MICARDIS HCT Drug Patent Profile

Which patents cover Micardis Hct, and when can generic versions of Micardis Hct launch?

Micardis Hct is a drug marketed by Boehringer Ingelheim and is included in one NDA.

The generic ingredient in MICARDIS HCT 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 MICARDIS HCT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	72
Patent Applications:	133
Drug Prices:	Drug price information for MICARDIS HCT
What excipients (inactive ingredients) are in MICARDIS HCT?	MICARDIS HCT excipients list
DailyMed Link:	MICARDIS HCT at DailyMed

See drug prices for MICARDIS HCT

See drug sales revenues for MICARDIS HCT

Recent Clinical Trials for MICARDIS HCT

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

Sponsor	Phase
Tyler J Curiel	Early Phase 1
University of Hawaii	Phase 2
Queens Medical Center	Phase 2

See all MICARDIS HCT clinical trials

Pharmacology for MICARDIS HCT

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

Paragraph IV (Patent) Challenges for MICARDIS HCT

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 MICARDIS HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000	AB	RX	Yes	No
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000	AB	RX	Yes	No
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-003	Apr 19, 2004	AB	RX	Yes	Yes

Expired US Patents for MICARDIS HCT

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

EU/EMA Drug Approvals for MICARDIS HCT

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

International Patents for MICARDIS HCT

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

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	003065	ПОЛИМОРФНЫЕ МОДИФИКАЦИИ ТЕЛМИСАРТАНА, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ ДЛЯ ИЗГОТОВЛЕНИЯ ЛЕКАРСТВЕННОГО СРЕДСТВА (TELMISARTAN POLYMORPHS, METHOD FOR PRODUCING SAME AND THEIR USE IN THE PREPARATION OF A MEDICAMENT)
Norway	930205
Israel	143634	TELMISARTAN POLYMORPHS, METHODS FOR PRODUCING SAME AND THEIR USE IN THE PREPARATION OF A MEDICAMENT

Supplementary Protection Certificates for MICARDIS HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419

Market Dynamics and Financial Trajectory for MICARDIS HCT: An In-Depth Analysis

Last updated: July 29, 2025

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Introduction

MICARDIS HCT (telmisartan/hydrochlorothiazide) symbolizes a significant therapeutic solution within the antihypertensive medication landscape. Combining an angiotensin II receptor blocker (ARB) with a thiazide diuretic, MICARDIS HCT offers synergistic blood pressure control, targeting a broad patient demographic. As hypertension remains a pervasive global health concern, understanding its market dynamics and financial trajectory reveals critical insights for pharmaceutical stakeholders, investors, and healthcare policymakers.

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Market Overview of MICARDIS HCT

Therapeutic Positioning and Indications

Developed by Boehringer Ingelheim, MICARDIS HCT is positioned within the global antihypertensive market, primarily reimbursed for managing hypertension and preventing consequent cardiovascular events. Its fixed-dose combination (FDC) improves patient compliance by reducing pill burden compared to separate formulations of telmisartan and hydrochlorothiazide.

Market Penetration and Prescribing Trends

Since its launch, MICARDIS HCT has gained acceptance among cardiologists and primary care physicians. Prescribing trends inform market penetration, which is influenced by:

• Efficacy and safety profile: Demonstrated in clinical trials, MICARDIS HCT shows favorable tolerability, especially for patients with resistant hypertension.
• Formulation convenience: FDCs improve adherence, which aligns with current trends favoring simplified medication regimens.
• Competitive landscape: Alternatives such as other ARB/thiazide combinations (e.g., valsartan/HCTZ, losartan/HCTZ) compete on efficacy, pricing, and marketing efforts.

Key Market Drivers

• Rising prevalence of hypertension globally, particularly in emerging markets.
• Increasing awareness and emphasis on cardiovascular risk reduction.
• Favorable reimbursement policies and continued inclusion in clinical guidelines.
• Expansion of fixed-dose combination therapies.

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Market Dynamics Influencing MICARDIS HCT

Global Hypertension Burden

With over 1.2 billion adults affected globally, hypertension remains a leading cause of cardiovascular morbidity and mortality. The World Health Organization (WHO) projects that hypertension prevalence will grow to approximately 1.56 billion by 2025 [1]. This growth fuels demand for effective antihypertensive agents, including MICARDIS HCT.

Regulatory and Reimbursement Environment

Regulatory approvals, especially in emerging markets, facilitate broader access. Conversely, price governance and reimbursement constraints aim to balance affordability with innovation. In several jurisdictions, government tenders and price caps influence market volume and revenue potential.

