HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE - Generic Drug Details

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

Hydrochlorothiazide; metoprolol tartrate is the generic ingredient in two branded drugs marketed by Validus Pharms, Alembic, Mylan, Senores Pharms, and Sun Pharm Inds, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	5
Clinical Trials:	3
DailyMed Link:	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE at DailyMed

Recent Clinical Trials for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

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

Sponsor	Phase
Mylan Pharmaceuticals	Phase 1
Vanderbilt University Medical Center	Phase 1
Vanderbilt University	Phase 1

See all HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

Drug Class	Thiazide Diuretic beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

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

C07AB	Beta blocking agents, selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	076792-002	Aug 20, 2004	AB	RX	No	No
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-001	Dec 31, 1984	AB	RX	Yes	No
Sun Pharm Inds	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	090654-002	Jan 19, 2012		DISCN	No	No
Mylan	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	076792-003	Aug 20, 2004	AB	RX	No	No
Senores Pharms	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	215789-001	Jan 8, 2025	AB	RX	No	No
Alembic	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	202870-001	Nov 6, 2013	AB	RX	No	No
Sun Pharm Inds	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	090654-001	Jan 19, 2012		DISCN	No	No

Expired US Patents for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-001	Dec 31, 1984	3,876,802
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984	3,998,790
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-001	Dec 31, 1984	3,998,790
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984	3,876,802
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-002	Dec 31, 1984	3,998,790
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-002	Dec 31, 1984	3,876,802

Market Dynamics and Financial Trajectory for Hydrochlorothiazide; Metoprolol Tartrate

Last updated: February 20, 2026

What Are the Current Market Drivers?

Hydrochlorothiazide (HCTZ) and metoprolol tartrate are established medications used predominantly for hypertension and cardiovascular diseases. The market's growth is driven by the increasing prevalence of these conditions globally.

• Prevalence: Hypertension affects over 1.28 billion adults worldwide, with a rising trend due to aging populations and lifestyle factors (World Health Organization [WHO], 2021).
• Guideline Adoption: Clinical guidelines favor these drugs as first-line treatments, maintaining consistent demand.
• Generic Availability: Both drugs are off-patent, with numerous generic manufacturers reducing costs and expanding access.

What Are the Market Sizes and Trends?

Global Market Valuations

Year	Estimated Global Market Size (USD billion)	Growth Rate (CAGR)	Remarks
2020	1.2	3-5%	Reflects steady generic market volume
2021	1.3	8%	Driven by increased hypertensive cases
2022	1.4	7.7%	Sustained demand across regions

Note: The higher growth rate in 2021 relates to increased generic sales as healthcare systems relaxed pandemic restrictions.

Regional Market Distribution

• North America accounts for approximately 45% of the market, with high hypertension prevalence and mature generic sectors.
• Europe contributes 30%, with stable demand and strong generic penetration.
• Asia-Pacific holds roughly 20%, with fast-growing markets due to expanding healthcare access.

How Do Patent and Regulatory Frameworks Affect Market Dynamics?

• Patent Expiry: Both drugs have long expired patents (metoprolol tartrate in 1997; hydrochlorothiazide in 1983), enabling multiple generics.
• Regulatory Approval: Regulatory bodies (FDA, EMA, NMPA) have streamlined processes for generics, further supporting market volume.
• Pricing Policies: Governments in various regions implement price controls, which suppress profit margins but incentivize volume sales.

What Are the Key Competitive Factors?

• Manufacturing Scale: Large-scale production decreases unit costs.
• Brand Recognition: Well-established generics dominate due to physician familiarity.
• Supply Chain Stability: Reliance on API suppliers, primarily from China and India, introduces supply risks.

How Will Market Demand Evolve?

• Demographics: Aging populations intensify demand.
• Treatment Guidelines: Continued reliance on these drugs as first-line therapies sustains demand.
• Emerging Markets: Rapid expansion of healthcare infrastructure boosts market growth.

What Are the Financial Projections?

Revenue Projections (2023-2027)

Year	Estimated Market Value (USD billion)	Compound Growth Rate (CAGR)	Main Influences
2023	1.45	8-10%	Growing hypertension prevalence
2024	1.58	9%	Increased access in developing countries
2025	1.72	9%	Expanded use due to aging populations
2026	1.87	8.8%	Market maturation, pricing pressures
2027	2.03	8.5%	Ongoing generic competition

Profit Margins and Pricing

• Gross Margins: Typically range from 20-40%, depending on manufacturing scale and geographic location.
• Pricing Trends: Declining with increased competition but offset by volume growth.

What Are Challenges Facing the Market?

• Regulatory Changes: Stricter pharmacovigilance requirements may increase compliance costs.
• Market Saturation: Price erosion limits profit margins.
• Supply Chain Risks: Dependence on API manufacturing from Asia introduces geopolitical uncertainties.

Key Takeaways

• The market for hydrochlorothiazide and metoprolol tartrate remains stable with slow growth driven by global hypertension prevalence.
• Generics dominate, leading to low prices but high volume demand.
• Maturation of the market constrains profit margins but ensures steady revenue streams.
• Emerging markets and aging demographics will sustain demand growth.
• Supply chain vulnerabilities and regulatory pressures pose ongoing risks.

FAQs

1. Will patent protections for these drugs be reinstated?
No. Both drugs are off-patent; no new patents are expected.

2. How does increased competition influence pricing?
Price reductions occur as multiple generic manufacturers enter markets, reducing profit margins.

3. Are biosimilars or new formulations poised to replace these drugs?
No. Both drugs are small-molecule medications with no biosimilar alternative. New formulations are unlikely to replace widespread use.

4. What regulatory hurdles exist for generic manufacturers?
Generic submissions require bioequivalence studies; deviations from standards can delay approval.

5. How might supply chain disruptions impact market supply?
Persistent reliance on Asian API sources could cause shortages during geopolitical or pandemic-related disruptions.

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References:

1. World Health Organization. (2021). Hypertension. https://www.who.int/news-room/fact-sheets/detail/hypertension
2. Assessments based on industry reports from IQVIA (2022) and market analysis from Global Data (2022).
3. U.S. Food and Drug Administration. (2022). Bioequivalence Guidelines. https://www.fda.gov/drugs/guidances-biologics/guidances-drug-products-biological-products-and-drug-device-combinations