HYDROCHLOROTHIAZIDE; TELMISARTAN - Generic Drug Details

What are the generic drug sources for hydrochlorothiazide; telmisartan and what is the scope of freedom to operate?

Hydrochlorothiazide; telmisartan is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Mankind Pharma, Natco, Prinston Inc, Torrent, and Zydus Pharms, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Eight suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; TELMISARTAN

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	48
DailyMed Link:	HYDROCHLOROTHIAZIDE; TELMISARTAN at DailyMed

Recent Clinical Trials for HYDROCHLOROTHIAZIDE; TELMISARTAN

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

Sponsor	Phase
Yuhan Corporation	PHASE4
IlDong Pharmaceutical Co Ltd	Phase 1
IlDong Pharmaceutical Co Ltd	Phase 3

See all HYDROCHLOROTHIAZIDE; TELMISARTAN clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; TELMISARTAN

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCHLOROTHIAZIDE; TELMISARTAN

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

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

Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; TELMISARTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MICARDIS HCT	Tablets	hydrochlorothiazide; telmisartan	80 mg/12.5 mg and 40 mg/12.5 mg	021162	1	2008-12-31

US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE; TELMISARTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mankind Pharma	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	218406-003	Mar 3, 2025		DISCN	No	No
Macleods Pharms Ltd	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	204169-002	Nov 2, 2015		DISCN	No	No
Zydus Pharms	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	204221-003	Aug 15, 2017	AB	RX	No	No
Aurobindo Pharma	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	208727-002	Dec 15, 2016	AB	RX	No	No
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000	AB	RX	Yes	No

Expired US Patents for HYDROCHLOROTHIAZIDE; TELMISARTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-003	Apr 19, 2004
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000

EU/EMA Drug Approvals for HYDROCHLOROTHIAZIDE; TELMISARTAN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Krka, d.d., Novo mesto	Tolucombi	telmisartan, hydrochlorothiazide	EMEA/H/C/002549Tolucombi fixed-dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Tolucombi 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.	Authorised	yes	no	no	2013-03-13
Bayer AG	Kinzalkomb	telmisartan, hydrochlorothiazide	EMEA/H/C/000415Treatment of essential hypertension.Kinzalkomb fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.Kinzalkomb fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on Kinzalkomb (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.	Authorised	no	no	no	2002-04-19
Bayer AG	PritorPlus	telmisartan, hydrochlorothiazide	EMEA/H/C/000414Treatment of essential hypertension.PritorPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.PritorPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on PritorPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.	Authorised	no	no	no	2002-04-22
Actavis Group hf	Actelsar HCT	telmisartan, hydrochlorothiazide	EMEA/H/C/002676Treatment of essential hypertension.Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.Actelsar HCT fixed-dose combination (80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.Actelsar HCT fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg / 12.5 mg (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.	Authorised	yes	no	no	2013-03-13

Market Dynamics and Financial Trajectory for Hydrochlorothiazide (HCTZ) and Telmisartan

Last updated: February 19, 2026

What Is the Current Market Landscape for Hydrochlorothiazide and Telmisartan?

Hydrochlorothiazide (HCTZ) and Telmisartan are widely prescribed antihypertensive agents. HCTZ, a thiazide diuretic, remains one of the most common first-line medications for hypertension, while Telmisartan, an angiotensin receptor blocker (ARB), targets resistant hypertension and cardiovascular risk. The combined market value for these drugs is driven by age-related cardiovascular conditions, with an increasing shift towards newer therapies.

How Do Market Sizes and Sales Trends Compare?

Hydrochlorothiazide Market

• Estimated global sales: $1.2 billion in 2022.
• Market growth rate: 1.8% compound annual growth rate (CAGR) 2022–2027.
• Major markets: United States accounts for over 50% of sales; Europe accounts for nearly 20%.

Telmisartan Market

• Estimated global sales: $850 million in 2022.
• Market growth rate: 4.5% CAGR 2022–2027.
• Major markets: United States, Europe, Japan.

