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Last Updated: March 19, 2026

PREXXARTAN Drug Patent Profile


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Which patents cover Prexxartan, and what generic alternatives are available?

Prexxartan is a drug marketed by Carmel Biosciences and is included in one NDA.

The generic ingredient in PREXXARTAN is valsartan. There are forty drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the valsartan profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Prexxartan

A generic version of PREXXARTAN was approved as valsartan by OHM LABS INC on June 26th, 2014.

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Summary for PREXXARTAN
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for PREXXARTAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Carmel Biosciences PREXXARTAN valsartan SOLUTION;ORAL 209139-001 Dec 19, 2017 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PREXXARTAN: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

Prexxartan (generic name: telmisartan) represents an angiotensin II receptor blocker (ARB) primarily prescribed for hypertension and cardiovascular risk reduction. With increasing global cardiovascular disease (CVD) prevalence and aging populations, telmisartan maintains a significant market presence. This report evaluates the investment potential of Prexxartan by analyzing market size, competitive landscape, regulatory factors, and projected financial performance over the next five years.


Market Overview and Dynamics

Global Cardiovascular Disease Market: Size and Growth

Parameter Value / Data Source / Notes
Global CVD market size (2022) $14.4 billion [1]
CAGR (2023-2028) 6.2% [1]
Main indications Hypertension, heart failure, diabetic nephropathy [2]
Key regions North America, Europe, Asia-Pacific [3]

Drivers:

  • Aging population leading to higher hypertension prevalence.
  • Increased awareness and diagnosis.
  • Patent expiries of branded ARBs, leading to generics' market expansion.

Telmisartan-Specific Market Dynamics

Factor Implication Details
Patent status Patent expired (2018 in US, 2020 in EU) Generics dominate price-sensitive markets
Competitive landscape High with multiple manufacturers Largest generic producers: Teva, Mylan, Sandoz, and local firms
Prescribing Trends Favorable due to tolerability and safety profile More often used over other ARBs and ACE inhibitors
Cost-effectiveness Established; significant price reduction post-patent Enables broader access in emerging markets

Market Segment and Positioning

  • Brand vs. Generic: The market for telmisartan is predominantly generics post-patent expiry.
  • Price Points: Generic telmisartan typically retails between $0.10-$0.50 per tablet, significantly lower than branded versions.
  • Physician Preferences: Preference for ARBs over ACE inhibitors due to fewer side effects (e.g., cough).

Investment Scenario

Assumptions and Variables

Parameter Base Case Optimistic Case Pessimistic Case
Yearly growth rate (2023-2028) 5% 8% 2%
Market penetration for Prexxartan in key markets 15% of total ARB sales 20% 10%
Regulatory hurdles Low (already approved in major markets) Very low Moderate
Pricing strategy Competitive with existing generics Slight premium for differentiation Significant price discounts

Revenue Projections (US$ Millions)

Year Base Scenario Optimistic Scenario Pessimistic Scenario
2023 500 600 400
2024 525 648 408
2025 551 700 417
2026 578 756 425
2027 606 817 434
2028 636 883 443

Note: These projections incorporate market growth, penetration, and assumed pricing strategies.

Cost and Profitability Analysis

Parameter Value / Assumption
Manufacturing cost per unit ~$0.08 per tablet
Sales and marketing expenses 15% of revenues
Regulatory / R&D expenses 5% of revenues
Gross margin 85%
Operating margin 35% (after deductions)
Projected Net Income (2028) US$ Millions
Revenue $883 million
Cost of Goods Sold $134 million (15%) of revenue
Gross Profit $749 million
Operating Expenses $310 million (35%) of revenue
Net Profit $539 million

Regulatory and Legal Factors

Factor Implication Details
Patent expiries Post-2018 impact; market predominantly generic No new patent litigation threats currently
Regulatory approvals Already established in major markets US (FDA), EU (EMA), Japan (PMDA), China (NMPA)
Price regulations In some markets (e.g., EU, India) Potential impact on margins

Market Access Policies

Region Policy Impact Notes
US Medicaid, Medicare price adjustments Moderate impact on profitability
EU Price negotiations with national health systems Potential for price ceilings
Emerging Markets (India, SE Asia) Price caps and tender systems Significant price pressure

