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.

Seven suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; TELMISARTAN

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	7
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
Lupin Ltd	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	091351-001	Aug 7, 2014	AB	RX	No	No
Lupin Ltd	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	091351-003	Aug 7, 2014	AB	RX	No	No
Natco	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	091648-003	Feb 25, 2014		DISCN	No	No
Glenmark Pharms Ltd	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	202544-002	Mar 4, 2019	AB	RX	No	No
Prinston Inc	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	209028-002	Nov 6, 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	021162-003	Apr 19, 2004
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000
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
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	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 and Telmisartan

Last updated: July 27, 2025

Introduction

Hydrochlorothiazide (HCTZ) and telmisartan are key pharmacological agents in managing hypertension and cardiovascular risk. While hydrochlorothiazide, a thiazide diuretic, has been a cornerstone in antihypertensive therapy for decades, telmisartan, an angiotensin receptor blocker (ARB), is a relatively newer agent renowned for its efficacy and favorable side-effect profile. This comprehensive analysis explores the current market landscape, evolving dynamics, and projected financial trajectories for these medications.

Market Overview

Hydrochlorothiazide: Longevity and Market Saturation

Hydrochlorothiazide remains one of the most prescribed antihypertensive drugs globally. Its low cost, extensive clinical validation, and long-standing presence in treatment protocols sustain its dominance. According to IQVIA, HCTZ accounted for a significant segment of antihypertensive prescriptions in 2022, with annual sales exceeding USD 1 billion in the U.S. alone. Despite the advent of newer agents, HCTZ's affordability ensures continued utilization, particularly in resource-limited settings.

Telmisartan: Niche and Growing Adoption

Telmisartan, introduced in 1998 and widely marketed since the early 2000s, offers advantages such as cardiovascular protection and metabolic benefits. Its patent exclusivity, which lasted until 2018, allowed for premium pricing. Post-patent expiration, a proliferation of generic versions has precipitated price reductions, fostering broader accessibility.

The global ARB market, valued at approximately USD 16 billion in 2022, exhibits a robust CAGR of 4-6%, with telmisartan contributing a notable share. Its dual efficacy in blood pressure control and metabolic syndrome management has driven expanding prescriptions, especially among diabetic and high-risk patients.

Market Dynamics

Competitive Landscape

• Hydrochlorothiazide: Market dominance driven by generic proliferation and low manufacturing costs. Its replacement or supplementation by other antihypertensives (ACE inhibitors, ARBs, calcium channel blockers) in some circumstances reflects evolving treatment paradigms but has not substantially diminished its market share.

• Telmisartan: Faces competition from other ARBs (valsartan, losartan, irbesartan) and emerging novel agents. However, its superior pharmacokinetic profile and additional pleiotropic effects give it a differentiating edge.

Regulatory and Patent Influences

Patent expirations have significantly impacted market trajectories:

• Hydrochlorothiazide: No recent patent protections, ensuring perpetual availability as a generic.

• Telmisartan: Patent expiry in multiple jurisdictions in 2018 led to a surge in generic supply, reducing prices by 50-70%, thereby expanding access.

Regulatory guidelines and clinical trial data continue to influence prescribing patterns. Resistance to switching from well-established medications like HCTZ sustains its role, though newer agents gain favor due to improved safety profiles and added benefits.

Prescribing Trends and Patient Preferences

Physicians increasingly favor ARBs over older agents like HCTZ due to:

• Lower incidence of electrolyte imbalance (e.g., hypokalemia).
• Better tolerability.
• Additional cardiovascular and renal protective effects.

Simultaneously, cost considerations remain pivotal, especially in public healthcare systems, favoring generics like HCTZ.

Impact of Combination Therapies

Fixed-dose combination (FDC) formulations integrating HCTZ and telmisartan are gaining prominence. These FDCs simplify regimens, improve adherence, and are supported by clinical evidence demonstrating superior blood pressure control. The growing adoption of combination therapies significantly influences the revenue streams for both agents.

Financial Trajectory

Hydrochlorothiazide

• Current Status: Stable with consistent demand in emerging markets.

