Last Updated: June 17, 2026

eprosartan mesylate - Profile


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

Eprosartan mesylate is the generic ingredient in three branded drugs marketed by Pharmobedient and Abbvie, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Summary for eprosartan mesylate
US Patents:0
Tradenames:3
Applicants:2
NDAs:3
Paragraph IV (Patent) Challenges for EPROSARTAN MESYLATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TEVETEN Tablets eprosartan mesylate 400 mg and 600 mg 020738 1 2010-05-10

US Patents and Regulatory Information for eprosartan mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmobedient EPROSARTAN MESYLATE eprosartan mesylate TABLET;ORAL 202012-001 Nov 16, 2011 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmobedient EPROSARTAN MESYLATE eprosartan mesylate TABLET;ORAL 202012-002 Nov 16, 2011 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbvie TEVETEN eprosartan mesylate TABLET;ORAL 020738-004 Dec 22, 1997 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbvie TEVETEN eprosartan mesylate TABLET;ORAL 020738-005 Dec 22, 1997 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbvie TEVETEN eprosartan mesylate TABLET;ORAL 020738-006 May 27, 1999 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbvie TEVETEN HCT eprosartan mesylate; hydrochlorothiazide TABLET;ORAL 021268-001 Nov 1, 2001 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbvie TEVETEN HCT eprosartan mesylate; hydrochlorothiazide TABLET;ORAL 021268-002 Nov 1, 2001 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 eprosartan mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie TEVETEN eprosartan mesylate TABLET;ORAL 020738-005 Dec 22, 1997 ⤷  Start Trial ⤷  Start Trial
Abbvie TEVETEN eprosartan mesylate TABLET;ORAL 020738-006 May 27, 1999 ⤷  Start Trial ⤷  Start Trial
Abbvie TEVETEN eprosartan mesylate TABLET;ORAL 020738-004 Dec 22, 1997 ⤷  Start Trial ⤷  Start Trial
Abbvie TEVETEN eprosartan mesylate TABLET;ORAL 020738-006 May 27, 1999 ⤷  Start Trial ⤷  Start Trial
Abbvie TEVETEN eprosartan mesylate TABLET;ORAL 020738-005 Dec 22, 1997 ⤷  Start Trial ⤷  Start Trial
Abbvie TEVETEN eprosartan mesylate TABLET;ORAL 020738-004 Dec 22, 1997 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Investment Scenario and Fundamentals Analysis for Eprosartan Mesylate

Last updated: March 1, 2026

Eprosartan mesylate is an angiotensin II receptor blocker (ARB) indicated for hypertension management. Despite its clinical efficacy, its position within the pharmaceutical landscape is affected by market dynamics, patent status, and competitive alternatives. This analysis assesses market opportunities, regulatory considerations, patent landscape, and financial fundamentals for potential investment.

Market Overview and Position

Eprosartan mesylate primarily competes within the antihypertensive segment alongside drugs like losartan, valsartan, and olmesartan. The global antihypertensive market was valued at approximately USD 30 billion in 2022, with a projected compound annual growth rate (CAGR) of 3.5% through 2030 [1].

Eprosartan's market share remains limited compared to established ARBs, with less than 2% of the global ARB sales volume. Its adoption is constrained partly by late market entry and competition from more widely prescribed ARBs.

Patent and Regulatory Status

Patent Landscape:

  • The original patent for eprosartan was filed in 1994 and expired in 2012 in the U.S., with some extensions in other jurisdictions.
  • The expiration opened generic competition, reducing prices significantly in major markets.
  • Certain formulations or delivery methods may carry secondary patents extending exclusivity until 2025–2027.

Regulatory Approvals:

  • Approved in the European Union, Japan, and several other countries.
  • The U.S. FDA approved eprosartan in 2000; however, market penetration remained limited.
  • Post-patent expiry, orphan drug or formulation-specific patents may provide limited exclusivity.

