CLINICAL TRIALS PROFILE FOR TEVETEN

505(b)(2) Clinical Trials for teveten

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01631227 ↗	Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension	Completed	author! et al. BV	Phase 3	2012-06-01	Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
New Formulation	NCT01631227 ↗	Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension	Completed	Quintiles, Inc.	Phase 3	2012-06-01	Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
New Formulation	NCT01631227 ↗	Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension	Completed	Synexus	Phase 3	2012-06-01	Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
New Formulation	NCT01631227 ↗	Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension	Completed	Abbott	Phase 3	2012-06-01	Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.

All Clinical Trials for teveten

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01087749 ↗	Pharmacokinetic Study in Patients With Chronic Kidney Disease and Healthy Volunteers	Completed	University of California, San Francisco	Phase 1	2010-03-01	The purpose of this study is to find out how chemicals in the blood of patients with chronic kidney disease affect how medications are removed from the body. The patient will take one dose of three different drugs, one on each week, for a total of three single doses. The investigators want to find out if these three different medications are affected in different ways by the chemicals in the blood of patients with kidney disease.
NCT01631227 ↗	Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension	Completed	author! et al. BV	Phase 3	2012-06-01	Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
NCT01631227 ↗	Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension	Completed	Quintiles, Inc.	Phase 3	2012-06-01	Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
NCT01631227 ↗	Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension	Completed	Synexus	Phase 3	2012-06-01	Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.

Clinical Trial Conditions for teveten

Condition Name

Condition Name for teveten
Intervention	Trials
Essential Hypertension	1
Kidney Disease	1
Uric Acid Concentration, Serum, Quantitative Trait Locus 7	1

Condition MeSH

Condition MeSH for teveten
Intervention	Trials
Metabolic Syndrome	1
Hypertension	1
Essential Hypertension	1
Renal Insufficiency, Chronic	1

Clinical Trial Locations for teveten

Trials by Country

Trials by Country for teveten
Location	Trials
Russian Federation	1
Germany	1
United States	1
United Kingdom	1

Trials by US State

Trials by US State for teveten
Location	Trials
California	1

Clinical Trial Progress for teveten

Clinical Trial Phase

Clinical Trial Phase for teveten
Clinical Trial Phase	Trials
Phase 3	1
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for teveten
Clinical Trial Phase	Trials
Completed	3

Clinical Trial Sponsors for teveten

Sponsor Name

Sponsor Name for teveten
Sponsor	Trials
Abbott	1
Medical University of Lodz	1
University of California, San Francisco	1

Sponsor Type

Sponsor Type for teveten
Sponsor	Trials
Other	4
Industry	2

Teveten (Eprosartan) Clinical Trials Update, Market Analysis, and Exclusivity-Driven Projection for 2024–2034

Last updated: May 27, 2026

Teveten’s commercial outlook is constrained by long-dated patent and regulatory maturity typical of an older ARB. The likely trajectory is low growth from a declining US base unless new label expansion, new formulation, or geographies outside the US drive incremental demand.

Teveten (eprosartan): What clinical trials exist and what is the latest update?

Teveten is an ARB (eprosartan mesylate). Public trial activity for eprosartan is limited relative to newer cardiovascular agents, with most competitive attention moving to next-wave ARBs, ARNI strategies, SGLT2 inhibitors, and newer hypertension regimens.

Where do eprosartan trials show up (and what categories did they target)?

Eprosartan historical development and post-marketing studies have clustered around:

• Hypertension efficacy and tolerability endpoints
• Renal and cardiovascular outcomes in subsets of hypertensive or at-risk populations
• Switching and head-to-head comparisons versus other antihypertensives/ARBs

What is the direction of the clinical pipeline for eprosartan now?

No sustained late-stage, registrational trials at meaningful scale appear to be driving new FDA approvals for eprosartan in current cycles. Clinical investigation activity tends to be:

• Smaller mechanistic or observational studies
• Trials in specific comorbidity cohorts
• Non-US or non-registrational programs that do not materially shift global labeling

Clinical bottom line: Teveten’s current “clinical trials update” is best characterized as mature-label, low incremental evidence generation rather than active late-stage expansion.

How large is the Teveten market, and where does it trade strongest by region?

Market characterization

Teveten is positioned as a hypertension ARB with established clinician familiarity in some markets, but market share pressure is structurally high because:

• ARB classes are commoditizing in mature markets
• Lower-cost generics dominate most of the ARB landscape
• Formularies have shifted toward preferred generics and bundle-optimized regimens

Region-by-region demand profile

• United States: Low-to-mid single-digit market significance for older ARBs relative to branded and preferred generic ARBs. Teveten’s impact is more likely as a historical option than as a dominant current brand.
• Europe and other established markets: Some persistence where brand loyalty or historical procurement patterns exist, offset by generic penetration.
• Emerging markets: Potential for ARB use growth, but dominated by price-led competition unless brand protection or supply advantages persist.

Market bottom line: Teveten demand is likely a function of residual brand share and prescriber inertia, not a catalyst-driven growth curve.

Teveten exclusivity and patent estate: When does it lose exclusivity and what patents cover eprosartan?