• Growth Drivers: Cost-effectiveness, longstanding clinical acceptance, and integration into fixed-dose combinations.

• Forecasts: Moderate growth estimated at 2-3% CAGR through 2030, primarily driven by volume rather than price increases due to generic saturation.

Telmisartan

• Current Status: Post-patent expiry, prices have declined sharply; however, volume growth remains strong.

• Growth Drivers:

  • Increased adoption for hypertension and metabolic syndromes.
  • Expansion into emerging markets.
  • Integration into combination therapies.

• Forecasts: Anticipated CAGR of 4-8% up to 2030, propelled by demand in high-risk populations, aging demographics, and expanding indication scope.

Market Risks and Opportunities

• Risks:

  • Pricing pressures from generic competition.
  • Regulatory restrictions or safety concerns (e.g., angioedema, renal issues).
  • Market saturation in developed regions.

• Opportunities:

  • Development of improved formulations and delivery systems.
  • Expansion into neglected markets.
  • Lifecycle management through new indications and combination products.

Emerging Trends Influencing Market Trajectory

Personalized Medicine

Genetic testing and biomarker-driven prescribing optimize therapy, potentially influencing demand. Patients with specific genetic polymorphisms exhibit differential responses to ARBs and diuretics, guiding tailored regimens.

Digital and Telemedicine Integration

Remote monitoring of blood pressure and adherence initiatives are prompting physicians to favor agents with proven efficacy and safety, favoring telmisartan’s profile.

Regulatory Landscape

New guidelines favor combination therapies and newer agents with proven efficacy, promising a positive outlook for telmisartan-backed formulations.

Conclusion

Hydrochlorothiazide sustains its market position as a cost-effective, widely accessible antihypertensive, with moderate growth prospects influenced by generic availability and stable prescribing practices. Telmisartan, benefiting from clinical advantages and expanding indications, exhibits robust growth potential, especially as demand for combination therapies and personalized medicine increases. The transition toward integrated treatment strategies and demographic shifts towards aging populations are likely to underpin sustained financial growth for both agents, albeit with competitive pressures necessitating continuous innovation.

Key Takeaways

• Hydrochlorothiazide remains a foundational, low-cost diuretic with stable global demand, driven by generics and emerging markets, exhibiting modest growth.

• Telmisartan’s growth hinges on its clinical advantages, expanding indications, and integration into fixed-dose combinations, with projected CAGR of 4-8% until 2030.

• Patent expirations have shifted market dynamics, fostering price competition but also expanding access and volume.

• The rise of personalized medicine and digital health technologies will further shape prescribing patterns, favoring agents with proven safety and efficacy profiles.

• Companies poised to succeed will innovate in formulation, expand indications, and penetrate emerging markets, securing favorable financial trajectories.

FAQs

1. What factors contribute to the continued market relevance of hydrochlorothiazide?
   Its affordability, extensive clinical validation, and integration into fixed-dose combinations ensure sustained demand, especially in resource-constrained settings.

2. How did patent expiration affect telmisartan's market share?
   Patent expiry led to a surge in generic versions, causing price declines but also expanding utilization due to increased affordability.

3. What are the main competitive pressures facing telmisartan?
   Competition from other ARBs, generics, and emerging antihypertensive agents, alongside safety concerns, pose challenges.

4. How will combination therapies influence future sales?
   Fixed-dose combinations involving HCTZ and telmisartan increase adherence, improve outcomes, and drive revenue growth for both agents.

5. What are the key opportunities for pharmaceutical companies in this market?
   Developing novel formulations, expanding indications, targeting emerging markets, and leveraging personalized medicine approaches will be crucial for growth.

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References

1. IQVIA. Global use of medicines in 2022: Prescriptions and sales data.
2. MarketWatch. Hypertension drugs market report.
3. Clinical pharmacology reviews. Efficacy and safety profiles of hydrochlorothiazide and telmisartan.
4. World Health Organization. Guidelines for hypertension management.
5. Statista. ARBs market size and growth projections.