Sales Trends

Year	Hydrochlorothiazide (USD billion)	Telmisartan (USD billion)
2018	1.35	0.75
2019	1.3	0.8
2020	1.2	0.85
2021	1.2	0.8
2022	1.2	0.85

HCTZ's market remains stable, but declining in some regions due to patent expirations and competition from combination drugs. Telmisartan shows consistent growth, driven by expanding use in resistant hypertension.

What Drivers Are Influencing Market Dynamics?

Patent Expirations and Generic Entry

HCTZ's patent expired in the late 1980s. Generics dominate the market, leading to price erosion and volume-driven sales.

Regulatory Preferences and Clinical Guidelines

Recent guidelines favor combination therapies, often substituting HCTZ with other diuretics. Conversely, telmisartan benefits from guidelines prioritizing ARBs for resistant hypertension.

Patent Protections and Market Exclusivity

Telmisartan's patent expired in 2018. However, new formulations and combination pills sustain revenue streams.

Emerging Therapies and Competition

SGLT2 inhibitors and novel ARBs challenge traditional therapies. Fixed-dose combinations incorporating telmisartan and other agents expand market options.

Regional Variations

Emerging markets show increased adoption of older, cost-effective drugs like HCTZ. Developed markets shift toward combination therapies with newer agents.

How Will Market Trajectories Evolve?

Projections for 2027

Drug	Forecasted Market Size (USD billion)	CAGR (2022–2027)
Hydrochlorothiazide	1.05	0.5%
Telmisartan	1.2	4.5%

HCTZ's sales will decline slightly due to market saturation and competition. Telmisartan's growth will continue, supported by increasing adoption in resistant hypertension management.

Key Factors Influencing Growth

• Regulatory approvals for combination drugs.
• Patent cliffs prompting generic competition.
• New clinical data supporting efficacy and safety.
• Regional adoption variations driven by healthcare policies.

What Are the Implications for Investment and R&D?

Investors should note the declining trend in HCTZ sales, with moderate opportunities in generic markets. Telmisartan and other ARBs present growth potential, especially with combination formulations. R&D investments are shifting toward novel therapies, including direct renin inhibitors and SGLT2 inhibitors, which may eventually supplant traditional drugs.

Key Takeaways

• Hydrochlorothiazide remains a low-cost, widely used antihypertensive, but its market is mature with slow growth.
• Telmisartan's market expands due to its efficacy in resistant hypertension and cardiovascular risk reduction.
• Patent expirations influence the competitive landscape, favoring generics.
• The future market will favor combination therapies and drugs with novel mechanisms.
• Regional differences persist, with emerging markets increasing their use of traditional therapies.

FAQs

1. Why is Hydrochlorothiazide still widely used despite newer medications?
HCTZ's low cost, extensive clinical experience, and proven effectiveness sustain its popularity, especially in resource-limited settings.

2. How do patent expirations affect the market outlook for Telmisartan?
Patent expirations enable generic competition, leading to price reductions and increasing volume sales, but can reduce revenues for original manufacturers.

3. Are combination therapies reducing the demand for individual agents like HCTZ?
Yes. Many fixed-dose combinations include other diuretics or ARBs, replacing monotherapies and streamlining treatment.

4. What emerging therapies could impact this market?
SGLT2 inhibitors and direct renin inhibitors offer new mechanisms for blood pressure control and heart failure management, challenging traditional drugs.

5. How do regional differences affect the market?
Developed countries favor newer, branded therapies, while emerging markets continue to rely heavily on older, cost-effective drugs like HCTZ.

References

[1] GlobalData. (2023). Market analysis of antihypertensive drugs.
[2] IQVIA. (2022). Worldwide Pharmaceutical Sales Data.
[3] American Heart Association. (2022). Clinical guidelines for hypertension management.
[4] European Medicines Agency. (2018). Patent and regulatory decisions.
[5] Pharmaceutical Technology. (2023). Trends in combination therapies.