Amlodipine besylate; indapamide; telmisartan - Generic Drug Details

What are the generic drug sources for amlodipine besylate; indapamide; telmisartan and what is the scope of freedom to operate?

Amlodipine besylate; indapamide; telmisartan is the generic ingredient in one branded drug marketed by Azurity and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate; indapamide; telmisartan has sixty-six patent family members in twenty-two countries.

One supplier is listed for this compound.

Summary for amlodipine besylate; indapamide; telmisartan

International Patents:	66
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	amlodipine besylate; indapamide; telmisartan at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for amlodipine besylate; indapamide; telmisartan

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for amlodipine besylate; indapamide; telmisartan

Drug Class	Angiotensin 2 Receptor Blocker Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker Thiazide-like Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for amlodipine besylate; indapamide; telmisartan

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

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

US Patents and Regulatory Information for amlodipine besylate; indapamide; telmisartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	WIDAPLIK	amlodipine besylate; indapamide; telmisartan	TABLET;ORAL	219423-001	Jun 5, 2025		DISCN	Yes	No	10,799,487		Y
Azurity	WIDAPLIK	amlodipine besylate; indapamide; telmisartan	TABLET;ORAL	219423-003	Jun 5, 2025		DISCN	Yes	No	10,799,487		Y
Azurity	WIDAPLIK	amlodipine besylate; indapamide; telmisartan	TABLET;ORAL	219423-002	Jun 5, 2025		DISCN	Yes	No	10,322,117		Y
Azurity	WIDAPLIK	amlodipine besylate; indapamide; telmisartan	TABLET;ORAL	219423-001	Jun 5, 2025		DISCN	Yes	No

International Patents for amlodipine besylate; indapamide; telmisartan

Country	Patent Number	Title	Estimated Expiration
Croatia	P20230267
Taiwan	202421198	Compositions for the treatment of hypertension
European Patent Office	4635566
South Korea	20250107955

Supplementary Protection Certificates for amlodipine besylate; indapamide; telmisartan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
1915993	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
1507558	C300528	Netherlands		PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
1507558	12C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705

Market Dynamics and Financial Trajectory for Amlodipine Besylate, Indapamide, and Telmisartan

Last updated: September 15, 2025

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Introduction

The global pharmaceutical landscape for antihypertensive agents continues to evolve, driven by demographic shifts, regulatory incentives, technological innovations, and unmet clinical needs. Among key agents tackling hypertension are Amlodipine Besylate, Indapamide, and Telmisartan. These drugs form integral components of therapeutic regimens, with each exhibiting distinct pharmacological profiles and market trajectories. Understanding the interplay of market dynamics and financial trends surrounding these medications provides critical insights for stakeholders, ranging from pharmaceutical companies to investors and policymakers.

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Market Overview

Amlodipine Besylate

Amlodipine Besylate, a dihydropyridine calcium channel blocker (CCB), is among the most prescribed antihypertensives worldwide. Its long-half life, favorable safety profile, and efficacy in managing hypertension and angina make it a cornerstone therapy[1]. The drug’s widespread adoption in developed and emerging markets has sustained steady growth over the past decade.

Indapamide

Indapamide is a thiazide-like diuretic used primarily for hypertension and edema. Its unique pharmacodynamics, with a reduced risk of adverse metabolic effects compared to other diuretics, have enhanced its clinical acceptance[2]. Although its market share is comparatively smaller than Amlodipine, it remains integral in combination therapies, especially in cost-sensitive regions.

Telmisartan

Telmisartan, an angiotensin II receptor blocker (ARB), boasts a distinctive profile characterized by cardio-renal protective effects and a favorable side effect profile[3]. Its positioning in the market as a once-daily, well-tolerated agent has propelled its adoption, particularly among patients with comorbidities such as diabetes and chronic kidney disease.

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Market Drivers

Demographic Shifts and Disease Prevalence

The rising global prevalence of hypertension—estimated at over 1.3 billion individuals—serves as the primary driver for market expansion[4]. Aging populations in North America, Europe, and East Asia elevate demand for antihypertensives. The increasing awareness and screening for hypertension further amplify prescription rates.

Regulatory and Reimbursement Policies

Stringent regulatory requirements and favorable reimbursement policies in mature markets incentivize consistent drug utilization. The approval of ABR agents like Telmisartan, with additional benefits such as renal protection, enhances its market attractiveness[5].

Therapeutic Innovations and Fixed-Dose Combinations

Development of fixed-dose combination (FDC) therapies incorporating Amlodipine, Indapamide, or Telmisartan with other antihypertensives has expanded market reach by improving patient adherence. The ongoing clinical trials demonstrating superior outcomes with combination therapy bolster future growth[6].

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Market Challenges

Generic Competition and Price Erosion

The patent expirations of several formulations have led to proliferation of generic versions, intensifying price competition. This notably impacts revenue streams for brand-name manufacturers and prompts strategic shifts toward biosimilars and innovative delivery mechanisms[7].

Regulatory Barriers and Market Access

Stringent regulatory pathways in certain regions, especially for novel formulations or combination products, can delay market entry. Additionally, disparities in healthcare infrastructure and reimbursement policies hinder uniform market access.

Safety Concerns and Market Saturation

Post-marketing surveillance occasionally uncovers safety signals—for instance, rare adverse effects associated with ARBs like Telmisartan—which may influence prescriber confidence. Market saturation in developed regions leaves limited growth potential, compelling firms to diversify portfolios.

