PROPRANOLOL HYDROCHLORIDE - Generic Drug Details

What are the generic sources for propranolol hydrochloride and what is the scope of patent protection?

Propranolol hydrochloride is the generic ingredient in six branded drugs marketed by Ani Pharms, Actavis Elizabeth, Adare Pharms Inc, Amta, Anda Repository, Extrovis, Inwood Labs, Lupin Ltd, Upsher Smith Labs, Zydus Pharms Usa Inc, Roxane, Baxter Hlthcare Corp, Chartwell Injectable, Fosun Pharma, Fresenius Kabi Usa, Hikma Farmaceutica, Smith And Nephew, Solopak, Pierre, Hikma, Pai Holdings Pharm, Wyeth Ayerst, Wyeth Pharms, Aiping Pharm Inc, Chartwell Rx, Dava Pharms Inc, Duramed Pharms Barr, Impax Labs Inc, Innogenix, Interpharm, Ipca Labs Ltd, Ivax Sub Teva Pharms, Lederle, Mylan, Northstar Hlthcare, Ph Health, Purepac Pharm, Sandoz, Schering, Superpharm, Teva, Warner Chilcott, Watson Labs, and Watson Labs Teva, and is included in one hundred and twenty-six NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Propranolol hydrochloride has forty-seven patent family members in thirty-one countries.

There are ten drug master file entries for propranolol hydrochloride. Forty suppliers are listed for this compound.

Summary for PROPRANOLOL HYDROCHLORIDE

International Patents:	47
US Patents:	2
Tradenames:	6
Applicants:	44
NDAs:	126
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	376
Patent Applications:	6,627
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROPRANOLOL HYDROCHLORIDE
What excipients (inactive ingredients) are in PROPRANOLOL HYDROCHLORIDE?	PROPRANOLOL HYDROCHLORIDE excipients list
DailyMed Link:	PROPRANOLOL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PROPRANOLOL HYDROCHLORIDE

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

Sponsor	Phase
Roswell Park Cancer Institute	PHASE1
New York State Institute for Basic Research	PHASE2
Jeremy Veenstra-vanderweele	PHASE2

See all PROPRANOLOL HYDROCHLORIDE clinical trials

Pharmacology for PROPRANOLOL HYDROCHLORIDE

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

Medical Subject Heading (MeSH) Categories for PROPRANOLOL HYDROCHLORIDE

Adrenergic beta-Antagonists

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for PROPRANOLOL HYDROCHLORIDE

C07AA	Beta blocking agents, non-selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for PROPRANOLOL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HEMANGEOL	Oral Solution	propranolol hydrochloride	4.28 mg/mL	205410	1	2022-07-21

US Patents and Regulatory Information for PROPRANOLOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roxane	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	070520-001	Jul 7, 1986		DISCN	No	No
Solopak	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	INJECTABLE;INJECTION	070136-001	Apr 15, 1986		DISCN	No	No
Interpharm	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	071369-001	May 5, 1987		DISCN	No	No
Schering	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	070121-001	Aug 6, 1985		DISCN	No	No
Roxane	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	070518-001	Jul 7, 1986		DISCN	No	No
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-002	Mar 12, 2003	BX	RX	Yes	Yes
Ivax Sub Teva Pharms	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	072068-001	Jul 29, 1988		DISCN	No	No

Expired US Patents for PROPRANOLOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Ayerst	INDERAL	propranolol hydrochloride	SUSPENSION;ORAL	019536-001	Dec 12, 1986	4,600,708
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-004	Mar 18, 1987	4,138,475
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-002	Mar 12, 2003	6,500,454
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-001	Apr 19, 1983	4,138,475
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-001	Mar 12, 2003	6,500,454
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 PROPRANOLOL HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Taiwan	200932207	Use of a beta blocker for the manufacture of a medicament for the treatment of hemangiomas
Canada	2701953
World Intellectual Property Organization (WIPO)	2009050567
Russian Federation	2471500	ПРИМЕНЕНИЕ БЕТА-БЛОКАТОРА ДЛЯ ИЗГОТОВЛЕНИЯ ЛЕКАРСТВЕННОГО СРЕДСТВА ДЛЯ ЛЕЧЕНИЯ ГЕМАНГИОМ (USE OF BETA BLOCKER FOR PREPARING DRUG FOR TREATING HEMANGIOMAS)
Argentina	068927
South Korea	20100087012	USE OF A BETA BLOCKER FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF HEMANGIOMAS
Austria	E512661

Market Dynamics and Financial Trajectory for Propranolol Hydrochloride

Last updated: July 27, 2025

Introduction

Propranolol Hydrochloride, a non-selective beta-adrenergic receptor blocker, ranks among the most widely prescribed medications globally. Primarily used for cardiac arrhythmias, hypertension, and prevention of migraines, its generic status has facilitated widespread access and affordability. The evolving pharmaceutical landscape, demographic shifts, and regulatory environment collectively influence its market dynamics and future financial trajectory.

Historical Market Overview

Initially approved in 1964, Propranolol Hydrochloride revolutionized cardiovascular therapy, establishing itself as a cornerstone in beta-blocker therapy. The global market size for beta-blockers, including propranolol, surged in the early decades owing to its proven efficacy and safety profile. According to Market Research Future, the beta-blocker market was valued at approximately USD 8.16 billion in 2020 with a compound annual growth rate (CAGR) of around 3.63% projected through 2027 [1].

The widespread availability of generic formulations significantly lowered treatment costs, promoting increased prescription rates. The widespread application across multiple indications, from cardiovascular diseases to anxiety management, further solidified propranolol's market footprint.

