Hydrochlorothiazide; moexipril hydrochloride - Generic Drug Details

What are the generic sources for hydrochlorothiazide; moexipril hydrochloride and what is the scope of patent protection?

Hydrochlorothiazide; moexipril hydrochloride is the generic ingredient in two branded drugs marketed by Chartwell Rx, Glenmark Pharms, Heritage, Teva, and Ucb Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Summary for hydrochlorothiazide; moexipril hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Clinical Trials:	3
DailyMed Link:	hydrochlorothiazide; moexipril hydrochloride at DailyMed

Recent Clinical Trials for hydrochlorothiazide; moexipril hydrochloride

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

Sponsor	Phase
Teva Pharmaceuticals USA	Phase 1
Paddock Laboratories, Inc.	Phase 1

See all hydrochlorothiazide; moexipril hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for hydrochlorothiazide; moexipril hydrochloride

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

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
UNIRETIC	Tablets	hydrochlorothiazide; moexipril hydrochloride	7.5mg/12.5mg, 15 mg/25 mg and 15 mg/12.5 mg	020729	1	2004-01-15

US Patents and Regulatory Information for hydrochlorothiazide; moexipril hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Heritage	MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	202150-002	Mar 7, 2014		DISCN	No	No
Chartwell Rx	MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	090096-001	Sep 25, 2008		DISCN	No	No
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-001	Jun 27, 1997		DISCN	No	No
Heritage	MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	202150-003	Mar 7, 2014		DISCN	No	No

Expired US Patents for hydrochlorothiazide; moexipril hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-001	Jun 27, 1997	4,344,949
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-001	Jun 27, 1997	4,743,450
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-002	Jun 27, 1997	4,743,450
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-002	Jun 27, 1997	4,344,949

Market Dynamics and Financial Trajectory for Hydrochlorothiazide and Moexipril Hydrochloride

Last updated: February 15, 2026

What are the current market statuses of hydrochlorothiazide and moexipril hydrochloride?

Hydrochlorothiazide (HCTZ) remains one of the most prescribed diuretics worldwide, primarily used for hypertension and edema. It accounts for an estimated 25-30% of all antihypertensive prescriptions globally, with a U.S. market size of approximately $250 million in 2022[1].

Moexipril hydrochloride, an angiotensin-converting enzyme (ACE) inhibitor, has a niche market in hypertension management but faces competition from more established ACE inhibitors like lisinopril and enalapril. Its U.S. market peaked at roughly $30 million in 2019 and has since declined by approximately 10% annually[2].

How are market trends affecting these drugs?

Hydrochlorothiazide

Market share remains solid due to generic availability and low cost. However, shifts toward combination therapies and evidence questioning its safety profile, specifically regarding risks of glucose intolerance and electrolyte imbalance, have prompted some prescribers to prefer other agents. The USFDA issued a warning in 2014 about potential increased risk of skin cancer, which may influence future prescribing patterns[3].

Moexipril Hydrochloride

Limited in market scope, moexipril's use is constrained by generic competition and newer drugs with improved side-effect profiles. An industry trend favors ACE inhibitors with once-daily dosing and fewer adverse effects, further reducing moexipril’s market share.

What are the key drivers impacting market growth and decline?

• Generic Competition: Both drugs are off-patent, leading to price erosion and intense competition from other generics.
• Clinical Evidence: Growing evidence questions hydrochlorothiazide's safety, potentially limiting its future use.
• New Therapies: The rise of fixed-dose combination pills, including with calcium channel blockers or ARBs, reduces reliance on individual agents.
• Regulatory Landscape: Warnings and post-marketing surveillance impact prescriber confidence.

How do financial dynamics compare?

Revenue Estimates

Drug	Global Market Size (2022)	CAGR (2018-2022)	Major Markets	Trends
Hydrochlorothiazide	$250 million	-1.2%	US, Europe	Decline due to safety concerns
Moexipril Hydrochloride	$30 million	-4.0%	US	Declining, limited due to competition

Cost Structures and Margins

Both drugs benefit from low manufacturing costs due to generic status but face pricing pressures. Gross margins for these products average around 50-60%, with potential declines expected as competition intensifies[4].

Impact of Patent expiries and regulatory changes

Patent expiries occurred more than a decade ago, stabilizing revenue but reducing profitability margins. Regulatory actions, including safety warnings, have few financial impacts owing to the widespread availability of generics.

What are the future prospects?

Hydrochlorothiazide's future hinges on safety profile reassessment, with some markets phasing it out as a first-line agent. Moexipril hydrochloride's prospects depend on clinician preference shifts and development of improved ACE inhibitors. Investment in novel drug formulations or combination therapies could alter their trajectories but are currently minimal.

Key factors shaping the market outlook

• Prospects depend heavily on clinical guidelines updates.
• Pricing and reimbursement policies influence uptake.
• Ongoing safety concerns may further reduce prescriber reliance.

Key Takeaways

Hydrochlorothiazide maintains a significant market presence but faces decline risks from safety and replaced by combination therapies. Moexipril hydrochloride's market remains narrowly focused, shrinking due to generic competition and preference for newer agents. Industry trends favor drugs with better safety profiles, dosing convenience, and fixed-dose combinations. Revenue growth opportunities exist primarily through formulation innovations rather than standalone use.

FAQs

Q1: Will hydrochlorothiazide remain a first-line treatment?
Answer: Its role is declining in some regions as guidelines incorporate safety signals and alternative therapies, but it remains a widely prescribed generic.

Q2: Is moexipril hydrochloride an attractive investment?
Answer: Its market is shrinking, and it faces competition from other ACE inhibitors, limiting growth prospects unless new formulations are developed.

Q3: How do safety concerns affect these drugs?
Answer: They influence prescribing behavior, especially for hydrochlorothiazide, which has safety warnings impacting its use in some patient populations.

Q4: What role do regulatory agencies play?
Answer: Agencies issue warnings and guidelines that can directly influence market size and drug stability, particularly for long-established medications.

Q5: Are there any emerging alternatives threatening these drugs?
Answer: Yes. Fixed-dose antihypertensive combinations, novel diuretics, and new classes like SGLT2 inhibitors challenge traditional use.

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References:

[1] IQVIA, "Global and US Diuretic Market Data," 2022.

[2] MedTrack, "US Prescription Trends for Moexipril," 2023.

[3] FDA Drug Safety Communication, "Hydrochlorothiazide and Skin Cancer Risk," 2014.

[4] EvaluatePharma, "Generic Drug Pricing and Margins," 2022.