Last Updated: June 9, 2026

Eprosartan mesylate - Generic Drug Details


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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.

There are nine drug master file entries for eprosartan mesylate.

Summary for eprosartan mesylate
Recent Clinical Trials for eprosartan mesylate

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

SponsorPhase
Quintiles, Inc.Phase 3
AbbottPhase 3
author! et al. BVPhase 3

See all eprosartan mesylate clinical trials

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
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
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 020738-006 May 27, 1999 DISCN Yes 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 020738-004 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

Eprosartan Mesylate: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What is the commercial positioning of eprosartan mesylate?

Eprosartan mesylate is an angiotensin II receptor blocker (ARB) used for hypertension. Commercially, ARBs have matured into a crowded, price-sensitive category where differentiation shifts from initial efficacy to dosing convenience, tolerability, and payor contracting.

In the context of global ARB market structure, eprosartan mesylate’s positioning is best described as a late-stage, off-patent branded-to-generics transition product profile, exposed to generic erosion and class-wide price competition. The product’s financial trajectory is therefore governed more by (i) patent status and generic entry timing, (ii) channel contracting dynamics (tendering and reimbursement), and (iii) regional strength of local branded portfolios than by novel clinical value.

How do market dynamics shape ARB pricing and share outcomes?

ARB markets typically evolve along four fast-moving levers that determine revenue trajectory for any single molecule:

  1. Generic substitution pressure

    • Once key patents expire in a region, payors and wholesalers accelerate switching to lower-cost equivalents.
    • For older ARBs, the revenue curve usually shifts from brand-led growth to volume retention with declining net price.
  2. Class substitution and formulary preference

    • ARBs are interchangeable for most payer formularies and treatment guidelines.
    • When multiple ARBs are available as generics, contracting often drives selection toward the lowest net price rather than the highest brand premium.
  3. Tendering and procurement

    • Many markets price ARBs through national or hospital tenders.
    • Tender outcomes can cause abrupt share swings across suppliers, even when epidemiology is stable.
  4. Segment concentration and adherence

    • Hypertension is high-prevalence and high-volume, but adherence is sensitive to pill burden and side effect profiles.
    • ARBs generally have favorable tolerability; thus the competitive differentiator narrows to dosing and price rather than clinical differentiation.

Eprosartan mesylate competes within this framework against other ARBs that have larger branded histories, broader payer familiarity, and often more aggressive generic penetration depending on country-specific entry dates.

What is the likely financial trajectory for eprosartan mesylate?

For mature ARB products, the financial trajectory usually follows a predictable path:

  • Brand maturity and consolidation: plateau period as generics approach.
  • Erosion phase: step-down in net sales after generic entries, driven by pharmacy substitution and payor switching.
  • Volume stabilization: revenue partially stabilized by maintaining prescriptions at lower prices.
  • Subsequent decline: continued net price compression across the class eventually outweighs stable volume.

For eprosartan mesylate specifically, the same mechanics apply because ARBs are long-established molecules and the commercial lifecycle for older antihypertensives is defined by patent expiration and competitive tendering.

What commercial evidence exists for eprosartan mesylate’s current footprint?

A direct, audited global revenue series for “eprosartan mesylate” requires a market database (company filings, IQVIA, or paid datasets) at a product-specific level. Public sources do not consistently provide molecule-level worldwide sales for eprosartan mesylate alone in a way that supports a complete financial trajectory statement across regions.

What public pharmacovigilance and regulatory data does consistently indicate is product continuity in hypertension treatment through established regulatory registrations, which supports ongoing commercial presence in at least some markets.

How is the molecule regulated and how does that affect commercialization?

The principal commercialization implications for eprosartan mesylate come from regulatory listing and the stability of generic supply:

  • Regulatory acceptance: ARB generics rely on demonstrating bioequivalence and maintaining manufacturing compliance.
  • Manufacturing and supply continuity: mature products can face episodic shortages or quality recalls, which temporarily shift share, but these events are not molecule-specific unless documented.
  • Label stability: no market-moving label expansions are expected without new dosing regimens or outcomes indications.

This structure tends to keep the molecule in a “maintenance” business model: incremental formulary position rather than innovation-driven revenue growth.

Where does eprosartan mesylate sit versus key ARB competitors?

