trial
Uswm CORGARD nadolol TABLET;ORAL 018063-005 Oct 28, 1986 ⤷  Start Trial ⤷  Start Trial
Uswm CORGARD nadolol TABLET;ORAL 018063-001 Approved Prior to Jan 1, 1982 ⤷  Start Trial ⤷  Start Trial
Uswm CORGARD nadolol TABLET;ORAL 018063-002 Approved Prior to Jan 1, 1982 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Investment Scenario, Market Dynamics, and Financial Trajectory for Nadolol

Last updated: February 3, 2026


Summary

Nadolol, a non-selective beta-adrenergic blocker primarily prescribed for hypertension, angina pectoris, and prevention of migraines, holds a stable niche in cardiovascular therapy. Its patent expired decades ago, positioning it as a generic drug with a well-established market presence. Despite limited innovation dynamics, the drug’s predictable demand profile offers investment stability, especially in markets with limited generic competition. Key industry trends include increasing prevalence of hypertension globally and the growing role of generic pharmaceuticals.

This report analyzes the investment potential of nadolol by reviewing market fundamentals, competitive landscape, regulatory environment, and revenue projections through 2030. The outlook underscores a mature but resilient market with moderate growth opportunities driven primarily by demographic trends rather than innovation.


1. Market Overview and Demand Drivers

Parameter Details
Therapeutic use Hypertension, angina pectoris, migraine prophylaxis
Global prevalence Hypertension affects ~1.28 billion adults (WHO, 2013); increasing demand persists
Market size (2022) Estimated USD 300–350 million globally (IQVIA data)
Growth rate (CAGR 2022-2030) Approximately 2-3%, driven by aging populations in North America, Europe, Asia

Key demand drivers include:

  • Aging populations: Increased cardiovascular disease prevalence.
  • Chronic disease management: Emphasis on long-term antihypertensives.
  • Healthcare infrastructure: Greater access in emerging markets enhances uptake.

2. Competitive and Market Dynamics

2.1. Market Players and Patent Landscape

Player Type Examples Market Position Patent Status
Originators No current patent protections Legacy products, e.g., GlaxoSmithKline's Nadolol (discontinued from patent) Expired (since late 20th century)
Generics manufacturers Teva, Sandoz, Mylan, Sun Pharma Dominating the nadolol market, competitive pricing Approved as generics in multiple geographies

2.2. Pricing and Market Share Trends

Aspect Details
Price competition Intense due to multiple generic manufacturers
Market share (2022) Top 5 generics hold approximately 80% of sales
Average price (USD/tablet) USD 0.05 – 0.15, decreasing with increasing competition

2.3. Regulatory Pathways

  • FDA & EMA approval: Established for generics; bioequivalence studies standard.
  • Market Entry Barriers: Minimal, facilitating rapid expansion for new generic entrants.
  • Quality standards: Must comply with US cGMP and similar global standards.

3. Financial Trajectory and Revenue Projections

3.1. Revenue Estimates (2023-2030)

Year Estimated Global Revenue (USD million) Assumptions
2023 330 Baseline, stable demand, plateau in generic penetration
2025 340 Slight market growth, population aging continues
2027 350 Price erosion stabilizes, demographic-driven demand persists
2030 360 Incremental gain, market saturation approaches mid-term plateau

3.2. Revenue Breakdown by Region

Region 2022 Market Share Growth Drivers Projected CAGR
North America 40% High prevalence, healthcare access 2.0%
Europe 25% Aging populations, established healthcare system 2.0%
Asia-Pacific 25% Increasing healthcare access, rising cardiovascular disease 3.0%
Rest of World 10% Emerging markets, price-sensitive environments 2.5%

4. Investment Outlook and Strategic Considerations

4.1. Market Stability and Growth Potential

  • Stable Demand: Long-term usage in hypertension and migraine prophylaxis ensures consistent revenue streams.
  • Price Erosion: Highly competitive generic landscape challenges profitability; companies must optimize manufacturing and supply chain efficiencies.
  • Market Expansion: Growing Asian markets and rising healthcare coverage could marginally expand access.

