Propranolol hydrochloride - Generic Drug Details

What are the generic drug sources for propranolol hydrochloride and what is the scope of freedom to operate?

Propranolol hydrochloride is the generic ingredient in six branded drugs marketed by Ani Pharms, Actavis Elizabeth, Adare Pharms Inc, Amta, Inwood Labs, Lupin Ltd, Nortec Dev Assoc, Rising, 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 Fabre, Hikma, Pai Holdings Pharm, Wyeth Ayerst, Wyeth Pharms, Aiping Pharm Inc, Chartwell Rx, Dava Pharms Inc, Duramed Pharms Barr, Endo Operations, Impax Labs Inc, Innogenix, Interpharm, Ipca Labs Ltd, Ivax Sub Teva Pharms, Lederle, Mylan, Northstar Hlthcare, 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-two 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:	42
Raw Ingredient (Bulk) Api Vendors:	156
Clinical Trials:	338
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
AIDS Malignancy Consortium	Phase 2
Zealand University Hospital	Phase 2
Rigshospitalet, Denmark	Phase 2

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
Actavis Elizabeth	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078494-002	Aug 10, 2007	AB	RX	No	No
Innogenix	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	070322-002	Oct 22, 1985	AB	RX	No	No
Lupin Ltd	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204349-001	Jan 12, 2024		DISCN	No	No
Hikma	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	SOLUTION;ORAL	070979-001	May 15, 1987		RX	No	Yes

Expired US Patents for propranolol hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-001	Mar 12, 2003
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-004	Mar 18, 1987
Wyeth Ayerst	INDERAL	propranolol hydrochloride	SUSPENSION;ORAL	019536-001	Dec 12, 1986
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-002	Mar 12, 2003

International Patents for propranolol hydrochloride

Country	Patent Number	Title	Estimated Expiration
Chile	2008003083	Uso de un beta bloqueador seleccionado de un beta bloqueador no selectivo y/o un beta bloqueador selectivo beta-1 para preparar un medicamento util para el tratamiento de los hemangiomas.
Malaysia	156750	USE OF A BETA BLOCKER FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF HEMANGIOMAS
Russian Federation	2010112816	ПРИМЕНЕНИЕ БЛОКА-БЛОКАТОРА ДЛЯ ИЗГОТОВЛЕНИЯ ЛЕКАРСТВЕННОГО СРЕДСТВА ДЛЯ ЛЕЧЕНИЯ ГЕМАНГИОМ
Cyprus	1113597

Propranolol hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Propranolol Hydrochloride

Introduction

Propranolol hydrochloride, a nonselective beta-adrenergic receptor-blocking agent, has been a cornerstone in the treatment of various cardiovascular and noncardiovascular conditions for decades. This article delves into the market dynamics and financial trajectory of propranolol hydrochloride, highlighting its current status, growth prospects, and key factors influencing its market.

Market Size and Growth Projections

The global propranolol hydrochloride market is experiencing significant growth, driven by increasing demand for effective treatments for cardiovascular diseases and other conditions.

• Current Market Size: As of 2024, the global propranolol market was valued at approximately $397.9 million[4].
• Growth Projections: The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.1% from 2024 to 2030, reaching a projected value of $477.8 million by 2030[4].

Market Segmentation

The propranolol hydrochloride market is segmented based on several key factors:

By Type

• Oral: This is the largest segment, accounting for over 98% of the market share. Oral formulations, including extended-release capsules, are widely used due to their convenience and efficacy[4].
• Injection: Although less common, injectable forms of propranolol hydrochloride are used in specific clinical settings.

By Application

• Arrhythmia: This segment is expected to expand significantly, driven by the increasing prevalence of arrhythmias and the effectiveness of propranolol in managing these conditions[3][4].
• Hypertension: Propranolol hydrochloride is widely used in the management of hypertension, contributing substantially to the market's growth[2][5].
• Other Applications: These include migraine prophylaxis, hyperthyroid-induced thyrotoxicosis, and the management of hypertrophic subaortic stenosis[5].

By Region

The market is segmented into major regions such as North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region has its own set of drivers and restraints, with Asia Pacific expected to show significant growth due to increasing healthcare expenditure and a large patient population[3][4].

Key Drivers and Opportunities

Several factors are driving the growth of the propranolol hydrochloride market:

Increasing Prevalence of Cardiovascular Diseases

The rising incidence of cardiovascular diseases such as hypertension, arrhythmias, and coronary artery disease is a major driver. Propranolol hydrochloride's efficacy in managing these conditions makes it a preferred treatment option[5].

Expanding Applications

Beyond cardiovascular diseases, propranolol hydrochloride is used in various other conditions, including migraine prophylaxis and hyperthyroid-induced thyrotoxicosis. This broad range of applications contributes to its market growth[5].

