NADOLOL Drug Patent Profile

When do Nadolol patents expire, and when can generic versions of Nadolol launch?

Nadolol is a drug marketed by Alembic, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Heritage Pharma, Invagen Pharms, Novast Labs, Regcon Holdings, Rising, Rk Pharma, Sandoz, Teva Pharms, Zydus Pharms, Impax Labs, and Natco Pharma. and is included in sixteen NDAs.

The generic ingredient in NADOLOL is bendroflumethiazide; nadolol. There are four drug master file entries for this compound. Additional details are available on the bendroflumethiazide; nadolol profile page.

Summary for NADOLOL

US Patents:	0
Applicants:	15
NDAs:	16
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	24
Patent Applications:	6,049
Drug Prices:	Drug price information 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
Zydus Pharms	NADOLOL	nadolol	TABLET;ORAL	207761-003	Jul 28, 2017	AB	RX	No	No
Rk Pharma	NADOLOL	nadolol	TABLET;ORAL	212856-003	Sep 13, 2019	AB	RX	No	No
Natco Pharma	NADOLOL AND BENDROFLUMETHIAZIDE	bendroflumethiazide; nadolol	TABLET;ORAL	078688-002	Feb 15, 2008		DISCN	No	No
Rising	NADOLOL	nadolol	TABLET;ORAL	074172-002	Oct 31, 1993	AB	RX	No	No
Sandoz	NADOLOL	nadolol	TABLET;ORAL	074501-001	Nov 9, 1995	AB	RX	No	No
Rising	NADOLOL	nadolol	TABLET;ORAL	074172-003	Oct 31, 1993	AB	RX	No	No

Market Dynamics and Financial Trajectory for Nadolol

Last updated: February 13, 2026

Nadolol is a non-selective beta-adrenergic antagonist approved by the FDA in 1981 for treating hypertension, angina pectoris, and certain arrhythmias. It is a generic drug with no recent branded product developments. Its market has remained relatively stable, constrained by generic competition and limited therapeutic innovation.

Market Size and Revenue Trends

The global beta-blocker market was valued at approximately $5.3 billion in 2021, with nadolol comprising a smaller segment due to its niche indications. Precise revenue figures for nadolol specifically are not published separately but are believed to be in the hundreds of millions globally, primarily driven by prescription volume in hypertension and arrhythmia management.

Recent sales data suggest that the nadolol market has experienced a mild decline, correlating with the widespread adoption of newer beta-blockers like atenolol, metoprolol, and bisoprolol, which offer improved side effect profiles or dosing convenience.

Competitive Landscape

Nadolol's main competitors include:

• Atenolol
• Metoprolol
• Propranolol

These alternatives have outsized market share owing to their established clinical profiles and patent statuses. Despite this, nadolol remains used in specific scenarios, such as for portal hypertension, where it is considered effective.

Regulatory and Patent Status

Nadolol is off-patent. No recent patents restrict manufacturing, facilitating generic availability. Regulatory stability is maintained, with no significant recent changes affecting its marketing status.

Pricing and Reimbursement

The average wholesale price (AWP) for nadolol is lower than branded beta-blockers, often in the $0.05 to $0.10 per tablet range. Insurance reimbursement rates are aligned with generic drug policies, limiting revenue growth potential but maintaining stable income.

Market Challenges

• Therapeutic competition: Availability of newer agents with better tolerability impacts market share.
• Clinician preferences: Frequent updates in hypertension management guidelines prioritize other beta-blockers or alternative classes like ACE inhibitors.
• Global access: In emerging markets, generic access sustains demand; in developed markets, declining prescriptions reduce revenues.

Potential Growth Areas

Limited growth prospects are tied to niche uses such as portal hypertension, where it remains a first-line therapy. Rising prevalence of cardiovascular diseases worldwide sustains some demand but not enough to significantly alter revenue trajectories.

Financial Trajectory Forecasts

Given the patent expiration and market competition, revenue from nadolol is expected to decline gradually over the next five years, approximately 2–4% annually. No major regulatory changes or development pipelines are underway to alter this trajectory.

Investment Considerations

For pharmaceutical companies, continued manufacturing of nadolol remains a low-margin, low-investment activity. For investors, changes in prescribing patterns and the emergence of new therapies for hypertension and arrhythmias diminish nadolol's market value over time.

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Key Takeaways

• Nadolol is a low-cost, off-patent generic with stable but declining sales primarily due to competition from newer beta-blockers.
• Its revenue accounts for a minor share of the overall beta-blocker market, estimated in the hundreds of millions globally.
• Market pressures and evolving clinical guidelines are expected to cause a gradual revenue decline over the next five years.
• Limited growth opportunities exist outside niche indications like portal hypertension.
• Ongoing generic manufacturing is unlikely to generate significant profit margins, given intense price competition.

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FAQs

1. What factors influence the declining market share of nadolol?
The entry of newer beta-blockers with better side effect profiles and dosing flexibility, along with clinical guideline updates favoring other therapies, reduces nadolol's prescriber preference.

2. Are there any new clinical indications for nadolol?
Currently, no new indications are under development or approved. Its use remains mainly for existing indications like portal hypertension, where it retains some clinical preference.

3. How does the pricing of nadolol compare globally?
In developed markets, prices are lower due to generic competition and reimbursement policies. In emerging markets, it remains affordable but less competitive relative to local generics.

4. Will patent protections or exclusivity impact nadolol's market?
Nadolol is off-patent with no new patents or exclusivity rights, leading to non-protected generic availability and price competition.

5. What are the prospects of innovation or reformulation for nadolol?
There are no active pipelines or reformulation efforts. Its position is stabilized as a generic therapy with no foreseeable innovation prospects.

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References

1. MarketWatch. Global Beta-Blocker Market Size & Trends. 2022.
2. U.S. Food & Drug Administration. Nadolol Product Information. 2023.
3. IQVIA. Prescription Data Reports. 2022.
4. Pharma Intelligence. Beta-Blocker Market Analysis. 2023.
5. World Health Organization. Cardiovascular Disease Statistics. 2022.