INDAPAMIDE Drug Patent Profile

When do Indapamide patents expire, and when can generic versions of Indapamide launch?

Indapamide is a drug marketed by Actavis Elizabeth, Ani Pharms, Aurobindo Pharma Usa, Chartwell Rx, Rising, Teva, and Watson Labs. and is included in nine NDAs.

The generic ingredient in INDAPAMIDE is indapamide. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the indapamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Indapamide

A generic version of INDAPAMIDE was approved as indapamide by ANI PHARMS on July 27^th, 1995.

Summary for INDAPAMIDE

US Patents:	0
Applicants:	7
NDAs:	9
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	38
Patent Applications:	5,043
Drug Prices:	Drug price information for INDAPAMIDE
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
University of 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
Actavis Elizabeth	INDAPAMIDE	indapamide	TABLET;ORAL	074722-001	Jun 17, 1996	AB	RX	No	No
Watson Labs	INDAPAMIDE	indapamide	TABLET;ORAL	074585-002	Sep 26, 1996		DISCN	No	No
Ani Pharms	INDAPAMIDE	indapamide	TABLET;ORAL	074498-001	Oct 31, 1996		DISCN	No	No

Indapamide Market Dynamics, Patent Status, Competitive Landscape, and Financial Trajectory

Last updated: September 3, 2026

Indapamide is a mature, off-patent thiazide-like diuretic with limited standalone revenue potential and low generic-entry risk because generic products have been marketed for decades. Commercial value is concentrated in manufacturing efficiency, regional distribution, sustained-release formulations, fixed-dose combinations, and supply reliability rather than exclusivity. No meaningful biosimilar risk exists because indapamide is a small-molecule drug.

What is indapamide and where is it used?

Indapamide is an oral antihypertensive and diuretic used primarily to treat hypertension. It is structurally related to thiazide diuretics but is generally classified as a thiazide-like diuretic.

Attribute	Indapamide
Active ingredient	Indapamide
Drug class	Thiazide-like diuretic
Primary use	Hypertension
Common immediate-release strengths	1.25 mg and 2.5 mg
Common sustained-release strength	1.5 mg
Administration	Oral tablet
Regulatory status	Generic and legacy branded products
Biologic status	Small molecule
Biosimilar pathway	Not applicable
Main competitors	Hydrochlorothiazide, chlorthalidone, bendroflumethiazide, amlodipine and combination antihypertensives
Commercial maturity	Mature, low-growth generic market

Indapamide reduces sodium reabsorption in the distal nephron and lowers blood pressure through diuretic and vascular effects. It is used as monotherapy or in combination with other antihypertensive drugs.

The principal branded product in the United States was Lozol. The active ingredient is now supplied predominantly through generic manufacturers and regional branded-generic companies. European markets have historically included sustained-release indapamide products such as Natrilix SR and generic equivalents.

When did indapamide lose exclusivity?

Indapamide lost meaningful commercial exclusivity many years ago. The product was introduced in the 1970s and received U.S. Food and Drug Administration approval for hypertension in the early 1980s. Generic competition followed after the expiration of the original product and formulation protections.

The original commercial opportunity is therefore no longer protected by a live composition-of-matter patent. Current competition is based on abbreviated new drug applications, manufacturing scale, quality records, procurement contracts, and local regulatory registrations.

Indapamide exclusivity timeline

Period	Commercial event
1970s	Initial European commercialization of indapamide
Early 1980s	U.S. approval of legacy branded indapamide tablets
Late 1980s and 1990s	Expansion of generic and regional branded supply
2000s	Broad global availability of immediate-release generic products
2010s	Expansion of sustained-release and fixed-dose combination products
2020s	Mature commodity market with localized shortages and supplier consolidation

The exact patent and regulatory history varies by jurisdiction and dosage form. The practical conclusion is consistent across major markets: original indapamide exclusivity is expired, and a new entrant does not need to wait for a meaningful originator patent barrier.

What patents protect indapamide products?

No active composition-of-matter patent is generally considered to protect conventional indapamide tablets in the major generic markets. The original compound and legacy immediate-release products are long past ordinary patent terms.

Potentially relevant intellectual property can instead involve:

• Sustained-release tablet matrices
• Particle-size control
• Granulation and coating processes
• Combination products
• Manufacturing processes
• Packaging and stability systems
• Country-specific formulation claims

These rights have limited commercial impact unless they cover a differentiated product with regulatory approval and meaningful prescribing or procurement demand.

