HYDROCHLOROTHIAZIDE; TELMISARTAN - Generic Drug Details

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What are the generic drug sources for hydrochlorothiazide; telmisartan and what is the scope of freedom to operate?

Hydrochlorothiazide; telmisartan is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Lupin, Macleods Pharms, Mankind Pharma, Natco, Prinston Inc, Torrent, and Zydus Pharms, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Eight suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; TELMISARTAN

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	48
DailyMed Link:	HYDROCHLOROTHIAZIDE; TELMISARTAN at DailyMed

Recent Clinical Trials for HYDROCHLOROTHIAZIDE; TELMISARTAN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Yuhan Corporation	PHASE4
IlDong Pharmaceutical Co Ltd	Phase 1
IlDong Pharmaceutical Co Ltd	Phase 3

See all HYDROCHLOROTHIAZIDE; TELMISARTAN clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; TELMISARTAN

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCHLOROTHIAZIDE; TELMISARTAN

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; TELMISARTAN

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 HYDROCHLOROTHIAZIDE; TELMISARTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	204221-002	Aug 15, 2017	AB	RX	No	No
Mankind Pharma	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	218406-003	Mar 3, 2025		DISCN	No	No
Lupin	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	091351-002	Aug 7, 2014		DISCN	No	No
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000	AB	RX	Yes	No
Prinston Inc	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	209028-003	Nov 6, 2017	AB	RX	No	No
Natco	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	091648-003	Feb 25, 2014		DISCN	No	No

Expired US Patents for HYDROCHLOROTHIAZIDE; TELMISARTAN

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	5,591,762
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000	6,358,986
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000	5,591,762
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000	6,358,986
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-003	Apr 19, 2004	5,591,762

EU/EMA Drug Approvals for HYDROCHLOROTHIAZIDE; TELMISARTAN

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

Market dynamics and financial trajectory for hydrochlorothiazide; telmisartan

Last updated: April 25, 2026

Hydrochlorothiazide (HCTZ) plus telmisartan is a long-established fixed-dose combination (FDC) for hypertension with mature patent and generic penetration in most major markets. The financial trajectory is dominated by (1) patent expiration and low-cost generic competition, (2) persistent demand from hypertension screening and chronic-disease treatment, and (3) periodic pricing resets driven by payer formularies and wholesale contract cycles. The market’s growth ceiling is primarily set by volume expansion (patient prevalence and adherence) rather than premium pricing power.

What does the product map look like across key markets?

The HCTZ/telmisartan FDC sits in a crowded ARB + diuretic segment. Competitive pressure is structurally high because many ARB monotherapies and ARB combinations are genericized, while HCTZ itself is off-patent. Net sales and margins therefore depend on brand differentiation only where products retain payer preference or where generics face supply and contracting frictions.

Typical competitive structure

• Off-patent base components: HCTZ and telmisartan are widely available as generics in most markets.
• FDC competition: multiple generic entrants across different strength combinations.
• Ongoing utilization: fixed-dose convenience supports persistence, but does not prevent substitution to equivalent generics.

Implication for financial trajectory

• Rapid erosion of brand-like pricing after initial generic entry.
• Plateauing unit growth with late-cycle pricing compression driven by payer step edits and lowest-cost contracting.

What are the demand drivers sustaining volume?

Hypertension prevalence and chronic treatment adherence are the main tailwinds. The FDC formulation supports persistence through once-daily dosing and reduced pill burden.

Demand drivers

• High disease prevalence and long treatment duration: hypertension therapy is measured in years, not months.
• Dosing simplicity: FDC reduces regimen complexity compared with separate titration.
• Guideline consistency: ARB plus diuretic is a common combination strategy across multiple treatment algorithms.

Where volume growth typically comes from

• New diagnoses and up-titration from monotherapy
• Switching from monotherapy when targets are not met
• Refill stability among patients already on an established regimen

Where growth typically stalls

• Payer-driven substitution at equivalent strengths
• Generic-to-generic consolidation among supply chains
• Clinical preference shifts to alternative combination classes (for example, ARB plus calcium channel blocker) in some formularies

How do pricing dynamics usually work for HCTZ/telmisartan FDCs?

Pricing is mostly a contracting function once generic entry occurs. For investors and R&D planners, the key is that the product’s economics tend to move with:

• tender cycles and wholesale negotiations
• payer formulary placement (preferred vs non-preferred tiers)
• step-edit logic (forcing trial of ARB or diuretic monotherapy first, depending on local rules)
• pharmacy benefit manager (PBM) cost-management strategies

Pricing pattern after genericization (typical)

• Initial brand premium collapses to generic parity
• Follow-on generics further compress net price
• Dispersion widens between contracts and less liquid strengths

What is the likely financial trajectory: revenue, margin, and risk profile?

Given HCTZ/telmisartan’s mature status and general generic accessibility, the financial profile is expected to look like a “mature volume story” with declining or low margin unless a firm has defensible contracting positions.

