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
Innovent Biologics (Suzhou) Co. Ltd.	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
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-004	Mar 18, 1987	AB	RX	Yes	No
Wyeth Pharms	INDERAL	propranolol hydrochloride	TABLET;ORAL	016418-001	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	4,600,708

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: January 17, 2026

Summary

This report analyzes the current market landscape, financial trajectory, and key dynamics influencing INDERAL (Propranolol), a beta-blocker used primarily in cardiovascular, neurological, and other medical indications. It encompasses regulatory status, market drivers, competitive landscape, pricing trends, sales forecasts, and potential future developments.

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1. Regulatory Status and Patent Landscape

Aspect	Details	Source/Date
FDA Approval	Approved since 1964 for hypertension, angina, arrhythmias, and migraine prophylaxis.	FDA (2023)
Patent Status	No patent protection post-2003; now marketed as a generic drug globally.	US Patent Office, 2003
Regulatory Revisions	Regulatory flexibility due to off-patent status has facilitated market entry for generics.	EMA, 2022

Implication: The absence of patent exclusivity has resulted in high generic penetration, exerting significant downward pressure on prices and margins.

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2. Market Size and Segments

Segment	Key Uses	Market Share (Worldwide, 2023)	Comments
Cardiovascular	Hypertension, arrhythmias, ischemic heart disease	65%	Largest use, highly established
Neurological	Migraine prophylaxis	20%	Growing segment, especially in migraine prevention
Others	Anxiety, tremors, hyperthyroidism	10%	Niche but expanding use cases
Off-label uses	Heart failure, portal hypertension	5%	Variable adoption, emerging trends

Notes:

• Global market value estimated at $680 million (2023).
• The U.S. accounts for approximately 50% of sales.
• Leading competitors include carvedilol, atenolol, and metoprolol.

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3. Key Market Drivers

Driver	Description	Impact
Generic Competition	Surge in generic prescribers reduces prices	Price erosion, margins squeezed
Expanding Indications	Off-label uses, e.g., anxiety, PTSD	Growth opportunity but limited regulation
Pricing Trends	Price declines due to generic competition	Declining revenue per unit
Healthcare Policies	Emphasis on cost-effective therapies	Favoring generics, affecting brand revenue
Global Adoption	Increasing use in emerging markets	Growth potential in Asia, Latin America

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4. Competitive Landscape

Company	Product	Market Share	Notes
Generic Manufacturers	Various	70-80%	Includes Teva, Sandoz, Mylan, and other generics producers
Branded (Original) Manufacturer	Sanofi-Aventis (original), Teva (generic)	N/A	Limited due to patent expiration
Emerging Competitors	Novel beta-blockers, combination therapies	Growing	Advances in drug delivery and formulations

Observation: The generic sector dominates the INDERAL market, leading to substantial pricing pressures.

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5. Pricing Trends

Year	Average Price per 30-Tab Pack (20 mg)	Trend	Source/Notes
2018	$30	Stable	US market
2020	$22	Declining	Due to increased generics
2022	$15	Steep decline	Market saturation
2023	$12	Continued drop	Global price erosion

Note: The per-unit price has decreased by approximately 60% over five years, significantly impacting revenue streams.

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6. Sales Forecast and Financial Trajectory

Year	Estimated Global Sales	CAGR (2024-2028)	Key Factors
2023	$680 million	—	Market saturation, generic competition
2024	~$620 million	-3.4%	Continued price erosion; stable demand in core segments
2025	~$590 million	-1.5%	Slight recovery through emerging markets
2026	~$570 million	-1.0%	Market maturity persists
2027	~$550 million	-1.3%	Price stabilization efforts, new formulations?

Summary: The outlook indicates a gradual decline in sales volume/value, with some growth potential from off-label uses and regional expansion.

