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
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
University of Hawaii	Phase 2
Queens Medical Center	Phase 2

See all MICARDIS clinical trials

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	020850-001	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-003	Apr 4, 2000

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
Austria	141270
Austria	166346
Australia	1070792
Australia	3196293
Australia	3679693
Australia	4209493

Supplementary Protection Certificates for MICARDIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0502314	91802	Luxembourg		91802, EXPIRES: 20170131

Last updated: July 20, 2026

MICARDIS (telmisartan): Market dynamics and financial trajectory

Executive summary: MICARDIS (telmisartan) is a long-running, branded angiotensin II receptor blocker (ARB). Its US growth profile is dominated by patent/brand-life dilution from generics and negotiated payor access, with further pressure from ARB substitutes and broader antihypertensive formularies. Financial performance has shifted from brand-led expansion to value-protecting contracting, limited incremental share gains, and share loss to generic telmisartan and other ARBs. The net effect across major markets is a mature brand with declining unit and revenue momentum tied to generic penetration and competitive switching rather than new clinical expansion.

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What is the market size and competitive landscape for MICARDIS (telmisartan)?

MICARDIS competes in the antihypertensive and cardiovascular risk-reduction space, anchored in hypertension management and, in selected geographies, cardiovascular risk use cases aligned to product labeling and guideline practice.

Where does MICARDIS sit within ARB competition?

• MICARDIS is an ARB alongside branded and generic rivals including losartan, valsartan, irbesartan, olmesartan, and others.
• Competitive dynamics in ARBs are largely payer- and formulary-driven because class members are clinically substitutable and typically priced competitively after generic entry.

Key market drivers

• Formulary placement and rebate structure: ARBs are frequently managed via step therapy and preferred-drug lists.
• Generic telmisartan availability: Generic entry caps sustained branded price/margin unless protected by contract design and narrow differentiated channels.
• Switching behavior: Patients switch when cost-sharing changes; prescribers switch when payors restrict non-preferred ARBs.
• Me-too vs differentiated use: ARB class homogeneity shifts “brand advantage” toward access, not differentiated outcomes.

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How has MICARDIS performed financially over time?

Featured snippet answer: MICARDIS follows a mature branded trajectory: post-peak growth gives way to revenue shrinkage as generic telmisartan penetrates and payor competition tightens, with intermittent stabilization only when contracts and segment-specific access slow the decline.

Financial trajectory mechanics

1. Peak-to-dilution transition
   • Once generic telmisartan is widely available, branded volumes typically decline as wholesalers and prescribers reduce branded fill.
2. Contracting and channel management
   • Brand holders can slow revenue decline through rebated pricing, restricted alternative coverage, and targeted managed-entry agreements.
3. Ongoing ARB price compression
   • Even when patients remain on telmisartan, competitive pricing across ARBs and generic ARB availability compress brand realization.

Where revenue exposure concentrates

• Revenue exposure is strongest in geographies and payer segments where:
  • telmisartan remains on preferred lists,
  • contract terms delay full substitution to the lowest-cost options,
  • and prescriber behavior sustains brand-level retention.

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When does generic telmisartan reduce MICARDIS revenue and market share?

Featured snippet answer: Generic telmisartan reduces branded MICARDIS share immediately upon broad market adoption, with additional lag effects for patient persistence and contract-driven retention.

Market timing pattern seen in mature ARBs

• Launch of generics: earliest unit share loss occurs right after market entry.
• Wholesaler stocking dynamics: downstream channel de-stocking of branded product can extend the decline over quarters.
• Rebate and formulary updates: payors renegotiate preferred status after generic price discovery.
• Prescriber switching lag: brand erosion continues as patients with stable therapy transition through benefit changes.

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What payer and reimbursement dynamics affect MICARDIS pricing?

Payer reimbursement is a primary determinant of branded telmisartan realization.

Rebate pressure and net-price erosion

• Branded ARBs typically face:
  • rebate intensity increases as generics expand,
  • tighter utilization management,
  • and broader substitution controls at pharmacy benefit managers.

Formulary design trends

• Preference is frequently assigned to the lowest net-cost ARB after rebates.
• Step therapy and non-medical switching provisions increase the speed of erosion for non-preferred brands.

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Which ARBs are the main competitors to MICARDIS, and how does MICARDIS compare?

MICARDIS competes with other ARBs in efficacy, tolerability, and class-level outcome profiles that make head-to-head differentiation difficult once generic options exist.

Competitive set

• Losartan (generic-dominant; sometimes preferred on cost)
• Valsartan (generic-dominant; common preferred status due to net pricing)
• Olmesartan and irbesartan (often preferred in segments depending on contracting)
• Brand ARBs may persist in specific segments but compete under the same cost pressure

How MICARDIS tends to lose ground

• When payors broaden preferred lists for generics or move to class-tiering with incentives, branded telmisartan volume declines.
• Switching is facilitated because ARBs are interchangeable for many patients without requiring new titration beyond standard practice.

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What growth pockets can still benefit MICARDIS despite generics?

Featured snippet answer: Residual brand support can persist where contracts keep telmisartan branded on-preferred lists, and where patient persistence or prescriber preference limits rapid switching.

Potential pockets

• Institutional formularies that maintain brand telmisartan longer under negotiated pricing.
• High persistence cohorts where patients remain due to stable BP control.
• Regional payor arrangements that delay generic substitution by maintaining differentiated access terms.

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How do manufacturing and supply-chain factors influence MICARDIS market dynamics?

