EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE - Generic Drug Details

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What are the generic drug sources for eprosartan mesylate; hydrochlorothiazide and what is the scope of patent protection?

Eprosartan mesylate; hydrochlorothiazide is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	3
Patent Applications:	32
DailyMed Link:	EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

US Patents and Regulatory Information for EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE

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	021268-002	Nov 1, 2001		DISCN	No	No
Abbvie	TEVETEN HCT	eprosartan mesylate; hydrochlorothiazide	TABLET;ORAL	021268-001	Nov 1, 2001		DISCN	No	No

Expired US Patents for EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TEVETEN HCT	eprosartan mesylate; hydrochlorothiazide	TABLET;ORAL	021268-002	Nov 1, 2001	5,656,650
Abbvie	TEVETEN HCT	eprosartan mesylate; hydrochlorothiazide	TABLET;ORAL	021268-001	Nov 1, 2001	5,185,351
Abbvie	TEVETEN HCT	eprosartan mesylate; hydrochlorothiazide	TABLET;ORAL	021268-002	Nov 1, 2001	5,185,351
Abbvie	TEVETEN HCT	eprosartan mesylate; hydrochlorothiazide	TABLET;ORAL	021268-001	Nov 1, 2001	5,656,650

Eprosartan Mesylate and Hydrochlorothiazide Market Dynamics, Patent Status, and Financial Trajectory

Last updated: September 9, 2026

Eprosartan mesylate/hydrochlorothiazide is a fixed-dose antihypertensive combination historically marketed as Teveten HCT in the United States and Teveten Plus in some international markets. Its commercial trajectory has been negative: the product faced intense generic competition from angiotensin-receptor blockers, thiazide combinations, and lower-cost standard therapies, while its relatively small prescription base limited manufacturing and promotional economics.

The combination has no meaningful current U.S. branded-market position. Public records identify no active U.S. Orange Book exclusivity protecting the product, and the historical brand has been discontinued or commercially inactive in the United States. Product-level revenue was not separately disclosed by the original manufacturers, preventing a reliable stand-alone sales estimate.

What is eprosartan mesylate and hydrochlorothiazide?

Eprosartan mesylate/hydrochlorothiazide combines:

• Eprosartan, an angiotensin II receptor blocker, or ARB.
• Hydrochlorothiazide, a thiazide diuretic.

The combination was developed for hypertension in patients requiring dual blood-pressure control. Eprosartan blocks angiotensin II-mediated vasoconstriction, while hydrochlorothiazide increases renal sodium and water excretion. The commercial rationale was consistent with the broader fixed-dose combination strategy used across the ARB market.

What strengths and dosage forms were marketed?

The U.S. product, Teveten HCT, was marketed in tablet strengths generally identified as:

Product	Strength	Intended use
Teveten HCT	Eprosartan 600 mg/hydrochlorothiazide 12.5 mg	Hypertension
Teveten HCT	Eprosartan 600 mg/hydrochlorothiazide 25 mg	Hypertension

The product was an oral, once-daily tablet. The FDA-approved labeling described use in patients not adequately controlled on monotherapy or in patients appropriate for combination treatment.[1]

In Europe, the corresponding combination was marketed under names including Teveten Plus, subject to country-specific authorization and commercial availability. European regulatory status should not be treated as evidence of current commercial supply in every market.

When did eprosartan/hydrochlorothiazide lose exclusivity?

The product’s meaningful market exclusivity has expired. The original eprosartan technology was developed before the widespread adoption of current ARB combination products, and the relevant U.S. patent terms ran during the period when the product was commercially active. No current U.S. regulatory exclusivity appears to support a premium branded market for eprosartan/hydrochlorothiazide.

The commercial loss of exclusivity occurred in stages:

1. Eprosartan entered the ARB market after losartan, valsartan, irbesartan, candesartan, and other competitors.
2. Generic versions of major competing ARBs became available.
3. Fixed-dose ARB/thiazide combinations became broadly substitutable.
4. Eprosartan’s brand-level differentiation declined as prescribers shifted toward higher-volume ARBs.
5. The product’s remaining commercial value moved from branded pricing toward low-volume, generic or regional supply.

What is the patent expiration status?

Publicly available FDA and patent records do not establish a current, enforceable U.S. patent estate that materially delays generic entry for the fixed-dose combination. The relevant composition and formulation rights are historical rather than active commercial barriers.

A patent review should distinguish among:

• Core eprosartan compound patents.
• Eprosartan salt patents, including the mesylate form.
• Fixed-dose eprosartan/hydrochlorothiazide composition patents.
• Tablet formulation and manufacturing patents.
• Method-of-use patents for hypertension.
• Country-specific supplementary protection certificates or patent-term extensions.

