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. Eight 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

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

International Patents for MICARDIS

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

Country	Patent Number	Title	Estimated Expiration
Slovakia	394492	BENZIMIDAZOLES, PROCESS FOR THEIR PREPARATION AND DRUG CONTAINING THE SAME
Mexico	9302034	BENCIDAZOLES, MEDICAMENTOS QUE CONTIENEN ESTOS COMPUESTOS Y PROCEDIMIENTOS PARA SU PREPARACION.
Brazil	1100667
New Zealand	513528	Telmisartan polymorphs and their use as angiotensin antagonists
Japan	2002535315
Luxembourg	91802

Supplementary Protection Certificates for MICARDIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0502314	SPC/GB99/014	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/98/089/001 19981211; UK EU/1/98/089/002 19981211; UK EU/1/98/089/003 19981211; UK EU/1/98/089/004 19981211; UK EU/1/98/089/005 19981211; UK EU/1/98/089/006 19981211; UK EU/1/98/089/007 19981211; UK EU/1/98/089/008 19981211; UK EU/1/98/089/009 19981211; UK EU/1/98/089/010 19981211
0502314	23/1999	Austria		PRODUCT NAME: TELMISARTAN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/98/089/001-010 19981211; FIRST REGISTRATION: BE K (1998) 4288-DE 19981211
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	SPC/GB11/010	United Kingdom		PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
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

Investment and Fundamentals Analysis of MICARDIS (Tadalafil)

Last updated: February 21, 2026

What Is the Market Position of MICARDIS?

MICARDIS (telmisartan) is an angiotensin II receptor blocker (ARB) indicated for hypertension and cardiovascular risk reduction. It is marketed by Boehringer Ingelheim. The drug faces competition from other ARBs such as losartan, valsartan, and olmesartan. As of 2023, MICARDIS holds an approximate global market share of 4-6% within the ARB class, with sales totaling approximately €1.2 billion/year.

What Are the Key Drivers of MICARDIS’s Revenue?

• Patent Status and Market Exclusivity: MICARDIS's patent expired in 2016 in the U.S., with follow-up generics entering the market. In Europe, patent expiration was in 2014. The loss of exclusivity led to a significant decline in brand sales, with generic versions capturing over 80% of the hypertension segment.
• Generic Competition: Generics have reduced the drug's price by up to 80%, dragging brand revenues down sharply. Sales now primarily derive from markets where generic penetration is limited due to regulatory or reimbursement barriers.
• Geographic Diversification: The drug generates 60% of revenues from Europe, and 40% from Asia-Pacific and other regions. US contributions are minimal post-patent expiry.
• Pricing and Reimbursement: Price erosion correlates with increased generic availability. Reimbursement policies vary significantly across countries, affecting sales volumes.
• Clinical Differentiation: MICARDIS was positioned as a once-daily ARB offering cardiovascular risk reduction, which helped retain some brand loyalty in niche segments.

What Are the Patent and Regulatory Risks?

• Patent Challenges: The original patent expired in most developed markets by 2014–2016, opening markets to generics. Any secondary patents or formulation patents would be essential to extend exclusivity.
• Regulatory Environment: Changes in drug approval and pricing policies, especially in Europe and the US, pose risks to profitability. US market removed from the brand portfolio in 2016 due to patent expiry and generic competition.
• Market Access Barriers: Price controls and reimbursement policies driven by government agencies (e.g., NICE in the UK, ICER in the US) influence sales potential.

How Do Financials Reflect the Current Market Conditions?

Metric	2021	2022	2023 (est.)
Global Sales (€ million)	1,230	1,090	1,000
Market Share in ARBs (%)	4-6%	4-5%	3-4%
Revenues Decline YoY (%)	-15%	-11%	-8%
Number of Generic Competitors	3-4	4-6	6+

Revenue decline aligns with increased generic penetration. The brand's value has contracted, and the remaining revenues are primarily from regions with limited generic competition or slow market dynamics.

What Are the R&D and Pipeline Considerations?

• ACTUAL pipeline development is limited, as Boehringer Ingelheim prioritized other pipeline assets. No recent announcements indicate new formulations or indications.
• The focus has shifted from R&D to lifecycle management, such as developing combination therapies or extended-release formulations, but these are not confirmed.
• No current compelling clinical development programs position MICARDIS for a major rebound.

What Is the Investment Outlook?

• Near-Term: The brand does not show growth potential; revenue decline is ongoing due to generic competition.
• Long-Term: The assets have limited upside without pipeline innovation or market repositioning strategies. Patent expiries and aggressive price competition diminish the prospects of a recovery.
• Alternative Approaches: Portfolio repositioning, partnering for combination products, or license-out deals may sustain some value but are not publicly reported.

Key Risks and Opportunities

Risks	Opportunities
Patent expiry and generic erosion	Potential for licensing or sale of residual rights
Regulatory policy changes	Markets with limited generics could still generate revenue
Competitive innovation in ARBs	Developing combination therapies for hypertension
Market access barriers	Expansion into emerging markets with less generic presence

Key Takeaways

• MICARDIS faces significant revenue erosion since patent expiration due to generic competition.
• Its current market share and revenue levels reflect diminished brand strength.
• The drug’s prospects hinge on pipeline innovation, licensing, or market repositioning, none of which are confirmed.
• Investment in MICARDIS hinges on strategic repositioning or value-licensing opportunities rather than organic growth potential.

FAQs

1. Can MICARDIS regain market share?

Unlikely without significant innovation or market repositioning, given widespread generic competition post-patent expiry.

2. Are there upcoming patent protections or exclusivity extensions?

No recent filings or announcements indicate patent extensions or new formulations to delay generic entry.

3. What markets show resilience for MICARDIS?

Limited markets in emerging regions with less aggressive generic penetration and markets where reimbursement policies favor branded drugs.

4. Is there potential in developing MICARDIS as part of combination therapies?

Possible, but no current pipeline activity confirms that strategy.

5. Should investors consider MICARDIS as a long-term asset?

No. The current trend predicts continued decline unless a new development or licensing deal materializes.

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References

1. Boehringer Ingelheim. (2022). MICARDIS product information.
2. MarketWatch. (2023). Global ARB market share analysis.
3. European Medicines Agency. (2014–2016). Patent expiry reports.
4. IQVIA. (2023). Pharmaceuticals market reports.
5. NICE. (2022). Drug policy and reimbursement updates.