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. Thirty-nine 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:	39
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	378
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
Bloom Mental Health, LLC	EARLY_PHASE1
Zhongda Hospital	NA

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
Schering	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	070123-001	Oct 29, 1986		DISCN	No	No
Ivax Sub Teva Pharms	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	072069-001	Jul 29, 1988		DISCN	No	No
Schering	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	070120-001	Aug 6, 1985		DISCN	No	No

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	6,500,454
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

International Patents for PROPRANOLOL HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Malaysia	156750	USE OF A BETA BLOCKER FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF HEMANGIOMAS
Hong Kong	1148940
Chile	2008003083

Market Dynamics and Financial Trajectory of Propranolol Hydrochloride

Last updated: January 16, 2026

Executive Summary

Propranolol Hydrochloride (Propranolol HCl) is a non-selective beta-adrenergic antagonist introduced in the 1960s. It remains a cornerstone in the treatment of hypertension, angina pectoris, arrhythmias, and certain anxiety disorders. Its widespread adoption, patent expirations, generics proliferation, and emerging therapeutic applications significantly influence its market dynamics. The global propranolol market is projected to grow steadily, driven by aging populations, expanding indications, and regulatory factors, with an estimated compound annual growth rate (CAGR) of approximately 3-4% over the next five years. This analysis provides insights into current market drivers, challenges, competitive landscape, and financial trajectories, offering strategic insights for stakeholders.

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1. What Are the Key Market Drivers for Propranolol Hydrochloride?

a. Established Therapeutic Indications

Propranolol remains a first-line treatment for:

• Hypertension
• Angina pectoris
• Cardiac arrhythmias
• Myocardial infarction prophylaxis
• Migraine prevention
• Certain anxiety disorders (performance anxiety)

b. Patent Expiry and Generic Competition

Patent expiration in the 1980s and 1990s precipitated widespread availability of generic versions, significantly reducing costs:	Year	Patent Expiry	Impact
1980s	Early 1980s	Entry of generic manufacturers
2000	Multiple patents expire	Market saturation

c. Growing Prevalence of Cardiovascular Diseases

Rising global incidence of hypertension and ischemic heart disease propels demand:	Region	Projected CAGR (2022-2027)	Drivers
North America	3%	Aging demographics, lifestyle
Asia-Pacific	4%	Urbanization, lifestyle changes

d. Emerging Indications and Off-Label Use

Propranolol’s off-label use in:

• Performance anxiety
• Certain vascular anomalies
• Infantile hemangiomas (FDA-approved in some regions)

e. Regulatory Approvals and Policy Trends

• WHO essential medicines list inclusion (WHO 2004)
• Inclusion in national formularies, increasing accessibility

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2. What Challenges Affect the Propranolol Market?

a. Competition from Newer Beta-Blockers

• Cardioselective agents (e.g., atenolol, bisoprolol)
• Intriguing formulations (extended-release, combination therapies)

b. Safety Profile and Side Effects

• Bradycardia, hypotension, bronchospasm
• Caution in asthma and COPD patients

c. Limitations in Indication Expansion

• Limited in treating certain conditions for which newer drugs are preferred

d. Regulatory and Patent Environment

• Patent expirations facilitated generic entry
• Patent protection now limited, constraining innovation

e. Market Saturation and Price Pressures

• Price erosion due to generics
• Margin compression for manufacturers

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3. How Is the Competitive Landscape Structured?

a. Key Players

Company	Market Share (Estimated, 2022)	Strategies
Teva Pharmaceuticals	~30%	Large generic portfolio, global reach
Sandoz (Novartis)	~25%	Broad portfolio, biosimilars
Mylan (Part of Pfizer)	~15%	Cost leadership, wide distribution
Others	~30%	Niche players, regional markets

b. Market Segmentation

Segment	Share	Key Characteristics
Generic formulations	~85%	Dominant, price-sensitive, high volume
Branded formulations	~15%	Often for institutional use, formulations with niche indications

c. Distribution Channels

• Hospitals and clinics
• Pharmacist-led retail outlets
• Online pharmacies (growing segment)

d. Regional Market Trends

Region	Market Share	Notable Trends
North America	High (~40%)	Advanced healthcare infrastructure
Europe	Moderate (~25%)	Aging population, regulatory control
Asia-Pacific	Growing (~20%)	Increasing access, generic uptake
Latin America / Africa	Remaining	Growing markets, affordability constraints

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4. What Are the Financial Trajectories and Forecasts?

a. Market Size and Revenue Estimates

Year	Global Market Value (USD Billion)	Notes
2022	~$1.1	Mature market dominated by generics
2027	~$1.4 - 1.5	CAGR of ~3-4% driven by demand and new indications

b. Revenue Breakdown by Region (2022)

