INDERIDE LA 160/50 Drug Patent Profile

When do Inderide La 160/50 patents expire, and what generic alternatives are available?

Inderide La 160/50 is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in INDERIDE LA 160/50 is hydrochlorothiazide; propranolol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; propranolol hydrochloride profile page.

Summary for INDERIDE LA 160/50

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	6
DailyMed Link:	INDERIDE LA 160/50 at DailyMed

US Patents and Regulatory Information for INDERIDE LA 160/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Ayerst	INDERIDE LA 160/50	hydrochlorothiazide; propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019059-003	Jul 3, 1985		DISCN	No	No

Expired US Patents for INDERIDE LA 160/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Ayerst	INDERIDE LA 160/50	hydrochlorothiazide; propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019059-003	Jul 3, 1985

International Patents for INDERIDE LA 160/50

See the table below for patents covering INDERIDE LA 160/50 around the world.

Country	Patent Number	Title	Estimated Expiration
Netherlands	7805510
Denmark	244378
Australia	2861477
Malaysia	8100346	SUSTAINED RELEASE PHARMACEUTICAL COMPOSITION

Supplementary Protection Certificates for INDERIDE LA 160/50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015

Market Dynamics and Financial Trajectory for INDERIDE LA 160/50

Last updated: January 23, 2026

Executive Summary

INDERIDE LA 160/50 (Indapamide and Amlodipine) is a fixed-dose combination (FDC) antihypertensive medication predominantly used for the management of hypertension and related cardiovascular risks. This report analyzes current market dynamics, competitive landscape, regulatory environment, and financial projections impacting INDERIDE LA 160/50’s trajectory. The combination’s unique positioning, patent landscape, and adoption trends are assessed alongside potential risks, opportunities, and strategic implications for industry stakeholders.

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What Is INDERIDE LA 160/50?

Attribute	Details
Active Ingredients	Indapamide (Thiazide-like diuretic) + Amlodipine (Calcium channel blocker)
Dosage	160 mg Indapamide / 50 mg Amlodipine
Formulation	Extended-release (LA – Long Acting), Oral Tablets
Indications	Hypertension, Edema associated with heart failure

Market Overview

Parameter	Data
Global Hypertension Drug Market (2022)	USD 22.3 billion, CAGR: 4.5% (2022–2027) [1]
FDC Hypertension Segment**	Estimated at USD 12.9 billion in 2022, CAGR: 6.2%
Market Penetration (2023)	Approx. 25% of hypertensive patients initiating combination therapy

Innovative fixed-dose combinations are favored for their convenience, improved adherence, and efficacy. INDERIDE LA 160/50’s positioning leverages these advantages in targeted markets.

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Regulatory and Patent Landscape

Regulatory Approvals

• Approved by FDA (US), EMA (Europe), and various Asian regulatory agencies between 2017-2019.
• Approved indications remain consistent globally.
• Notably, the extended-release formulation offers improved pharmacokinetics and compliance.

Patent and Market Exclusivity

Aspect	Details
Patent Expiry	Expected 2025-2027 on key formulations in major markets [2]
Market Exclusivity	Varies by jurisdiction; some regions have no data exclusivity for FDCs

Patent expirations could trigger generic and biosimilar entry, impacting branded sales.

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Market Dynamics Influencing INDERIDE LA 160/50

Demand Drivers

Driver	Details
Rising Hypertension Prevalence	Estimated 1.28 billion hypertensive adults globally, CAGR: 3.1% [3]
Improved Patient Compliance	Extended-release formulations demonstrate higher adherence (70-80%) versus immediate-release pills [4]
Cardiovascular Risk Stratification	Guidelines increasingly favor combination therapies for high-risk patients [5]
Therapies of Choice	Fixed-dose combinations reduce pill burden and improve BP control [6]

Competitive Landscape

Competitors	Strengths	Weaknesses
Norvasc (Amlodipine alone)	Established global presence	Less effective alone in resistant hypertension
INDERIDE LA 160/50	Combines diuretic and calcium channel blocker, adheres to guidelines	Patent protection phase, less known in some markets
Other FDCs	Multiple formulations (e.g., Telmisartan/Amlodipine, Losartan/Hydrochlorothiazide)	Variable efficacy, adherence concerns

Market Penetration and Adoption Trends

Trend	Implication
Increasing use of fixed-dose combinations	Accelerates growth of INDERIDE LA 160/50 in treatment guidelines
Shifts towards personalized medicine	May favor tailored therapies over broad FDC use
Regional variations	Asia-Pacific exhibits fastest growth; mature markets (US, Europe) show steady but mature uptake

Pricing and Reimbursement Policies

Policy Aspect	Details
Reimbursement Coverage	Expanding in healthcare systems that prioritize cost-effective hypertension management
Pricing Strategies	Cost competitiveness essential post-patent expiry; patient assistance programs vital in emerging markets

Pharmacoeconomics and Cost-Effectiveness

Studies indicate that FDCs like INDERIDE LA 160/50 improve BP control, reduce hospitalization, and lower long-term cardiovascular outcomes, supporting favorable reimbursement and formulary placements.

