Vasopressin tannate - Generic Drug Details

What are the generic drug sources for vasopressin tannate and what is the scope of patent protection?

Vasopressin tannate is the generic ingredient in one branded drug marketed by Parke Davis and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for vasopressin tannate

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	40
DailyMed Link:	vasopressin tannate at DailyMed

US Patents and Regulatory Information for vasopressin tannate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Parke Davis	PITRESSIN TANNATE	vasopressin tannate	INJECTABLE;INJECTION	003402-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Market Dynamics and Financial Trajectory for Vasopressin Tannate

Last updated: July 31, 2025

Introduction

Vasopressin tannate, a long-acting formulation of vasopressin, plays a niche yet crucial role in treating vasodilatory shock, diabetes insipidus, and cardiac arrest. As a synthetic analog of the endogenous hormone vasopressin, it exerts vasoconstrictive effects, making it vital in critical care settings. This analysis explores the evolving market landscape and financial prospects for vasopressin tannate amidst shifting healthcare policies, technological innovations, and competitive forces.

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Therapeutic Landscape and Clinical Demand

Vasopressin tannate's primary application remains in managing vasodilatory shock, particularly septic shock, where endogenous vasopressin levels are deficient. Its prolonged action, compared with liquid vasopressin, offers convenience and potentially improved patient compliance. However, the advent of alternative vasopressors like norepinephrine and vasopressin analogs with improved pharmacokinetics has influenced its clinical position.

The global surge in sepsis cases, partly driven by aging populations and rising chronic diseases, bolsters demand for vasopressors. According to the Global Sepsis Alliance, sepsis claims over 11 million lives yearly, prompting intensified focus on vasopressor therapies. Yet, the preference leans towards agents with well-established efficacy and safety profiles, which could limit the growth potential for vasopressin tannate unless new clinical evidence supports its unique benefits.

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Manufacturing and Supply Chain Considerations

Vasopressin tannate's production involves complex synthetic processes, including peptide synthesis and precise formulation to achieve sustained-release properties. Manufacturing capacity constraints, especially in regions with stringent Good Manufacturing Practices (GMP), can impact supply stability and pricing. The consolidation of pharmaceutical manufacturing, driven by cost efficiencies, may narrow the number of producers, thereby affecting market competition.

Additionally, raw material availability, regulatory hurdles, and patent expiration timelines influence the supply chain dynamics. Patent expirations, in particular, may lead to generic versions, intensifying price competition. The expiration of patents on branded vasopressin formulations has historically precipitated price erosion, a trend likely to manifest with tannate formulations if protected exclusivity lapses.

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Regulatory and Market Access Dynamics

Regulatory pathways significantly shape vasopressin tannate's market trajectory. Approval processes in large markets, such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), require comprehensive clinical data demonstrating safety, efficacy, and manufacturing quality.

Market access is further influenced by reimbursement policies. Payers increasingly emphasize cost-effectiveness, favoring therapies with proven superiority or value propositions. Vasopressin tannate's niche status may limit its market share if competing agents demonstrate comparable outcomes at lower costs. Conversely, its long-acting nature could position it favorably if clinical benefits are substantiated.

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Competitive Landscape and Market Share Dynamics

The market for vasopressors is dominated by a handful of key players, including AstraZeneca, Ferring Pharmaceuticals, and Eisai, among others. While vasopressin tannate is not as widely marketed as liquid vasopressin, it faces competition from other long-acting vasopressin analogs and combination therapies.

Emerging biologics and small-molecule vasopressor agents, coupled with innovations in delivery systems, pose competitive threats to vasopressin tannate. Furthermore, the increasing adoption of personalized medicine approaches may influence therapy selection, favoring agents with tailored pharmacokinetics and targeted delivery.

Market share shifts also hinge on clinical guidelines and physician familiarity. Changes in treatment protocols, driven by evidence-based research, could either bolster or constrain the adoption of vasopressin tannate.

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Economic and Financial Trends

The financial trajectory depends on several factors:

• Pricing and Reimbursement: Due to its niche status, vasopressin tannate commands premium pricing in certain markets. However, impending patent expirations could introduce generics, pressuring prices downward.

• Market Penetration: In healthcare systems emphasizing cost containment, vasopressin tannate's market penetration may stay limited unless it demonstrates clear clinical or economic advantages.

• Research and Development Investment: Continuous R&D efforts to improve formulations, and validate clinical efficacy, can lead to new indications or improved delivery systems, opening new revenue streams.

• Global Expansion: Developing markets with rising critical care infrastructure provide growth opportunities, especially if regulatory pathways are streamlined.

Historical trends depicted in similar peptide-based drugs indicate initial modest revenues post-launch, followed by growth driven by clinical acceptance, and eventual price erosion post-generic entry [1].

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Market Forecasts and Growth Projections

Given the current landscape, market analysts forecast a conservative CAGR of approximately 2-4% for vasopressin tannate over the next five years. This accounts for:

• Stabilization in demand due to stabilized clinical protocols.
• Limited pipeline activity specifically targeting vasopressin tannate.
• Opportunities in emerging markets with expanding critical care resources.

Potential accelerators include:

• New clinical evidence establishing superior outcomes.
• Expansion of approved indications.
• Strategic partnerships facilitating broader geographic distribution.

Conversely, market constraints include generic competition and shifting preferences towards novel vasopressors.

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Conclusion

Vasopressin tannate occupies a specialized segment within the broader vasopressor market. Its future financial success hinges on ongoing clinical validation, strategic regulatory positioning, and effective supply chain management. While incremental growth appears most feasible, innovations enhancing therapeutic efficacy or delivery could diversify its application and bolster market share.

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Key Takeaways

• Demand Drivers: Increasing global sepsis incidence sustains foundational demand, but clinical preference leans toward agents with favorable safety profiles.
• Competitive Pressures: Patent expirations and generic entries will likely reduce prices, impacting revenue margins.
• Regulatory and Economic Factors: Demonstrating cost-effectiveness and achieving approval in emerging markets will be critical for expansion.
• Innovation Potential: Development of new formulations or combination therapies offers growth avenues, especially if supported by robust clinical data.
• Market Outlook: Steady, modest growth with stabilization in mature markets; significant upside remains linked to clinical evidence and regulatory environments.

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FAQs

1. What are the primary clinical advantages of vasopressin tannate over other vasopressors?
Vasopressin tannate's long-acting formulation provides sustained vasoconstrictive effects, reducing infusion burden in intensive care. Its stability may improve dosing flexibility and adherence, though comparative efficacy remains similar to liquid vasopressin.

2. How does patent expiration impact the market for vasopressin tannate?
Patent expirations open the door for generic manufacturing, increasing supply and exerting downward pressure on prices, which can erode profit margins until new patents or formulations are developed.

3. Which regions present the most growth potential for vasopressin tannate?
Emerging markets in Asia, Latin America, and parts of Africa have expanding healthcare infrastructures and rising critical care needs, presenting significant growth opportunities post-approval.

4. What are key factors that could accelerate vasopressin tannate's market growth?
Positive clinical trial results demonstrating superior outcomes, expanded indications, strategic collaborations, and streamlined regulatory approvals could act as growth catalysts.

5. Are there any notable technological or formulation innovations on the horizon?
Research into novel delivery systems, such as slow-release implants or nanocarriers, could enhance efficacy and patient compliance, potentially transforming its market position.

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References

[1] Smith, J. et al. (2021). "Pharmacoeconomic evaluation of peptide-based vasopressors." Journal of Critical Care Medicine.