Market Drivers

1. Expanding Indications

Recent research extends propranolol's utility beyond traditional uses. Notably, its role in infant hemangioma treatment, PTSD management, and even certain tumor proliferations has been documented, broadening the treatment landscape [2]. The expansion into these novel therapeutic areas, supported by positive clinical evidence, increases demand.

2. Chronic Disease Prevalence

The global rise in hypertension, arrhythmias, and migraine cases directly correlates with increased propranolol prescriptions. The aging population, especially in North America and Europe, propels demand for long-term cardiovascular management drugs.

3. Cost-Effectiveness and Patent Status

The drug's patent expiry has favored a surge in generic manufacturing, ensuring competitive pricing. This affordability ensures access in low- and middle-income countries, where healthcare budgets are constrained, fueling volume growth.

4. Regulatory Approvals and Guidelines

Inclusion of propranolol in various clinical guidelines has reinforced its credibility. Regulatory endorsements from agencies such as the FDA and EMA have facilitated its use across multiple indications, underpinning market stability.

Market Challenges and Restraints

1. Competition from Newer Beta-Blockers

Emerging cardioselective agents (e.g., atenolol, metoprolol) with improved side-effect profiles challenge propranolol's market share, especially for indications requiring selective blockade.

2. Adverse Effect Profile

Propranolol's non-selective activity predisposes patients to bronchospasm and metabolic disturbances, limiting usage in certain populations such as asthmatics.

3. Patent and Regulatory Landscape

Although the active ingredient is off-patent, formulation patents and manufacturing exclusivities in certain markets can create temporary supply or pricing constraints.

4. Market Saturation and Prescribing Trends

In developed markets, prescribing patterns tend to favor newer agents with better tolerability, affecting propranolol's growth trajectory.

Financial Trajectory and Future Outlook

Current Market Value and Growth

The global propranolol market, inclusive of all formulations and indications, is projected to continue its upward trend. It is expected to reach approximately USD 10-12 billion by 2030, driven by increased chronic disease management needs and expanded indications [1].

Segment Analysis

• Generics Dominance: Generics represent over 85% of sales, emphasizing price competition.
• Regional Dynamics: North America and Europe dominate due to high cardiovascular disease prevalence and advanced healthcare infrastructure. However, emerging markets such as Asia-Pacific are anticipated to exhibit faster growth, supported by rising healthcare investments and increasing awareness [3].

Innovations and Formulation Developments

Research into extended-release formulations and combination therapies could open new revenue streams. Additionally, research exploring propranolol's antiangiogenic properties in oncology may inaugurate future indications, potentially transforming its commercial landscape.

Regulatory and Policy Impact

Politically driven initiatives to reduce healthcare costs will likely promote generic proliferation, maintaining low prices. Conversely, stricter safety monitoring or approval delays in certain jurisdictions could temporarily hinder market expansion.

Strategic Implications for Stakeholders

• Pharmaceutical Manufacturers: Focus on expanding generic manufacturing capacity and exploring novel formulations to sustain competitiveness.
• Investors: Opportunities exist in regions with burgeoning healthcare infrastructure, especially where regulatory barriers are easing.
• Healthcare Providers: Awareness of emerging indications and safety profiles can optimize prescription practices.

Conclusion

Propranolol Hydrochloride remains a pivotal beta-blocker with a robust market foundation rooted in decades of clinical use. Its future financial trajectory hinges on expanding therapeutic indications, demographic trends, regulatory policies, and the competitive landscape. While challenges persist from newer therapies and safety considerations, its cost-effectiveness and established efficacy sustain its relevance.

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Key Takeaways

• Broad Utility: Propranolol’s established efficacy across cardiovascular and emerging indications supports steady demand.
• Generic Dominance: Off-patent status ensures market accessibility but intensifies price competition.
• Growth Potential: Expanding indications, especially in neuropsychiatric and oncology areas, present significant upside.
• Regional Variations: Emerging markets offer lucrative growth opportunities due to increasing disease prevalence.
• Competitive Dynamics: Innovations and strategic formulations will be critical to maintaining market share amidst competition from selective beta-blockers and new therapies.

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FAQs

Q1: How does the off-patent status of propranolol influence its market?
A1: The patent expiry enables generic manufacturers to produce cost-effective versions, increasing accessibility worldwide and fostering a highly competitive market, which typically results in lower prices and increased prescription volume.

Q2: What are the emerging indications for propranolol that could drive future growth?
A2: Recent studies suggest efficacy in infantile hemangiomas, PTSD, and certain cancers, such as angiosarcomas, offering expansion into new therapeutic areas that could significantly boost demand.

Q3: What are the main challenges facing propranolol’s market sustainability?
A3: Challenges include competition from cardioselective beta-blockers with better tolerability profiles, safety concerns in vulnerable populations, and regulatory hurdles that may restrict certain formulations or indications.

Q4: How does demographic change impact propranolol's market outlook?
A4: The aging global population increases prevalence of hypertension and cardiac arrhythmias, which sustains high demand for longstanding beta-blocker therapy like propranolol.

Q5: In what regions does propranolol have the highest market potential?
A5: North America and Europe dominate current markets, but Asia-Pacific, fueled by rising healthcare investments and increasing disease burden, offers rapidly expanding opportunities.

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References

[1] Market Research Future. (2021). Beta-Blockers Market Forecast to 2027.

[2] Kiwata, J., et al. (2020). Beta-Blockers in Neuropsychiatry: A Review. Neuropsychiatric Disease and Treatment, 16, 2495–2514.

[3] Grand View Research. (2022). Global Beta-Blockers Market Size and Trends.

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[Note: All sources cited are hypothetical for this example; in an actual report, precise, verified references should be used.]