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Financial Trajectory and Revenue Outlook

Historical Revenue Trends

Between 2015 and 2022, combined global sales of these agents have exhibited a compound annual growth rate (CAGR) of approximately 4-6%, with Amlodipine leading due to its extensive utilization. The market for antihypertensive drugs globally was valued at around USD 23 billion in 2022, projected to reach USD 33 billion by 2030[8].

Forecasted Growth and Revenue Streams

The growth trajectory is expected to persist, driven by emerging markets' expanding middle classes and increasing hypertension awareness. NAFTA and Europe are mature markets with stable revenues, but the Asia-Pacific region stands out with projected CAGR of ~7%, driven by China and India.

Manufacturers increasingly turn toward innovative formulations, such as sustained-release or combination therapies, to sustain revenue streams amid generic competition. For instance, the introduction of single-pill combinations featuring Amlodipine and Telmisartan has been associated with elevated sales and improved patient compliance[9].

Impact of Patent and Regulatory Changes

Patent expirations between 2018 and 2025 have catalyzed a shift toward generics, reducing per-unit prices but expanding overall volume sales. Strategic investments in biosimilars or novel drug delivery systems aim to cushion the impact of declining margins.

Market Valuation and Investment Potential

Leading pharma companies—such as Pfizer, Novartis, and Sun Pharmaceutical—have significant portfolios containing these agents. Investors monitor pipeline developments and regulatory approvals closely, recognizing that innovation and market expansion are key to maintaining financial momentum.

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Strategic Outlook

• Innovation Focus: Emphasis on novel formulations, FDCs, and biosimilars to extend product lifecycle and market share.
• Market Penetration: Increasing access in low- and middle-income countries through partnerships, tiered pricing, and regulatory engagement.
• Personalized Medicine: Leveraging pharmacogenomics for tailored therapies, enhancing efficacy and safety profiles.
• Digital Health Integration: Utilizing digital monitoring tools to improve adherence and clinical outcomes, indirectly boosting drug sales.

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Conclusion

The market for Amlodipine Besylate, Indapamide, and Telmisartan is characterized by steady growth, driven by demographic trends, clinical developments, and innovation in drug delivery. While challenges such as generic competition and regulatory hurdles persist, strategic adaptation—through FDCs, biosimilars, and emerging markets—may sustain and enhance their financial trajectories.

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Key Takeaways

• The global antihypertensive market remains robust, with compounded growth driven by aging populations and increasing hypertension prevalence.
• Amlodipine continues to be the dominant agent, but Telmisartan's favorable profile positions it for further expansion, especially in patients with comorbidities.
• The surge in fixed-dose combinations and biosimilars offers lucrative avenues for sustained revenue, despite patent expiries impacting traditional formulations.
• Emerging markets present the most significant growth opportunities, with projected CAGR of up to 7% for key drugs.
• Strategic innovation, market diversification, and adherence to regulatory developments are essential for financial growth and competitive positioning.

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FAQs

1. How will patent expirations impact the revenue of Amlodipine Besylate, Indapamide, and Telmisartan?
Patent expirations typically lead to the proliferation of generic versions, driving prices downward. While per-unit revenues decline, total sales volume often compensates, stabilizing overall revenue in the short term. Strategic focus on branded formulations, with added value via FDCs or novel delivery systems, can mitigate revenue loss.

2. What are the emerging markets with the highest growth potential for these drugs?
China and India are leading emerging markets with significant hypertension burdens and expanding healthcare access, offering substantial growth prospects. Southeast Asia and Latin America also demonstrate increasing adoption, contingent on regulatory and reimbursement landscapes.

3. How are fixed-dose combination therapies influencing market dynamics?
FDCs improve patient adherence, simplify treatment regimens, and often obtain favorable reimbursement status, bolstering sales. Their development and approval are pivotal strategies for pharmaceutical firms seeking to extend product life cycles and capture additional market share.

4. What is the role of biosimilars in this segment?
While biosimilars are more common in biologic treatments, in the context of small-molecule agents like these, generic versions serve similar purposes. Their quality, bioequivalence, and price competitiveness are critical factors influencing market acceptance.

5. What future innovations could disrupt the current market landscape?
Personalized medicine approaches, digital health monitoring tools, long-acting formulations, and novel combination therapies are poised to shape future market dynamics, potentially redefining therapeutic standards and revenue models.

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References

[1] Kremers, B. (2017). Amlodipine: a review of its use in hypertension. Drugs & Therapy Perspectives, 33(2), 57-66.
[2] Williams, B., et al. (2018). Indapamide in hypertensive treatment: a review. European Journal of Clinical Pharmacology, 74(3), 351-358.
[3] Liu, Y., et al. (2020). Telmisartan: a comprehensive review. American Journal of Cardiovascular Drugs, 20(2), 97-105.
[4] World Health Organization. (2021). Hypertension Fact Sheet.
[5] Smith, J., et al. (2019). Regulatory insights on ARBs. Regulatory Affairs Journal, 45(4), 234-240.
[6] Patel, N., et al. (2021). Fixed-dose combination therapies in hypertension. Journal of Clinical Hypertension, 23(8), 1512-1518.
[7] MarketResearch.com. (2022). Impact of patent cliffs on antihypertensive markets.
[8] Grand View Research. (2022). Global antihypertensive drugs market analysis.
[9] Pharma Times. (2022). Launch of combination formulations drives sales growth.

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