Exclusivity timeline (US-focused structure)

For older small-molecule ARBs, the relevant exclusivity typically includes:

• Patent term expiration for the original active and key compositions/methods
• Any pediatric exclusivity (if it exists) extending the relevant term
• Regulatory exclusivity windows are usually not long after initial approval for older molecules

Practical implication: For Teveten, exclusivity has effectively already lapsed in major jurisdictions, enabling generic entry pathways in prior years.

What patent types usually protect eprosartan products?

Even when primary composition patents expire, remaining patent value can come from:

• Specific salt/formulation claims
• Dosage-form manufacturing method claims
• Method-of-use claims (less common for mature antihypertensives, but possible in subsets)

Estate bottom line: The patent landscape for eprosartan is not expected to create a modern “hard wall” against generics for Teveten in major markets.

What is the Orange Book status of Teveten (eprosartan) and what does it imply for generics?

Orange Book-driven implication (US): If Teveten is discontinued or has no active “listed” patents supporting current reference product status, then generic competition is legally and commercially likely to already be present for most strengths/formats.

Generic risk view: High. For mature ARBs, once reference product listing and listed exclusivities are out, Paragraph IV strategy and at-risk launches are common.

Which companies are competing with Teveten, and how does Teveten compare with other ARBs?

Competitive set

Teveten competes within the ARB class against:

• Preferred generic ARBs by payer formularies
• Branded ARBs only where they still have formulary access and incentive structures

How Teveten stacks up on differentiation

Teveten’s differentiation is limited by:

• Class-level substitution (therapeutic equivalence across ARBs for many payers)
• Brand vs generic pricing pressure
• Lack of recent registrational upgrades compared with newer CV risk management strategies

Competitive bottom line: Teveten’s realistic competitive advantage is not efficacy innovation but niche persistence.

Paragraph IV and biosimilar risk: Are there any modern generic-launch or biosimilar threats for Teveten?

Paragraph IV (small molecule)

For teveten/eprosartan:

• The generic launch threat is structurally high in the post-exclusivity period
• Modern “at-risk” events are typically older and already played out in prior cycles for mature ARBs

Biosimilar risk

Eprosartan is a small molecule, so there is no biosimilar pathway.

Threat bottom line: No biosimilar risk. Generic substitution risk remains the main overhang.

What formulations are protected for Teveten, and what does that mean for product differentiation?

Mature antihypertensive brands often live on:

• Fixed-dose combinations (if any exist) protected by formulation patents
• Specific salt/formulation and manufacturing methods
• Extended-release or special dosage claims

For eprosartan brand products, any formulation IP typically has limited staying power once primary composition patents expire.

Formulation bottom line: Teveten’s ability to defend share through formulation IP alone is limited by the class’s generic substitutability.

FDA regulatory pathway and status: What is known about Teveten’s current US approval posture?

For a mature ARB:

• Teveten’s initial FDA approval predates current modern pathways
• Current regulatory posture is dominated by generic availability and class-wide clinical use
• No recent regulatory catalyst is typical unless a new strength, new dosage form, or new indication is added

Regulatory bottom line: Regulatory status is unlikely to create a near-term expansion catalyst.

Commercial projection for Teveten (2024–2034): What market and revenue trajectory is most likely?

Base case projection

• Volume: Slow decline or flat-to-slight decrease in mature markets due to continued generic dominance and formulary preference for lower-cost alternatives.
• Pricing/revenue: Net revenue likely compresses toward class-average generic pricing influence, unless Teveten holds specialty contracts or maintains niche share.
• Growth drivers: Expansion into lower-competitive geographies, contract pharmacy wins, or niche prescriber usage, not label-changing clinical advancement.

Downside and upside scenarios

• Downside: Continued brand discounting, further loss of formulary positioning, and stronger generic substitution lead to a sharper revenue decline.
• Upside: Any rebranding, re-entry in markets with less generic penetration, or new combination/formulation launch can stabilize demand.

Projection bottom line: Teveten’s most plausible path is modest share drift downward with limited upside absent a new clinical or regulatory catalyst.

What patent litigation affects Teveten (eprosartan), and what matters for investors today?

For older small-molecule ARBs:

• Modern litigation is often resolved or stale
• The key investor question is whether any remaining listed patents block generic supply for specific strengths/dosage forms

Litigation bottom line: No expectation of active, future-blocking patent disputes that would materially change Teveten’s near-term competitive posture.

Key takeaways

• Teveten (eprosartan) is a mature ARB with limited current late-stage clinical activity and no evident registrational catalyst.
• The market is structurally exposed to ARB class substitution and generic pricing pressure.
• Exclusivity and patent barriers are largely exhausted in major jurisdictions, driving high generic risk and limiting brand growth.
• A 2024–2034 outlook is most consistent with low growth or gradual decline, unless Teveten regains traction via geography expansion, contracts, or new product/formulation initiatives.

FAQs

1. Is eprosartan still prescribed for hypertension in the US, and who typically uses it?
2. Do payers prefer eprosartan over other ARBs, and what drives formulary placement?
3. What generic alternatives have the closest substitution profile to Teveten?
4. Are there any combination products involving eprosartan that change the competitive landscape?
5. What would be the most plausible regulatory path for eprosartan to regain growth traction?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA. (Accessed via FDA Orange Book database).
2. ClinicalTrials.gov. Search results for eprosartan. (Accessed via ClinicalTrials.gov).