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. Sixteen 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:	60
Clinical Trials:	2
Patent Applications:	4,544
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
Invion, Inc.	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	018063-004	Approved Prior to Jan 1, 1982
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-002	Approved Prior to Jan 1, 1982
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-004	Approved Prior to Jan 1, 1982
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-005	Oct 28, 1986
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-003	Approved Prior to Jan 1, 1982
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-002	Approved Prior to Jan 1, 1982

International Patents for CORGARD

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

Country	Patent Number	Title	Estimated Expiration
Denmark	142454
Canada	979912	TETRAHYDRONAPHTHYLOXYAMINOPROPANOLS AND RELATED COMPOUNDS
Hong Kong	34479	TETRAHYDRONAPHTHYLOXYAMINOPROPANOLS AND RELATED COMPOUNDS
Germany	2258995
Japan	S51125054	PROCESS FOR PREPARING TETRAHYDROO NAPHTYLOXY AMINO PRORANOLS AND ASSOCIATED COMPOUND THEREOF
United Kingdom	1358721

CORGARD Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CORGARD (Nadolol)

Introduction to CORGARD (Nadolol)

CORGARD, known generically as nadolol, is a non-selective beta-adrenergic receptor blocking agent used to treat high blood pressure, heart pain (angina), atrial fibrillation, and other conditions such as migraine headaches and complications of cirrhosis[1][5].

Market Size and Forecast

The global market for nadolol was estimated to be worth US$236 million in 2023. However, it is forecast to decline to a readjusted size of US$183 million by 2030, with a Compound Annual Growth Rate (CAGR) of -3.6% during the forecast period of 2024-2030. This decline is indicative of the challenges faced by branded pharmaceuticals as they approach patent expiry and face competition from generic alternatives[1].

Market Segmentation

By Region

The nadolol market is segmented by region, including North America (U.S., Canada, Mexico), Europe (Germany, France, UK, Italy, etc.), Asia Pacific (China, Japan, South Korea, India, etc.), South America (Brazil, etc.), and the Middle East and Africa. Each region has its own growth trends and market dynamics, influenced by local healthcare demands, regulatory environments, and economic conditions[1].

By Type

Nadolol is available in various dosages, including 20mg, 40mg, and 80mg tablets. The market segmentation by type helps in understanding the demand for different strengths of the medication, which can vary based on patient needs and clinical guidelines[1].

By Application

The primary applications of nadolol include treating high blood pressure, heart pain (angina), and atrial fibrillation. Understanding these segments is crucial for pharmaceutical companies to target their marketing and distribution strategies effectively[1].

Pricing and Cost Structure

The cost of CORGARD can vary significantly depending on the dosage and the pharmacy. For instance, a 20mg oral tablet can cost around $446 for a supply of 100 tablets, while a generic version can be as low as $23.12 for 30 tablets. The pricing dynamics are influenced by factors such as pharmacy discounts, insurance plans, and the availability of generic alternatives[2].

Competitive Landscape

The nadolol market is competitive, with several key players including Zydus Pharms, Vgyaan, Sandoz, Novast Labs, Mylan, Lupin, Invagen Pharms, Heritage Pharma, Beximco Pharms, Amneal Pharms, and Worldmeds. These companies must navigate the challenges of patent expiries, generic competition, and stringent regulatory environments to maintain their market share[1].

Impact of Patent Expiry

The expiry of patents for branded pharmaceuticals like nadolol significantly impacts their market dynamics. Once a patent expires, generic versions of the drug can enter the market, leading to a rapid erosion of brand revenues. The rate of this erosion can vary depending on the complexity of the drug formulation and the number of generic entrants. For example, drugs with complex non-oral formulations may experience slower erosion compared to those with simpler oral formulations[3].

Strategies Post-Patent Expiry

Pharmaceutical companies employ various strategies to mitigate the impact of patent expiry. One such strategy is the introduction of authorized generics, which can help maintain some market share and revenue. However, the effectiveness of this strategy depends on the specific dynamics of the drug and the market. For fast-eroding brands, authorized generics may have minimal impact, while for slower-eroding brands, they could significantly erode patented revenues[3].

Global Pharmaceutical Market Context

The global pharmaceutical market, which includes both chemical and biological drugs, is a vast and growing sector. In 2022, the global pharmaceutical market was valued at $1,475 billion, with a CAGR of 5% expected over the next six years. The market is driven by increasing demand for healthcare, technological advancements, and the rising prevalence of chronic diseases. However, it also faces challenges such as stringent regulations, high R&D costs, and patent expiries[1].

Challenges and Opportunities

Challenges

• Stringent Regulations: Pharmaceutical companies must comply with strict regulatory requirements, which can be time-consuming and costly.
• High R&D Costs: The development of new drugs is expensive and risky, with many candidates failing in clinical trials.
• Patent Expiries: The loss of patent protection leads to generic competition, eroding brand revenues.
• COVID-19 Pandemic: The pandemic has highlighted the need for agile and responsive pharmaceutical companies, particularly in vaccine development and supply chain management[1].

Opportunities

• Increasing Demand for Healthcare: Growing populations and aging demographics increase the demand for healthcare services and pharmaceuticals.
• Technological Advancements: Advances in technology can improve drug development, manufacturing, and distribution.
• Rising Prevalence of Chronic Diseases: Conditions like hypertension, which nadolol treats, are becoming more prevalent, driving demand for effective treatments[1].

Key Takeaways

• The global nadolol market is forecast to decline due to generic competition and patent expiry.
• The market is segmented by region, type, and application, each with its own dynamics.
• Pricing varies significantly between branded and generic versions.
• Pharmaceutical companies must adapt to post-patent expiry strategies to maintain market share.
• The broader pharmaceutical market is driven by increasing healthcare demand and technological advancements but faces regulatory and R&D challenges.

FAQs

What is the primary use of CORGARD (nadolol)?

CORGARD (nadolol) is primarily used to treat high blood pressure, heart pain (angina), and atrial fibrillation, as well as to prevent migraine headaches and complications of cirrhosis[1][5].

How is the global nadolol market expected to perform in the forecast period?

The global nadolol market is expected to decline from US$236 million in 2023 to US$183 million by 2030, with a CAGR of -3.6% during the forecast period of 2024-2030[1].

What are the main factors driving the decline in the nadolol market?

The decline is primarily driven by the expiry of patents and the subsequent entry of generic versions into the market, leading to a reduction in brand revenues[1][3].

How does the pricing of CORGARD compare to its generic version?

The pricing of CORGARD can be significantly higher than its generic version. For example, a 20mg oral tablet of CORGARD can cost around $446 for 100 tablets, while a generic version can cost as low as $23.12 for 30 tablets[2].

What strategies do pharmaceutical companies use to mitigate the impact of patent expiry?

Pharmaceutical companies use strategies such as introducing authorized generics, which can help maintain some market share and revenue post-patent expiry[3].

What are the broader market trends influencing the pharmaceutical industry?

The pharmaceutical industry is influenced by increasing demand for healthcare, technological advancements, and the rising prevalence of chronic diseases, but also faces challenges such as stringent regulations and high R&D costs[1].