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. Seven 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:	7
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	32
Patent Applications:	6,546
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
Insel Gruppe AG, University Hospital Bern	Phase 2
University of Bern	Phase 2
All India Institute of Medical Sciences, New Delhi	Phase 4

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
Teva	INDAPAMIDE	indapamide	TABLET;ORAL	074665-001	Apr 4, 1997		DISCN	No	No
Rising	INDAPAMIDE	indapamide	TABLET;ORAL	074461-001	Mar 27, 1996	AB	RX	No	No
Ani Pharms	INDAPAMIDE	indapamide	TABLET;ORAL	074498-002	Feb 12, 1998		DISCN	No	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

INDAPAMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Indapamide

Introduction to Indapamide

Indapamide is a thiazide-like diuretic, commonly known by the brand name Lozol, used primarily to treat high blood pressure (hypertension) and salt and fluid retention (edema) caused by congestive heart failure. It works by reducing the amount of water in the body, thereby increasing urine flow and helping to lower blood pressure[2].

Market Drivers

The global indapamide market is driven by several key factors:

Increasing Prevalence of Hypertension

High blood pressure affects a significant portion of the adult population worldwide. According to the American Heart Association, approximately 103 million US adults suffered from high blood pressure in 2018, which is nearly half of all adults in the US. This widespread prevalence of hypertension is a major driver for the indapamide market[1].

Growing Incidence of Heart Failure

The rising incidence of congestive heart failure, which often requires the use of diuretics like indapamide, further contributes to the market's growth. Indapamide's effectiveness in managing fluid retention and reducing blood pressure makes it a crucial medication in this context[1][2].

Aging Population and Lifestyle Factors

An aging global population and lifestyle factors such as poor diet, lack of physical activity, and increasing obesity rates also contribute to the higher demand for antihypertensive medications like indapamide[4].

Market Segmentation

The global indapamide market is segmented based on several criteria:

By Product

The market is bifurcated into 1.25 mg and 2.5 mg indapamide. The 1.25 mg dosage holds a significant market share due to its extensive application in treating hypertension[1].

By Application

The market is segmented into high blood pressure, heart failure, and other applications. The high blood pressure segment dominates the market, driven by the high prevalence of hypertension globally[1].

By Geography

The market is analyzed across four major regions: North America, Europe, Asia-Pacific, and the Rest of the World. Each region has its own set of key countries, such as the US and Canada in North America, and China, Japan, and India in Asia-Pacific[1][4].

Financial Trajectory

Market Size and Growth Rate

The global indapamide market is estimated to grow at a compound annual growth rate (CAGR) of over 2.0% during the forecast period. This growth is attributed to the increasing demand for antihypertensive medications and the expanding patient population suffering from hypertension and heart failure[1][4].

Regional Market Performance

• North America: This region is a significant market for indapamide, driven by the high prevalence of hypertension in the US and Canada.
• Europe: Countries like the UK, Germany, Italy, Spain, and France contribute substantially to the European market.
• Asia-Pacific: This region is expected to show robust growth due to the large patient population and increasing healthcare expenditure in countries like China, Japan, and India[1][4].

Key Players and Competitive Landscape

The global indapamide market is competitive, with several key players:

Major Companies

• ANI Pharmaceuticals, Inc.
• Apotex Inc.
• Krka Group
• Glenmark Pharmaceuticals Ltd
• Les Laboratoires Servier, SAS
• Sandoz International GmbH (A Novartis Division)
• Taj Pharmaceuticals Ltd.
• Torrent Pharmaceuticals Ltd.
• Teva Pharmaceutical Industries Ltd.[1]

Strategic Moves

Companies are adopting various growth strategies such as acquisitions and expansions to increase their market share. For example, ANI Pharmaceuticals, Inc. acquired the US portfolio of 23 generic products from Amrigen Pharmaceuticals Ltd in January 2020[1].

Challenges and Opportunities

Side Effects and Safety Concerns

Indapamide, like other diuretics, can cause side effects such as electrolyte imbalances, dizziness, and changes in blood sugar levels. These safety concerns can impact patient compliance and market growth[2].

Regulatory Environment

Approvals from regulatory bodies like the FDA play a crucial role in the market's growth. Liberal policies and approvals can boost the confidence of manufacturers and patients, thereby driving market expansion[3].

Emerging Markets

The Asia-Pacific region, particularly countries like China and India, presents significant opportunities for growth due to their large and growing patient populations and increasing healthcare spending[1][4].

Technological and Research Trends

Generic and Biosimilar Market

The availability of generic versions of indapamide has increased competition in the market. However, this also presents opportunities for cost-effective treatments, which can drive market growth in price-sensitive regions[1].

Combination Therapies

Research into combination therapies involving indapamide and other antihypertensive medications is ongoing. These combinations can offer better blood pressure control and may expand the market for indapamide[2].

Key Takeaways

• The global indapamide market is driven by the increasing prevalence of hypertension and heart failure.
• The market is segmented by product dosage (1.25 mg and 2.5 mg) and application (high blood pressure, heart failure, and others).
• Key players are adopting various strategies to expand their market share.
• Regulatory approvals and safety profiles are critical factors influencing market growth.
• Emerging markets, particularly in the Asia-Pacific region, offer significant growth opportunities.

FAQs

Q: What is indapamide used for? Indapamide is used to treat high blood pressure (hypertension) and salt and fluid retention (edema) caused by congestive heart failure[2].

Q: What are the common side effects of indapamide? Common side effects include electrolyte imbalances, dizziness, drowsiness, dry mouth, and changes in blood sugar levels[2].

Q: Which regions are key markets for indapamide? North America, Europe, and the Asia-Pacific region are significant markets for indapamide, with the US, Canada, UK, Germany, China, Japan, and India being key countries[1][4].

Q: Who are the major players in the indapamide market? Major players include ANI Pharmaceuticals, Inc., Apotex Inc., Krka Group, Glenmark Pharmaceuticals Ltd, and others[1].

Q: What is the expected growth rate of the global indapamide market? The global indapamide market is expected to grow at a CAGR of over 2.0% during the forecast period[1].

Cited Sources

1. OMR Global: Indapamide Market Size, Share | Global Trends, Analysis and Forecast.
2. Mayo Clinic: Indapamide (oral route) - Mayo Clinic.
3. GlobeNewswire: Global Prils Market is estimated to be US$ 3496.8 million by 2030.
4. Cognitive Market Research: Global Indapamide Market Report 2024 Edition.