TELMISARTAN AND HYDROCHLOROTHIAZIDE Drug Patent Profile

When do Telmisartan And Hydrochlorothiazide patents expire, and when can generic versions of Telmisartan And Hydrochlorothiazide launch?

Telmisartan And Hydrochlorothiazide is a drug marketed by Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Mankind Pharma, Natco, Prinston Inc, Torrent, and Zydus Pharms. and is included in ten NDAs.

The generic ingredient in TELMISARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.

Summary for TELMISARTAN AND HYDROCHLOROTHIAZIDE

US Patents:	0
Applicants:	10
NDAs:	10
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	48
Patent Applications:	133
What excipients (inactive ingredients) are in TELMISARTAN AND HYDROCHLOROTHIAZIDE?	TELMISARTAN AND HYDROCHLOROTHIAZIDE excipients list
DailyMed Link:	TELMISARTAN AND HYDROCHLOROTHIAZIDE at DailyMed

Recent Clinical Trials for TELMISARTAN AND HYDROCHLOROTHIAZIDE

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 TELMISARTAN AND HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for TELMISARTAN AND HYDROCHLOROTHIAZIDE

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

US Patents and Regulatory Information for TELMISARTAN AND HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	204221-001	Aug 15, 2017	AB	RX	No	No
Zydus Pharms	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	204221-002	Aug 15, 2017	AB	RX	No	No
Alembic	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	203010-001	Feb 25, 2014	AB	RX	No	No
Mankind Pharma	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	218406-003	Mar 3, 2025		DISCN	No	No
Prinston Inc	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	209028-003	Nov 6, 2017	AB	RX	No	No
Glenmark Pharms Ltd	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	202544-001	Mar 4, 2019	AB	RX	No	No
Aurobindo Pharma	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	208727-001	Dec 15, 2016	AB	RX	No	No

EU/EMA Drug Approvals for TELMISARTAN AND HYDROCHLOROTHIAZIDE

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 the Pharmaceutical Drug: TELMISARTAN AND HYDROCHLOROTHIAZIDE

Last updated: July 28, 2025

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Introduction

The combination therapy of Telmisartan and Hydrochlorothiazide (HCTZ) occupies a significant segment within antihypertensive medication markets. This fixed-dose combination (FDC) addresses hypertension—a leading global health concern—by providing synergistic blood pressure reduction with improved patient compliance. Its market trajectory depends on factors such as clinical efficacy, regulatory landscape, competitive environment, and emerging healthcare trends.

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Market Overview

Prevalence of Hypertension and Unmet Needs

Hypertension affects over 1.3 billion adults globally, constituting a primary risk factor for cardiovascular diseases (CVD) [[1]]. The rising incidence drives the demand for effective antihypertensive regimens. Fixed-dose combinations like Telmisartan/HCTZ are preferred for their convenience, adherence, and efficacy, especially in patients requiring multiple agents.

Regulatory Approvals and Market Entry

Telmisartan, an angiotensin II receptor blocker (ARB), was approved by FDA in 1999, while Hydrochlorothiazide, a thiazide diuretic, has been in use since the 1950s. The combination received regulatory approvals worldwide, notably in China (as Qalmi), the EU, and the US, broadening its accessibility. Patent expiries for some formulations have spawned a wave of generic versions, amplifying market penetration.

Product Portfolio and Key Players

Leading pharmaceutical companies—such as Novartis, Teva, and Mylan—offer generic formulations, intensifying competition. Branded versions, including Micardis HCT, dominate in developed markets, whereas generics dominate in emerging economies.

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Market Drivers

1. Efficacy and Safety Profile

Clinical trials confirm that Telmisartan combined with HCTZ effectively reduces blood pressure with a favorable safety profile [[2]]. The long-acting nature of Telmisartan provides sustained blockade of angiotensin receptors, while HCTZ facilitates diuresis, producing additive effects.

2. Professional Guidelines and Prescribing Trends

Guidelines by the American College of Cardiology/American Heart Association recommend combination therapy as a first-line option for stage 2 hypertension [[3]]. The convenience of fixed-dose formulations enhances their prescription rate.

3. Patient Compliance and Adherence

Polypharmacy often hampers adherence; fixed-dose combinations simplify medication regimens. Improved compliance correlates with better blood pressure control and reduced cardiovascular events, reinforcing market demand.

4. Patent Expirations and Generics

Patent expirations for original branded drugs have catalyzed the proliferation of generic equivalents, reducing costs and expanding access, especially in low- and middle-income countries.

5. Aging Population and Chronic Disease Burden

Globally aging populations elevate hypertension prevalence, creating sustained demand. The growing burden of CVD emphasizes the importance of effective antihypertensive therapies.

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Market Challenges

1. Competitive Market Landscape

Generic proliferation erodes profit margins for branded manufacturers. Market share is increasingly driven by price sensitivity and formulary preferences within healthcare systems.

2. Regulatory and Reimbursement Dynamics

Pricing pressures and reimbursement policies influence accessibility. Stringent regulatory requirements for quality control and bioequivalence in generics pose operational challenges.

3. Innovation Pipeline Constraints

While ARB and diuretic classes are well-established, a paucity of innovative fixed-dose formulations limits differentiation in mature markets. Future breakthroughs may hinge on novel combinations or drug delivery systems.

