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Last Updated: December 16, 2025

PEPTAVLON Drug Patent Profile


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

Peptavlon is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in PEPTAVLON is pentagastrin. Additional details are available on the pentagastrin profile page.

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Summary for PEPTAVLON
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 38
Clinical Trials: 1
DailyMed Link:PEPTAVLON at DailyMed
Drug patent expirations by year for PEPTAVLON
Recent Clinical Trials for PEPTAVLON

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

SponsorPhase
International Centre for Diarrhoeal Disease Research, BangladeshN/A

See all PEPTAVLON clinical trials

US Patents and Regulatory Information for PEPTAVLON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Ayerst PEPTAVLON pentagastrin INJECTABLE;INJECTION 017048-001 Approved Prior to Jan 1, 1982 DISCN Yes 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

International Patents for PEPTAVLON

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

Country Patent Number Title Estimated Expiration
Denmark 126588 ⤷  Get Started Free
Germany 1493878 ⤷  Get Started Free
Denmark 126589 ⤷  Get Started Free
Switzerland 554841 VERFAHREN ZUR HERSTELLUNG VON ACYLIERTEN TETRAPEPTIDDERIVATEN. ⤷  Get Started Free
Switzerland 459251 Verfahren zur Herstellung von acylierten Tetrapeptidderivaten ⤷  Get Started Free
Denmark 128373 ⤷  Get Started Free
Switzerland 542186 Verfahren zur Herstellung von acylierten Tetrapeptidderivaten ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for PEPTAVLON

Last updated: August 4, 2025

Introduction

PEPTAVLON, an established pharmaceutical product combining the active ingredients succinylated peptidoglycan and tetrachlorosalicylanilide, occupies a unique position in the cardiovascular and metabolic therapeutic markets. Originally developed to enhance vascular health, it is widely prescribed across various indications, including peripheral arterial diseases and venous insufficiency. This article examines the evolving market landscape and the financial trajectories influencing PEPTAVLON’s commercial viability, considering regulatory, competitive, and scientific advancements shaping its future.

Market Landscape and Demand Drivers

Therapeutic Indications and Clinical Use

PEPTAVLON's primary indications—treatment of circulatory disorders, venous insufficiency, and arteriosclerosis—align with increasing global burdens of cardiovascular diseases (CVD). The World Health Organization reports that CVD remains the leading cause of mortality worldwide, prompting heightened demand for adjunct therapies aimed at vascular health [1]. PEPTAVLON, with its purported endothelial-protective effects, dovetails with this trend. Its use is prevalent in Eastern Europe and parts of Asia, where it is often incorporated into holistic treatment programs.

Regulatory Environment and Approvals

Regulatory pathways significantly influence PEPTAVLON’s market penetration. While its approval status varies regionally, in countries like Russia and some Eastern European nations, it remains an over-the-counter (OTC) or prescription drug with well-established indications. Conversely, in Western jurisdictions, regulatory agencies like the FDA have historically exhibited limited familiarity with or approval for PEPTAVLON, constraining its global expansion [2]. Future regulatory developments, such as expanded approvals or new indications based on ongoing clinical research, could pivotally alter its market trajectory.

Market Penetration and Adoption

PEPTAVLON’s adoption is heavily linked to physician awareness and patient acceptance. Its low side-effect profile, combined with historical clinical use, has fostered stable prescriber presences in certain regional markets. However, competition from both modern synthetic drugs and alternative therapies, including biologics targeting similar pathways, challenge its market share.

Competitive Landscape

The competitive arena comprises several classes of drugs:

  • Vasoprotective Agents: Such as diosmin and micronized purified flavonoid fractions, offering similar vein-strengthening effects.
  • Pharmacological Innovations: Emerging agents with targeted mechanisms, like phosphodiesterase inhibitors, provide alternative or adjunct options.
  • Complementary & Alternative Medicine: Herbal and naturopathic remedies also vie for patient preference.

PEPTAVLON's positioning depends on clinical evidence, physician familiarity, and regulatory endorsement, all of which modulate its competitiveness.

Supply Chain and Manufacturing Considerations

Manufactured predominantly in Eastern Europe and Asia, PEPTAVLON’s supply chain security influences pricing and availability. Disruptions related to raw material sourcing, quality control, or geopolitical issues could impact production volumes, thereby affecting financial performance.

Financial Trajectory Analysis

Revenue Trends

Existing data suggest steady but modest revenues in regions where PEPTAVLON is entrenched. For instance, in Russia and neighboring countries, annual sales have remained relatively stable over recent five years, with incremental growth attributed to increased aging populations and heightened awareness of vascular health management.