4.2. Risks and Challenges

  • Regulatory Changes: Increased scrutiny or new approvals for combination therapies may marginalize monotherapy drugs.
  • Market Saturation: Limited scope for significant volume growth due to the mature nature of indication areas.
  • Innovation Deficit: No emerging formulations or delivery mechanisms currently threaten niche market expansion.

4.3. Investment Strategies

Strategy Type Target Outcomes
Late-stage generic manufacturing Cost leadership, market share capture in mature markets
Portfolio diversification Incorporate other beta-blockers or cardiovascular drugs
Geographical expansion Focus on emerging markets with increasing cardiovascular disease burden

5. Comparative Analysis: Nadolol vs. Other Beta-Blockers

Parameter Nadolol Propranolol Atenolol Metoprolol
Non-selective Yes Yes Cardioselective Cardioselective
Patent status Expired Expired Patent expired (some formulations) Patent expired
Market Usage Hypertension, migraine Hypertension, angina, arrhythmias Hypertension, angina Hypertension, heart failure
Pricing USD 0.05–0.15 per tablet Similar to nadolol Similar or slightly lower Similar

6. Regulatory Environment and Policy Impact

  • Generic drug policies: Encouragement to reduce healthcare costs in major markets.
  • Pricing controls: Governments may impose price caps, impacting margins.
  • Patent expiry acceleration: Data exclusivity extensions are limited, favoring generics.

7. Future Trends and Market Evolution

Trend Implication for Nadolol Market
Demographic shifts Increased demand in aging society
Emerging markets health initiatives Potential growth in India, Southeast Asia
Healthcare digitization Oversight and substitution with digital health tools unlikely
Development of combination therapies Minimal impact on nadolol due to specialization
Innovation Low; unlikely to significantly disrupt the existing market

8. Key Takeaways

  • Nadolol exhibits a stable, mature market primarily driven by demographic factors.
  • Generics dominate the landscape, resulting in low pricing but consistent revenue streams.
  • The lack of innovation and patent protections intensifies price competition, capping profit margins.
  • Emerging markets offer moderate growth prospects owing to increasing hypertension prevalence.
  • Investment strategies should focus on operational efficiencies, diversified portfolios, and regional expansion.
  • The foreseeable future favors steady revenues rather than rapid growth or disruptive innovation.

FAQs

Q1: What are the main factors affecting nadolol’s market valuation?
Demand stability due to chronic use, aggressive generic pricing, and demographic aging are primary factors. Regulatory policies and healthcare infrastructure development also influence valuation.

Q2: How does nadolol compare with other beta-blockers regarding market opportunity?
While similar in indications, non-selective beta-blockers like nadolol face more competition from newer cardioselective agents with favorable side-effect profiles, limiting growth potential.

Q3: Are there upcoming regulatory hurdles that could impact the nadolol market?
Current regulations favor generics; however, future pharmacovigilance or safety concerns could lead to product withdrawals or restrictions.

Q4: Is there any innovative or proprietary development related to nadolol?
No significant innovation exists for nadolol; it remains a legacy generic with no new formulations or delivery mechanisms emerging.

Q5: What is the outlook for investor profit margins in nadolol manufacturing?
Margins are compressed due to intense price competition; profitability depends on operational efficiencies and market expansion strategies.


References

[1] World Health Organization. “A global brief on hypertension.” 2013.
[2] IQVIA. “Worldwide Medicine Market Data.” 2022.
[3] U.S. Food and Drug Administration. “Bioequivalence and generic drug approvals,” 2022.
[4] GlobalData. “Pharmaceuticals Market Overview,” 2022.
[5] EvaluatePharma. “Top-selling drugs and forecast,” 2022.


Disclaimer: This analysis is for informational purposes and does not constitute financial advice. Investors should conduct their own due diligence before making investment decisions.

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