NADOLOL - Generic Drug Details

What are the generic drug sources for nadolol and what is the scope of freedom to operate?

Nadolol is the generic ingredient in two branded drugs marketed by Uswm, Alembic, Amneal Pharms Co, Aurobindo Pharma, Beximco Pharms Usa, Chartwell Rx, Heritage Pharma, Invagen Pharms, Novast Labs, Rising, Rk Pharma, Sandoz, Teva Pharms, and Zydus Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for nadolol. Sixteen suppliers are listed for this compound.

Summary for NADOLOL

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	15
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	23
Patent Applications:	6,813
Drug Prices:	Drug price trends for NADOLOL
Drug Sales Revenues:	Drug sales revenues for NADOLOL
What excipients (inactive ingredients) are in NADOLOL?	NADOLOL excipients list
DailyMed Link:	NADOLOL at DailyMed

See drug prices for NADOLOL

See drug sales revenues for NADOLOL

Recent Clinical Trials for NADOLOL

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

Sponsor	Phase
Unity Health Toronto	N/A
National Institute on Aging (NIA)	Phase 4
The New York Community Trust	Phase 4

See all NADOLOL clinical trials

Pharmacology for NADOLOL

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

Medical Subject Heading (MeSH) Categories for NADOLOL

Adrenergic beta-Antagonists

Anti-Arrhythmia Agents

Antihypertensive Agents

Sympatholytics

Anatomical Therapeutic Chemical (ATC) Classes for NADOLOL

C07AA	Beta blocking agents, non-selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for NADOLOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Beximco Pharms Usa	NADOLOL	nadolol	TABLET;ORAL	210955-001	Jul 23, 2018	AB	RX	No	No
Aurobindo Pharma	NADOLOL	nadolol	TABLET;ORAL	201893-002	Sep 16, 2015	AB	RX	No	No
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Heritage Pharma	NADOLOL	nadolol	TABLET;ORAL	074229-001	Aug 30, 1996		DISCN	No	No
Aurobindo Pharma	NADOLOL	nadolol	TABLET;ORAL	201893-001	Sep 16, 2015	AB	RX	No	No
Teva Pharms	NADOLOL	nadolol	TABLET;ORAL	074368-002	Aug 31, 1994		DISCN	No	No
Invagen Pharms	NADOLOL	nadolol	TABLET;ORAL	203455-001	Dec 18, 2015	AB	RX	No	No

Expired US Patents for NADOLOL

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	3,982,021
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-002	Approved Prior to Jan 1, 1982	3,935,267
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-004	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	3,935,267
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-002	Approved Prior to Jan 1, 1982	3,982,021
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-001	Approved Prior to Jan 1, 1982	3,982,021

NADOLOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nadolol

Introduction to Nadolol

Nadolol is a nonselective beta-adrenoceptor blocking drug, widely used in the treatment of hypertension and angina pectoris. Its unique pharmacological properties, such as its long duration of action and lack of intrinsic sympathomimetic or membrane stabilizing activity, make it an attractive option for once-daily administration[3].

Market Size and Growth

The global nadolol market has been experiencing steady growth. As of 2023, the nadolol market size was valued at USD 180 million. It is projected to reach USD 270 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.2% from 2024 to 2031[4].

Industry Chain Analysis

The nadolol market is influenced by several factors within the industry chain, including raw material suppliers, manufacturers, distributors, and end-users. The availability and cost of raw materials, manufacturing processes, and regulatory approvals play crucial roles in determining the market dynamics. Additionally, the distribution network and the demand from healthcare providers and patients are key drivers of market growth[1].

Market Dynamics

Demand and Supply

The demand for nadolol is driven by the increasing prevalence of hypertension and angina pectoris. As the global population ages and the incidence of cardiovascular diseases rises, the need for effective and convenient antihypertensive and anti-anginal medications like nadolol increases. On the supply side, the market is characterized by a few key manufacturers and a robust distribution network that ensures widespread availability of the drug[1].

Competitive Landscape

The beta-blocker market, in which nadolol operates, is competitive with several other drugs like propranolol, atenolol, and metoprolol. Nadolol's unique selling point is its long duration of action, allowing for once-daily dosing, which can enhance patient compliance. However, other beta-blockers may offer advantages such as cardioselectivity or different pharmacokinetic profiles, influencing the competitive landscape[3].

