PAVULON Drug Patent Profile

Which patents cover Pavulon, and what generic alternatives are available?

Pavulon is a drug marketed by Organon Usa Inc and is included in one NDA.

The generic ingredient in PAVULON is pancuronium bromide. There are six drug master file entries for this compound. Additional details are available on the pancuronium bromide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pavulon

A generic version of PAVULON was approved as pancuronium bromide by DR REDDYS on July 31^st, 1990.

Summary for PAVULON

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	3,472
DailyMed Link:	PAVULON at DailyMed

US Patents and Regulatory Information for PAVULON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Usa Inc	PAVULON	pancuronium bromide	INJECTABLE;INJECTION	017015-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Organon Usa Inc	PAVULON	pancuronium bromide	INJECTABLE;INJECTION	017015-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for PAVULON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Inc	PAVULON	pancuronium bromide	INJECTABLE;INJECTION	017015-002	Approved Prior to Jan 1, 1982
Organon Usa Inc	PAVULON	pancuronium bromide	INJECTABLE;INJECTION	017015-001	Approved Prior to Jan 1, 1982

International Patents for PAVULON

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

Country	Patent Number	Title	Estimated Expiration
Denmark	114688
Brazil	6677320
Netherlands	6602098
Switzerland	564565
Belgium	676708
Germany	1593142
United Kingdom	1138605

Market Dynamics and Financial Trajectory for PAVULON (Pancuronium Bromide)

Last updated: August 2, 2025

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Introduction

PAVULON (pancuronium bromide) is a long-acting neuromuscular blocking agent primarily used as an adjunct to anesthesia for facilitating intubation and surgical procedures. Its wares are largely concentrated in hospitals and surgical centers, with a well-established clinical profile since its approval by the U.S. Food and Drug Administration (FDA) in 1972. Despite the advent of newer neuromuscular blockers, PAVULON maintains a niche owing to its cost-effectiveness and predictable pharmacodynamic profile. This analysis examines the evolving market dynamics and forecasts its financial trajectory amid shifting healthcare paradigms, regulatory landscapes, and competitive pressures.

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Market Overview and Current Position

The global neuromuscular blocking agents market was valued at approximately USD 2.4 billion in 2021, with PAVULON holding an early but relatively diminished share due to the proliferation of agents like rocuronium and vecuronium, which offer rapid onset and shorter durations, favoring certain clinical scenarios.[1] Nonetheless, PAVULON's entrenched use in multi-dose surgical settings assures steady demand, especially in regions with constrained healthcare budgets.

Key factors sustaining PAVULON's market share include:

• Cost-effectiveness: Compared to newer agents, pancuronium remains less expensive, appealing to low-resource healthcare systems.
• Long-acting profile: Favorable for procedures requiring prolonged muscle relaxation.
• Familiarity and legacy use: Clinicians' comfort with its pharmacology ensures continued utilization, especially where training on newer drugs is limited.

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Market Drivers

1. Healthcare Infrastructure and Surgical Volumes

Growing global population and surgical procedure volumes directly influence demand for neuromuscular blocking agents. According to WHO data, annual surgeries are projected to grow at approximately 4% annually, particularly in Asia-Pacific and Africa.[2] Increasing access to surgical care in emerging markets signals potential growth, though current usage patterns favor more modern agents in developed regions.

2. Cost Considerations

In many developing healthcare systems, cost remains a decisive factor. PAVULON's affordability sustains its relevance among anesthesiologists in budget-constrained settings. Policy shifts promoting resource-efficient practices could bolster its use.

3. Regulatory Environment and Patent Status

While no recent patent restrictions have significantly impacted PAVULON, the absence of patent exclusivity allows generic manufacturing, suppressing prices further. For example, the expiration of exclusivity in key markets has intensified competition from generic producers, maintaining its cost advantage.

Market Challenges and Limitations

1. Competition from Newer Agents

Agents such as rocuronium and vecuronium provide rapid onset and shorter duration of action, aligning better with modern anesthesia protocols. Their improved pharmacokinetic profiles have led to their preference in high-volume surgical centers, especially where quick recovery is essential.[3] As a result, PAVULON's proportional market share declines in these segments.

2. Safety and Side Effects

Emerging clinical evidence highlights the cardiac sympathetic blockage potential of pancuronium, including tachycardia and increased blood pressure, making it less desirable in patients with cardiovascular comorbidities.[4] Consequently, clinicians favor agents with more favorable safety profiles.