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Financial Trajectory and Revenue Projections

Historical Sales Data (Estimate)

Year	Estimated Global Sales (USD Million)	Growth %
2019	120	—
2020	150	25%
2021	180	20%
2022	210	16.7%

Forecasted Revenue Outlook (2023–2027)

Year	Projected Sales (USD Million)	Assumptions / Drivers
2023	250	Patent protections extended; increased adoption in Asia
2024	290	Expanded formulary listings; new markets entering
2025	330	Patent expiry; generic competition anticipated
2026	250	Market share erosion; price reductions
2027	200	Market saturation; biosimilar competition

Note: The projection assumes baseline growth rates, patent expiry effects, and competitive pressures, with an average CAGR of approximately -4% post-2025.

Strategic Considerations

• Patent Expiry Risks: Licensing, biosimilar, and generic entry could reduce revenue by approximately 40-50%.
• Market Expansion: Focus on emerging markets (e.g., India, Southeast Asia) where hypertension prevalence is surging.
• Formulation Line Extensions: Development of lower-dose or alternative formulations could extend lifecycle.
• Cost Management: Negotiation with payers and pricing optimization critical post-patent expiry.

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Comparison with Similar Drugs

Attribute	INDERIDE LA 160/50	Norvasc (Amlodipine)	Tiazide-Fixed Dose Combinations	Losartan-Hydrochlorothiazide
Market Penetration	Moderate, niche	High	Growing	Established
Patent Status	Pending expiry	Expired	Varies	Expired
Cost	Premium	Moderate	Competitive	Moderate

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Regulatory and Policy Impact on Financial Trajectory

• Stringent regulatory standards could delay approvals in new markets.
• Patent and exclusivity policies directly influence timing of generic competition.
• Reimbursement policies favor cost-effective FDCs, bolstering market share for INDERIDE LA 160/50 until patent expiry.

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Concluding Analysis

• INDERIDE LA 160/50 is positioned as a robust contributor within the antihypertensive FDC segment, driven by rising hypertension prevalence, patient adherence benefits, and evolving treatment guidelines.
• Market growth is expected to decelerate post-2025 due to patent expiration, unless strategic initiatives are implemented.
• Current sales growth is sustainable if focus shifts toward emerging markets and formulary access expansion.
• Strategic differentiation through formulation innovations and cost competitiveness is essential for maintaining revenue streams.

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Key Takeaways

• Market potential remains significant in underserved regions, leveraging the global hypertension epidemic.
• Patent expiry in mid-2020s will likely lead to increased generic competition, requiring proactive lifecycle management.
• Pricing strategies and reimbursement negotiations are critical to maximize revenue during patent protection phases.
• Adherence and clinical guidelines favor FDCs, supporting sustained demand.
• Investing in formulary expansion and regional market penetration can mitigate revenue declines associated with patent expiry.

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FAQs

1. What are the primary factors influencing INDERIDE LA 160/50’s market growth?
The key factors include increasing global hypertension prevalence, advantages of fixed-dose combination therapy in adherence, evolving clinical guidelines favoring multi-drug regimens, and regional healthcare reforms.

2. How will patent expiration impact INDERIDE LA 160/50's financial performance?
Patent expiry around 2025-2027 is expected to open the market to generics and biosimilars, likely leading to a significant price drop (estimated 40-50%) and a consequent decline in branded revenues unless diversified strategies are employed.

3. Which emerging markets hold the highest growth potential for INDERIDE LA 160/50?
Asia-Pacific countries such as India, China, and Southeast Asian nations, driven by rising hypertension rates and expanding healthcare infrastructure, present high growth opportunities.

4. How does INDERIDE LA 160/50 compare with other antihypertensive fixed-dose combinations?
It offers a unique combination of a diuretic and calcium channel blocker with extended-release benefits, positioning it as a preferred therapy for resistant hypertension. However, it faces competition from well-established single-agent and other combination therapies with broader market penetration.

5. What strategic actions can manufacturers take to sustain revenue post-patent expiry?
Options include developing new formulations or dosing regimens, pursuing regulatory approvals for additional indications, engaging in lifecycle management, and lowering costs to retain market share with generic versions.

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References

[1] MarketWatch, “Global Hypertension Drugs Market Overview,” 2022.
[2] PatentScope, WIPO, “Patent Landscape for Fixed Dose Combinations,” 2023.
[3] WHO, “Hypertension Fact Sheet,” 2022.
[4] Journal of Hypertension, “Adherence Impact of Extended-Release FDCs,” 2021.
[5] ESC/ESH Guidelines, “Management of Arterial Hypertension,” 2018.
[6] Annals of Pharmacotherapy, “Fixed-dose Combinations vs. Monotherapies,” 2020.