The original compound and formulation protections are no longer sufficient to support U.S. market exclusivity. Patent expiration dates can vary by jurisdiction and by patent family, but the commercial conclusion is consistent: the product is post-exclusivity.

What is the Orange Book status of eprosartan/hydrochlorothiazide?

The historical U.S. reference product was Teveten HCT. FDA Orange Book treatment of discontinued products can differ from the status of an actively marketed reference product. A discontinued listing does not, by itself, establish that the product was withdrawn for safety reasons or that all historical regulatory records were removed.

The relevant regulatory facts are:

Regulatory issue	Assessment
U.S. reference product	Teveten HCT
Active branded commercial position	No meaningful current position identified
Active U.S. exclusivity	None identified
Orange Book patent barrier	No material current barrier identified
Generic substitution	Technically possible if an approved ANDA exists
Commercial availability	Limited or absent in the United States
Safety withdrawal finding	No basis to classify the product as a safety withdrawal solely from commercial discontinuation

FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the Orange Book, remains the primary source for current reference-product, patent, exclusivity, and therapeutic-equivalence analysis.[2]

Which companies marketed or controlled the product?

Eprosartan was associated with Solvay Pharmaceuticals and later Abbott Laboratories. Abbott acquired Solvay’s pharmaceutical business in 2010, including products and commercial rights associated with Teveten. The business was later affected by Abbott’s separation of its research-based pharmaceutical operations into AbbVie in 2013.

The ownership sequence was commercially relevant:

Period	Corporate relationship
Original development and commercialization	Solvay Pharmaceuticals
Post-acquisition period	Abbott Laboratories
Later pharmaceutical corporate structure	AbbVie inherited much of Abbott’s branded pharmaceutical portfolio
Current commercial status	No major active global commercial franchise identified

The Teveten franchise was small relative to Abbott’s major products. Public company filings did not generally report Teveten HCT revenue as a separate product line, so precise annual sales cannot be derived from SEC disclosures alone.[3]

What drove the market decline?

The main pressures were therapeutic substitution, generic pricing, and low brand visibility.

ARB class competition

Eprosartan entered a crowded ARB market. Losartan, valsartan, irbesartan, candesartan, telmisartan, and olmesartan all competed for hypertension prescriptions. Several competitors had:

• Larger clinical trial programs.
• Greater physician familiarity.
• Stronger payer coverage.
• Higher prescription volumes.
• Established fixed-dose combinations with hydrochlorothiazide.
• More extensive generic supply after loss of exclusivity.

Eprosartan did not establish a durable clinical or economic advantage over these alternatives.

Generic erosion

Hydrochlorothiazide has long been available as a low-cost generic. Once major ARB combinations became generic, the fixed-dose combination market became highly price-sensitive. A branded eprosartan/hydrochlorothiazide product had limited ability to preserve premium pricing.

Prescribing and formulary dynamics

Hypertension treatment is heavily influenced by formularies and generic substitution. Payers commonly prefer:

• Generic losartan/hydrochlorothiazide.
• Generic valsartan/hydrochlorothiazide.
• Generic irbesartan/hydrochlorothiazide.
• Generic candesartan/hydrochlorothiazide.
• Low-cost monotherapy followed by titration.

This reduced the addressable market for an older branded combination without a differentiated delivery system or outcome advantage.

Limited differentiation

The product did not have a novel delivery mechanism, extended-release platform, or protected patient subgroup capable of sustaining a premium market. Its value proposition was convenience through once-daily combination dosing, a benefit available from competing products.

What is the financial trajectory of eprosartan/hydrochlorothiazide?

The financial trajectory was a long-term decline from branded hypertension revenue to negligible or unreported commercial revenue.

Phase	Financial profile	Primary driver
Launch and early adoption	Modest branded revenue	Entry into ARB market
Growth period	Limited expansion	Combination use in hypertension
Mature branded period	Erosion	Strong ARB competition and payer pressure
Post-generic period	Sharp decline	Generic substitution and price compression
Current period	No material publicly disclosed revenue	Discontinuation or limited regional supply

Neither Abbott nor AbbVie disclosed a separate revenue line for Teveten HCT in their principal public financial statements. The product was grouped within broader pharmaceutical sales, making a precise revenue reconstruction unavailable from company filings.[3,4]

Why was revenue likely modest?

The product operated in a high-volume but low-differentiation therapeutic area. Its revenue ceiling was constrained by:

• A late position within the ARB class.
• Competition from multiple branded and generic alternatives.
• Low prices for hydrochlorothiazide.
• Lack of a unique clinical indication.
• Limited evidence of large institutional or specialty demand.
• Absence of a durable patent-based premium after exclusivity expired.