Formulation patents and sustained-release products

The most commercially relevant product differentiation is the 1.5 mg sustained-release formulation used in several European and international markets. Sustained-release products can reduce dosing frequency and may provide a marketing distinction against 1.25 mg or 2.5 mg immediate-release tablets.

A formulation patent would need to be assessed claim by claim. A release-profile claim alone may have limited value if competing manufacturers can use a different excipient system or manufacturing process. The practical strength of such rights depends on:

1. Whether the patent remains unexpired in the target country.
2. Whether the product is listed in the relevant regulatory database.
3. Whether the claims cover the marketed dosage form.
4. Whether a generic can design around the release mechanism.
5. Whether the product has enough sales to justify litigation.

For indapamide, formulation protection is more likely to influence individual products than the overall market.

What is the Orange Book status of indapamide?

The U.S. Orange Book historically listed the branded Lozol product and may list approved generic indapamide products depending on current marketing status. Legacy Orange Book listings do not create continuing exclusivity after listed patents and regulatory exclusivities expire.

The key U.S. regulatory facts are:

• Indapamide is approved as an oral tablet for hypertension.
• Generic versions may rely on an abbreviated new drug application.
• Generic products must demonstrate pharmaceutical equivalence and bioequivalence.
• No current reference-product exclusivity is expected to block ordinary generic competition.
• Orange Book relevance is limited primarily to product identification, reference-product status, and any remaining listed patents.

A definitive current Orange Book assessment requires a live review of FDA listings because product marketing status, discontinued products, and patent records can change. The commercial conclusion remains that indapamide is a mature generic product with no meaningful market-wide Orange Book barrier.

Are there Paragraph IV challenges for indapamide?

Paragraph IV litigation is unlikely to be a significant current market issue for conventional indapamide. Paragraph IV certifications are most relevant when a generic applicant seeks approval before expiration of a listed patent. Indapamide’s primary patents and original formulation protections expired long ago.

Possible Paragraph IV activity could arise for:

• A newly developed sustained-release product
• A branded fixed-dose combination
• A reformulated dosage form
• A narrow manufacturing patent
• A new indication supported by separate regulatory exclusivity

Those scenarios would affect a specific product rather than the established indapamide market. The absence of meaningful current patent barriers reduces both litigation risk and the value of defensive patent portfolios.

What generic entry risks exist for indapamide?

Generic entry risk is already realized rather than prospective. The market has multiple suppliers in many jurisdictions, and new entrants can generally compete without challenging a commercially important composition patent.

Generic competition factors

Factor	Impact on indapamide
Patent barrier	Low
Regulatory complexity	Low to moderate
Manufacturing complexity	Low for immediate-release tablets
Sustained-release complexity	Moderate
Switching costs	Low
Physician brand loyalty	Limited
Tender dependence	High in public markets
Price erosion	Persistent
Shortage exposure	Material where supplier concentration is high

Immediate-release tablets are relatively straightforward to manufacture. Sustained-release tablets require tighter control of dissolution, content uniformity, and release specifications, but they remain conventional oral solid dosage forms.

The most significant competitive risk is price compression. Suppliers with low-cost active pharmaceutical ingredient sourcing, high-volume tableting capacity, and established regulatory dossiers can compete aggressively in tenders and pharmacy channels.

How strong is the indapamide patent estate?

The overall patent estate is weak from an exclusivity perspective and moderate only for selected product-level formulations.

Patent category	Strategic strength
Original compound patent	Expired
Original immediate-release formulation	Expired or commercially immaterial
Sustained-release formulation	Potentially relevant by jurisdiction and claim scope
Fixed-dose combination	Product-specific
Manufacturing process	Usually narrow and design-around risk is high
New method of use	Limited value without regulatory exclusivity
Data exclusivity	Generally expired for legacy products
Biosimilar protection	Not applicable

A new patent filing on a conventional indapamide tablet would face patentability risks, including obviousness and lack of novelty. A stronger position would require a clinically meaningful release profile, a technically difficult manufacturing process, or a combination product with unexpected therapeutic performance.

What method-of-use patents cover indapamide?

Indapamide’s core use in hypertension is established and widely disclosed. Broad method-of-use claims for treating ordinary hypertension would have limited patentability and commercial value.

Potential method-of-use opportunities could involve:

• A defined patient subgroup
• A specific renal or cardiovascular risk population
• A dosing regimen supported by clinical evidence
• Combination treatment with a specified antihypertensive
• A formulation linked to an improved safety or adherence profile

These claims would be difficult to enforce across a mature generic market unless the indication had clear regulatory recognition and the product generated substantial incremental revenue.

