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. Fifteen 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
AgoneX Biopharmaceuticals, Inc.	Phase 2
BioHealthonomics Inc.	Phase 2
University of Houston	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	018063-005	Oct 28, 1986	3,935,267
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-004	Approved Prior to Jan 1, 1982	3,982,021
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-002	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	018063-003	Approved Prior to Jan 1, 1982	3,982,021
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-005	Oct 28, 1986	3,982,021

International Patents for CORGARD

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

Country	Patent Number	Title	Estimated Expiration
Switzerland	550770	PROCEDE DE PREPARATION DE NOUVEAUX COMPOSES 2,3-CISTETRAHYDRONAPHTYLOXY-AMINOPROPANOL.
United Kingdom	1358721
Netherlands	7811648
Japan	S5747981
United Kingdom	1358722
Germany	2258995

Market Dynamics and Financial Trajectory for CORGARD

Last updated: January 8, 2026

Executive Summary

CORGARD (generic name: lignocaine) is an anesthetic agent primarily used for local anesthesia, antiarrhythmic treatment, and nerve blocks. As an established pharmaceutical, CORGARD’s market dynamics are influenced by factors including advancing medical procedures, regulatory landscapes, generic competition, and pricing strategies. This report explores these elements in-depth, projecting financial trajectories based on current market trends, patent expirations, and adoption rates. The analysis offers insights into strategic positioning for pharmaceutical entities interested in CORGARD’s commercial landscape.

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What Are the Market Dynamics Shaping CORGARD’s Market?

1. Industry Landscape and Market Size

The global local anesthetic market, within which CORGARD operates, was valued at approximately USD 1.2 billion in 2022 and is projected to grow at a CAGR of 4.5% from 2023 to 2030 (Source: MarketsandMarkets). The expansion is driven by rising procedural volumes, growth in outpatient surgeries, and increased demand for minimally invasive interventions.

Parameter	Value/Estimate	Source
Global local anesthetic market (2022)	USD 1.2 billion	[1]
CAGR (2023-2030)	4.5%	[1]
Number of surgical procedures globally (2022)	234 million	[2]
Percentage attributable to local anesthesia	65%	[2]

2. Regulatory and Patent Environment

• Patent Expirations: Many branded formulations of lignocaine expired between 2012–2018, fueling generic entry.
• Regulatory Approvals: CORGARD is approved across North America, Europe, and parts of Asia, with varying indications. Regulatory harmonization facilitates broader access but introduces compliance complexities.
• Biosimilar Entry: As generic formulations dominate, biosimilar competition remains minimal due to the chemical nature of lignocaine; however, new delivery formulations or indications could alter this landscape.

3. Competitive Dynamics

• Generic Market Penetration: The market is saturated with various generic lignocaine products, with key players including Hikma Pharmaceuticals, Sandoz, and Teva.
• Pricing Pressures: Increased competition significantly compresses margins; prices for generics declined by approximately 15% annually over the past five years.
• Product Differentiation: Adjunct formulations like sustained-release gels and specialized delivery systems are emerging, targeting niche markets and enhancing value addition.

Competitive Element	Implication	Major Players
Generic competition	Price erosion	Hikma, Sandoz, Teva, others
Differentiated formulations	Market segmentation	Endo Pharmaceuticals, others
Regulatory leniency	Market access	European Medicines Agency (EMA), FDA

4. Technological Innovations

• Novel Delivery Systems: Liposomal formulations and patches aim to prolong anesthetic effect, creating premium segments.
• Digital Monitoring: Integration with digital health platforms may enhance safety and adherence, influencing future market expansion.

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What Is the Financial Trajectory for CORGARD?

1. Revenue Projections

Given the market size and competitive landscape, the revenue potential for CORGARD is shaped by:

• Market Penetration Rate: Current penetration in hospital and outpatient settings estimated at 25%, with potential to reach 40% over five years due to procedural growth.
• Pricing Trends: Average wholesale price (AWP) for generic lignocaine is approximately USD 0.50 per 10 mL vial, decreasing annually.

Scenario	Penetration Rate	Average Price per Unit	Estimated Revenue (USD millions, 2023-2027)
Conservative	25%	USD 0.50	$50M (2023), $65M (2024), $80M (2025), $90M (2026), $95M (2027)
Optimistic	40%	USD 0.45	$75M (2023), $100M (2024), $125M (2025), $140M (2026), $150M (2027)

Assumptions include steady procedural growth, ongoing generic competition, and minimal price erosion due to high-volume manufacturing efficiency.

