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
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	021162-001	Nov 17, 2000
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000
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
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-003	Apr 19, 2004

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
Australia	655794

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
0502314	91802	Luxembourg		91802, EXPIRES: 20170131

Micardis HCT (telmisartan + hydrochlorothiazide) market dynamics and financial trajectory: exclusivity, competition, and earnings pressure across the patent life cycle

Last updated: July 30, 2026

Micardis HCT (telmisartan/hydrochlorothiazide, fixed-dose combo) faces a shrinking opportunity window as key U.S. exclusivities end and generic fixed-dose combinations scale. The core market dynamics are driven by (1) the durability of the telmisartan and combo patent estate, (2) FDA regulatory permissibility for ANDA entrants to rely on listed combination and component data, (3) payer substitution and rebate pressure versus other ARB/thiazide and ARB/beta blocker or ARB/CCB offerings, and (4) channel mix shifts toward higher-volume strengths once lower-strength exclusivities lapse.

What patents protect Micardis HCT in the U.S., and when do they expire?

Micardis HCT is a combination product built on telmisartan plus hydrochlorothiazide (HCTZ). The patent estate that matters commercially is the one that prevents FDA approval and commercial launch of generic telmisartan/HCTZ fixed-dose combinations for the listed strengths (and, where applicable, prevents certain manufacturing or formulation variants).

Which patent types block generic Micardis HCT combos?

For branded fixed-dose combinations like Micardis HCT, the practical barriers tend to be:

• Composition-of-matter and combination patents on telmisartan and its salts or specific telmisartan/HCTZ pairings.
• Formulation and manufacturing method patents for tablet composition, granulation, coating, or stability improvements.
• Method-of-use patents (less common for simple combo hypertension labeling, but possible if the brand’s label includes specific claims that can be carved out).

What are the key expiration and “loss of exclusivity” checkpoints?

Featured-snippet answer: Micardis HCT’s exclusivity timeline is dominated by (a) U.S. patent expirations for telmisartan/HCTZ combination coverage and (b) any remaining regulatory exclusivity tied to application originality. When those end, ANDA approvals and generic launch typically follow quickly, especially once multiple ANDA filers are on file and Orange Book barriers are cleared.

Market impact mechanism

• As soon as Orange Book blocking patents fall out (expiration or invalidation via litigation), at-scale generic entrants can launch fixed-dose equivalents, increasing unit competition and compressing net price through payer contracting and pharmacy substitutions.

Patent estate coverage by strength and dosage form: what to model commercially

From a revenue protection perspective, brands usually face generic entry in waves by strength where different patents cover different ratios or where different ANDA applicants certify against specific Orange Book listings.

Commercial modeling implication

• Expect the highest early revenue dilution in the strengths with the largest prescribing base, not necessarily the ones with the most patents in the abstract.
• Strengths that clear first tend to set the substitution tempo, then spill over to neighboring ratios.

When does Micardis HCT lose exclusivity, and how fast do generics typically capture volume?

Featured-snippet answer: Loss of U.S. exclusivity for a branded ARB/HCTZ fixed-dose combination typically triggers a rapid volume transition to generics within 6 to 18 months, with pricing following more gradually as payers re-contract. The fastest erosion is in formularies where tiering and rebate offers shift quickly to the lowest net-cost options.

What timeline drives generic ramp?

A realistic launch/ramp shape in ARB/thiazide combos:

1. ANDA approval stage: Entry may occur soon after approval if barriers are removed and supply and contracting are ready.
2. First-wave substitution: Pharmacy claims switch where pharmacy benefits and state substitution rules favor the approved generic product.
3. Second-wave consolidation: Multiple generics reduce the brand’s negotiating leverage. Net price declines accelerate as payers lock in additional low-cost SKUs.

Key market drivers that affect speed of erosion for Micardis HCT

• Payer policy: Step therapy and preferred drug lists often push ARB/HCTZ fixed-dose combinations into formulary rows where generics can displace branded products.
• Wholesale buying and rebates: Brands typically rely on rebate intensity to slow switching. When generics multiply, rebate leverage weakens.
• Switchability: Fixed-dose alternatives with equivalent strengths (and comparable bioavailability) are easy to substitute.

How many Paragraph IV challenges target Micardis HCT, and which generic companies are likely to launch?

Featured-snippet answer: For a mature branded combo like Micardis HCT, the market typically sees multiple ANDA filings and at least some Paragraph IV certifications once Orange Book listings are challenged. The practical outcome is that generic entry tends to become competitive even if only one filer succeeds.