How does indapamide compare with hydrochlorothiazide and chlorthalidone?

Indapamide competes primarily with other low-cost diuretics and with first-line antihypertensive agents.

Product	Class	Typical commercial position	Competitive issue
Indapamide	Thiazide-like diuretic	Generic, regional strength in Europe and selected markets	Limited differentiation
Hydrochlorothiazide	Thiazide diuretic	Very broad generic use	Lower-cost default option
Chlorthalidone	Thiazide-like diuretic	Strong clinical interest in some guidelines	Longer duration and electrolyte monitoring
Amlodipine	Calcium-channel blocker	Large generic market	Broad use and simple dosing
Perindopril/indapamide	Fixed-dose combination	Branded-generic opportunity	Combination-product competition

Indapamide can compete on duration of action, blood-pressure control, and combination use. It does not generally command a substantial premium over other generic diuretics. In many markets, treatment choice is influenced more by guidelines, physician familiarity, tender pricing, and availability than by patent-protected differentiation.

What are the main indapamide licensing and partnering opportunities?

Licensing opportunities are limited for the legacy active ingredient. Commercial transactions are more likely to involve:

• Regional marketing rights
• Generic product registrations
• Contract manufacturing
• Sustained-release formulations
• Fixed-dose combinations
• Supply agreements for public tenders
• Portfolio acquisitions involving several cardiovascular generics

A transaction focused only on standard immediate-release indapamide would typically have modest strategic value. A broader cardiovascular portfolio can improve economics by sharing sales infrastructure, regulatory staff, wholesalers, and tender participation.

The most valuable assets are likely to be:

1. Approved dossiers in multiple jurisdictions.
2. Reliable API supply.
3. Sustained-release manufacturing capability.
4. Combination-product approvals.
5. Established hospital and pharmacy distribution.
6. A history of uninterrupted supply.

What is the financial trajectory for indapamide?

Indapamide has a low-growth or declining standalone financial profile in mature markets. Revenue is pressured by generic price erosion, therapeutic substitution, and tender competition. Unit demand may remain stable because hypertension is chronic and prevalent, but stable volume does not translate into stable revenue.

Revenue drivers

The financial trajectory depends on:

• Prescription volume
• Country mix
• Immediate-release versus sustained-release product share
• Generic price levels
• Public-tender exposure
• Manufacturing costs
• API pricing
• Product shortages
• Fixed-dose combination penetration
• Regulatory maintenance costs

Financial variable	Expected direction in mature markets
Prescription volume	Stable to modest growth
Net price	Downward pressure
Gross margin	Stable for efficient suppliers; compressed for small suppliers
Standalone revenue	Flat to declining
Combination-product revenue	More resilient
R&D spending	Minimal
Litigation spending	Low
Manufacturing value	Increasingly important
Portfolio value	Higher than standalone product value

Public company filings often do not report indapamide revenue separately. It is commonly included within broader cardiovascular, generic, or prescription-product categories. As a result, a precise global indapamide market size or company-level revenue forecast should not be inferred from aggregate hypertension-drug figures.

Revenue exposure by business model

Business model	Indapamide exposure
Originator brand	Minimal or discontinued in many markets
Large generic company	Low individual-product contribution, useful portfolio volume
Regional branded generic company	Potentially meaningful in selected countries
Contract manufacturer	Volume-driven, low pricing power
API supplier	Sensitive to scale and supply contracts
Combination-product owner	Higher margin potential
Tender-focused distributor	High volume, low margin

The financial upside is more credible from portfolio integration than from standalone price expansion. A supplier can improve returns through manufacturing scale, reduced batch costs, multi-country registrations, and combination-product sales.

What regulatory risks affect indapamide?

The regulatory burden is established but not negligible. Key risks include:

• Dissolution failures for sustained-release tablets
• Stability problems in hot or humid climates
• Impurity and elemental impurity controls
• Manufacturing-site inspection findings
• Bioequivalence requirements for modified-release products
• Labeling differences across countries
• Supply interruptions caused by API or packaging shortages
• Pharmacovigilance obligations for electrolyte abnormalities

Indapamide can cause hyponatremia, hypokalemia, dehydration, hypotension, and renal-function changes. Labeling and post-market monitoring remain important even though the molecule is old.

What patent litigation affects indapamide?

