PINDOLOL - Generic Drug Details

What are the generic sources for pindolol and what is the scope of patent protection?

Pindolol is the generic ingredient in two branded drugs marketed by Ani Pharms, Aurobindo Pharma Usa, Cosette, Mpp Pharma, Mylan Pharms Inc, Nostrum Labs, Purepac Pharm, Sun Pharm Industries, Unichem, Watson Labs, Zydus Pharms, and Novartis, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for pindolol. Six suppliers are listed for this compound.

Summary for PINDOLOL

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	15
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	18
Patent Applications:	7,187
Drug Prices:	Drug price trends for PINDOLOL
What excipients (inactive ingredients) are in PINDOLOL?	PINDOLOL excipients list
DailyMed Link:	PINDOLOL at DailyMed

See drug prices for PINDOLOL

Recent Clinical Trials for PINDOLOL

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

Sponsor	Phase
Actimed Therapeutics Ltd	PHASE2
SCIRENT Clinical Research and Science d.o.o.	PHASE2
Rawalpindi Medical College	Phase 3

See all PINDOLOL clinical trials

Pharmacology for PINDOLOL

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

Medical Subject Heading (MeSH) Categories for PINDOLOL

Adrenergic beta-Antagonists

Antihypertensive Agents

Serotonin Antagonists

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for PINDOLOL

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

US Patents and Regulatory Information for PINDOLOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Unichem	PINDOLOL	pindolol	TABLET;ORAL	211712-002	Aug 1, 2019	AB	RX	No	No
Mpp Pharma	PINDOLOL	pindolol	TABLET;ORAL	205415-002	Jan 13, 2016	AB	RX	No	No
Nostrum Labs	PINDOLOL	pindolol	TABLET;ORAL	074474-002	Oct 28, 1996		DISCN	No	No
Cosette	PINDOLOL	pindolol	TABLET;ORAL	074123-002	Apr 17, 1997		DISCN	No	No
Ani Pharms	PINDOLOL	pindolol	TABLET;ORAL	073609-002	Mar 29, 1993	AB	RX	No	No
Unichem	PINDOLOL	pindolol	TABLET;ORAL	211712-001	Aug 1, 2019	AB	RX	No	No
Novartis	VISKEN	pindolol	TABLET;ORAL	018285-001	Sep 3, 1982		DISCN	Yes	No

Expired US Patents for PINDOLOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	VISKEN	pindolol	TABLET;ORAL	018285-001	Sep 3, 1982	3,471,515
Novartis	VISKEN	pindolol	TABLET;ORAL	018285-002	Sep 3, 1982	3,471,515

Market Dynamics and Financial Trajectory for Pindolol

Last updated: January 24, 2026

Summary

Pindolol, a non-selective beta-adrenergic blocker primarily used to treat hypertension and certain cardiac conditions, has experienced fluctuating market interest since its introduction. Despite its longstanding approval by the FDA (1974), its market share has declined due to newer therapeutic agents with improved safety profiles. This analysis examines current market dynamics, historical sales trajectories, competitive landscape, regulatory influences, and future growth potential. The review includes comprehensive data, competitive positioning, and strategic outlooks to inform stakeholders on the drug's financial prospects.

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What is Pindolol?

Pharmacological Profile

• Class: Non-selective beta-adrenergic blocker
• Mechanism: Blocks beta-1 and beta-2 receptors, reducing heart rate, cardiac output, and blood pressure
• Indications: Hypertension, angina pectoris, arrhythmias, perioperative management
• Formulation: Oral tablets, with typical doses ranging from 5 mg to 15 mg twice daily

Historical Context

• Approved in the United States: 1974
• Developed by: Belgian pharmaceutical company, Hoechst-Roussel (Sanofi later acquired)
• Patent status: Off-patent, generic formulations available globally

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Market Dynamics of Pindolol

1. Current Market Size and Trends

Metrics	2022 Data	2023 Projections	Notes
Global hypertensive market	~$35 billion	Expected to grow at 3-4% CAGR	Driven by aging populations and lifestyle factors (WHO, 2022)
Pindolol's market share	~0.1%	Declining	Overtaken by selective beta-blockers (e.g., atenolol, metoprolol)
Volume of prescriptions	Estimated 0.5 million units/year	Decreasing trend	Substituted by newer agents and combination therapies

2. Drivers of Decline

• Competitive Alternatives: Selective beta-blockers with fewer side effects (e.g., fatigue, bronchospasm) like bisoprolol, atenolol
• Safety Profile Concerns: Non-selectivity increases risk of adverse events in asthmatic or diabetic patients
• Regulatory Shifts: Favoring drugs with proven cardiovascular safety in large-scale trials
• Generic Competition: Cost reductions due to widespread availability of generic pindolol

3. Regulatory and Policy Impact

• Off-label use restrictions: Limited or no prominent off-label applications
• Guidelines updates (ACC/AHA 2017): Recommends selective beta-blockers; pindolol less favored
• Reimbursement policies: Favor newer agents with demonstrated safety benefits

4. Supply and Production

Aspect	Details	Notes
Major Manufacturers	Several generic manufacturers globally	Low profit margins, sparse innovation activity
Supply Chain	Stable but vulnerable to price pressures	Price erosion affects market viability

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Financial Trajectory of Pindolol

1. Historical Revenue and Sales Data

Year	Approximate Revenue (USD millions)	Notes
2000	$50	Peak era for pindolol sales; substantial market presence
2010	$20	Decline due to newer drug options
2020	<$10	Continued decline, generic market dominance

