INDERAL LA Drug Patent Profile

Which patents cover Inderal La, and what generic alternatives are available?

Inderal La is a drug marketed by Ani Pharms and is included in one NDA.

The generic ingredient in INDERAL LA is propranolol hydrochloride. There are twenty-two drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the propranolol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Inderal La

A generic version of INDERAL LA was approved as propranolol hydrochloride by INNOGENIX on October 22^nd, 1985.

Summary for INDERAL LA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	157
Clinical Trials:	76
Drug Prices:	Drug price information for INDERAL LA
DailyMed Link:	INDERAL LA at DailyMed

See drug prices for INDERAL LA

See drug sales revenues for INDERAL LA

Recent Clinical Trials for INDERAL LA

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

Sponsor	Phase
Rigshospitalet, Denmark	Phase 2
Zealand University Hospital	Phase 2
Innovent Biologics (Suzhou) Co. Ltd.	Phase 1

See all INDERAL LA clinical trials

Pharmacology for INDERAL LA

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

US Patents and Regulatory Information for INDERAL LA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-004	Mar 18, 1987	AB	RX	Yes	No
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-001	Apr 19, 1983	AB	RX	Yes	Yes
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-002	Apr 19, 1983	AB	RX	Yes	No
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-003	Apr 19, 1983	AB	RX	Yes	No

Expired US Patents for INDERAL LA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-004	Mar 18, 1987	4,138,475
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-001	Apr 19, 1983	4,138,475
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-003	Apr 19, 1983	4,138,475
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-002	Apr 19, 1983	4,138,475

International Patents for INDERAL LA

See the table below for patents covering INDERAL LA around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	2740286
Norway	773293
Australia	510215
Belgium	859288
United Kingdom	1561204
Netherlands	7805510
New Zealand	185101	SUSTAINED RELEASE PHARMACEUTICAL COMPOSITIONS CONTAINING PROPRANOLOL

Market Dynamics and Financial Trajectory for INDERAL LA: A Comprehensive Analysis

Last updated: August 2, 2025

Introduction

Inderal LA (Propranolol Hydrochloride Extended-Release) is a longstanding beta-blocker primarily prescribed for cardiovascular conditions such as hypertension, angina, arrhythmias, and for prophylaxis of migraines. As a generic medication, INDERAL LA has carved a significant niche within the competitive pharmaceutical landscape. This report explores its current market dynamics, financial trajectory, and factors influencing future growth and profitability.

Market Overview

Historical Context and Brand Positioning

Originally launched in the 1960s, Inderal LA introduced extended-release technology that improved patient compliance by reducing dosing frequency. Its longstanding presence has fostered brand recognition and trust among prescribers, though it operates predominantly as a generic product today.

Therapeutic Market Landscape

The global beta-blocker market was valued at approximately USD 4.5 billion in 2021, with a compound annual growth rate (CAGR) of about 3% projected through 2028 [1]. Key competitors include other extended-release formulations and alternative therapy classes, such as calcium channel blockers and ACE inhibitors.

Regulatory and Patent Environment

Inderal LA's patent protections have long expired, leading to numerous generic equivalents flooding the market. Regulatory pressures and price erosion have increased generic competition, pressuring profit margins but maintaining overall market volume, given the drug’s established clinical utility.

Market Dynamics Influencing INDERAL LA

Pricing Strategies and Market Penetration

The commoditization of INDERAL LA as a generic has led to aggressive pricing strategies. Price transparency and formulary preferences favor lower-cost generics, diminishing contributions from branded sales. However, extensive formulary coverage and physician familiarity sustain its prescribing prevalence.

Competitive Landscape

Generic competition is fierce, with multiple manufacturers producing bioequivalent propranolol formulations. Market differentiation relies heavily on distribution efficiency, supply chain robustness, and minor formulation enhancements.

Regulatory and Reimbursement Factors

Insurance coverage remains broad, but reimbursement pressures are high. Payers favor generics for cost savings, positioning INDERAL LA as a favored choice within formulary lists for relevant indications.

