MICARDIS Drug Patent Profile

When do Micardis patents expire, and what generic alternatives are available?

Micardis is a drug marketed by Boehringer Ingelheim and is included in two NDAs.

The generic ingredient in MICARDIS 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

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	72
Drug Prices:	Drug price information for MICARDIS
Drug Sales Revenues:	Drug sales revenues for MICARDIS
What excipients (inactive ingredients) are in MICARDIS?	MICARDIS excipients list
DailyMed Link:	MICARDIS at DailyMed

See drug prices for MICARDIS

See drug sales revenues for MICARDIS

Recent Clinical Trials for MICARDIS

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 clinical trials

Pharmacology for MICARDIS

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Paragraph IV (Patent) Challenges for MICARDIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MICARDIS	Tablets	telmisartan	20 mg, 40 mg and 80 mg	020850	1	2006-12-26

US Patents and Regulatory Information for MICARDIS

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	telmisartan	TABLET;ORAL	020850-003	Apr 4, 2000		DISCN	Yes	No
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000	AB	RX	Yes	No
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-001	Nov 10, 1998	AB	RX	Yes	No
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998		DISCN	Yes	No
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-003	Apr 19, 2004	AB	RX	Yes	Yes
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000	AB	RX	Yes	No

Expired US Patents for MICARDIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-003	Apr 4, 2000
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-001	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-001	Nov 10, 1998

EU/EMA Drug Approvals for MICARDIS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Micardis	telmisartan	EMEA/H/C/000209HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;type-2 diabetes mellitus with documented target-organ damage.	Authorised	no	no	no	1998-12-16
Krka, d.d., Novo mesto	Tolura	telmisartan	EMEA/H/C/001196HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease or peripheral arterial disease) or;type 2 diabetes mellitus with documented target organ damage.	Authorised	yes	no	no	2010-06-04
Teva B.V.	Telmisartan Teva Pharma	telmisartan	EMEA/H/C/002511Treatment of essential hypertension in adults.	Authorised	yes	no	no	2011-10-03
Teva B.V.	Telmisartan Teva	telmisartan	EMEA/H/C/001146Treatment of essential hypertension in adults	Withdrawn	yes	no	no	2010-01-25
Actavis Group PTC ehf	Telmisartan Actavis	telmisartan	EMEA/H/C/001168HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;type 2 diabetes mellitus with documented target organ damage.	Authorised	yes	no	no	2010-09-29
Bayer AG	Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)	telmisartan	EMEA/H/C/000211HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;type-2 diabetes mellitus with documented target-organ damage.	Authorised	no	no	no	1998-12-16

International Patents for MICARDIS

See the table below for patents covering MICARDIS 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
World Intellectual Property Organization (WIPO)	9920260
Israel	143634	TELMISARTAN POLYMORPHS, METHODS FOR PRODUCING SAME AND THEIR USE IN THE PREPARATION OF A MEDICAMENT
European Patent Office	0581166
Finland	105547

Supplementary Protection Certificates for MICARDIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0502314	1190006-5.L	Sweden		PRODUCT NAME: TELMISARTAN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT, OCH AMLODIPIN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT SAERSKILT AMOLODIPINBESILAT; REG. NO/DATE: EU/1/10/648/001-028 " EESGODKLANDKOD="EG" EESGODKDATUM="2010-10-07" SEGODKNR="EU/1/10/648/001-028 " SEGODKLANDKOD="EG" SEGODKDATUM="2010-10-07" FLAG="L" SPCNR="1190006-5" 20101007
0502314	C00502314/03	Switzerland		PRODUCT NAME: TELMISARTAN + AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 61270 08.11.2010
0502314	91802	Luxembourg		91802, EXPIRES: 20170131
0502314	C990007	Netherlands		PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT; REGISTRATION NO/DATE: EU/1/98/089/001-EU/1/98/089/010 19981211
0502314	CA 2011 00008	Denmark
0502314	CA 2002 00023	Denmark

Market Dynamics and Financial Trajectory for MICARDIS

Last updated: July 27, 2025

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Introduction

MICARDIS (telmisartan) is an angiotensin II receptor blocker (ARB) primarily prescribed for hypertension and cardiovascular risk management. Since its launch, it has established a significant footprint in the global antihypertensive market, driven by its efficacy, safety profile, and strategic branding. This analysis examines the evolving market landscape, competitive forces, and financial trajectory influencing MICARDIS’s position over the coming years.

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Market Overview

The global hypertension treatment market is projected to surpass USD 60 billion by 2027, with ARBs comprising a substantial share. MICARDIS holds a notable position within this segment, partially attributable to its unique pharmacokinetics, once-daily dosing, and favorable tolerability profile. Rising prevalence of hypertension across emerging economies coupled with aging populations sustains robust demand; the World Health Organization estimates that approximately 1.28 billion adults worldwide have hypertension, a figure anticipated to grow annually (WHO, 2021).

The therapeutic class landscape features major competitors such as losartan, valsartan, olmesartan, and newer agents like sacubitril-valsartan. MICARDIS’s differentiation hinges on its pharmacodynamic properties, including high selectivity for angiotensin II type 1 receptors, and its additional indication for cardiovascular protection in high-risk populations.

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Competitive Dynamics

1. Patent Status and Generics:
Historically, patent exclusivity has protected MICARDIS, enabling premium pricing. However, patent expirations for telmisartan in key markets—such as the US (February 2019) and Europe—have ushered in generic competition, exerting downward pressure on prices and sales volumes.

2. Pricing and Reimbursement Trends:
Price erosion following generic entry challenges MICARDIS's revenue streams. Health policy reforms and expanded insurance coverage in emerging markets improve access but often favor generic options over branded drugs, further pressuring margins.