Regulatory Environment

Regulatory approvals and compliance are critical for the nadolol market. Changes in regulatory policies or the introduction of new guidelines can significantly impact the market. For instance, stricter regulations on drug safety and efficacy can affect the approval process for new formulations or generic versions of nadolol[1].

Financial Trajectory

Revenue Projections

The projected growth of the nadolol market from USD 180 million in 2023 to USD 270 million by 2031 indicates a stable financial trajectory. This growth is driven by increasing demand, expanding distribution channels, and potentially new indications or formulations of the drug[4].

Cost and Affordability

The cost-effectiveness of nadolol is an important factor in its financial trajectory. In many developing economies, the affordability of antihypertensive medications is a significant concern. Studies have shown that nadolol, being excreted entirely in its unmetabolized form, may offer cost advantages over other beta-blockers that require more frequent dosing or have higher acquisition costs[3][5].

Investment and Funding

Investments in research and development are crucial for the long-term financial health of the nadolol market. Funding for clinical trials, especially those exploring new indications or formulations, can drive innovation and expand the market. Additionally, investments in manufacturing processes and distribution networks can improve efficiency and reduce costs, contributing to a positive financial trajectory[1].

Key Drivers and Barriers

Drivers

• Increasing Prevalence of Cardiovascular Diseases: The rising incidence of hypertension and angina pectoris globally drives the demand for nadolol.
• Convenience of Once-Daily Dosing: Nadolol's long duration of action enhances patient compliance, making it a preferred choice for many healthcare providers.
• Cost-Effectiveness: The drug's pharmacokinetic properties and once-daily dosing regimen can reduce overall treatment costs[3].

Barriers

• Competitive Market: The presence of other beta-blockers with different advantages can pose a challenge to nadolol's market share.
• Regulatory Hurdles: Stricter regulatory requirements can delay approvals and impact market growth.
• Affordability in Developing Economies: Despite its cost-effectiveness, nadolol may still be unaffordable for some populations in developing countries[1][5].

Future Outlook

The future outlook for the nadolol market appears promising, driven by the increasing demand for antihypertensive and anti-anginal medications. As the global healthcare system continues to evolve, the need for effective, convenient, and cost-efficient treatments will remain a key driver of market growth.

"Nadolol is one of a few beta-blocking drugs which have clearly been shown to be effective in both hypertension and angina with once daily administration."[3]

Conclusion

The nadolol market is poised for steady growth, driven by its unique pharmacological properties, increasing demand, and cost-effectiveness. While it faces competition from other beta-blockers and regulatory challenges, its long duration of action and once-daily dosing regimen position it favorably in the market.

Key Takeaways

• The global nadolol market is projected to grow from USD 180 million in 2023 to USD 270 million by 2031.
• Nadolol's long duration of action and once-daily dosing regimen are key drivers of its market success.
• The drug's cost-effectiveness and lack of intrinsic sympathomimetic or membrane stabilizing activity are significant advantages.
• Regulatory approvals and compliance are critical for market growth.
• Increasing prevalence of cardiovascular diseases and patient compliance are major drivers of demand.

FAQs

What is nadolol used for?

Nadolol is used in the treatment of hypertension and angina pectoris due to its nonselective beta-adrenoceptor blocking properties.

What is the projected growth rate of the nadolol market?

The nadolol market is expected to grow at a CAGR of 5.2% from 2024 to 2031.

What are the unique selling points of nadolol?

Nadolol's unique selling points include its long duration of action, allowing for once-daily dosing, and its lack of intrinsic sympathomimetic or membrane stabilizing activity.

How does nadolol compare to other beta-blockers?

Nadolol is one of a few beta-blockers effective in both hypertension and angina with once-daily administration, but it lacks cardioselectivity, which may be a disadvantage in some patients.

What are the key drivers of the nadolol market?

The key drivers include the increasing prevalence of cardiovascular diseases, the convenience of once-daily dosing, and the cost-effectiveness of the drug.

Sources

1. Nadolol API Market Size 2024 Research Report by Industry Chain Analysis, Market Dynamics, and Forecast to 2032. Central News Channel Nebraska.
2. High-Dose Propranolol for Severe and Chronic Aggression in Individuals with Intellectual Disability. PMC.
3. Nadolol: a review of its pharmacological properties and therapeutic use. PubMed.
4. Nadolol Market Size and Projections - Market Research Intellect.
5. Metric Inclusion Exclusion - BMJ Global Health. BMJ Publishing Group Limited.