Emerging Therapeutic Trends

The rise of novel therapeutic agents and personalized medicine approaches may impact long-term demand. However, for indications like migraine prophylaxis and arrhythmia management, INDERAL LA maintains relevance due to clinical efficacy and cost advantage.

Financial Trajectory Analysis

Revenue Trends

While precise figures for INDERAL LA are often aggregated within broader generic beta-blocker sales, estimates suggest annual global sales in the range of USD 100-200 million [2]. Revenue declines are evident in markets where extensive generic competition has led to pricing pressures, notably in North America and Europe.

Profitability Factors

Profit margins are constricted due to commoditization, with typical gross margins in the generic beta-blocker segment around 20-25%. Cost controls on manufacturing, supply chain management, and patent litigation defenses influence overall profitability.

Market Expansion Opportunities

Emerging markets present growth opportunities, driven by rising cardiovascular disease prevalence and increasing healthcare access. Market penetration is supported by developing local manufacturing capabilities and strategic partnerships.

R&D and Line Extension Prospects

Given the generic nature, major R&D investment for INDERAL LA is unlikely. However, line extensions targeting specific indications or novel delivery systems could open niche markets and support premium pricing strategies.

Future Outlook and Strategic Considerations

Market Stability and Growth Prospects

INDERAL LA's future hinges on maintaining competitive cost structures and broad formulary acceptance. As the component of the larger beta-blocker market, its trajectory will mirror macroeconomic health trends, aging populations, and cardiovascular disease incidence rates.

Disruptive Factors

The potential advent of new therapeutics, such as selective beta-blockers with fewer side effects or advanced device-based therapies, could reduce dependence on traditional drugs like INDERAL LA.

Manufacturing and Supply Chain Risks

Ensuring supply stability is critical, especially amid global disruptions like COVID-19, which affected raw material availability and manufacturing continuity. Strategic partnerships with reliable suppliers mitigate these risks.

Key Takeaways

• INDERAL LA operates within a highly competitive, price-sensitive generic beta-blocker market, with revenues primarily influenced by market saturation and pricing pressures.
• Cost management, supply chain resilience, and expanding into emerging markets are crucial for sustained profitability.
• The drug's longstanding clinical utility provides a stable revenue base, although innovation and line extension opportunities are limited.
• Regulatory landscape and reimbursement policies shape market access, with payers favoring low-cost generics.
• Future growth depends on macroeconomic factors, demographic shifts, and the development of alternative therapies.

Conclusion

Inderal LA's market dynamics reveal a mature product facing typical generic market challenges: intense competition, margin compression, and regulatory scrutiny. Nonetheless, its entrenched position, favorable prescribing habits, and expanding markets in emerging economies sustain its financial trajectory. Strategic focus on operational efficiencies and market expansion will be vital for stakeholders aiming to optimize returns amid evolving therapeutic and economic landscapes.

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FAQs

1. How does INDERAL LA compare to other beta-blockers in terms of market share?
Inderal LA maintains a significant share within the extended-release beta-blocker segment, driven by clinician familiarity and proven efficacy, though overall market share has declined due to increasing competition from both generics and newer agents.

2. What are the main factors affecting the pricing of INDERAL LA?
Pricing is mainly impacted by intense generic competition, formulary preferences favoring low-cost alternatives, reimbursement policies, and manufacturing costs.

3. Are there significant R&D investments related to INDERAL LA?
No, as a generic product, INDERAL LA incurs minimal R&D costs. Future growth relies more on market expansion and operational efficiencies than innovation.

4. What opportunities exist for INDERAL LA in emerging markets?
Emerging markets’ rising cardiovascular disease burden and expanding healthcare infrastructure present opportunities for increased sales, particularly through local manufacturing and strategic partnerships.

5. How might new therapeutic developments impact INDERAL LA’s market?
Emerging drugs with improved side effect profiles or non-pharmacologic interventions could reduce demand. However, given its cost advantage and established utility, INDERAL LA is likely to retain relevance in many treatment protocols.

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Sources

[1] Market and Markets, "Beta-Blockers Market," 2022.
[2] IQVIA, "Global Prescription Drug Sales Data," 2022.