3. Innovation and Line Extensions:
The availability of additional formulations, fixed-dose combinations (e.g., telmisartan with hydrochlorothiazide), and expanded indications bolster market resilience. Pharmaceutical companies also invest in pharmacovigilance and clinical evidence generation to uphold the drug’s perceived value.

4. Regulatory Landscape:
Regulatory agencies increasingly prioritize cost-effectiveness evidence. Regulatory shifts, such as the approval of biosimilars and patent reforms, influence market share dynamics, compelling continued innovation and strategic positioning.

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Market Drivers and Barriers

Drivers:

• Growing Hypertension Prevalence: Elevated global hypertension rates propel demand.

• Cardiovascular Benefits: Evidence suggesting telmisartan’s protective effects against cardiovascular events sustains clinician preference.

• Expanded Indications: Approvals for additional uses, such as stroke risk reduction, enhance revenue potential.

Barriers:

• Pricing Pressure: Post-patent expiry generic competition compresses margins.

• Market Saturation: Mature markets exhibit slower growth; reliance on emerging economies becomes critical.

• Competing Therapies: Introduction of novel antihypertensive agents with superior efficacy or safety profiles could displace MICARDIS.

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Financial Trajectory and Revenue Analysis

Pre-Patent Expiry Period (Pre-2019):
During patent exclusivity, MICARDIS experienced strong growth driven by premium pricing and marketing investments. Global sales topped USD 2 billion annually, with key markets including the U.S., Europe, and Japan contributing substantially.

Post-Patent Expiry and Generic Competition:
Generics entered markets in 2019, leading to immediate price reductions. Reported global revenues declined significantly, with some estimates indicating a drop of 40-60% in key markets within the first two years post-patent expiry (IQVIA, 2020). However, branded sales persisted in regions with delayed generic entry or where premium formulations continued to command higher prices.

Current and Future Outlook:
The outlook hinges on several factors. The extension of indications, such as the use of telmisartan for cardioprotection, can offset some revenue decline. Strategic alliances, product innovations in dosage forms, and market penetration in emerging economies will influence revenue stabilization.

Forecast models suggest that MICARDIS’s global revenues will plateau around USD 1 billion in the next 3-5 years, contingent on regional market dynamics, pricing strategies, and competitive threats.

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Key Market Trends Impacting MICARDIS

• Biologics and Novel Therapeutics: While primarily oral small molecules, emerging therapies including biologics and device-based interventions challenge traditional antihypertensive drugs.

• Regulatory Favorability: Governments favor generic substitution to contain healthcare costs, impacting branded drug sales.

• Digital Health and Monitoring: Increased use of telemedicine and remote monitoring amplify adherence, which positively influences therapeutic outcomes and drug sales.

• Market Consolidation: Pharmaceutical mergers and acquisitions can streamline product portfolios, sometimes leading to the discontinuation of less profitable lines like MICARDIS.

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Strategic Recommendations

• Diversify Indications: Pursuing regulatory approval for additional cardiovascular and renal indications can expand revenue streams.

• Leverage Fixed-Dose Combinations: Developing and marketing combination therapies can improve patient adherence and retention of market share.

• Expand in Emerging Markets: Tailoring pricing and access strategies to fast-growth regions will bolster revenue.

• Enhance Patient Engagement: Digital tools to improve adherence and outcomes can differentiate MICARDIS in a commoditized market.

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Conclusion

MICARDIS’s market and financial profile exemplifies the typical trajectory of branded pharmaceuticals facing patent expiration. While initial dominance has waned due to generic competition, strategic product extensions, market expansion, and clinical evidence can sustain its relevance. Stakeholders must navigate competitive pricing, regulatory pressures, and evolving healthcare landscapes to optimize its growth potential.

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Key Takeaways

• MICARDIS's initial market success was driven by patent exclusivity, with revenues exceeding USD 2 billion annually pre-2019.
• Patent expirations and generic entry caused a substantial decline in branded sales, with a 40-60% revenue drop observed within two years.
• Future revenue will depend on expanding indications, diversification through fixed-dose combinations, and deepening penetration in emerging markets.
• Competitive and regulatory trends favor cost-effective generics, posing ongoing challenges.
• Strategic innovation and market adaptation are essential to prolong MICARDIS’s lifecycle and financial viability.

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FAQs

1. How has patent expiry affected MICARDIS’s market share?
Patent expiration in key markets led to significant revenue declines due to generic competition, with branded sales decreasing by up to 60% in some regions.

2. What strategies can sustain MICARDIS’s market presence?
Diversification of indications, development of fixed-dose combinations, expansion into emerging markets, and leveraging clinical evidence can prolong its competitive edge.

3. Are there upcoming regulatory approvals that could impact MICARDIS?
Regulatory agencies may approve new indications or formulations, but increasing focus on cost-effectiveness and biosimilar competition remains a challenge.

4. How significant is generic competition for MICARDIS globally?
It is substantial, especially in mature markets, where generics dominate antihypertensive prescriptions due to lower costs.

5. What role will digital health play in MICARDIS’s future?
Enhanced patient adherence through digital tools could improve treatment outcomes, maintaining demand and brand loyalty.

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References

[1] WHO. (2021). Hypertension Fact Sheet. World Health Organization.

[2] IQVIA. (2020). Global Pharmaceutical Market Report.

[3] U.S. Patent and Trademark Office. (2019). Patent Expiry Data for Telmisartan.

[4] Market Research Future. (2022). Hypertension Market Analysis & Trends.

[5] European Medicines Agency. (2021). Approval & Regulation of Antihypertensive Drugs.