Technological Advancements

Advancements in drug delivery systems, such as extended-release formulations, have improved the drug's efficacy and patient compliance, further boosting market growth[2].

Restraints and Challenges

Despite the positive growth trajectory, the market faces several challenges:

Side Effects and Contraindications

Propranolol hydrochloride has several side effects and contraindications, such as cardiogenic shock, sinus bradycardia, and bronchial asthma, which can limit its use in certain patient populations[2].

Regulatory Scrutiny

Stringent regulatory requirements and the need for continuous monitoring of drug safety can pose challenges to market growth[2].

Generic Competition

The presence of generic versions of propranolol hydrochloride can reduce the market share of branded products, affecting revenue[4].

Competitive Landscape

The propranolol hydrochloride market is highly competitive, with several key players:

• Atnas Pharma
• AstraZeneca
• Mylan
• Novartis
• Sanofi
• Yabang Pharma
• Sawai Seiyaku
• ABZ-Pharma
• Towa Yakuhin
• Zydus Pharma
• Nichi-Iko Pharmaceutical
• Intas Pharma
• IFET
• Iqfarma
• Zentiva[4]

These companies are focusing on expanding their product portfolios and strengthening their market presence through strategic initiatives.

Financial Performance

The financial performance of the propranolol hydrochloride market is robust, with steady revenue growth expected over the forecast period.

• Revenue Forecast: The market is projected to grow from $397.9 million in 2024 to $477.8 million by 2030[4].
• CAGR: A CAGR of 3.1% during the forecast period indicates a stable and growing market[4].

Regional Analysis

The market is segmented into several regions, each with its own growth dynamics:

• North America: This region is a significant market due to high healthcare expenditure and a large patient population.
• Europe: Europe also represents a substantial market, driven by advanced healthcare systems and high demand for cardiovascular treatments.
• Asia Pacific: This region is expected to show the highest growth rate due to increasing healthcare spending and a large population base[3][4].

Market Trends

Several trends are shaping the propranolol hydrochloride market:

• Increasing Focus on Generic Drugs: The rise of generic versions is a significant trend, as these drugs offer cost-effective alternatives to branded products[4].
• Advancements in Drug Delivery Systems: Extended-release formulations and other innovative delivery systems are enhancing patient compliance and drug efficacy[2].

SWOT Analysis

Strengths

• Established Efficacy: Propranolol hydrochloride has a well-established efficacy profile across various indications.
• Broad Range of Applications: The drug is used in multiple conditions, contributing to its market presence.

Weaknesses

• Side Effects and Contraindications: The drug has several side effects and contraindications that can limit its use.
• Generic Competition: The presence of generic versions can reduce the market share of branded products.

Opportunities

• Growing Demand for Cardiovascular Treatments: The increasing prevalence of cardiovascular diseases presents a significant opportunity.
• Expanding Applications: The potential for use in new indications can further boost market growth.

Threats

• Regulatory Scrutiny: Stringent regulatory requirements can pose challenges.
• Economic Factors: Economic downturns can affect healthcare spending and thus impact market growth.

Key Takeaways

• The propranolol hydrochloride market is expected to grow at a CAGR of 3.1% from 2024 to 2030.
• The oral segment dominates the market, with over 98% share.
• Arrhythmia and hypertension are key application segments driving market growth.
• The market faces challenges from side effects, contraindications, and generic competition.
• Key players are focusing on expanding their product portfolios and market presence.

FAQs

What is the current market size of the propranolol hydrochloride market?

The global propranolol market was valued at approximately $397.9 million in 2024[4].

What is the projected growth rate of the propranolol hydrochloride market?

The market is expected to grow at a CAGR of 3.1% from 2024 to 2030[4].

Which segment dominates the propranolol hydrochloride market?

The oral segment dominates the market, accounting for over 98% of the market share[4].

What are the main applications of propranolol hydrochloride?

The main applications include arrhythmia, hypertension, and other conditions such as migraine prophylaxis and hyperthyroid-induced thyrotoxicosis[5].

Who are the key players in the propranolol hydrochloride market?

Key players include Atnas Pharma, AstraZeneca, Mylan, Novartis, Sanofi, and others[4].

What are the major challenges facing the propranolol hydrochloride market?

The market faces challenges from side effects, contraindications, generic competition, and regulatory scrutiny[2][4].

Sources

1. Global Propranolol HCL Market Size, Scope And Forecast Report - Market Research Intellect
2. DESCRIPTION Rx Only Propranolol hydrochloride - FDA
3. Propranolol Drug Market Report 2024 (Global Edition) - Cognitive Market Research
4. Global Propranolol Market Insights, Forecast to 2030 - Valuates Reports
5. Propranolol - StatPearls - NCBI Bookshelf - NCBI