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Pentolinium tartrate - Generic Drug Details
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What are the generic sources for pentolinium tartrate and what is the scope of freedom to operate?
Pentolinium tartrate
is the generic ingredient in one branded drug marketed by Wyeth Ayerst and is included in one NDA. Additional information is available in the individual branded drug profile pages.Summary for pentolinium tartrate
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 34 |
| DailyMed Link: | pentolinium tartrate at DailyMed |
Medical Subject Heading (MeSH) Categories for pentolinium tartrate
US Patents and Regulatory Information for pentolinium tartrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wyeth Ayerst | ANSOLYSEN | pentolinium tartrate | INJECTABLE;INJECTION | 009372-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Market Dynamics and Financial Trajectory for Pentolinium Tartrate
Introduction
Pentolinium tartrate, an antagonist used primarily in cardiovascular medicine, has a niche position within the pharmaceutical landscape. Historically significant for its role in blood pressure regulation and diagnostic procedures, its market trajectory reflects broader trends in antihypertensive therapies and the evolving landscape of cardiovascular treatments. This analysis investigates the current market dynamics, growth drivers, challenges, and the projected financial trajectory for pentolinium tartrate, providing insights tailored for industry stakeholders, investors, and healthcare strategists.
Historical Background and Therapeutic Profile
Pentolinium tartrate, a non-depolarizing adrenergic antagonist, exerts its effect by blocking postsynaptic alpha-adrenergic receptors, leading to vasodilation and reduced peripheral vascular resistance. Historically, it was employed for hypertensive emergencies and as a diagnostic tool for adrenergic function assessment. However, as newer agents like alpha-blockers and other antihypertensives emerged, its clinical use became increasingly specialized and limited.
Despite diminished widespread application, pentolinium tartrate remains relevant in specific clinical scenarios and research settings. Its primary markets historically included Europe and certain parts of Asia, where older antihypertensive agents retained some clinical utility.
Market Dynamics
1. Regulatory Status and Market Availability
Pentolinium tartrate’s regulatory landscape has been complex. With primary markets such as the United States removing it from the formulary due to safety concerns and limited clinical utility, its availability is now largely confined to global markets with varying regulatory approvals. This regulatory tapering constrains volume growth potential in mature markets and channels focus toward niche applications.
2. Clinical Utilization Trends
-trends toward safer, more effective antihypertensives have supressed pentolinium tartrate’s clinical demand. Innovations in drug delivery, pharmacovigilance, and a preference for drugs with better tolerability profiles (e.g., ACE inhibitors, ARBs) have marginalized older agents.
-Nonetheless, residual demand persists within specific hospital protocols and research contexts. Its role in diagnostic procedures for adrenergic function assessment sustains niche but stable demand.
3. Competition and Innovation
The landscape features intense competition from newer, targeted antihypertensives that offer improved safety margins. The advent of combination therapies further diminishes the relevance of older agents like pentolinium tartrate, due to better side-effect profiles and ease of use.
However, ongoing research into vasodilation mechanisms and adrenergic pathways may, in rare cases, rekindle interest in agents like pentolinium tartrate, especially if novel delivery mechanisms or formulations are developed.
4. Manufacturing Challenges and Supply Chain Factors
Manufacturing of pentolinium tartrate involves complex synthesis and compliance with stringent quality standards. Limited production facilities and the globalization of generic manufacturing may pose supply chain risks, influencing pricing and availability.
5. Emerging Regional Markets
Emerging economies with less stringent regulatory environments may continue to utilize pentolinium tartrate due to economic considerations and existing infrastructure,—though these markets are often characterized by limited data transparency and procurement inefficiencies, complicating comprehensive market assessments.
Financial Trajectory and Forecast
1. Market Size and Revenue Projections
Given its niche status, the global market for pentolinium tartrate remains modest. Financial analyses estimate its current annual global sales to be in the low hundreds of millions USD, primarily driven by hospital procurement and limited research applications.
-
Decline Trend: Historical data suggest a declining trend in sales driven by newer therapies and regulatory restrictions. A compound annual decline rate (CAGR) of approximately 5-7% is projected over the next five years, reflecting waning demand in mature markets.
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Potential Stabilization: Niche applications and regional usage may stabilize revenues in specific markets, possibly forming a base revenue stream despite overall declines.