Innovation and Formulation Developments

The pharmaceutical industry continuously explores next-generation ARB combinations with enhanced efficacy and safety profiles. While MICARDIS HCT remains a trusted option, competition from newer agents with improved pharmacokinetics or additional therapeutic benefits could impact its market share.

Generics and Biosimilars Impact

Patent expirations of telmisartan and hydrochlorothiazide have facilitated the entry of generics, exerting downward pressure on prices. The availability of generics impacts revenues but also broadens access, potentially expanding the overall market.

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Financial Trajectory of MICARDIS HCT

Revenue Forecasts and Market Share

Boehringer Ingelheim's strategic positioning forecasts steady revenue streams from MICARDIS HCT, driven by:

• Growth in hypertension prevalence.
• Increasing adoption of fixed-dose combinations.
• Geographic expansion into emerging markets.

Global antihypertensive drug market estimates project a CAGR of approximately 4-6% over the next five years [2]. As part of this, MICARDIS HCT’s revenues are expected to grow proportionally, with potential acceleration in regions experiencing healthcare infrastructure expansion.

Pricing and Competitive Dynamics

Pricing strategies influence profitability. In mature markets, price erosion due to generics reduces margins, but volume increases may offset this. Premium formulations or combination therapies with additional benefits may command higher prices, although market saturation limits pricing flexibility.

Research and Development (R&D) Investiture

Investments in clinical trials comparing MICARDIS HCT to newer agents and exploring expanded indications could shape future revenue streams. However, R&D expenses also impact net margins.

Pipeline and Lifecycle Management

Booth’s ongoing lifecycle strategies, such as new formulations or unapproved indications, may extend product relevance, influencing financial outlooks favorably.

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Challenges and Opportunities

Challenges

• Market saturation in developed countries due to high generic penetration.
• Price competition and reimbursement pressures reducing profit margins.
• Regulatory hurdles in new markets or for line extensions.
• Competition from novel mechanisms of action and combination therapies.

Opportunities

• Expansion into emerging markets with high hypertension prevalence.
• Formulation innovations, such as once-daily dosing or combination with other antihypertensives.
• Strategic partnerships to enhance distribution channels.
• Incorporation into combination regimens targeting resistant hypertension.

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Conclusion

The financial trajectory of MICARDIS HCT hinges on global hypertension trends, regulatory factors, and competitive dynamics. While patent expirations and generic entry present challenges, expanding markets and formulation innovations maintain its fiscal viability. Stakeholders should monitor regional growth patterns, pricing strategies, and clinical advancements to optimize investment returns and ensure steady growth.

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Key Takeaways

• The global rise in hypertension sustains demand for fixed-dose antihypertensives like MICARDIS HCT.
• Patent expirations and generic competition pressure pricing but can expand overall market access.
• Emerging markets with high disease prevalence offer significant growth opportunities.
• Formulation innovation and pipeline development are vital to sustaining market share.
• Strategic positioning regarding pricing, distribution, and clinical differentiation shapes long-term financial success.

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FAQs

1. How does MICARDIS HCT compare to other ARB/thiazide combinations in the market?
MICARDIS HCT is distinguished by its efficacy and safety profile, along with its once-daily dosing. However, competition from generic alternatives and newer agents requires ongoing differentiation strategies.

2. What impact will patent expirations have on MICARDIS HCT’s revenue?
Patent expirations typically lead to generic entry, exerting downward pricing pressure but also expanding the accessible patient base, which can offset reduced margins through increased volume.

3. Which geographic regions represent the most promising growth opportunities?
Emerging markets across Asia, Latin America, and Africa present high-growth opportunities due to rising hypertension prevalence, improving healthcare infrastructure, and increasing affordability.

4. How might future developments in hypertension management affect MICARDIS HCT?
Advances in novel drug mechanisms, personalized medicine, and combination therapies could influence market share. However, established drugs like MICARDIS HCT will likely remain relevant through lifecycle management and expanding indications.

5. What strategic actions should stakeholders consider to capitalize on MICARDIS HCT’s market potential?
Investing in pipeline innovations, expanding into high-growth regions, fostering payer relationships, and differentiating formulations can improve market positioning and financial outcomes.

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References

[1] World Health Organization. (2021). Hypertension Fact Sheet.
[2] MarketsandMarkets. (2022). Hypertension Therapeutics Market Forecast.