The combination may have generated meaningful revenue during its protected commercial period, but it did not become a major franchise for Solvay, Abbott, or AbbVie.

What generic entry risks existed?

Generic entry risk was high once regulatory and patent barriers expired. A generic applicant could pursue an abbreviated new drug application, or ANDA, demonstrating pharmaceutical equivalence and bioequivalence to the reference product.

Potential generic entry scenarios

Scenario	Market effect
One approved generic	Moderate price pressure; limited supply competition
Multiple ANDA approvals	Rapid price erosion and payer substitution
No U.S. ANDA despite expired patents	Commercial unattractiveness rather than legal protection
Regional generic entry	Fragmented supply and country-specific pricing
Brand discontinuation before generic launch	Reference-product availability could complicate commercial entry

The absence of a large current market can deter generic manufacturers even when legal barriers have expired. Manufacturing a low-volume two-ingredient tablet may not justify regulatory, validation, packaging, and distribution costs.

What formulation patents protect eprosartan/hydrochlorothiazide?

The principal historical formulation value was the fixed-dose oral tablet combining eprosartan mesylate with hydrochlorothiazide. Potential formulation claims could cover:

• The ratio of eprosartan to hydrochlorothiazide.
• Tablet composition.
• Excipients and dissolution performance.
• Stability of the combination.
• Manufacturing conditions.
• Dosage regimens.

These claims typically have shorter practical value than the core active-ingredient patent because formulation patents are vulnerable to design-around strategies. A generic manufacturer may use different excipients, manufacturing parameters, or tablet architecture if it can demonstrate bioequivalence.

No current formulation patent has been identified as a material U.S. barrier to generic competition for the historical Teveten HCT product.

What method-of-use patents cover the product?

The main labeled use is treatment of hypertension. Method-of-use protection for hypertension has limited residual value because:

• Hypertension is a broad indication.
• The active ingredients have long been used for this condition.
• Generic manufacturers can often use a skinny-label strategy for non-protected indications where legally available.
• The core clinical use is difficult to differentiate from competing ARB/thiazide products.

No method-of-use patent appears to create a meaningful current U.S. commercial barrier.

How does eprosartan/hydrochlorothiazide compare with competing ARB combinations?

Product class	Commercial position	Generic pressure	Differentiation
Eprosartan/hydrochlorothiazide	Low or inactive	Very high	Limited
Losartan/hydrochlorothiazide	Broad generic use	Very high	High familiarity and volume
Valsartan/hydrochlorothiazide	Broad generic use	Very high	Established efficacy and supply
Irbesartan/hydrochlorothiazide	Generic use	Very high	Strong diabetes and hypertension prescribing familiarity
Candesartan/hydrochlorothiazide	Generic use	High	Clinical familiarity, smaller volume
Telmisartan/hydrochlorothiazide	Generic and branded regional use	High	Long half-life and regional brand presence
Olmesartan/hydrochlorothiazide	Generic and branded regional use	High	Established combination franchise

Eprosartan/hydrochlorothiazide is disadvantaged by lower prescribing volume and weaker brand recognition. It does not have a clear pharmacoeconomic advantage over established generic combinations.

What patent litigation or Paragraph IV challenges affected the product?

No major, commercially material U.S. Paragraph IV litigation campaign involving eprosartan/hydrochlorothiazide is identified in the principal public regulatory and litigation records reviewed for this analysis.

That absence is informative. High-value pharmaceutical products often attract multiple ANDA challenges before or shortly after patent expiration. Eprosartan/hydrochlorothiazide appears to have had too little expected future revenue to generate extensive branded litigation.

The relevant distinction is:

• No prominent Paragraph IV litigation does not mean the product was strongly protected.
• It may indicate that the commercial prize was too small to justify litigation.
• Generic entry risk can remain high even where litigation records are sparse.

Were there licensing deals for eprosartan/hydrochlorothiazide?

The product’s development and commercialization involved corporate transactions surrounding Solvay, Abbott, and later AbbVie. Public disclosures do not establish a major stand-alone licensing transaction centered exclusively on the eprosartan/hydrochlorothiazide combination.

The more important transaction was Abbott’s acquisition of Solvay Pharmaceuticals, which transferred a broader portfolio rather than creating a product-specific licensing valuation. The combination was a minor component of that portfolio and was not separately valued in public transaction disclosures.[5]

What is the biosimilar risk?

Biosimilar risk is not applicable. Eprosartan mesylate/hydrochlorothiazide is a synthetic small-molecule oral drug, not a biologic. The relevant competitive pathway is generic substitution through ANDAs or equivalent national procedures, not biosimilar approval under the Public Health Service Act.

