INDERAL Drug Patent Profile

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

Inderal is a drug marketed by Wyeth Ayerst, Wyeth Pharms, and Ani Pharms. and is included in three NDAs.

The generic ingredient in INDERAL 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

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

Summary for INDERAL

US Patents:	0
Applicants:	3
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	76
Patent Applications:	4,730
Drug Prices:	Drug price information for INDERAL
What excipients (inactive ingredients) are in INDERAL?	INDERAL excipients list
DailyMed Link:	INDERAL at DailyMed

See drug prices for INDERAL

Recent Clinical Trials for INDERAL

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

Sponsor	Phase
Zealand University Hospital	Phase 2
Rigshospitalet, Denmark	Phase 2
Second Xiangya Hospital of Central South University	Phase 1

See all INDERAL clinical trials

US Patents and Regulatory Information for INDERAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Ayerst	INDERAL	propranolol hydrochloride	SUSPENSION;ORAL	019536-001	Dec 12, 1986		DISCN	No	No
Wyeth Pharms	INDERAL	propranolol hydrochloride	TABLET;ORAL	016418-010	Oct 18, 1982		DISCN	Yes	No
Wyeth Pharms	INDERAL	propranolol hydrochloride	TABLET;ORAL	016418-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for INDERAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Ayerst	INDERAL	propranolol hydrochloride	SUSPENSION;ORAL	019536-001	Dec 12, 1986

International Patents for INDERAL

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

Country	Patent Number	Title	Estimated Expiration
Canada	1269619	FORMULATIONS LIQUIDES DE CHLORHYDRATE DE PROPANOLOL (PROPRANOLOL HYDROCHLORIDE LIQUID FORMULATIONS)

Market Dynamics and Financial Trajectory for Inderal (Propranolol)

Last updated: July 30, 2025

Introduction

Inderal, a widely recognized brand of propranolol, is a non-selective beta-adrenergic receptor blocker primarily used in treating cardiovascular conditions such as hypertension, arrhythmias, angina, and prevention of migraines. Since its approval in the 1960s, Inderal has experienced fluctuating market trajectories driven by evolving therapeutic indications, patent status, generic competition, and emerging technological and clinical developments. This report delineates the current market landscape, key drivers, barriers, and financial outlook for Inderal, contextualizing these factors within the broader pharmaceutical industry environment.

Market Overview

Historical Context and Therapeutic Portfolio

Developed by Imperial Chemical Industries (later acquired by AstraZeneca), propranolol was one of the first beta-blockers introduced into clinical practice. Its versatility across cardiovascular and neurological indications established it as a cornerstone therapy. Despite the advent of newer, more selective beta-blockers and alternative drug classes, propranolol maintains a significant presence due to well-established efficacy and cost-effectiveness.

Market Size and Revenue Streams

The global beta-blocker market was valued at approximately USD 6.2 billion in 2021, with propranolol accounting for a substantial share owing to its long-standing clinical use and affordability. The drug's revenues are generated through both branded Inderal sales and a growing array of generic formulations.

Regionally, North America and Europe constitute the largest markets, driven by mature healthcare systems and high prescribing rates. Emerging markets in Asia-Pacific and Latin America are witnessing increased adoption, propelled by expanding healthcare infrastructure and increasing awareness of cardiovascular diseases.

Patent and Regulatory Landscape

Inderal’s patent protections expired in various jurisdictions over the past decade, resulting in a proliferation of generic versions. This patent cliff significantly impacted branded sales, compelling AstraZeneca and other patent holders to focus on lifecycle management strategies, including formulation innovations, combination therapies, and expanding indications.

Market Dynamics Influencing Inderal’s Trajectory

Patent Expiry and Generic Competition

The generic wave has led to unprecedented price erosion in the propranolol market. As of 2018, the patent expiry in major jurisdictions like the U.S. and EU prompted a dramatic fall in branded revenues. According to IMS Health, generic propranolol's market share now exceeds 90% in several regions, underlining stiff price competition and reduced profit margins for the branded product.

Clinical Guidelines and Prescribing Trends

The decline of Inderal's market share has been partly offset by its entrenched position in clinical guidelines for migraines, tremors, and certain arrhythmias. However, newer agents with better side effect profiles and selective mechanisms have gained favor, influencing prescribing patterns.

