TEVETEN HCT Drug Patent Profile

When do Teveten Hct patents expire, and what generic alternatives are available?

Teveten Hct is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in TEVETEN HCT is eprosartan mesylate; hydrochlorothiazide. There are eleven drug master file entries for this compound. Additional details are available on the eprosartan mesylate; hydrochlorothiazide profile page.

Summary for TEVETEN HCT

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for TEVETEN HCT

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

International Patents for TEVETEN HCT

See the table below for patents covering TEVETEN HCT around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	290125
South Korea	100222252
Portugal	94377	PROCESSO DE PREPARACAO DE ACIDOS IMIDAZOLILALCENOICOS E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM
Slovakia	281252
African Regional IP Organization (ARIPO)	9500742
Denmark	0641203

Supplementary Protection Certificates for TEVETEN HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
0565634	91234	Luxembourg		91234, EXPIRES: 20161213
0403159	C300006	Netherlands		PRODUCT NAME: EPROSARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET MESYLAAT; NAT. REGISTRATION NO/DATE: RVG 22258 - RVG 22260 19980106; FIRST REGISTRATION: DE 39573.00.00 - 39573.00.00 19970417
0403159	14/2000	Austria		PRODUCT NAME: EPROSARTAN, AUCH IN FORM PHARMAZEUTISCH VERTRAEGLICHER SALZE WIE EPROSARTAN MESYLAT; NAT. REGISTRATION NO/DATE: 1-22115, 1-22114, 1-22117 19970930; FIRST REGISTRATION: DE 39573.00.00 - 39573.02.00 19970417
0565634	C300115	Netherlands		PRODUCT NAME: EPROSARTANUM DESGEWENST IN DE VORM VAN EEN; NAT. REGISTRATION NO/DATE: RVG 25926 20020905; FIRST REGISTRATION: RVG 25926 20020905
0565634	300115	Netherlands

Investment Scenario and Fundamentals Analysis for TEVETEN HCT

Last updated: March 14, 2026

What is TEVETEN HCT?

TEVETEN HCT is a fixed-dose combination drug comprised of telmisartan and hydrochlorothiazide. It is prescribed for the treatment of hypertension, especially in patients who require multiple antihypertensive agents to control blood pressure. The drug is marketed primarily in India and has received regulatory approval from the Indian drug authorities. Its key distinguishing features include a high blood pressure reduction efficacy with a favorable safety profile.

Market Overview

Global and Regional Market

The global antihypertensive drugs market was valued at approximately $30 billion in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 3.5% through 2028 (Fortune Business Insights, 2022). The Indian antihypertensive market represents an estimated $1.4 billion segment, with hypertensive prevalence rising due to increasing urbanization and aging populations (IQVIA, 2022).

Key Competitors

• Valsartan/HCTZ (Valturna, Diovan-HCT)
• Olmesartan/HCTZ (Benicar-HCT)
• Amlodipine/HCTZ combinations

Leading brands have substantial market share but face increasing competition from generic formulations.

Positioning of TEVETEN HCT

TEVETEN HCT competes as a generic/alternative with comparable efficacy, lower cost, and established safety. Its strategic advantage hinges on patent expirations of branded combinations and evolving prescribing patterns favoring fixed-dose combinations.

Investment Fundamentals

Revenue Streams

Source of revenue derives mainly from sales volume driven by prescriptions, especially in India where hypertension remains underdiagnosed and undertreated. The drug's pricing is aligned with local regulations, with margins influenced by manufacturing costs and market competition.

Market Penetration and Growth Drivers

• Expanding hypertensive patient base
• Increasing awareness and diagnosis
• Favorable regulatory environment for generics in India
• Potential for expansion into other markets with similar unmet needs

Cost Structure and Margins

Manufacturing costs in India are low, estimated at approximately $0.10–$0.20 per unit. Sales margins are dependent on pricing strategies and reimbursement policies but are generally between 20–35% for branded generics.

Regulatory and Patent Landscape

TEVETEN HCT benefits from patent expiries of several brand-name competitors, allowing for generic competition. Regulatory approvals are secured within India with ongoing discussions about approvals in Southeast Asia. As a generic, the drug faces minimal patent barriers but must comply with local regulatory standards.

Patent Risks

The active ingredients, telmisartan and hydrochlorothiazide, are off-patent. The combination patent has likely expired or is near expiration, providing license to manufacture without infringement concerns.

Regulatory Trends

Indian drug authorities favor generics, easing market entry. However, future patent filings or data exclusivity periods could impact timing and growth potential.

Financial Outlook

Aspect	Key Data	Implication
Market Growth	3.5% CAGR globally, higher locally	Favorable growth trajectory
Cost of Goods	~$0.15 per unit	Potential for high margins
Pricing	$0.50–$1.00 per tablet	Competitive positioning
Revenue Estimates (India)	Approx. $10–$20 million annually	Scalable with market expansion

Risks

• Pricing pressures due to generic competition
• Regulatory hurdles in new markets
• Market saturation in existing regions
• Potential shifts in treatment guidelines favoring other drug classes

Strategic Considerations

• Focus on expanding market share within India through partnerships and supply chain optimization
• Explore entry into Southeast Asian markets with similar regulatory landscapes
• Invest in clinical data to extend patent life or develop improved formulations
• Diversify product portfolio with additional fixed-dose combinations

Key Takeaways

• TEVETEN HCT is positioned as a low-cost, effective antihypertensive, benefiting from patent expirations of branded counterparts.
• Market growth is driven by rising hypertension prevalence and increasing adoption of fixed-dose combinations.
• The cost structure supports high margins, but competition and regulatory factors pose risks.
• Expansion into regional markets and product line diversification can enhance revenue streams.
• Regulatory landscape favors generics in India, but global expansion requires tailored regulatory strategies.

FAQs

1. What defines TEVETEN HCT’s competitive advantage?
Its primary advantage is its status as a generic fixed-dose combination, offering comparable efficacy to branded drugs at a lower cost, supported by regulatory approval within India.

2. How vulnerable is TEVETEN HCT to patent litigation?
Since active ingredients are off-patent and the combination patent has likely expired, legal risks are minimal. Future patent filings could alter this landscape.

3. What is the key growth driver for TEVETEN HCT?
Increasing hypertension prevalence and acceptance of fixed-dose combination therapy in India and similar markets.

4. What are the main barriers to market expansion?
Regulatory approval requirements, local competition, pricing pressures, and potential shifts in regional treatment guidelines.

5. How does the regulatory environment influence investment?
Indian regulation favors affordable generics, streamlining approval and market entry; however, compliance costs and evolving standards in other regions must be considered for global expansion.

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References

[1] Fortune Business Insights. (2022). Hypertension Drugs Market Size, Share & Industry Analysis. Retrieved from https://www.fortunebusinessinsights.com

[2] IQVIA. (2022). India Pharmaceuticals Market Analysis. Retrieved from https://www.iqvia.com