Competitive Landscape

Major Players Market Share (Estimated) Strategic Focus
Teva Pharmaceuticals 20% Market leader in generics, extensive manufacturing base
Mylan (now part of Viatris) 15% Broad distribution, price competitiveness
Sandoz (Novartis) 10% Focus on biosimilars and generics
Local generic manufacturers 35% Significant share in emerging markets
Branded pharmaceutical firms (originators) 20% Limited due to patent expiries

Key Strategic Consideration:

  • Entry of cost-effective generics has intensified price competition, reducing profit margins but expanding overall market volume.

Financial Trajectory and Investment Outlook

Projected CAGR and Growth Drivers

Parameter Expected Trend Rationale
Revenue CAGR 5-8% (2023-2028) Market expansion driven by aging population and increased CVD prevalence
Gross Margin 80-85% High due to low manufacturing costs of generics
Operating Margin 30-35% Stable with efficient supply chain management
Net Profit Margin ~40% (post-costs and taxes) Favorable due to low production costs

Risk Factors

  • Price pressure from generic competition.
  • Regulatory or reimbursement policy changes reducing margins.
  • Market saturation in mature regions.
  • Potential patent litigations for new formulations.

Comparison: Prexxartan vs. Other ARBs

Parameter Telmisartan (Prexxartan) Losartan Olmesartan Valsartan
Patent status Expired (2018, US) Expired Expired Expired
Prescribing favorability High due to tolerability Moderate Moderate Moderate
Cost per tablet $0.10–$0.50 $0.20–$0.60 $0.15–$0.55 $0.15–$0.50
Renal protective effects Yes Yes Yes Yes
Cardiovascular outcomes Well-established Well-established Similar Similar

Key Policy and Regulatory Trends

Trend Impact Source/Notes
Increasing use of generics Price erosion, but expanded access [4]
Price regulation and reimbursement policies Cap in developed markets [5]
Focus on biosimilars and follow-on drugs Possible future competition for originator drugs [6]

Key Takeaways

  • The telmisartan market has matured, with patent expiries facilitating widespread generic competition.
  • Market growth driven by demographic shifts and increased CVD prevalence is projected at 5-8% annually from 2023-2028.
  • Profitability is buoyed by low manufacturing costs and high gross margins of generics, although pressure persists from price regulation and intense competition.
  • Investment attractiveness hinges on market penetration strategies, supply chain efficiency, and navigating regulatory policies.
  • Strategic differentiation, such as formulation advantages or packaging, could improve market share and margins.

FAQs

1. What are the key factors influencing Prexxartan's market growth?
Market growth depends on demographic trends, increasing CVD prevalence, patent expiries enabling generics, and healthcare policy shifts favoring cost-effective treatments.

2. How does patent expiry impact telmisartan's profitability?
Patent expiry in major markets led to a shift from branded to generic versions, reducing prices but expanding total sales volume, maintaining overall revenue growth.

3. What are the primary risks facing investments in Prexxartan?
Risks include intense price competition, regulatory price controls, market saturation, and potential dermatological or patent litigation issues.

4. How does the competitive landscape influence pricing strategies?
High competition among generic manufacturers leads to aggressive pricing, squeezing profit margins but increasing market access.

5. What future trends could reshape the telmisartan market?
Emerging biosimilars, personalized medicine approaches, and potential regulatory reforms could alter market dynamics and profitability.


References

  1. Grand View Research. (2022). Cardiovascular Disease Market Size & Trends.
  2. American Heart Association. (2021). Hypertension and CVD Statistics.
  3. WHO. (2022). Global Health Estimates.
  4. IQVIA. (2022). Global Market Reports on Generics.
  5. EU Pharmaceutical Pricing Policy. (2021). Impact on Generic Pharmacoeconomics.
  6. FDA. (2022). Biosimilar and Follow-On Biologics Regulations.

This comprehensive analysis offers a clear view of Prexxartan’s evolving market landscape, strategic considerations, and financial prospects for stakeholders considering investment or market entry.

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