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. Eight 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:	144
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
Queens Medical Center	Phase 2
University of Hawaii	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	021162-002	Nov 17, 2000	6,358,986
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000	5,591,762
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000	5,591,762
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-003	Apr 19, 2004	5,591,762
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000	6,358,986

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
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

International Patents for MICARDIS HCT

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

Country	Patent Number	Title	Estimated Expiration
Austria	141270
Austria	166346
Australia	1070792
Australia	3196293
Australia	3679693
Australia	4209493

Supplementary Protection Certificates for MICARDIS HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0502314	3/2011	Austria		PRODUCT NAME: TELMISARTAN, GGF. IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE UND AMLODIPIN, GGF. IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE AMLODIPINBESILAT; REGISTRATION NO/DATE: EU/1/10/648/001 - EU/1/10/648/028 20101007
0502314	CA 2002 00023	Denmark
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0502314	C300478	Netherlands		PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
0502314	CA 2011 00008	Denmark

Market Dynamics and Financial Trajectory for MICARDIS HCT

Last updated: February 19, 2026

MICARDIS HCT (telmisartan/hydrochlorothiazide) is an antihypertensive medication used to manage high blood pressure. It combines telmisartan, an angiotensin receptor blocker (ARB), with hydrochlorothiazide, a thiazide diuretic. The drug is marketed primarily by Boehringer Ingelheim. Its market performance is influenced by multiple factors including competitive landscape, regulatory environment, and patient adoption patterns.

Market Overview

Global hypertension treatment market (2023) is valued at approximately USD 36 billion. The ARB class accounts for 28% of this market, with drugs like MICARDIS HCT capturing part of this segment.

Key drivers:

• Increasing prevalence of hypertension globally, set to reach above 1 billion affected adults by 2025.
• Rising awareness and diagnostic rates lead to higher prescription volumes.
• Preference for fixed-dose combination (FDC) therapies to improve adherence.

Market share of MICARDIS HCT is estimated at 4-6% of the ARB segment, with higher penetration in Europe and select Asia-Pacific countries. The drug's popularity is reliant on its efficacy profile, dosing convenience, and physician prescribing patterns.

Competitive Landscape

Drug Name	Class	Market Share (2023)	Key Competitors	Pricing (USD per month)	Regulatory Status
MICARDIS HCT	ARB + diuretic	4-6%	CoAprovel, Benicar-HCT, Diovan-HCT	80-120	Approved in US, EU, Asia-Pacific
CoAprovel (irbesartan/HCTZ)	ARB + diuretic	3%	Similar to MICARDIS HCT	75-110	EU, US approval in some markets
Benicar-HCT	ARB + diuretic	2.5%	Similar to MICARDIS HCT	70-110	US, EU approval
Diovan-HCT	ARB + diuretic	5%	Similar class	85-130	Approved worldwide

Market competition centers on efficacy, safety profile, and pricing strategies. Patent expirations and generic entries alter market shares over time.

Regulatory and Patent Timeline

• Patent expiration: The original patent for MICARDIS (telmisartan) expired in US 2018 and in EU 2019.
• Market authorization: Approved by FDA and EMA in 2008.
• Generic entry: Generic telmisartan launched in 2018 in the US, affecting MICARDIS HCT's sales.
• Regulatory exclusivity: Market exclusivity limited post-patent expiration, leading to price competition and loss of revenue.

Financial Trajectory

Boehringer Ingelheim's sales figures:

Year	Estimated Sales (USD millions)	Notes
2019	200	Post-patent expiry, slight decline
2020	180	Revenue drop due to generic competition
2021	165	Stabilization as market adjusts
2022	160	Continued pressure, market shifts
2023	155	Flat growth, market saturation

The decline in sales aligns with increased generic competition. Despite this, MICARDIS HCT retains a niche in formulations preferred in certain markets due to formulary inclusion and brand recognition.

Market Trends and Future Outlook

• Generic competition is expected to persist, compress margins, and reduce revenue for branded MICARDIS HCT.
• Formulation innovation, such as extended-release combinations or novel ARB components, may create new growth paths.
• Regional growth: Asia-Pacific and Latin America show increased adoption due to rising hypertension prevalence.
• Market consolidation and potential licensing deals could influence future pricing and sales.

Strategic Implications

• Continued generic erosion requires compelling value propositions to preserve revenue.
• Expanding into emerging markets offers potential growth but necessitates local regulatory approval.
• Combining MICARDIS HCT with other antihypertensive agents may broaden indication scope.

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Key Takeaways

• MICARDIS HCT faces declining sales due to generic competition following patent expiry in 2018-2019.
• The drug commands a modest market share within the ARB class, with regional variations.
• Market growth hinges on regional epidemiology, formulary preferences, and strategic innovation.
• Pricing pressures and patent expirations dominate the financial landscape.
• Opportunities exist in regional expansion and formulation advancements.

FAQs

Q1: What caused the decline in MICARDIS HCT sales after 2018?
A1: Patent expiration for telmisartan enabled generic competition, reducing branded product sales.

Q2: How does MICARDIS HCT compare to its competitors in efficacy?
A2: It has comparable efficacy to other ARB/HCTZ fixed-dose combinations, with some evidence favoring telmisartan for cardiovascular outcomes.

Q3: What regions offer the best growth prospects for MICARDIS HCT?
A3: Asia-Pacific and Latin America show increasing hypertension prevalence and less saturated markets.

Q4: Are there pending patent protections or exclusivities?
A4: Patent protections expired for key components; no new exclusivity periods are active for MICARDIS HCT.

Q5: What strategic measures can Boehringer Ingelheim take to sustain revenue?
A5: Focus on formulation innovations, expand regional markets, and consider combination therapies.

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References

[1] MarketResearch.com. (2023). Hypertension Treatment Market Size & Trends.

[2] Boehringer Ingelheim Annual Reports. (2019-2022).

[3] U.S. Food and Drug Administration (FDA). (2023). Approved Drug Products.

[4] European Medicines Agency (EMA). (2023). Market authorizations.

[5] IQVIA. (2023). Global Pharmaceutical Market Reports.