Region	Revenue Percentage	Driving Factors
North America	~40%	High prevalence, healthcare expenditure, established healthcare infrastructure
Europe	~25%	Aging populations, diverse healthcare systems
Asia-Pacific	~20%	Rapid urbanization, increasing healthcare access
Rest of World	~15%	Emerging markets, affordability constraints

c. Cost Dynamics and Profit Margins

Cost Element	Trend	Impact
Raw materials (API)	Stable, but affected by supply chain disruptions	Cost containment efforts, strategic sourcing
Manufacturing	Economies of scale, commoditized	Margin-pressure as generic market matures
Regulatory compliance	Increasing costs due to stricter standards	Margins may compress without innovation

d. Forecasted Financial Outcomes

• Revenue growth: Modest, driven primarily by volume rather than price
• Profitability: Stable for established brands; potential decline without differentiation
• Innovation Impact: Limited unless new indications or formulations are developed

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5. How Do Regulatory Policies Influence the Market?

Policy Aspect	Influence	Notable Examples
Patent Law	Enables generics post-expiry	US Hatch-Waxman Act, EU Data Exclusivity
Drug Pricing Regulations	Pressure on prices and margins	US, EU, forming a key factor in pricing strategies
Approval Pathways	Streamlined for bioequivalent generics	Abbreviated New Drug Application (ANDA) in US
Inclusion in Essential Medicines Lists	Promotes accessibility	WHO inclusion (2004)

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6. How Does Propranolol Compare with Newer Beta-Blockers?

Parameter	Propranolol	Newer Beta-Blockers (e.g., Bisoprolol, Metoprolol)
Selectivity	Non-selective (β1 and β2 blockade)	Cardioselective (β1 blockade)
Indications	Hypertension, arrhythmias, migraines	Hypertension, heart failure, ischemic heart disease
Side Effects	Bronchospasm, hypoglycemia risk	Fewer pulmonary side effects
Patent Status	Expired, open for generics	Patent protected, limited generics
Cost	Low, due to generics	Higher, especially in branded formulations

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7. What Are the Future Trends and Opportunities?

a. Development of Extended-Release and Combination Formulations

• Enhances patient adherence and convenience (“Propranolol ER” formulations)

b. Expansion of Indications

• Investigations into:
  • Post-traumatic stress disorder
  • Certain types of tremors
  • Vascular anomalies (infantile hemangiomas)

c. Biosimilars and Biobetters

• Though less relevant for propranolol, future biosimilar-like innovations could emerge via reformulation

d. Digital and Precision Medicine

• Digital adherence tools
• Pharmacogenomics for personalized titration

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Key Takeaways

Factor	Impact	Strategic Consideration
Patent expiry and generic competition	Market saturation, price erosion	Focus on cost efficiencies and market share
Increasing prevalence of cardiovascular diseases	Steady demand, demographic-driven growth	Invest in marketing, expanding indications
Emerging indications and off-label use	Market diversification and expansion	Pursue clinical research, regulatory approvals
Competitive landscape dominated by generics	Thin margins, need for differentiation	Innovate in formulations or new applications
Regulatory environment promotes access	Easier market penetration, increased competition	Navigate approvals efficiently

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FAQs

1. What are the primary therapeutic uses of propranolol?
Propranolol is primarily used for hypertension, angina pectoris, arrhythmias, migraine prophylaxis, and certain anxiety disorders.

2. How does patent expiration affect the propranolol market?
Patent expiration led to widespread generic manufacturing, resulting in reduced prices, increased accessibility, and a highly competitive environment.

3. Are there significant opportunities for innovation with propranolol?
While the drug’s established profile limits novel therapeutic development, opportunities exist in extended-release formulations, new indications, and combination therapies.

4. How does the regulatory landscape influence market growth?
Regulatory policies facilitate generic entry through abbreviated pathways, strengthening market competition but constraining innovation incentives.

5. What regions are driving the future growth of propranolol?
Asia-Pacific and Latin America exhibit the fastest growth due to rising healthcare access and demographic shifts, while North America and Europe maintain mature markets.

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References

[1] World Health Organization. "WHO Model List of Essential Medicines," 2004.
[2] GlobalData. "Beta-Blockers Market Analysis," 2022.
[3] U.S. Food and Drug Administration. "Abbreviated New Drug Application (ANDA) Process," 2021.
[4] IMS Health. "Healthcare Trends and Market Forecast," 2022.
[5] European Medicines Agency. "Market Authorizations for Beta-Blockers," 2020.