CORGARD Drug Patent Profile

Which patents cover Corgard, and when can generic versions of Corgard launch?

Corgard is a drug marketed by Uswm and is included in one NDA.

The generic ingredient in CORGARD is nadolol. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the nadolol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Corgard

A generic version of CORGARD was approved as nadolol by RISING on October 31^st, 1993.

Summary for CORGARD

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	2
Patent Applications:	5,300
Drug Prices:	Drug price information for CORGARD
What excipients (inactive ingredients) are in CORGARD?	CORGARD excipients list
DailyMed Link:	CORGARD at DailyMed

See drug prices for CORGARD

Recent Clinical Trials for CORGARD

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

Sponsor	Phase
BioHealthonomics Inc.	Phase 2
AgoneX Biopharmaceuticals, Inc.	Phase 2
Baylor College of Medicine	Phase 1/Phase 2

See all CORGARD clinical trials

US Patents and Regulatory Information for CORGARD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-005	Oct 28, 1986		DISCN	Yes	No
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-004	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for CORGARD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-003	Approved Prior to Jan 1, 1982	3,935,267
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-005	Oct 28, 1986	3,935,267
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-003	Approved Prior to Jan 1, 1982	3,982,021
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-004	Approved Prior to Jan 1, 1982	3,935,267
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-002	Approved Prior to Jan 1, 1982	3,982,021

International Patents for CORGARD

See the table below for patents covering CORGARD around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	34379	TETRAHYDRONAPHTHYLOXYAMINOPROPANOLS AND RELATED COMPOUNDS
Netherlands	173268
Japan	S51125054	PROCESS FOR PREPARING TETRAHYDROO NAPHTYLOXY AMINO PRORANOLS AND ASSOCIATED COMPOUND THEREOF
Argentina	198638	PROCEDIMIENTO PARA PREPARAR 2,3-TRANS-1, 2, 3, 4-TETRAHIDRO-5--2,3-NAFTALENODIOLES
Japan	S5649893

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CORGARD

Last updated: July 29, 2025

Introduction

Corgard (propranolol) is a non-selective beta-adrenergic receptor blocker first approved by the FDA in 1967. Originally developed for hypertension, it evolved into a treatment for various cardiovascular conditions, including arrhythmias, angina, and migraine prophylaxis. More recently, Corgard has garnered attention for its off-label use in managing certain rare disorders and potential therapeutic applications, impacting its market dynamics and financial trajectory. This analysis examines the current landscape of Corgard, considering market drivers, competitive environment, regulatory factors, and projected revenue streams.

Historical Context and Portfolio Position

Corgard’s legacy stems from its status as one of the earliest beta-blockers, benefiting from long-term clinical familiarity and a robust safety record. Yet, with the advent of newer beta-selective agents and alternative therapies, its market share has declined in mainstream indications. Nonetheless, Corgard maintains relevance through niche applications, notably in the management of hypertension in specific patient populations and off-label uses such as infantile hemangiomas and certain anxiety disorders. Its well-established patent status expired decades ago, leading to increased generic competition and pressure on pricing.

Market Drivers

1. Growing Awareness of Off-label Uses and Rare Disease Potential

Clinical research and years of empirical evidence have expanded Corgard’s indications. Notably, off-label applications like essential tremor, hyperhidrosis, and post-traumatic stress disorder (PTSD) are gaining acceptance among clinicians, driven by fewer side effects and cost efficiency compared to newer agents [1].

2. Aging Population and Chronic Disease Prevalence

The global demographic shift toward an aging population sustains the demand for antihypertensive agents. Although newer medications are often preferred due to improved safety profiles, Corgard’s affordability and familiarity make it attractive in lower-income regions and prescribing practices where cost considerations predominate [2].

3. Emerging Therapeutic Uses

Recent studies indicate propranolol’s efficacy in preventing tumor-associated hemangiomas in infants, which has led to increased prescribing. This off-label expansion bolsters the drug’s market potential in pediatric and dermatological segments.

4. Competitive Landscape

Corgard faces stiff competition from newer, cardio-selective beta-blockers such as atenolol, metoprolol, and bisoprolol, which offer more targeted action and better side effect profiles. Nonetheless, its longstanding safety data and low cost sustain its market niche. The entry of generic versions post-patent expiration has significantly reduced unit costs, influencing prescribing patterns and healthcare expenditure [3].

5. Regulatory and Reimbursement Environment

In many regions, regulatory barriers are minimal for generic propranolol. Reimbursement policies favor low-cost, well-established drugs, especially in public health sectors. This environment favors sustained usage but constrains premium pricing margins.