Paragraph IV dynamics that change the financial trajectory

• Settlement-accelerated launch: If litigation ends in a settlement allowing early generic entry, brand revenue compresses faster than a pure expiration model.
• Partial exclusivity carve-outs: Some settlements allow entry for certain strengths while other strengths remain blocked longer, creating staggered revenue dilution.
• Design-around: Where patents are method or formulation specific, generics may launch “close variants” that avoid specific claim coverage (if permitted by labeling and manufacturing differences).

Litigation and settlement effects to track

Commercially, the key question is not whether Micardis HCT is sued, but whether settlements or court decisions lift Orange Book barriers for all key strengths. This governs:

• expected date of generic entry,
• number of competitors at launch,
• pricing erosion pace.

What is the Orange Book status of Micardis HCT (telmisartan/HCTZ), and which patents appear as blockers?

Orange Book status determines whether generics can lawfully launch.

Featured-snippet answer: The Orange Book listings for Micardis HCT govern which patents are used for ANDA certifications and whether a generic can be launched immediately at patent expiry or must wait for settlement/litigation outcomes.

What to extract from the Orange Book for commercial forecasting

For each Micardis HCT strength listed, model:

• Patent number(s)
• Expiration date(s)
• Patent type (composition, formulation, method, or use)
• Whether patents are “listed” only for specific strengths
• Whether there are multiple listed patents expiring on different dates, creating stepwise generic entry

What generic entry risks exist for Micardis HCT?

Risk categories for brand revenue:

• High risk: multiple listed patents with near-term expirations for blockbuster strengths.
• Medium risk: patents with uncertain enforceability or prior validity challenges.
• Low risk: fewer Orange Book blockers, longer time to expiry, or limited ANDA certifications.

How does Micardis HCT compare with competing ARB/HCTZ fixed-dose combinations?

Micardis HCT sits in the ARB/thiazide hypertension combo segment, competing on net price, formulary access, and dose convenience.

Competitive landscape: key substitutes to model

Common substitutes include:

• Other telmisartan-based fixed-dose ARB/HCTZ products where available.
• ARB/HCTZ combos from different ARB backbones (losartan/HCTZ, valsartan/HCTZ, olmesartan/HCTZ) in multiple generics and branded remnants depending on the backbone’s patent stage.
• Combo strategies that move patients off thiazide combos into ARB/CCB or ARB/diuretic variants when tolerability or BP control warrants.

What changes when generics flood the ARB/thiazide segment?

When generic fixed-dose combinations scale:

• prescribers face fewer barriers to switching,
• payers standardize around lowest net cost,
• brand differentiation shifts from “being first” to contract performance.

How does Micardis HCT’s brand durability typically play out versus ARB/HCTZ peers?

Brands usually lose market share to generic fixed-dose equivalents first. If competing ARB backbones have already gone generic, Micardis HCT’s competitive differentiation compresses quickly as all options converge on similar pricing.

What formulations are protected by Micardis HCT patents, and what manufacturing/IP barriers slow generic manufacturing?

For tablet combinations, the generic barrier often becomes manufacturing and formulation patent scope rather than simple composition.

Formulation patent clusters to assess

• Tablet core composition and ratios
• Film coating and dissolution profile
• Stability claims (especially under stress conditions affecting HCTZ)
• Manufacturing steps that prevent bioavailability issues (granulation method, drying, compression conditions)

Manufacturing/IP barriers: what matters to ANDA approvals

Even when a generic can legally copy the active ingredients and strength, manufacturing method and dissolution consistency can become the battleground if formulation patents cover:

• specific dissolution profiles,
• controlled release or special coatings (less common for simple IR fixed-dose combos),
• process conditions tied to claimed product quality.

What is the FDA regulatory status of Micardis HCT, and how does it affect launch timing for generics and authorized competitors?

Featured-snippet answer: FDA approval pathways for generic fixed-dose combinations rely on bioequivalence and, in many cases, permission to reference listed drugs and component data already in the system. Once Orange Book barriers are cleared, FDA’s ability to approve an ANDA is typically the last gating item, with commercial launch driven by settlements, supply, and contracting.

ANDA mechanics that accelerate competition

• If FDA approves an ANDA with proper certifications against Orange Book patents, the sponsor can launch upon lawful entitlement.
• Labeling carve-outs tied to patent scope can allow partial launch for selected strengths or indications.

What to track on FDA filings for revenue forecasting

• ANDA approval dates
• exclusivity periods tied to application status (if any)
• labeling and strength-by-strength approvals

What patent litigation affects Micardis HCT, and how do settlements change the financial trajectory?

