INDERAL LA Drug Patent Profile

Which patents cover Inderal La, and what generic alternatives are available?

Inderal La is a drug marketed by Ani Pharms and is included in one NDA.

The generic ingredient in INDERAL LA 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 La

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

Summary for INDERAL LA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	157
Clinical Trials:	76
Drug Prices:	Drug price information for INDERAL LA
DailyMed Link:	INDERAL LA at DailyMed

See drug prices for INDERAL LA

See drug sales revenues for INDERAL LA

Recent Clinical Trials for INDERAL LA

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 LA clinical trials

Pharmacology for INDERAL LA

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

US Patents and Regulatory Information for INDERAL LA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-004	Mar 18, 1987	AB	RX	Yes	No
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-001	Apr 19, 1983	AB	RX	Yes	Yes
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-002	Apr 19, 1983	AB	RX	Yes	No
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-003	Apr 19, 1983	AB	RX	Yes	No

Expired US Patents for INDERAL LA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-004	Mar 18, 1987
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-002	Apr 19, 1983
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-001	Apr 19, 1983
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-003	Apr 19, 1983

International Patents for INDERAL LA

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

Country	Patent Number	Title	Estimated Expiration
Malaysia	8100346	SUSTAINED RELEASE PHARMACEUTICAL COMPOSITION
Israel	52914	SUSTAINED RELEASE PHARMACEUTICAL COMPOSITIONS COMPRISING PROPRANOLOL OR A PROPRANOLOL SALT
Denmark	153773
Australia	2861477
United Kingdom	1561204
Denmark	244378

Market Dynamics and Financial Trajectory for Inderal LA

Last updated: February 20, 2026

What is the current market landscape for Inderal LA?

Inderal LA (propranolol extended-release) is a beta-blocker primarily used for hypertension, arrhythmias, and certain migraine prophylaxes. The drug has seen steady demand over the past decade due to its established efficacy and off-label uses. Its patent expired in 2009, leading to increased generic competition, which has driven down prices and affected revenue. The market for beta-blockers globally was valued at approximately USD 3.3 billion in 2021 and is expected to grow at a compound annual growth rate (CAGR) of around 3% through 2028, driven by aging populations and cardiovascular disease prevalence[1].

How has patent expiration impacted Inderal LA's market share?

The loss of patent protection in 2009 allowed multiple generics to enter the market. This resulted in significant price erosion. Despite this, branded formulations continue to hold a niche among certain clinician and patient segments, often due to perceived differences in release profiles. Generic versions now account for over 80% of propranolol prescriptions, reducing overall revenue potential for the branded product[2].

What are the primary drivers influencing market growth?

• Aging Population: An increase in cardiovascular disease prevalence among older adults spurs demand for beta-blockers.
• Off-Label Uses: Expansion into migraine prophylaxis, tremors, and anxiety management sustains utilization.
• Regulatory Environment: Promotional restrictions and patent litigations influence market entry for new formulations.
• Competitive Landscape: The entry of generics has reduced prices but has not eliminated market demand for branded derivatives.
• Research Advances: New formulations like sustained-release variants offer potential to command premium pricing.

What is the forecasted financial trajectory for Inderal LA?

Exact sales data are proprietary, but industry analysts estimate:

Metric	2022 Estimate	2025 Projection	2028 Projection
Global sales for propranolol (all formulations)	USD 100 million	USD 125 million	USD 140 million
Branded Inderal LA market share	Approx. USD 30 million	USD 20 million	USD 15 million
Revenue from extended-release formulations	Decreasing post-2010 due to generics	Stabilizing with niche use	Slight decline expected as off-label uses plateau

The declining trend follows generics' market share, but niche applications and new formulations may stabilize revenues to some extent.

How do regulatory and patent strategies influence future prospects?

Patent expirations stripped exclusivity, paving the way for generics. Current strategies focus on reformulation or new delivery mechanisms to extend market differentiation. The FDA's approval of new formulations or combination products could influence future sales. Patent filings and exclusivity periods for such innovations could provide short-term revenue boosts, but the long-term outlook remains challenged by generic competition.

What are potential opportunities and risks?

Opportunities

• Development of extended-release formulations with improved pharmacokinetics.
• Expansion into niche markets like pediatric or post-myocardial infarction indications.
• Combination therapies integrating propranolol with other agents.

Risks

• Market saturation with generics.
• Price erosion pressures.
• Regulatory hurdles for new formulations.
• Off-label restrictions reducing demand.

Summary of key financial metrics

Market Segment	Current Status	Future Outlook
Sales volume	Stabilized post-patent expiry	Potential growth through niche uses
Pricing	Low, due to generic competition	Slight increase possible with new formulations
Revenue growth	Flat to slight decline	Stabilization expected in limited segments

Key Takeaways

• The market for propranolol, including Inderal LA, faces decline driven by generic competition.
• Revenue primarily derives from niche indications, off-label uses, and new formulation development.
• Innovating with reformulated or combination products presents growth opportunities but faces regulatory and patent challenges.
• The global market is projected to grow modestly, with revenues for branded Propranolol products declining or stabilizing.
• Strategic focus on niche markets and formulation innovation can mitigate some revenue erosion.

FAQs

1. Can Inderal LA regain market share?
Limited potential exists unless new formulations or indications are approved, which typically requires significant investment and regulatory approval.

2. How do generic prices impact revenue?
Generic entry drives prices downward, reducing branded product revenue. Branded formulations often sell at a premium, but this diminishes over time.

3. Are there unmet medical needs for propranolol?
Yes, particularly for new formulations with improved pharmacokinetics or for specific patient populations like children or those with comorbidities.

4. What is the impact of off-label uses on market dynamics?
Off-label prescriptions sustain demand but are subject to regulatory scrutiny, which could limit growth.

5. How does research influence the future of Inderal LA?
Research into new delivery systems and combination therapies could create new revenue streams, but patent strategies and regulatory pathways are critical hurdles.

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References

[1] MarketsandMarkets. (2022). Beta-Blocker Market by Type, Application, and Region: Global Forecast to 2028.
[2] IQVIA. (2021). The Use of Generic Drugs in the U.S. Market.
[3] U.S. Food and Drug Administration. (2022). Drug Approvals and Patents.