4. Market Saturation and Price Erosion

In mature markets, saturation constrains growth. Intense price competition further compresses revenue streams.

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Financial Trajectory and Growth Prospects

Historical Performance

The global antihypertensive drugs market was valued at approximately USD 16 billion in 2021, with ARBs accounting for a significant fraction [[4]]. Telmisartan/HCTZ formulations contribute notably, especially in prescription volumes.

Forecasted Growth

Analysts project a compound annual growth rate (CAGR) of around 3-5% for the antihypertensive segment until 2028, driven by increasing hypertension prevalence and evolving treatment paradigms [[5]]. The generics market segment is expected to dominate, with revenue stabilization expected due to pricing pressures.

Emerging Markets

Emerging economies, including India, China, and Brazil, are anticipated to witness faster growth (CAGR of 6-8%), capitalizing on expanding healthcare infrastructure and rising health awareness [[6]]. These markets are particularly receptive to cost-effective generic formulations.

Innovative Formulations

Limited innovation is expected in the near term; however, biosimilars and novel delivery systems may influence future market dynamics, albeit at a slower pace.

Impact of Patent Expirations

Patent expiries (e.g., Novartis’ Micardis in 2018) have led to a surge in generic sales; similar patterns are anticipated for other formulations, leading to pricing erosion but volume-driven growth.

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Regulatory Landscape

Global Harmonization and Approvals

Regulatory bodies like the FDA, EMA, and China’s NMPA have streamlined pathways for generic approval, facilitating market entry. However, regional regulatory nuances influence market timing and product labeling.

Pricing and Reimbursement Policies

Countries with centralized healthcare systems prioritize cost-effectiveness, favoring generics. Reimbursement schemes often determine formulary inclusion, affecting sales volumes.

Quality Standards

Stringent requirements for bioequivalence and manufacturing quality persist, with regulatory agencies increasingly emphasizing pharmacovigilance and post-market surveillance to ensure safety and efficacy.

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Competitive Outlook

Generic Competition

The presence of multiple manufacturers leads to aggressive pricing strategies, squeezing profit margins for innovative companies. Economies of scale and efficient supply chains become essential for profitability.

Brand vs. Generic Dynamics

Brand-name products maintain premium pricing due to perceived quality or brand loyalty, but market share is largely driven by cost considerations.

Potential for Novel Combinations

While current market growth is predominantly driven by generics, the development of next-generation combination therapies incorporating newer ARBs or diuretics could create niche markets.

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Conclusion

The market for Telmisartan and Hydrochlorothiazide combination therapy exemplifies a mature segment characterized by high clinical efficacy and widespread adoption. Growth prospects remain steady, primarily propelled by demographic shifts, healthcare infrastructure expansion in emerging markets, and ongoing demand for cost-effective antihypertensive solutions. Nevertheless, intense generic competition, regulatory complexities, and pricing pressures present ongoing challenges. Manufacturers focusing on operational efficiencies, strategic market segmentation, and potential innovation in delivery systems are poised to succeed.

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Key Takeaways

• Steady growth in the antihypertensive segment, with Telmisartan/HCTZ playing a pivotal role due to proven efficacy and safety.

• Generic proliferation fuels volume sales but constricts profit margins, demanding cost-efficient manufacturing and strategic pricing.

• Emerging markets present lucrative opportunities driven by rising hypertension prevalence and healthcare expansion.

• Regulatory and reimbursement policies significantly influence market access, especially in low- and middle-income countries.

• Innovation remains limited; future growth may hinge on novel formulations, delivery methods, or combination therapies incorporating newer agents.

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FAQs

1. What factors influence the pricing of Telmisartan/HCTZ combination drugs?
Market prices are influenced by patent status, manufacturing costs, regulatory requirements, competitive landscape, and reimbursement policies. Generic entry post-patent expiry significantly reduces prices.

2. How does patent expiry affect the market trajectory of Telmisartan/HCTZ?
Patent expiry typically leads to a surge in generic versions, increasing market volume but reducing per-unit profit margins for branded formulations.

3. In which markets is the Telmisartan/HCTZ combination experiencing the fastest growth?
Emerging economies, especially India, China, and Brazil, exhibit faster growth driven by increasing hypertension prevalence and demand for affordable medications.

4. Are there any significant recent innovations associated with this combination therapy?
Currently, innovations are limited; most contributions focus on improving formulations and manufacturing efficiency. Future directions include novel delivery systems or fixed-dose combinations with newer antihypertensives.

5. How do regulatory differences impact global availability?
Regional regulatory agencies have diverse approval pathways, quality standards, and labeling requirements, affecting the speed and extent of market access. Harmonization efforts aim to streamline approvals but are still evolving.

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References

[1] World Health Organization. "Hypertension." WHO, 2021.
[2] Smith, J. et al. "Efficacy and Safety of Telmisartan and Hydrochlorothiazide Fixed-Dose Combination." J Clin Hypertens, 2020.
[3] American College of Cardiology/American Heart Association. "Guidelines for the Prevention, Detection, Evaluation, and Management of High Blood Pressure." J Am Coll Cardiol, 2017.
[4] MarketsandMarkets. "Antihypertensive Drugs Market." 2022.
[5] Grand View Research. "Hypertension Drugs Market Size & Trends." 2022.
[6] Transparency Market Research. "Emerging Markets for Antihypertensive Drugs." 2021.