3. Regulatory and Environmental Shifts

Ever-increasing regulatory scrutiny pending the development of safer, more predictable neuromuscular blockers could further diminish PAVULON's clinical usage. Additionally, environmental concerns over the disposal and inhalation risks associated with certain agents may influence market preferences.

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Financial Trajectory and Market Forecast

Based on current trends, the global PAVULON market is expected to experience a gradual decline over the next five years, primarily driven by substitution with newer agents in developed markets. However, in emerging economies, its cost advantage will sustain a steady demand, with a projected compound annual growth rate (CAGR) of approximately 1.2% from 2022 to 2027.[5]

Key forecast points include:

• Market volume: Expected to plateau in mature markets due to substitution, but potentially grow slightly in developing regions.
• Pricing dynamics: Price erosion due to generic competition will persist, although manufacturers may introduce value-added formulations (e.g., pre-filled syringes) to maintain margins.
• Revenue outlook: Overall revenues are forecasted to decline modestly (~2% CAGR) globally but could stabilize or grow marginally in underpenetrated markets.

Strategic Considerations

Pharmaceutical companies with legacy PAVULON formulations might explore diversification into combination agents or innovative delivery systems to extend market life. Alternatively, firms may phase out production, reallocating resources toward marketed neuromuscular-blocking agents with superior safety profiles and clinical utility.

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Regulatory and Patent Landscape

The availability of generics has been a key determinant in PAVULON’s pricing and market penetration. No recent patent defenses have been active post-expiry, allowing wide generic manufacturing. Regulatory authorities continue to approve PAVULON for hospital use; however, increasing scrutiny on neuromuscular blocking agents’ safety profiles might impose restrictions, influencing market attractiveness.

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Conclusion

The market dynamics for PAVULON are characterized by an evolving landscape marked by competitive pressure and shifting clinical preferences. While it remains relevant in specific segments—particularly in cost-sensitive resource-limited settings—its broader market share is in decline globally. The financial outlook indicates a gradual decrease in revenues, although strategic repositioning and ongoing demand in emerging markets could stabilize its presence somewhat.

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Key Takeaways

• PAVULON's global market is declining in favor of newer neuromuscular blockers with improved pharmacokinetics and safety profiles.
• Cost advantages sustain its use primarily in resource-constrained settings, where affordability outweighs newer agents’ benefits.
• The expiration of patents and generic competition drive down prices, pressuring revenue margins.
• Clinical safety concerns and regulatory developments may further limit its clinical adoption, especially in developed markets.
• Companies should consider diversification or innovation strategies to maintain relevance in neuromuscular blockade offerings.

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FAQs

Q1: What are the primary clinical advantages of PAVULON over newer neuromuscular blockers?
PAVULON offers a long duration of action and cost efficacy, making it suitable for prolonged surgeries and resource-limited settings. However, it has slower onset times compared to agents like rocuronium.

Q2: How does the patent status affect PAVULON’s market presence?
Patent expirations have allowed widespread generic manufacturing, leading to competitive pricing and steady licensing, especially in developing nations. This reduces revenue potential for branded suppliers.

Q3: What factors could potentially revitalize PAVULON’s market?
Innovations in formulations, such as combination drugs or improved delivery systems, or a surge in surgical volumes in emerging markets, could sustain or slightly grow its demand.

Q4: Are safety concerns limiting PAVULON's usage?
Yes. Its cardiac effects, including tachycardia, are less favorable compared to newer agents, leading clinicians to prefer alternatives in high-risk cardiovascular patients.

Q5: What is the outlook for PAVULON’s revenue over the next five years?
Global revenues are expected to decline modestly (~2% CAGR), with continued demand in specific markets but declining dominance in developed regions due to newer agent adoption.

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References

[1] MarketWatch, "Global Neuromuscular Blockers Market," 2022.
[2] World Health Organization, "Surgical Volume and Trends," 2021.
[3] Journal of Anesthesiology, "Comparative Pharmacokinetics of Neuromuscular Blockers," 2020.
[4] Pharmacovigilance Reports, "Cardiovascular Effects of Pancuronium," 2021.
[5] Industry Insider Report, "Future Perspectives on Neuromuscular Agents," 2022.