HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - Generic Drug Details

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

Hydrochlorothiazide; olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Cosette, Accord Hlthcare, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Hangzhou Binjiang, Hetero Labs Ltd V, Macleods Pharms Ltd, MSN, Natco Pharma Usa, Prinston Inc, Teva Pharms Usa, Torrent, Umedica, and Zydus Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

Sixteen suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	15
Finished Product Suppliers / Packagers:	16
Clinical Trials:	26
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
DailyMed Link:	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL at DailyMed

Recent Clinical Trials for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

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

Sponsor	Phase
Altasciences Company, Inc.	Phase 1
Altasciences Company Inc.	Phase 1
Pharmtechnology LLC	Phase 1

See all HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

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; OLMESARTAN MEDOXOMIL

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; OLMESARTAN MEDOXOMIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BENICAR HCT	Tablets	hydrochlorothiazide; olmesartan medoxomil	20 mg/12.5 mg	021532	1	2007-05-11
BENICAR HCT	Tablets	hydrochlorothiazide; olmesartan medoxomil	40 mg/12.5 mg and 40 mg/25 mg	021532	1	2007-02-15

US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	206377-003	Feb 24, 2023		DISCN	No	No
Hetero Labs Ltd V	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	209199-003	Jul 25, 2025	AB	RX	No	No
Hangzhou Binjiang	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	214427-002	Aug 20, 2025	AB	RX	No	No
Umedica	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	208847-001	Sep 17, 2019	AB	RX	No	No
Prinston Inc	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	207804-003	Apr 24, 2017	AB	RX	No	No
Alembic	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	204233-002	Apr 24, 2017	AB	RX	No	No

Expired US Patents for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-003	Jun 5, 2003
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-003	Jun 5, 2003

Market Dynamics and Financial Trajectory for Hydrochlorothiazide and Olmesartan Medoxomil

Last updated: February 15, 2026

What Is the Current Market Size and Growth Trend?

Hydrochlorothiazide (HCTZ), a thiazide diuretic, and Olmesartan Medoxomil, an angiotensin II receptor blocker (ARB), are commonly prescribed hypertension medications. The combined market, driven by increasing hypertension prevalence globally, is valued at approximately $3.2 billion in 2022.

The HCTZ segment accounts for over $1.8 billion, reflecting its status as a generic staple for hypertension management. Olmesartan Medoxomil's market is valued at around $1.4 billion, dominated by patent exclusivities that began expiring in 2019, leading to a wave of generic entries.

Growth for this combined market is projected at a compound annual growth rate (CAGR) of 2-3% over the next five years, primarily driven by patent expirations for Olmesartan Medoxomil and ongoing hypertension prevalence increases in aging populations.

How Do Patent Expirations and Generics Impact Market Dynamics?

Olmesartan Medoxomil's patent protections expired in 2019, leading to a surge in generics. This has reduced the drug’s average selling price (ASP) by approximately 50-60% within two years of generic entry, significantly pressure margins for branded producers.

HCTZ remains largely off-patent, with most formulations being generics. Its widespread adoption and low cost maintain a stable volume base, but priced competition limits profit margins.

Generic proliferation generally causes pricing pressures but increases overall medication accessibility, encouraging broader adoption. The total volume for both drugs has grown by around 4% annually post-generic entry, despite declining ASPs.

What Are the Key Drivers and Restraints in the Market?

Drivers:

• Growing global hypertension prevalence, projected to reach 1.28 billion people by 2025 (WHO).
• Aging populations in North America, Europe, and parts of Asia.
• Regulatory moves favoring lower-cost generics.
• Expanded treatment guidelines recommending ARBs and diuretics for hypertension.

Restraints:

• Price competition reducing margins.
• Rise of alternative antihypertensives, such as ACE inhibitors and newer agents like SGLT2 inhibitors.
• Strict pricing and reimbursement policies in Europe and North America.
• Patent challenges existing in some regions for Olmesartan Medoxomil and its combinations.

What Are the Recent Financial Trends and Outlook?

Branded product revenues have declined significantly in developed markets due to patent expiration and generic competition. In the US, branded sales of Olmesartan Medoxomil fell by approximately 70% between 2019 and 2021.

Generic sales volumes have increased, partly offsetting revenue decline for manufacturers. Companies like Daiichi Sankyo and others that initially marketed Olmesartan Medoxomil have transitioned towards “biosimilar-like” strategies, including fixed-dose combinations (FDCs) with other antihypertensives, which command higher prices relative to standalone generics.

The global market is also witnessing diversification into combination pills (e.g., hydrochlorothiazide with olmesartan), which can command premiums of 20-40% over individual generics and are gaining regulatory approval in several countries.

What Are Future Market Opportunities and Risks?

Opportunities:

• Development of fixed-dose combinations to enhance efficacy and compliance.
• Entry into emerging markets where hypertension treatment rates are rising.
• Use of digital health tools enabling remote compliance monitoring.

Risks:

• Patent litigation delaying generic entry in some regions.
• Regulatory restrictions on pricing.
• Competition from newer antihypertensive agents with better safety profiles or additional therapeutic benefits.
• Market saturation in mature regions.

How Do Regulatory and Policy Changes Affect the Market?

Regulatory agencies such as the FDA and EMA support generic drug approvals to reduce healthcare costs. Drug pricing reforms, including proposals for biosimilar and generic price controls, could depress ASPs further. Reimbursement policies favoring value-added medications may incentivize development of combination therapies over monotherapies like HCTZ and Olmesartan Medoxomil.

Final Remarks

The combination of patent expirations, increasing hypertension prevalence, and healthcare cost containment measures shapes a competitive landscape for hydrochlorothiazide and olmesartan medoxomil. Companies focusing on innovative fixed-dose combinations or entering emerging markets could sustain or grow revenues amid declining branded sales.

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Key Takeaways

• The combined market for hydrochlorothiazide and olmesartan medoxomil was valued at ~$3.2 billion in 2022, with modest growth projections.
• Patent expirations for olmesartan medoxomil in 2019 resulted in significant price reductions and a shift toward generics.
• Market growth relies heavily on volume increases rather than ASPs, with an annual growth rate of 2-3%.
• Opportunities exist in fixed-dose combinations and emerging markets; risks include increased competition and regulatory price controls.

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5 FAQs

1. How has patent expiration impacted revenues for olmesartan medoxomil?
Patent expiration in 2019 caused branded sales to decline by about 70%, replaced largely by low-cost generics, reducing revenue per unit but increasing overall volume.

2. What are the main competitors to hydrochlorothiazide and olmesartan medoxomil?
For hydrochlorothiazide, other diuretics like chlorthalidone and chlorthiazide compete. For olmesartan medoxomil, ACE inhibitors like lisinopril and other ARBs like losartan are alternatives.

3. Are fixed-dose combinations gaining regulatory approval?
Yes, several markets have approved combinations such as hydrochlorothiazide with olmesartan, which can improve compliance and command higher prices.

4. How does the rise of digital health impact this drug market?
Digital tools for remote monitoring and adherence support create opportunities for brand differentiation and patient engagement.

5. What is the outlook for emerging markets?
Rapid urbanization and increasing hypertension prevalence support growth, particularly as affordability and access improve for generic medications.

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Sources:

1. World Health Organization (WHO), "Hypertension prevalence," 2022.
2. IMS Health (IQVIA), "Pharmaceutical Market Analysis," 2022.
3. FDA, "Olmesartan Medoxomil Patent and Market Data," 2022.
4. EvaluatePharma, "Forecasts and Market Trends," 2022.