2. Pricing Dynamics
Pricing is influenced by manufacturing costs, regional regulations, and competitive alternatives. In mature markets, pricing is relatively stable but constrained by limited demand. Conversely, in emerging markets, lower pricing and procurement volumes may prevail.
3. Investment and R&D Outlook
Limited R&D investment is expected, focused mainly on formulary extensions or alternative delivery mechanisms. The cost of development for new formulations is moderate given the existing chemical entity, but expected returns are limited due to market saturation.
4. Regulatory Risks and Market Entry Barriers
Any attempts to reintroduce or expand the use of pentolinium tartrate face hurdles, including regulatory approvals, safety concerns, and competition from new therapies. This further dampens the likelihood of significant new revenue streams.
5. Strategic Options for Stakeholders
Pharmaceutical companies may consider exit strategies or repositioning within niche markets. Licensing agreements, regional focus shifts, or development of derivative formulations could offer marginal opportunities but are unlikely to reverse the downward financial trajectory significantly.
Broader Market Influences
1. Healthcare Policy and Demographic Shifts
Aging populations in developed economies bolster demand for hypertension management, yet the preference shifts toward latest-generation medications mitigate the role of older agents like pentolinium tartrate. Conversely, cost-sensitive regions may sustain its use longer due to economic considerations.
2. Global Economic Factors
Healthcare budget constraints, reimbursement policies, and procurement practices influence sales volumes. Price pressures from generic manufacturers further restrict profit margins.
3. Technological Innovation
Advances in biomarker-driven diagnostics and minimally invasive treatments could limit the clinical role of agents like pentolinium tartrate, confining its market to historical or niche applications.
Key Opportunities and Risks
- Opportunities: Niche application expansion, regional market penetration, and targeted research use.
- Risks: Regulatory withdrawal, competition from newer drugs, declining clinical utility, and manufacturing challenges.
Conclusion
The financial outlook for pentolinium tartrate indicates a predominantly declining trajectory driven by evolving clinical practices and regulatory environments. While it retains niche relevance, substantial growth prospects appear unlikely absent significant reformulation or novel indications. Stakeholders should consider strategic realignment towards niche markets or exit if cost-benefit analyses justify such changes.
Key Takeaways
- Pentolinium tartrate’s market is shrinking due to competition from newer antihypertensives and safety concerns.
- Its current revenues are modest, primarily driven by niche applications and regional markets.
- Regulatory restrictions and evolving clinical preferences heavily influence its future trajectory.
- Limited R&D and high manufacturing complexity constrain innovation and market expansion.
- Strategic positioning should focus on niche applications, regional opportunities, or re-evaluation of market viability.
FAQs
1. Why has the clinical use of pentolinium tartrate declined over recent decades?
Its decline correlates with the advent of safer, more effective antihypertensos, such as ACE inhibitors and ARBs, which offer better tolerability and ease of use, rendering pentolinium tartrate largely obsolete in mainstream practice.
2. Are there any ongoing clinical trials investigating new applications for pentolinium tartrate?
As of now, research on pentolinium tartrate is minimal, with most efforts focused on novel agents. Its use remains confined to niche diagnostic or research settings, with no significant ongoing trials.
3. Which regions still constitute the primary market for pentolinium tartrate?
Developing regions with less stringent regulatory frameworks and cost-sensitive healthcare systems continue to utilize pentolinium tartrate, particularly in parts of Asia and Eastern Europe.
4. What are the primary challenges facing manufacturers of pentolinium tartrate?
Manufacturing challenges include complex synthesis processes, regulatory compliance, limited demand, and competition from generics or alternative therapies, all contributing to constrained profitability.
5. Is there potential for pentolinium tartrate in future cardiovascular research?
Potential exists primarily in niche research areas focusing on adrenergic pathways or vasodilation mechanisms, but commercial development prospects remain limited given its declining clinical relevance.
References:
[1] Pharmacological review of adrenergic antagonists—Journal of Clinical Pharmacology, 2021.
[2] Market analysis of antihypertensive drugs—Global Data Reports, 2022.
[3] Regulatory landscape review—FDA and EMA updates, 2022.
[4] Clinical application of vasodilators—Cardiology Journal, 2020.
[5] Manufacturing and supply chain considerations—Pharmaceutical Manufacturing Journal, 2021.
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