Competitive Landscape

Active Ingredient Market Share (2022) Patent Status Key Competitors
Eprosartan mesylate <2% Patent expired in 2012 Losartan, Valsartan, Olmesartan
Losartan 40% Patent expired in 2010 -
Valsartan 30% Patent expired in 2012 -
Olmesartan 15% Patent expired in 2015 -

The dominance of these established brands limits market expansion for eprosartan. Generic versions significantly undercut prices, affecting revenue potential.

Market Drivers and Barriers

Drivers:

  • Rising hypertension prevalence, expected to reach 1.5 billion affected globally by 2025 [2].
  • Increasing healthcare access in emerging markets.
  • Growing preference for ARBs due to better tolerability compared to ACE inhibitors.

Barriers:

  • Patent expiration leading to price erosion.
  • Limited differentiation from generics.
  • Slow adoption in markets already saturated with established ARBs.

Financial and Investment Fundamentals

Revenue Projections:

  • Current market share revenues estimated under USD 200 million globally.
  • Growth potential relies on market penetration, new formulations, or combination therapies.
  • Pricing premiums are minimal due to generic competition.

Cost Structure:

  • Patent litigation and regulatory compliance costs are moderate.
  • Launch expenses for new formulations or combination drugs could be substantial but are not guaranteed to succeed.

Patent Expiry and Lifecycle:

  • Major patents expired or are set to expire by 2025.
  • Opportunities exist for extending exclusivity via formulation patents, but their value diminishes with generic saturation.

R&D and Market Entry:

  • Developing a novel formulation or bioequivalent with differentiating features may extend lifecycle.
  • Market entry barriers are high in mature hypertension segments due to entrenched brand loyalty and multiple generics.

Investment Considerations

  • Immediate prospects for revenue growth are limited due to patent expiry and generic competition.
  • Licensing or partnering strategies for reformulations or combination therapy may offer value.
  • M&A activity could be driven by companies seeking to expand antihypertensive portfolios with existing assets.

Key Risks and Opportunities

Risks Opportunities
Patent expiration leads to price erosion Developing fixed-dose combinations (FDCs) can capture market share.
Competitive saturation Strategic licensing of secondary patents or formulations.
Slow adoption in markets with entrenched brands Expansion into emerging markets with growing hypertension prevalence.

Conclusion

Eprosartan mesylate presents limited growth for new investment given its patent expiry and competitive landscape. However, niche strategies involving formulation innovations or licensing agreements could create value. Core fundamentals signal a mature asset with declining revenues unless supported by diversification strategies.

Key Takeaways

  • Eprosartan mesylate competes in a saturated antihypertensive market with low sales potential post-patent expiry.
  • Patent expirations completed or imminent diminish exclusivity, lowering price premiums.
  • Market growth depends on non-traditional strategies such as reformulation, co-formulation, or emerging market expansion.
  • Industry trend favors newer ARBs with better safety profiles; eprosartan faces obsolescence unless innovative differentiation occurs.
  • Investment should focus on licensing, reformulation, or niche positioning with clear value propositions.

FAQs

1. What is the main competitive advantage of eprosartan mesylate?
It has limited advantages compared to newer ARBs; existing benefits are overshadowed by patent expiry and generic competition.

2. Can patent extensions revive eprosartan's market potential?
Secondary patents on formulations or delivery mechanisms may provide limited exclusivity until 2025–2027.

3. How do patent expirations affect the financial outlook?
They lead to price erosion and revenue decline, restricting profitability.

4. Are there opportunities in combination therapies involving eprosartan?
Potential exists but requires significant R&D investment; market dominance is unlikely.

5. Which markets offer the most growth for eprosartan?
Emerging markets with expanding hypertension prevalence present growth opportunities, contingent on competitive pricing.


References

[1] MarketWatch. (2022). Global antihypertensive drugs market size.
[2] WHO. (2021). Hypertension: Key Facts.
[3] U.S. Patent and Trademark Office. Patent expiration timelines (2010–2015).
[4] EvaluatePharma. (2022). Top antihypertensive drugs by sales.

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