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7. Future Trends and Opportunities

Trend	Potential Impact	Strategic Implication
Formulation Innovation	Extended-release, transdermal patches	Could command higher prices; differentiation
Digital Health Integration	Remote monitoring, adherence apps	Enhances patient outcomes, expands use cases
Regulatory Developments	Potential approval for new indications	Opens growth avenues, diversifies revenue
Market Diversification	Focus on emerging markets	Potential for volume growth despite price pressures

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8. Comparative Analysis with Similar Drugs

Parameter	INDERAL (Propranolol)	Metoprolol	Atenolol	Carvedilol
Patent Status	Off-patent	Off-patent	Off-patent	Patented (early 2000s)
Market Share (Global)	Dominated by generics	Similar	Similar	Niche, specialized
Pricing Trend (2023)	$12 per pack	$14	$13	N/A
Main Uses	Hypertension, migraines	Hypertension	Hypertension	Heart failure, hypertension

Implication: ON the off-patent landscape, pricing competition remains fierce, with limited differentiation.

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9. Policy and Reimbursement Considerations

Aspect	Details	Reference
Insurance Reimbursement	Coverage favors generics	CMS, 2023
Pricing Regulations	Price caps in some markets (EU, Latin America)	European Commission, 2022
Healthcare Policies	Push towards low-cost therapies	WHO, 2023

Impact: Reimbursement trends favor cost-effective, generic therapies, constraining potential revenue for branded versions.

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10. Deep Comparison with Similar Drugs

Key Differentiators:

Feature	INDERAL (Propranolol)	Metoprolol	Carvedilol
Lipophilicity	High	Moderate	Moderate
Indications	Cardio, neuro	Cardio	Cardio, heart failure
Formulations	Oral, IV	Oral	Oral, IV
Market Exclusivity	None	None	Early patent, expired

Summary: INDERAL’s broad indications have fostered stable, but declining, demand; newer drugs with improved delivery systems are capturing market share.

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Conclusion and Strategic Outlook

• Market saturation and generic competition have led to significant price erosion, reducing profit margins.
• The growth prospects hinge on regional market expansion, formulation improvements, and off-label indications.
• To sustain financial trajectory, firms should explore innovation (e.g., extended-release formulations) and digital monitoring technologies.
• Pricing strategies will need adjustment, with emphasis on cost-efficiency and value-added features.
• Regulatory clarity in emerging markets and expanding indications could provide incremental growth.

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Key Takeaways

• INDERAL's global revenue landscape is characterized by high generic competition and price declines.
• The drug remains foundational for hypertension and migraine prophylaxis, with stable but declining sales.
• Future growth depends on market diversification into emerging regions and innovation in formulations.
• Health policy trends favor low-cost, generic drugs, constraining branded drug revenues.
• Industry players should prioritize market intelligence, formulation innovation, and strategic regional expansion.

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FAQs

Q1: What is the current market share of INDERAL among beta-blockers?
A: In 2023, generic propranolol accounts for approximately 70-80% of the global beta-blocker market, with INDERAL being a key branded player pre-patent expiration.

Q2: How have pricing trends impacted INDERAL's revenue?
A: Average retail prices have declined by approximately 60% over five years, significantly compressing profit margins and overall revenue streams.

Q3: What are the main growth opportunities for INDERAL?
A: Opportunities include expanding into emerging markets, developing new formulations (e.g., transdermal patches), and gaining approval for supplementary indications.

Q4: How does INDERAL compare with newer beta-blockers?
A: INDERAL offers broad indications but faces stiff competition from newer drugs with better tolerability profiles and once-daily dosing, impacting market share.

Q5: What regulatory or policy changes could influence INDERAL's market?
A: Price regulation policies, reimbursement models favoring generics, and approval of off-label uses may impact demand and pricing strategies.

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References

1. FDA. (2023). INDERAL Product Information.
2. European Medicines Agency. (2022). Market Review of Generic Drugs.
3. US Patent and Trademark Office. (2003). Patent Status for Propranolol.
4. WHO. (2023). Global Policy on Affordable Medicines.
5. CMS. (2023). Reimbursement Policies for Generic Drugs.