In brand fixed-dose portfolios, the decisive litigation variable is whether settlements allow “early entry” before full patent expiration.

How to translate litigation outcomes into revenue impact

• If a court invalidates or narrows a listed patent, expect near-term erosion.
• If a settlement includes an agreed-upon launch date, model revenue decline beginning at settlement effective date, not at original expiration.
• If settlements cover only certain strengths, model staggered dilution with a first drop in the largest-volume strengths and a slower follow-through in smaller strengths.

What to model in financial statements

• Gross-to-net pressure from payer contracting
• Reduced average selling price (ASP) as generics enter
• Volume mix shifting toward lower net-cost SKUs

How do licensing deals and authorized generics affect Micardis HCT pricing?

Authorized generics or licensing arrangements change the nature of competition.

Authorized generic dynamics

• They can lead to faster ASP declines because the “generic” product becomes available without the delay of typical market ramp.
• They can reduce the brand’s ability to maintain market share through non-price levers.

What contract strategy does this force?

• Brands must intensify rebate and formulary retention earlier.
• If authorized generics are used, expect sharper net price compression even if unit volume remains less affected initially.

What generic entry scenarios are most likely for Micardis HCT?

Three scenario lanes drive board-level planning:

Scenario A: Clean patent expiry, no litigation settlement early entry

• Generic launches at or shortly after expiry.
• Brand loses share quickly in large strengths.
• Pricing compression follows as payers re-contract.

Scenario B: Settlement allows early entry for some strengths

• Staggered dilution.
• Brand may keep remaining blocked strengths in higher ASP brackets longer.
• Financial trajectory shows stepwise decline rather than a single inflection.

Scenario C: Patent estate breakdown through litigation

• Either invalidation or narrowing accelerates generic approvals and launch.
• Revenue loss can begin earlier than expected if barriers are removed by court decisions.

Key financial trajectory indicators for Micardis HCT

Micardis HCT’s financial trajectory in a mature ARB/HCTZ category generally tracks:

• growth in late-stage volume before generic entry,
• rapid decline after generic availability,
• slower plateau as competition stabilizes.

What KPIs map to market dynamics

• Net sales trend vs. generic penetration timeline
• ASP vs. gross-to-net
• Pharmacy and payer share shifts
• Mix of strengths (higher-strength sales typically move first depending on patient profile and guideline adoption)

How to interpret “brand resilience” signals

Signs the brand is holding up better than peers:

• sustained formulary positioning,
• fewer competing generics at launch,
• higher rebate intensity relative to rivals.

Signs of impending erosion:

• increasing use of competitors as brand share drops by strength,
• early ANDA activity tied to Orange Book certifications for key blockers.

Key takeaways

• Micardis HCT’s revenue trajectory is primarily governed by U.S. Orange Book blocker removal and the resulting pace of generic fixed-dose substitution across strengths.
• Generic competition timing typically follows Orange Book barrier clearance within 6 to 18 months, with the fastest share loss in the largest-volume strengths.
• Patent litigation and settlements can shift the launch clock earlier and create stepwise dilution by strength.
• Payer contracting and rebate dynamics determine whether the brand’s ASP decline is gradual or abrupt once generics scale.
• Formulation and manufacturing patents can affect how quickly ANDA entrants can launch and at what breadth of strengths.

FAQs

1. What is Micardis HCT’s main competitive threat in the U.S. ARB/thiazide market?
Generic telmisartan/HCTZ fixed-dose equivalents and payer-driven substitution across equivalent strengths.

2. Do Micardis HCT formulation or manufacturing patents delay generic entry?
They can if claims are specific to dissolution, stability, or manufacturing process parameters that a generic must replicate or design around.

3. How does Orange Book listing by strength impact Micardis HCT generic launch dates?
It can enable staggered launches when ANDA certifications clear for some strengths earlier than others.

4. What determines whether a settlement accelerates Micardis HCT erosion?
Whether settlement terms permit early launch and whether they cover all major strengths.

5. Does FDA approval alone guarantee generic launch for Micardis HCT?
No. Launch is typically driven by lawful entitlement after patent/settlement barriers are cleared, then commercial contracting and supply ramp.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. Drug Approvals and Databases: ANDA and approval information. https://www.fda.gov/drugs/drug-approvals-and-databases
3. FDA. Paragraph IV certifications and ANDA litigation framework (Hatch-Waxman overview). https://www.fda.gov/drugs/hatch-waxman-competition-act-and-paragraph-iv-certifications