Emerging Therapies and Technological Developments

Innovation in beta-blocker therapy and alternative treatments has challenged propranolol's dominance. For instance, novel agents like carvedilol and nebivolol offer improved safety profiles. Furthermore, advances in drug delivery systems, such as extended-release formulations, aim to enhance therapeutic adherence and efficacy, threatening traditional formulations like Inderal.

Regulatory and Safety Considerations

Regulatory agencies have issued warnings regarding contraindications related to asthma, diabetes, and peripheral vascular disease, potentially limiting widespread use. These safety concerns influence market dynamics, especially in sensitive patient populations.

Competitive Strategies and Lifecycle Management

Manufacturers of propranolol have adopted multiple strategies to sustain revenue:

• Formulation innovations: Development of sustained-release and topical formulations.
• Combination therapies: Pairing propranolol with other agents to target specific indications.
• Marketing to niche markets: Focused promotion in specialized areas such as pediatric migraine prophylaxis.

Financial Trajectory and Forecast

Revenue Projections

The propranolol market is expected to experience a declining overall trend driven by generic erosion, with total revenues forecasted to decline at an annual rate of approximately 4-6% over the next five years (2023-2028). Despite this, specific segments—such as pediatric migraine management—may sustain niche revenues due to clinical guideline reinforcement.

Impact of Patent and Market Penetration

Branded Inderal sales are likely to decline sharply as patents expire. However, branded manufacturers may offset revenue loss through:

• Premium pricing for specialized formulations.
• Expansion into emerging markets where generic competition is less intense.
• Development of combination products for new indications.

Cost of Development and Market Entry Barriers

Entry into decline-phase markets with established generic brands imposes high pricing and marketing hurdles. Conversely, innovation in delivery systems or novel therapeutic niches can open new revenue streams. Nonetheless, high regulatory and development costs act as barriers, limiting significant expansion.

Opportunities and Risks

Opportunities:

• Licensing of specialized formulations or approved indications.
• Geographic expansion into underserved markets.
• Development of combination therapies.

Risks:

• Accelerated generic erosion.
• Market displacement by newer beta-blockers and alternative therapies.
• Regulatory restrictions related to safety concerns.

Conclusion

The market landscape for Inderal (propranolol) is characterized by a mature, declining revenue trajectory driven primarily by patent expirations and intense generic competition. While its long-standing clinical utility ensures continued niche demand, significant revenue erosion is inevitable. Strategic lifecycle management, innovation in formulations, and expansion into emerging markets may mitigate revenue declines temporarily, but the long-term outlook remains subdued unless novel indications or formulations emerge.

Key Takeaways

• Patent expirations have precipitated a significant decline in branded Inderal revenues, supplanted largely by generic competitors.
• The drug maintains niche roles in migraine prophylaxis, arrhythmia management, and tremor control, but faces stiff competition from newer agents.
• Innovation in drug delivery and combination therapies represent potential revenue-extending strategies.
• Market growth is primarily driven by emerging markets, although pricing pressures persist.
• Future revenue stability hinges on regulatory environment, clinical guideline updates, and the success of lifecycle management initiatives.

FAQs

1. What are the primary indications for Inderal (propranolol)?

Propranolol is indicated for hypertension, angina pectoris, arrhythmias, myocardial infarction prophylaxis, migraine prevention, and selected tremors. Its versatility makes it a staple in cardiovascular and neurological treatments.

2. How has patent expiration impacted Inderal’s market revenues?

Patent expiration led to a surge of generic versions flooding the market, drastically reducing branded revenues. This patent cliff has resulted in revenue declines of approximately 4-6% annually over recent years.

3. Are there any upcoming formulations or indications that could revive Inderal’s market?

Currently, no significant new formulations or indications are in advanced development stages. Lifecycle strategies focus on extending formulations and niche market applications.

4. How does the competitive landscape influence the future of propranolol?

Competition from newer beta-blockers with better safety profiles and from highly genericized propranolol formulations limits growth prospects. Successful differentiation through formulations or new indications could offer some respite.

5. What are the key risks for investors considering the propranolol market?

The primary risks include ongoing patent expirations, aggressive generic competition, regulatory restrictions due to safety concerns, and the emergence of superior alternative therapies.

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Sources

[1] IQVIA. "Global Beta-Blockers Market Insights and Forecasts." 2022.
[2] IMS Health. "Pharmaceutical Market Trends 2022."
[3] FDA. "Propranolol Labeling and Safety Notices."
[4] MarketsandMarkets. "Cardiovascular Drugs Market by Segment and Region." 2021.