The product has no biologic manufacturing barrier. Its manufacturing challenges are conventional:

• Active pharmaceutical ingredient sourcing.
• Control of blend uniformity.
• Tablet compression.
• Dissolution and stability testing.
• Bioequivalence.
• Commercial-scale packaging.

These requirements are manageable for established generic manufacturers.

What is the geographic market outlook?

The product’s outlook varies by jurisdiction, but the common pattern is post-exclusivity erosion.

United States

The U.S. market is commercially weak or inactive. The historical brand has no meaningful current position, and no active patent or exclusivity barrier appears to support premium pricing.

Europe

Availability may persist in selected countries under local brands or national reimbursement systems. European commercial status is fragmented, and national marketing authorizations do not guarantee active supply. Generic ARB combinations remain the main competitive threat.

Emerging markets

Some markets may retain demand for eprosartan combinations because of local prescribing habits, legacy registrations, or limited generic competition. That demand is unlikely to support a large global franchise.

What manufacturing and intellectual-property barriers remain?

The remaining barriers are operational rather than proprietary.

A manufacturer would need to establish:

1. Reliable supply of eprosartan mesylate and hydrochlorothiazide.
2. Bioequivalent tablet performance.
3. Stability across the intended shelf life.
4. Regulatory approval in each target jurisdiction.
5. Commercial distribution through wholesalers and pharmacies.
6. Sufficient volume to offset fixed regulatory and manufacturing costs.

The principal risk is market size. A technically feasible generic may still be unattractive if the product has low prescription demand and significant supply-chain complexity.

What generic launch scenarios are most likely?

The most probable scenarios are:

• Continued absence of a major U.S. generic launch because the market is too small.
• Limited regional generic supply in countries where the combination remains registered.
• Use of alternative ARB/hydrochlorothiazide combinations instead of direct substitution.
• Low-price institutional or tender procurement where available.
• Further decline in branded sales without a recovery opportunity.

A successful U.S. relaunch would require evidence of persistent demand, reliable reference-product or regulatory comparability, and a cost structure compatible with a low-volume market. The public record does not indicate those conditions.

Key Takeaways

• Eprosartan mesylate/hydrochlorothiazide was a historical fixed-dose ARB/thiazide product marketed as Teveten HCT in the United States and Teveten Plus in some international markets.
• The product is post-exclusivity and has no identified active U.S. patent estate capable of sustaining branded market protection.
• Its commercial decline resulted from late entry into a crowded ARB class, generic substitution, payer pressure, and weak differentiation.
• Abbott’s acquisition of Solvay transferred the product portfolio, but public filings did not disclose Teveten HCT revenue separately.
• Paragraph IV litigation and major patent disputes do not appear to have materially shaped the product’s U.S. decline.
• Biosimilar risk is irrelevant because the product is a synthetic small-molecule drug.
• The remaining barriers are regulatory execution, API supply, manufacturing economics, and limited market demand.
• The product’s financial trajectory is best characterized as modest branded revenue followed by post-exclusivity erosion and negligible or unreported current sales.

FAQs

Is eprosartan hydrochlorothiazide still sold in the United States?

The historical U.S. brand Teveten HCT has no meaningful current commercial position. Availability of any equivalent product should be verified through current FDA and pharmacy-distribution records.

Does eprosartan hydrochlorothiazide have active U.S. patents?

No material active U.S. patent barrier has been identified for the historical fixed-dose combination. The relevant protection is historical and post-exclusivity.

Is eprosartan hydrochlorothiazide interchangeable with losartan hydrochlorothiazide?

The products are not automatically interchangeable solely because both contain an ARB and hydrochlorothiazide. Substitution depends on the specific product, strength, regulatory approval, and prescriber or pharmacist authorization.

Why did eprosartan lose market share to other ARBs?

Eprosartan faced stronger competitors with larger clinical and commercial franchises, broader generic availability, greater formulary acceptance, and more established fixed-dose combinations.

Could a generic manufacturer relaunch eprosartan hydrochlorothiazide?

A relaunch is technically possible, but the commercial case is weak unless a manufacturer identifies sufficient regional demand, secures API supply, and achieves a cost structure suited to a low-volume post-exclusivity market.

References

1. U.S. Food and Drug Administration. (n.d.). Teveten HCT prescribing information: Eprosartan mesylate and hydrochlorothiazide tablets.

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. Orange Book.

3. Abbott Laboratories. (2010). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

4. AbbVie Inc. (2013). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

5. Abbott Laboratories. (2010). Abbott completes acquisition of Solvay Pharmaceuticals. Corporate transaction announcement.