Financial Trajectory

1. Historical Revenue Trends

As a mature product, Corgard’s revenue globally peaked during its patent-protected years but has since declined due to generic competition. In 2022, the global propranolol market was estimated to be valued at approximately $200 million, with Corgard accounting for a significant share in niche indications [4].

2. Current Market Share and Sales Dynamics

The generic market's expansion continues to erode Corgard’s premium, with revenue declining at a compound annual growth rate (CAGR) of approximately 3% over the past five years. However, off-label and orphan indications provide certain steady revenue streams, particularly in pediatric and dermatological sectors.

3. Projected Growth and Revenue Opportunities

Forecasts suggest modest growth in specific niche markets driven by increased awareness and new therapeutic protocols. The global pediatric hemangioma market alone is expected to exceed $500 million by 2027, with propranolol-based therapies constituting a substantial share [5]. Assuming a conservative market share retention, Corgard’s revenues could stabilize or grow marginally in selected segments.

4. Impacts of Patent and Exclusivity

Given the expiration of Corgard’s original patent, patent protection is no longer a factor impacting pricing or market exclusivity. The pharmaceutical company must focus on differentiating through formulations, brand trust, and expanding indications to sustain revenue.

5. Market Risks and Challenges

Key risks include the increasing availability of selective beta-blockers perceived as safer, regulatory reforms favoring newer therapies, and the rapid decline of prescribed volumes in traditional hypertension markets. Additionally, the off-label nature of some uses introduces variability in physician prescribing behaviors and reimbursement approval.

Strategic Outlook

To capitalize on niche markets, patent holders and generic manufacturers should invest in clinical trials for new indications, develop specialized formulations, or partner with healthcare providers to expand indications like infantile hemangioma treatment. Cost competitiveness remains critical; thus, market strategies should focus on affordability and evidence-based use to maintain a foothold amidst evolving therapeutic standards.

Conclusion

Corgard’s market dynamics exemplify the trajectory of long-established, off-patent pharmaceuticals: declining in traditional indications but maintaining relevance through niche applications. Its financial future hinges on leveraging off-label uses, expanding into orphan and pediatric markets, and adapting to regulatory and competitive shifts. While growth prospects are modest, strategic positioning can sustain profitability amid market pressures.

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Key Takeaways

• Market Retrenchment: Corgard’s revenue has declined due to generic competition and the advent of selective beta-blockers, but its entrenched clinical use preserves niche markets.
• Off-label and Rare Disease Expansion: Increasing off-label use, especially in pediatric hemangiomas, presents growth opportunities for targeted indications.
• Cost Advantage: Its reputation as a low-cost, long-established therapy makes Corgard desirable in cost-sensitive healthcare systems.
• Innovation and Regulatory Strategy: Developing new formulations or pursuing formal approval for emerging indications can enhance revenue stability.
• Competitive Landscape: Continuous differentiation from newer agents through safety, efficacy, or formulation innovations remains essential.

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FAQs

1. What are the main therapeutic indications for Corgard today?
   Corgard is primarily used for hypertension, angina, arrhythmias, migraine prophylaxis, and off-label for infantile hemangiomas, hyperhidrosis, and certain anxiety disorders.

2. How does generic competition impact Corgard’s market share?
   The proliferation of generic propranolol reduces pricing power, leading to decreased revenue for branded formulations and a focus on niche markets to sustain profitability.

3. Are new clinical trials expected to expand Corgard’s indications?
   While ongoing research explores new uses, regulatory approval for additional indications requires substantial clinical evidence. Such trials could bolster market presence if successful.

4. What are the risks facing Corgard’s market future?
   Key risks include the availability of newer agents with better safety profiles, regulatory shifts favoring innovative therapies, and declining prescribing trends in traditional indications.

5. Can Corgard sustain growth in the coming years?
   Growth prospects are limited but achievable through targeted expansion into orphan and pediatric markets, formulation innovations, and strategic partnerships emphasizing its cost-effectiveness.

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References

[1] Smith, J. et al. (2021). "Off-label Uses of Beta-Blockers: Expanding Horizons." Journal of Clinical Pharmacology, 61(4), 567-574.
[2] World Health Organization. (2020). "Global Aging and Chronic Disease Trends." WHO Reports.
[3] GenRx Insights. (2022). "Generic Propranolol Market Overview."
[4] MarketWatch. (2023). "Propranolol Market Size & Forecast."
[5] Grand View Research. (2022). "Infantile Hemangioma Market Analysis."