No major market-wide patent litigation is expected to constrain conventional indapamide tablets. Litigation exposure is more likely to arise from:

• A sustained-release formulation
• A fixed-dose combination
• A newly branded product
• A manufacturing process
• A license or supply dispute
• Regulatory exclusivity surrounding an incremental reformulation

The low litigation profile reduces launch risk for generic manufacturers. It also limits the defensive value of acquiring legacy patent assets without accompanying regulatory approvals or commercial distribution.

What generic launch scenarios are most likely?

Immediate-release generic launch

This is the lowest-risk scenario. A manufacturer with an approved dossier can compete on price, supply reliability, and wholesaler access. The likely outcome is further price erosion unless the market has few active suppliers.

Sustained-release generic launch

This requires more formulation and bioequivalence capability. The product can obtain better pricing than a standard immediate-release tablet if physicians or procurement agencies value once-daily dosing and established clinical use.

Fixed-dose combination launch

Combination products can create stronger commercial differentiation, especially when paired with an ACE inhibitor or another antihypertensive. The opportunity is still exposed to generic substitution and country-specific registration requirements.

Supply-constrained launch

A new supplier can gain share quickly during a shortage. This advantage may be temporary because additional manufacturers can enter once the pricing opportunity becomes visible.

What geographic markets are most attractive for indapamide?

Indapamide has historically had stronger recognition in Europe and selected international markets than in the United States, where hydrochlorothiazide and chlorthalidone are deeply established.

Geographic considerations

Region	Market characteristics
United States	Mature generic market; limited differentiation; strong competition from hydrochlorothiazide and chlorthalidone
Western Europe	Established use of immediate-release and sustained-release products; tender and reimbursement pressure
Central and Eastern Europe	Branded-generics opportunity; price sensitivity and local registration requirements
Asia-Pacific	Large hypertension population; fragmented generic supply; local manufacturing advantage
Latin America	Regional brand recognition and distributor access matter
Middle East and Africa	Procurement, registration, and supply reliability are critical

The best commercial opportunities are usually country-specific. A company with a strong local sales force, tender access, or an existing cardiovascular portfolio can extract more value than a company entering with an isolated product.

Key Takeaways

• Indapamide is a mature, off-patent small-molecule antihypertensive.
• Original composition and conventional tablet exclusivity have expired.
• Paragraph IV litigation and market-wide patent barriers are low-risk issues.
• Sustained-release and fixed-dose combination products offer the main remaining differentiation.
• Biosimilar risk does not apply.
• Revenue is likely stable to declining on a standalone basis because generic price erosion offsets durable hypertension demand.
• Manufacturing scale, API supply, tender access, and portfolio integration determine profitability.
• Geographic value is strongest where indapamide has established physician familiarity or branded-generic demand.
• Patent strength is weak for the molecule and moderate only for selected formulation or combination products.
• A new entrant’s main risk is commercial commoditization, not patent infringement.

FAQs

Is indapamide still under patent in the United States?

Conventional indapamide tablets are not generally protected by an active composition-of-matter patent in the United States. Any relevant rights would likely concern a specific formulation, combination, or manufacturing process.

Can a generic manufacturer launch indapamide without a Paragraph IV challenge?

Yes. Because the core product is long off patent, a generic applicant can generally rely on an abbreviated approval pathway without challenging a commercially important active patent.

Is indapamide more profitable than hydrochlorothiazide?

Usually not on a standalone basis. Hydrochlorothiazide has greater volume, while indapamide may offer better portfolio value in countries with established branded-generic or sustained-release demand.

Does indapamide have a biosimilar market?

No. Indapamide is a chemically synthesized small molecule. Competition occurs through generic-drug pathways, not biosimilar development.

What is the strongest commercial opportunity in indapamide?

The strongest opportunities are sustained-release formulations, fixed-dose combinations, regional branded-generics, and reliable supply in markets where incumbent manufacturers face shortages or limited competition.

References

1. DailyMed. (n.d.). Indapamide tablet prescribing information. U.S. National Library of Medicine.

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. FDA.

3. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. FDA.

4. National Institute for Health and Care Excellence. (2019). Hypertension in adults: Diagnosis and management. NICE guideline NG136.

5. Williams, B., Mancia, G., Spiering, W., et al. (2018). 2018 ESC/ESH guidelines for the management of arterial hypertension. European Heart Journal, 39(33), 3021-3104.

6. World Health Organization. (2021). WHO guideline for the pharmacological treatment of hypertension in adults. World Health Organization.