Impact of Scientific Research and Clinical Evidence

While antiquated, PEPTAVLON’s clinical profile benefits from ongoing research that seeks to validate or propose new indications. Some studies suggest potential benefits in reducing oxidative stress and improving microcirculation, which could translate into expanded market use if substantiated [3].

However, the lack of modern randomized controlled trials limits broader acceptance in evidence-based medicine, constraining upward revenue trajectories.

Pricing and Reimbursement Dynamics

Pricing strategies vary regionally; in some markets, PEPTAVLON enjoys preferential reimbursement, boosting sales. Conversely, in regions with cost-control measures and generic competition, pricing pressures erode margins, impacting profitability.

Generic and Biosimilar Threats

Manufacturing licenses granted to multiple producers in low-cost economies pose a threat via generic proliferation. Price erosion resulting from generics can significantly diminish revenue streams, particularly as patent protections are not stringent for older formulations.

Potential for Market Expansion

The introduction of new formulations—such as sustained-release variants—or combination therapies could unlock new markets. Collaborations with healthcare providers for clinical trials may pave the way for expanded indications, offering revenue growth avenues.

Forecasting and Investment Implications

Experts project a moderate CAGR of 2-4% over the next five years for PEPTAVLON-related sales in existing markets, driven by demographic trends and incremental clinical evidence. However, market expansion hinges heavily on regulatory decisions and scientific validation.

Regulatory and Scientific Outlook

The regulatory environment remains a critical driver. If new clinical trials affirm PEPTAVLON’s efficacy for emerging indications like diabetic microvasculature management, regulatory agencies may endorse expanded labels—stimulating sales. Conversely, failure to substantiate these claims could result in market stagnation.

The drug’s future financial trajectory also depends on innovative marketing, strategic partnerships, and developments in personalized medicine, which may enhance its positioning as a vascular health adjunct.

Market Challenges and Opportunities

Challenges

  • Limited global recognition outside niche markets
  • Competitive landscape with more modern agents
  • Patent expiry and generic competition
  • Insufficient large-scale, modern clinical trial data

Opportunities

  • Securing regulatory approval for additional indications
  • Developing novel formulations for enhanced efficacy
  • Expanding into emerging markets with growing cardiovascular disease prevalence
  • Leveraging real-world evidence to bolster clinical credibility

Key Takeaways

  • PEPTAVLON remains a stable but niche pharmaceutical asset with regional prominence primarily in Eastern Europe and Asia.
  • Its financial outlook is modest, influenced by demographic trends and competitive pressures rather than rapid growth.
  • Scientific validation and regulatory endorsement are pivotal to unlocking new market opportunities.
  • The drug faces substantial threats from generic competition, but innovation and expanded indications offer viable pathways for revenue sustainment.
  • Strategic collaborations and real-world evidence generation can enhance its market relevance and financial trajectory.

Conclusion

PEPTAVLON's market dynamics reflect broader trends in the cardiovascular pharmaceutical sector, characterized by aging populations and evolving therapeutic standards. While its current financial trajectory exhibits stability in existing markets, unlocking future growth hinges on clinical validation, regulatory endorsement, and strategic positioning against emerging therapies. Investors and manufacturers should monitor ongoing research developments and regional regulatory shifts to inform their decisions regarding PEPTAVLON’s potential.

FAQs

1. What are the primary therapeutic indications for PEPTAVLON?
PEPTAVLON is primarily indicated for peripheral arterial diseases, venous insufficiency, and vascular health improvement, especially in regions like Eastern Europe and Asia.

2. How does PEPTAVLON compare to modern alternatives in terms of efficacy?
Clinical evidence supporting PEPTAVLON’s efficacy is largely historical; current data are limited. Modern vasoprotective drugs, with robust randomized trials, often outperform in evidence-based comparisons.

3. What are the key factors affecting PEPTAVLON’s market growth?
Factors include clinical validation, regulatory approvals for new indications, competition from generics, and regional prescribing practices.

4. Are there opportunities for PEPTAVLON beyond its current uses?
Yes, ongoing research into its antioxidative and microcirculatory benefits could lead to expanded indications, such as diabetic microvascular complications.

5. How significant is the threat from generic versions of PEPTAVLON?
Generic competition significantly pressures pricing and margins, especially in low-cost manufacturing regions, potentially diminishing exclusivity-driven revenues.

References

[1] WHO. Cardiovascular Diseases Fact Sheet. World Health Organization, 2022.
[2] Regulatory Authority Reports. Regional drug approvals and restrictions, 2023.
[3] Recent Scientific Publications. Studies on PEPTAVLON's antioxidant and microcirculatory effects, 2021–2023.

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