INDAPAMIDE - Generic Drug Details

What are the generic sources for indapamide and what is the scope of freedom to operate?

Indapamide is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Ani Pharms, Aurobindo Pharma Usa, Chartwell Rx, Rising, Teva, Watson Labs, and Sanofi Aventis Us, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for indapamide. Eight suppliers are listed for this compound.

Summary for INDAPAMIDE

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	10
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	38
Patent Applications:	6,933
Drug Prices:	Drug price trends for INDAPAMIDE
What excipients (inactive ingredients) are in INDAPAMIDE?	INDAPAMIDE excipients list
DailyMed Link:	INDAPAMIDE at DailyMed

See drug prices for INDAPAMIDE

Recent Clinical Trials for INDAPAMIDE

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

Sponsor	Phase
Lars Rejnmark	PHASE4
Shin Poong Pharmaceutical Co. Ltd.	PHASE2
Insel Gruppe AG, University Hospital Bern	Phase 2

See all INDAPAMIDE clinical trials

Pharmacology for INDAPAMIDE

Drug Class	Thiazide-like Diuretic
Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for INDAPAMIDE

Antihypertensive Agents

Diuretics

Sodium Chloride Symporter Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for INDAPAMIDE

C03BA	Sulfonamides, plain
C03B	LOW-CEILING DIURETICS, EXCL. THIAZIDES
C03	DIURETICS
C	Cardiovascular system

US Patents and Regulatory Information for INDAPAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	INDAPAMIDE	indapamide	TABLET;ORAL	075201-001	Dec 4, 1998		DISCN	No	No
Watson Labs	INDAPAMIDE	indapamide	TABLET;ORAL	074585-001	Sep 26, 1996		DISCN	No	No
Rising	INDAPAMIDE	indapamide	TABLET;ORAL	074461-001	Mar 27, 1996	AB	RX	No	No
Sanofi Aventis Us	LOZOL	indapamide	TABLET;ORAL	018538-002	Apr 29, 1993		DISCN	Yes	No

Expired US Patents for INDAPAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	LOZOL	indapamide	TABLET;ORAL	018538-001	Jul 6, 1983	3,565,911

Market Dynamics and Financial Trajectory for Indapamide

Last updated: February 14, 2026

Overview

Indapamide, a thiazide-like diuretic primarily prescribed for hypertension and edema, has maintained a steady position in the global pharmaceutical market. Its distinct pharmacological profile, coupled with patent expirations and competitive generics, influences market dynamics and revenue streams.

Market Size and Growth Trends

The global diuretic market, including indapamide, was valued at approximately $4.2 billion in 2021. Compound annual growth rate (CAGR) estimates project around 3.5% from 2022 to 2028, driven by rising hypertension prevalence and cardiovascular disease awareness. Indapamide accounts for an estimated 15-20% share within this segment.

Key Drivers

• Epidemiological Factors: Increasing cases of hypertension, especially in aging populations in North America, Europe, and Asia, sustain demand.
• Clinical Adoption: Indapamide’s favorable profile—lower risk of metabolic disturbances compared to other diuretics—supports prescription rates.
• Patent Status and Generics: Original patents expired in major markets between 2010-2015, encouraging formulations by multiple generic manufacturers. The influx of generics has reduced prices but increased volume sales.

Market Challenges

• Pricing Pressure: Widespread generic competition has driven prices down by an estimated 30-50% over the past decade.
• Regulatory Variability: Different approval and manufacturing requirements across jurisdictions impact market entry and product availability.
• Therapeutic Competition: Other antihypertensive agents, including ACE inhibitors and calcium channel blockers, compete for similar patient populations.

Revenue Trends

Major pharmaceutical companies generating revenue from indapamide include Servier, Sandoz, Teva, and Mylan. The following data reflects revenue trajectories:

Company	Revenue (2021)	Revenue Change (2020-2021)	Notes
Servier	~$120 million	+2%	Original manufacturer, maintains significant share
Sandoz / Novartis	~$90 million	+1.5%	Leading generic provider
Teva	~$70 million	-3%	Market decline due to strategic shifts
Mylan / Viatris	~$50 million	+0.5%	Steady sales, focused on generics

Forecasts and Financial Outlook

Projections suggest stabilized revenues for indapamide over the next 5 years as generic competition exacerbates but consumption remains high. The market is expected to grow modestly at 2-3% CAGR, with revenues potentially reaching $1.2 billion globally by 2028, considering current market dynamics.

Pricing and Market Penetration

Average wholesale prices (AWP) for indapamide have declined by approximately 5% annually since 2015. Price stabilization is predicted as the market matures, with some markets seeing minimal further decreases due to established generics and price controls.

Regulatory and Patents

Patents protecting original formulations typically expired between 2010-2015 in key markets, including the US and EU. Current market landscape largely composed of generics, with some formulations still under proprietary protection in emerging markets.

Competitive Landscape

Segment	Major Players	Market Share (Estimated)	Strategy
Brand (Original)	Servier	60%	Focus on product differentiation
Generics	Sandoz, Teva, Mylan, others	40%	Price competition, expanding access

Key Takeaways

• Indapamide’s market is driven by ongoing hypertension treatment needs.
• Patent expirations have shifted revenue from branded to generic manufacturers.
• Revenue growth is modest, with significant price erosion but sustained volume sales.
• Competition from other antihypertensive drugs limits market expansion.
• Regulatory and pricing environments vary globally, impacting profitability.

FAQs

1. What factors influence indapamide's market longevity?
Patent expirations, ongoing demand for antihypertensive therapies, and the availability of generics sustain its market presence. Competition from newer drug classes constrains growth.

2. How does patent status affect revenue?
Patents provide exclusivity, allowing higher prices. Once expired, generics enter, reducing prices by up to 50% but increasing volume sales.

3. Which regions dominate indapamide sales?
Europe and North America comprise the largest markets. Emerging markets in Asia and Latin America also contribute significantly due to growing hypertension prevalence.

4. How does pricing pressure impact profitability?
Widespread generic competition has driven prices down, affecting profit margins but offset by high sales volumes.

5. What are emerging opportunities for indapamide?
Developments in combination therapies, formulations for resistant hypertension, and markets with limited drug access may provide growth avenues.

Sources

1. GlobalData Pharma Intelligence, 2022.
2. IMS Health, 2022.
3. MarketWatch, “Diuretics Market Size, Share & Trends,” 2021.
4. European Medicines Agency, 2015.
5. US Patent Office, 2015.