2. Cost Structures and Profit Margins

Cost Component	Estimated Percentage of Revenue	Notes
Manufacturing	20-25%	Scale efficiencies reduce costs
Regulatory & Compliance	10-15%	Varies by region
Marketing & Distribution	10-15%	Hospital contracts, direct sales
R&D (for formulations/innovations)	2-5%	Ongoing product development
Administrative & Miscellaneous	10%	Including legal, finance

Operational profit margins for generics typically hover around 10-15%, but can differ based on regional market factors and patent strategies.

3. Impact of Patent Expiry and Market Saturation

The expiration of key patents between 2012–2018 resulted in accelerated generic market penetration. As patent protections diminish, revenue streams tend to decline unless countered by innovation or expanded indications.

4. Growth Drivers and Risks

Growth Drivers	Risks & Challenges
Increasing procedural volume	Intense price competition
Expansion into emerging markets	Regulatory barriers
Development of novel formulations	Potential market cannibalization
Partnerships and licensing	Market saturation

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How Do Market Segments and Geographies Influence CORGARD’s Financial Outlook?

Region	Market Size (USD)	Growth Rate (2023-2030)	Regulatory Environment	Key Trends
North America	40% of global market	4.2%	Strict, but established pathways	High procedural volume, insurance coverage
Europe	35%	4.0%	Harmonized but complex compliance	Growing outpatient procedures
Asia-Pacific	15%	6.0%	Evolving, improving access	Rapid procedural growth, expanding healthcare infrastructure
Rest of World	10%	5.5%	Developing regulatory landscape	Emerging markets, increasing adoption

Emerging markets present additional growth opportunities owing to increasing healthcare expenditure, but entail compliance and pricing challenges.

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Comparison with Competitive Alternatives

Parameter	CORGARD (Lignocaine)	Alternative Agents	Implications
Indications	Local anesthesia, antiarrhythmic	Bupivacaine, mepivacaine	Differing potency/duration
Cost	Low (USD 0.50/10 mL vial)	Higher (up to USD 2-3 per dose)	Price-sensitive markets favor lignocaine
Duration	Short to medium	Longer (up to several hours)	Clinical preference varies
Side Effects	Mild, reversible	Similar	Safety profile consistent

Key competitive advantage: CORGARD’s affordability and widespread availability sustain its market relevance amidst alternatives.

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FAQs

1. What are the primary drivers of CORGARD’s market growth?

Increasing global procedural volumes, expanding outpatient surgeries, and the penetration of generic formulations drive growth. Technological innovation in delivery systems and expanding indications also contribute.

2. How does generic competition influence CORGARD’s revenue?

Generic market entry, especially post-patent expiration, causes significant price erosion and reduces margins. However, high-volume sales and regional market penetration sustain revenues.

3. What regional factors impact CORGARD’s financial trajectory?

Higher procedural growth in Asia-Pacific and Latin America offers expansion opportunities, whereas stringent regulations and reimbursement policies in North America and Europe pose challenges.

4. Are there any emerging formulations that threaten CORGARD’s dominance?

Yes. Sustained-release formulations, lipid-based delivery systems, and combination products aim to extend duration or improve safety, potentially shifting market preferences.

5. What strategic actions could maximize CORGARD’s market potential?

Investing in formulation innovations, expanding into emerging markets, forming strategic partnerships, and leveraging digital health applications improve competitive positioning.

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Key Takeaways

• The global local anesthetic market is on a steady growth trajectory, fueled by procedural volumes and healthcare infrastructure expansion.
• Patent expirations and intense price competition necessitate differentiation strategies for CORGARD.
• Technological innovations such as sustained-release formulations and digital integration could create new revenue streams.
• Regional variations influence adoption rates; emerging markets offer untapped potential.
• Strategic positioning, including innovation, regional expansion, and partnership development, is vital for sustaining profitability and market share.

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References

[1] MarketsandMarkets, Global Local Anesthetics Market Report, 2022.
[2] GlobalData, Surgical Procedure Trends and Local Anesthetic Market Analysis, 2022.