Within the ARB class, the competitive landscape is dominated by originators and high-turnover generics such as:

  • Losartan
  • Valsartan
  • Irbesartan
  • Telmisartan
  • Olmesartan
  • Candesartan

Against these, eprosartan mesylate competes largely as a price and access product. Where eprosartan mesylate retains a foothold, it typically comes from localized brand entrenchment or early generic availability in particular markets.

Comparative market mechanics (not tied to any one dataset)

Competitive factor Typical effect on eprosartan mesylate
Generic entry density in the country Drives rapid net price compression
Formulary tiers and step therapy Limits premium brand position
Tender rollovers and procurement Causes episodic sales share shifts
Originator loyalty in cardiology/primary care Can slow share erosion but not stop it

What are the main revenue drivers and constraints?

Revenue drivers

  • Hypertension prevalence and long treatment duration: increases prescription volume stability.
  • Switching within class: patients remain on ARBs even as specific brands change.
  • Generic availability across channels: supports continued patient access.

Revenue constraints

  • Net price erosion: persistent across mature ARBs.
  • Share dilution: multiple competing generics reduce incremental upside.
  • Channel concentration: pharmacy and hospital procurement increasingly select low-cost options.

What does the “financial trajectory” look like in stages?

The financial path for an established ARB like eprosartan mesylate typically presents as:

  1. Pre-generic / late-brand stage

    • Gradual revenue plateau
    • Price holds due to brand protections and limited substitutions
  2. Generic entry and early substitution

    • Fast decline in net price
    • Revenue declines less than price due to volume retention
  3. Mature generic stage

    • Revenue stabilizes at lower net price levels
    • Ongoing decline driven by contracting aggressiveness and competitor share shifts
  4. Late lifecycle

    • Continued revenue pressure
    • Supplier consolidation and further tendering compression

Because eprosartan mesylate is an older ARB, investors and R&D strategists should treat its revenue profile as primarily “maintenance and cash generation with downside risk” rather than “growth and reinvestment powered by product differentiation.”

How does R&D and lifecycle strategy connect to market dynamics for eprosartan mesylate?

From a business planning perspective, the presence of a mature, class-constrained molecule influences what strategy is rational:

  • Line extensions: low probability unless supported by distinct dose forms or fixed-dose combinations with competitive advantages.
  • Manufacturing and cost-down: likely a primary lever for generic suppliers (margin preservation through sourcing, scale, and yield improvements).
  • Portfolio effects: eprosartan mesylate often behaves as part of a broader hypertension basket rather than a standalone growth engine.

Key Takeaways

  • Eprosartan mesylate is a mature ARB in a highly interchangeable and price-sensitive therapeutic class where generic substitution and contracting determine the revenue curve.
  • Market dynamics that drive ARB pricing in general imply a multi-stage financial trajectory: plateau, erosion after generic entry, volume stabilization at lower net prices, and continued decline as contracting tightens.
  • The molecule’s competitive outcomes are dominated by country-specific generic entry timing, tendering mechanics, and formulary positioning rather than by clinical differentiation.
  • For commercial planning and investment screening, treat eprosartan mesylate as a maintenance-lifecycle product: cash generation with margin compression risk.

FAQs

  1. Is eprosartan mesylate considered an innovation-driven product in the ARB market?
    No. Its commercialization is governed by mature ARB market dynamics (generic entry and formulary contracting) rather than by differentiation typical of late-stage innovation.

  2. What is the primary driver of financial decline for mature ARBs?
    Net price erosion after generic substitution and procurement contracting.

  3. Do ARB class guidelines create resilience for eprosartan mesylate volume?
    Yes. Patients typically remain on the ARB class even when specific brands shift, supporting partial volume resilience.

  4. How do tenders affect sales for ARBs like eprosartan mesylate?
    Tendors can create sharp share shifts between suppliers across contract cycles, independent of overall disease prevalence.

  5. What business levers matter most for mature eprosartan mesylate supply?
    Cost structure, manufacturing scale, and distribution access that supports bidding competitiveness in payor and tender systems.


References

[1] European Medicines Agency. Eprosartan containing products: EPAR and related information (search portal). EMA. https://www.ema.europa.eu/
[2] FDA. Drugs@FDA (eprosartan mesylate and related ARB entries). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD Index (eprosartan, antihypertensives). World Health Organization. https://www.whocc.no/atc_ddd_index/

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