Revenue trajectory

• Early phase: brand-led uptake and penetration in diagnosed populations
• Mid phase: growth slows, then tracks prevalence and adherence
• Late phase: revenue becomes highly sensitive to unit volume and net price reductions from contracting and substitution

Margin trajectory

• Gross margin typically declines after multiple generic entrants
• Net margin becomes dependent on scale, procurement efficiency, and payer contracting outcomes
• Margin volatility increases when supply constraints or tender resets affect bid pricing

Risk profile

• High substitution risk at equal strengths
• Lower pricing power versus patented specialties
• Regulatory risk is comparatively lower in the absence of novel clinical claims, but supply-chain and quality compliance remain critical for generics and FDC manufacturers

How do formulation/portfolio choices shape performance?

HCTZ/telmisartan performance depends on strength coverage and product format. In mature classes, the winners are often those with the broadest formulary coverage across strengths and consistent supply.

Portfolio levers

• Strength breadth (coverage across common dosing ranges)
• Supply reliability and manufacturing capacity
• Pharmacovigilance and quality performance (rejections and recalls can cause formulary removal)
• Localization (pack sizes and label positioning consistent with payer and pharmacy needs)

Competitive set behavior

• Some competitors concentrate on higher-volume strengths
• Others chase tender-based wins that can temporarily widen market share before contracting tightens

What market share dynamics should be expected in tenders and PBM contracts?

FDCs typically compete on:

• net price at the contracting level (not list price)
• rebate structures and utilization management
• formulary placement and pharmacy-level switching rates

Share mechanics

• Entry of a new generic tends to trigger a sudden net price reset for that strength
• Contracting usually concentrates share among the lowest effective-cost suppliers
• Subsequent rounds of tenders drive further compression or consolidation

What does “financial trajectory” mean for different stakeholder types?

Brand-origin holders

• Revenue: declines as generics expand substitution
• Key financial focus: cost management, portfolio switching, and defense via lifecycle strategies if available
• Primary constraint: lost pricing power after patent cliff

Generic manufacturers

• Revenue: tracks tender wins and distribution agreements
• Key financial focus: throughput efficiency, quality performance, and supply stability
• Primary constraint: margin compression from aggressive contracting

Distributors and PBMs

• Primary leverage: formulary placement and rebate structures
• Primary driver: competitive bid outcomes
• Margin profile: influenced by pharmacy switching and patient adherence persistence

How could R&D strategy be affected by these market dynamics?

In this class, R&D investment must map to a plausible path to differentiation or lifecycle value. For many firms, that means:

• improved patient convenience (dose timing, adherence support) rather than new molecular claims
• localized combination reformats (when feasible within regulatory constraints)
• broader market coverage across strengths and geographies

For others, the more bankable approach is to invest in next-generation cardiovascular or renal combinations rather than recapitulate an established FDC with limited differentiation.

What metrics should be tracked to model performance?

A practical monitoring set for financial trajectory:

• net revenue by strength and channel (wholesale vs retail)
• contracted price floors and tender participation wins
• share and utilization metrics by payer segment
• gross margin after rebates and chargebacks
• inventory days and supply constraints (for generic FDCs)
• pharmacovigilance signal rate and batch rejection rates

These metrics determine whether the company captures volume without ceding margin excessively.

What are the investor-relevant bottom lines?

1. The category’s growth is driven more by patient prevalence and adherence than by premium pricing.
2. Net revenue and margin trajectories are highly sensitive to generic entry count and tender cadence.
3. Competitive advantage usually comes from supply reliability and contracting execution, not molecular differentiation.
4. Portfolio breadth across strengths is a direct driver of formulary retention and channel share.

Key Takeaways

• Hydrochlorothiazide plus telmisartan is a mature hypertension FDC with market outcomes dominated by generic substitution and payer contracting cycles.
• Revenue growth is likely capped by diagnosis prevalence and adherence, while net pricing compresses with each additional competitor and tender reset.
• Profitability is mainly determined by scale, manufacturing efficiency, and ability to hold preferred positioning through contract cycles.
• R&D and commercialization strategies should focus on defensible lifecycle differentiation or next-generation alternatives rather than expecting durable premium economics in a generic-dense class.

FAQs

1) Does HCTZ/telmisartan compete mainly on clinical differentiation or pricing?
Pricing and formulary placement dominate after generic entry; clinical differentiation matters most for originator brands only until substitution accelerates.

2) What most affects net sales for FDCs in mature ARB/diuretic combinations?
Net price from payer contracts, strength-level utilization, and pharmacy switching behavior.

3) Why do fixed-dose combinations keep demand even with generics?
They improve convenience and persistence through reduced pill burden, supporting continued use in patients already stabilized.

4) What is the biggest financial risk for manufacturers in this category?
Margin compression from repeated tender cycles and loss of preferred placement after new low-cost entrants.

5) Where can growth still come from in a mature FDC market?
From incremental patient starts, up-titration from monotherapy, and maintaining supply and formulary access across common strengths.

References

[1] U.S. National Library of Medicine. “Hydrochlorothiazide and Telmisartan.” MedlinePlus Drug Information.
[2] World Health Organization. “Hypertension.” Fact sheets and guidance materials.
[3] American Heart Association. “High Blood Pressure.” Clinical practice and disease information resources.
[4] FDA. Drug safety and labeling databases (product labeling for telmisartan and HCTZ combination products).
[5] EMA. European public assessment and medicines information resources for telmisartan and diuretic-containing antihypertensive combinations.