Once generics dominate, supply reliability and batch continuity matter mainly for:

• maintaining branded inventory in contract channels,
• preventing share spikes for substitutes due to supply interruptions,
• ensuring stable lot availability for ongoing prescriptions and contracts.

Brand supply issues can temporarily improve branded share, but these are episodic rather than structural.

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What is the role of labeling, indications, and guideline positioning in MICARDIS sales?

MICARDIS is entrenched in hypertension care. For market dynamics, the practical question is not scientific differentiation but whether telmisartan remains:

• aligned with prescriber protocols,
• reimbursed under local guideline-backed formularies,
• and included in payer management programs.

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How does MICARDIS fit into global cardiovascular risk portfolios?

In many markets, ARBs are part of broader cardiovascular portfolios, including chronic kidney disease-related hypertension and cardiovascular risk management. Brand value is still constrained by generic pricing after widespread telmisartan access.

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What is the Orange Book status of MICARDIS and how does it relate to market timing?

MICARDIS is a small-molecule brand with extensive generic entry. The market timing for branded decline correlates with the clearing of:

• composition-of-matter and key formulation/method-of-use protections,
• and subsequent generic approvals and launch behavior.

In practice, the Orange Book timeline translates into:

• earlier generic availability reduces branded revenue earlier,
• secondary patents can delay some competitors but rarely reverse the post-generic class-wide pricing collapse for a mature ARB.

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What patent/settlement-driven events typically impact MICARDIS competition?

For older small-molecule brands, competitive behavior often reflects:

• Paragraph IV filings and litigation settlements that define “design-arounds” and launch dates for generics,
• settlement-driven “at-risk” launch reduction for some entrants.

These events matter structurally because they shift the number of generic competitors and the intensity of price compression, which then determines branded net price durability.

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How many generic entrants typically exist for telmisartan, and why does that matter?

In mature small-molecule ARBs, multiple generic entrants usually appear after initial exclusivity and patent barriers clear. The practical effect:

• rapid decline in generic pricing,
• strengthened payer incentives to substitute,
• lower branded willingness-to-contract unless rebates remain high.

This creates a feedback loop:

• more generic availability reduces branded share,
• reduced branded volume reduces the brand holder’s leverage and increases rebate burden to maintain access.

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What are the most likely Paragraph IV and biosimilar risks for MICARDIS?

MICARDIS is not a biologic, so biosimilar risk is not applicable. The relevant legal dynamic is the small-molecule generic landscape, typically driven by Paragraph IV certifications and patent challenges.

The market impact is measured through:

• generic entry count and timing,
• market share shift speed,
• net-price compression and rebate escalations for remaining brand access.

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Commercial scenario analysis: What generic entry risks exist for MICARDIS?

Featured snippet answer: The main generic entry risk for MICARDIS is not “additional protection removal” in the abstract but incremental generic entrants that expand price competition and accelerate substitution within payer programs.

Scenario patterns

• Scenario A: stable class competition
  • branded volumes decline gradually; net price stability depends on rebate management.
• Scenario B: increased generic competition intensity
  • additional entrants reduce net costs further; payors tighten substitution policies; branded volume declines faster.
• Scenario C: delayed competition
  • if certain patents or settlements limit early entry, branded revenue declines slower, then collapses as barriers expire.

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What do the MICARDIS financial dynamics imply for investors and licensors?

Featured snippet answer: MICARDIS is a “managed access” business once generics dominate, where returns depend on contract leverage and channel retention rather than product innovation.

Investor and licensing lens

• Buyers or licensors evaluate:
  • durability of brand-coded utilization versus automatic substitution,
  • net price under rebate pressure,
  • and whether any remaining differentiation exists in specific subsegments.
• For licensing and litigation, the primary economic question is:
  • whether any remaining IP can materially delay broad substitution and sustain branded net revenue.

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What Key Takeaways emerge for MICARDIS market and financial trajectory?

• MICARDIS operates in a mature ARB market where branded advantage is primarily access-driven after generic telmisartan entry.
• Revenue and share erosion are driven by payer contracting, rebate pressure, and substitutability within the ARB class.
• Structural financial trajectory is typically: peak brand period followed by sustained net-price compression and unit share loss as generics expand.
• Residual brand performance can persist in segments where contracts retain telmisartan branding longer, but the dominant market force remains generic substitution and class-level pricing competition.

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FAQs

1) Why does MICARDIS net revenue decline even if prescriptions persist?

Rebate pressure and tiering can reduce realized net price even when prescriptions stay on telmisartan branded product in managed channels.

2) How do step-therapy policies affect MICARDIS usage versus generics?

Step therapy accelerates switching to preferred or lower-cost ARBs after initial fills, reducing branded persistence.

3) What differentiates MICARDIS from other ARBs in real-world payer behavior?

In real-world reimbursement, net cost and formulary status usually outweigh subtle clinical differences among ARBs for prescribing decisions.

4) Does institutional purchasing slow MICARDIS brand erosion?

It can slow erosion temporarily where contracts lock in brand usage, but these contracts often reprice when generic options dominate.

5) Is MICARDIS growth dependent on new clinical trials?

Not materially for long-term revenue once generics are available; commercial outcomes depend more on managed access and competitive pricing than on incremental clinical differentiation.

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. World Health Organization. WHO Model List of Essential Medicines. World Health Organization.
3. Agency for Healthcare Research and Quality (AHRQ). Comparative effectiveness and medication utilization resources (class-level hypertension management context). Agency for Healthcare Research and Quality.

DrugChatter Q&A for MICARDIS

Generic micardis 80mg 30 tablets cash price?