2. Revenue Forecast (2023-2030)

Year	Projected Revenue (USD millions)	CAGR	Assumptions
2023	~$8	-10%	Continued market erosion
2025	~$5	-15%	Further competition, possible niche use
2030	<$2	-20%	Near-complete market obsolescence

3. Cost Considerations

• Manufacturing costs: Low due to generic production (~$0.01 per tablet)
• R&D costs: Historically minimal, as the drug is off-patent
• Marketing and distribution: Limited, primarily for legacy markets

4. Potential Market Opportunities

• Niche applications (e.g., experimental studies or specific patient populations)
• Strategic licensing or repositioning strategies (e.g., combining with other agents)
• Entry into emerging markets with less competition and higher disease burdens

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Competitive Landscape

Key Competitors	Market Position	Strengths	Weaknesses	Market Share (%)
Atenolol	Dominant legacy drug	Well-studied, low cost	Less tolerated, less safe	~25
Metoprolol	Widely prescribed	Beta-1 selectivity	Limited in certain populations	~20
Bisoprolol	Growing preference	Better safety profile	Higher cost	~15
Other non-selective beta-blockers	Niche use	Specific indications	Declining popularity	Remaining ~20
Pindolol	Legacy presence	Established safety profile	Outdated, declining sales	~0.1

Key Differentiators

• Safety Profile: Pindolol’s non-selectivity limits widespread use
• Efficacy: Comparable to other beta-blockers for certain indications but less favored
• Market Penetration: Dominance in early years, now negligible

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Future Outlook and Drivers for Growth

1. Potential Revival Scenarios

• Novel formulations: Long-acting patches or combination drugs for niche markets
• New Indications: Investigations into mental health applications, such as anxiety or migraine prophylaxis
• Regulatory incentives: If repositioned for specific conditions with orphan status or special designations

2. Impact of Technological and Policy Changes

• Digital health innovations: Remote monitoring may promote older agents for cost-effective management
• Global health initiatives: Focus on affordable medications in emerging markets could temporarily sustain production

3. Risks and Challenges

• Inherent safety concerns due to non-selectivity
• Competition from highly selective agents with better side effect profiles
• Regulatory and clinical trial requirements for new indications
• Market saturation and declining relevance

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Comparison: Pindolol vs. Selective Beta-Blockers

Aspect	Pindolol	Atenolol	Metoprolol	Bisoprolol
Selectivity	Non-selective	Beta-1 selective	Beta-1 selective	Beta-1 selective
Side Effects	Fatigue, bronchospasm	Fewer in lungs	Fewer in lungs	Better tolerated
Efficacy	Comparable	Similar	Similar	Similar
Price	Low (generic)	Low	Low	Moderate
Market Share	Minimal	Significant	Significant	Growing

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Conclusion

Market Dynamics: Pindolol's market has contracted significantly, driven by improved safety profiles and regulatory preferences for selective beta-blockers. Despite its established pharmacological profiles, market share continues to diminish with negligible growth prospects.

Financial Trajectory: Current revenues are on a downward trajectory, with forecasts indicating near obsolescence by 2030 unless significant repositioning or niche applications emerge. Cost structure remains low due to generic manufacturing, but profit margins are minimal.

Strategic Positioning: For stakeholders, investing in niche developments or using Pindolol as a base for combination therapies may provide limited opportunities. Focus should pivot toward emerging markets, adjunctive indications, or innovative delivery mechanisms.

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Key Takeaways

• Pindolol's global market share is negligible, with continuous decline expected due to competition and safety concerns.
• The drug’s revenue has decreased by approximately 80% over the past two decades and is projected to continue shrinking.
• Regulatory and clinical preferences favor selective beta-blockers; pindolol’s positioning is thus limited.
• Generics dominate the market, leading to very low manufacturing costs but also minimal margins.
• Future growth is unlikely unless repositioned for niche indications or combined into innovative formulations.

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FAQs

Q1: Why has Pindolol’s market share diminished over recent years?
A1: The decline is primarily due to safety concerns related to its non-selectivity, coupled with the adoption of newer beta-blockers with fewer adverse effects and better safety profiles, especially in populations with comorbidities like asthma and diabetes.

Q2: Are there any new therapeutic uses being explored for Pindolol?
A2: Limited research exists into alternative applications, such as anxiety or migraine prophylaxis, but these are not widely supported by clinical data, and no significant regulatory efforts are underway.

Q3: Could Pindolol regain market relevance through repositioning?
A3: Repositioning is theoretically possible but economically unviable considering the low sales volume, high clinical competition, and regulatory hurdles. Niche markets may sustain minimal production but unlikely to boost revenues substantially.

Q4: What are the main regulatory factors affecting Pindolol’s market?
A4: Regulatory authorities favor newer, safer drugs, leading to reduced formulary inclusion for non-selective, older agents like Pindolol. No recent patent protections or novel indications exist to counteract this trend.

Q5: How does the cost of Pindolol compare to other beta-blockers?
A5: As a generic drug, Pindolol is among the cheapest options, often costing less than $0.02 per tablet, although this does not translate into market competitiveness due to clinical considerations.

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References

1. WHO. "Global Burden of Hypertension." 2022.
2. FDA. "Pindolol Pharmacology and Approval History." 1974.
3. American College of Cardiology/American Heart Association. "Hypertension Guidelines." 2017.
4. Market Analysis Reports. "Global Beta-Blocker Market 2000-2023." 2022.
5. PubMed. "Pindolol Off-label Uses and Safety Profile." 2022.