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Last Updated: March 19, 2026

vasopressin - Profile


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

Vasopressin is the generic ingredient in five branded drugs marketed by Am Regent, Amneal, Amphastar Pharms Inc, Cipla, Dr Reddys, Eagle Pharms, Eugia Pharma, Fresenius Kabi Usa, Gland, Baxter Hlthcare Corp, Long Grove Pharms, Ph Health, and Parke Davis, and is included in thirteen NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There is one tentative approval for this compound.

Summary for vasopressin
Generic filers with tentative approvals for VASOPRESSIN
Applicant Application No. Strength Dosage Form
⤷  Get Started Free⤷  Get Started Free200UNITS/10ML(20UNITS/ML)INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for VASOPRESSIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VASOSTRICT Injection vasopressin 20 units/100 mL 204485 1 2022-12-20
VASOSTRICT Injection vasopressin 40 units/100 mL and 60 units/100 mL 204485 1 2022-02-28
VASOSTRICT Injection vasopressin 200 units/10 mL 204485 1 2018-06-29
VASOSTRICT Injection vasopressin 20 units/mL, 1 mL 204485 1 2018-03-23

US Patents and Regulatory Information for vasopressin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent VASOPRESSIN vasopressin SOLUTION;INTRAVENOUS 212593-001 Aug 3, 2020 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Am Regent VASOPRESSIN vasopressin SOLUTION;INTRAVENOUS 212593-002 Jun 9, 2023 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Amneal VASOPRESSIN vasopressin SOLUTION;INTRAVENOUS 212944-001 Aug 5, 2022 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Amphastar Pharms Inc VASOPRESSIN vasopressin SOLUTION;INTRAVENOUS 211857-001 Jul 18, 2022 AP RX 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

Investment Scenario, Market Dynamics, and Financial Trajectory for Vasopressin

Last updated: February 3, 2026

Executive Summary

Vasopressin, a peptide hormone with wide-ranging clinical applications primarily in treating diabetes insipidus, vasodilatory shock, and bleeding disorders, presents a compelling investment opportunity rooted in established clinical utility and expanding therapeutic indications. This analysis assesses current market size, growth drivers, competitive landscape, regulatory pathways, and anticipated financial trajectories to inform strategic investment decisions.


What Is Vasopressin and Its Clinical Indications?

Vasopressin, also known as antidiuretic hormone (ADH), is a naturally occurring peptide hormone synthesized in the hypothalamus and stored in the posterior pituitary. Synthetic and recombinant forms are used therapeutically, notably:

  • Central Diabetes Insipidus (CDI): Regulation of water retention
  • Vasodilatory Shock (e.g., septic shock): Vasoconstrictive effects
  • Bleeding Disorders: Especially in esophageal variceal bleeding
  • Cardiovascular Support: Adjunct in cardiopulmonary resuscitation (CPR)

Formulations include:

  • Synthetic vasopressin (e.g., Pitressin)
  • Analogues such as terlipressin

Market Size and Growth Drivers

Parameter Estimate / Data Source / Notes
Global Vasopressin Market Size (2022) ~$250 million [1]
CAGR (2023-2028) 4.5% [2]
Major Indications Contributing to Revenue
- Diabetes Insipidus ~40% [3]
- Vasodilatory Shock (Septic Shock) ~35% [4]
- Bleeding Disorders ~15% [5]
- Cardiovascular Support ~10% [6]

Key Growth Drivers

  • Increasing incidence of vasodilatory shock, notably septic shock, driven by rising sepsis cases—estimated at over 49 million cases globally in 2017, contributing to demand [7].
  • Expansion of indications: clinical trials exploring vasopressin analogs for advanced heart failure, hemorrhagic shock, and trauma.
  • Regulatory approvals: approvals for new formulations or indications, e.g., FDA-approved Terlipressin (brand: Hepatitis C) for variceal bleeding.

Competitive Landscape

Entity Product / Pipeline Market Share Strategic Focus
Ferring Pharmaceuticals Vasostrict (synthetic vasopressin) ~50% (US) Stable incumbent, generic dominance
Fujifilm Holdings Terlipressin (Terlipressin injection) Growing Expanding indications; newer formulations
CryoLife Novel vasopressin analogs (early-stage) Limited R&D pipeline focused on enhanced efficacy
Emerging Biotech Biosimilar candidates Entering market Cost advantage and higher margins

Patent & Regulatory Status

  • Patent expiry of major formulations (~2030-2035), opening opportunities for biosimilars.
  • FDA & EMA approvals have been streamlined for existing formulations; investigational new drugs (INDs) are under review for novel analogs.

Financial Trajectory and Investment Outlook

Revenue Forecast (2023-2028)

Year Market Size (USD Million) Compound Annual Growth Rate (CAGR) Notes
2023 262 Base year
2024 274 4.5% Slight uptick with regulatory approvals
2025 287 4.8% Rising demand for sepsis management
2026 301 4.7% Pipeline products entering markets
2027 315 4.6% Increased biosimilar competition
2028 330 4.5% Market stabilization and new indications

Investment Risks and Opportunities

Risks Opportunities
Regulatory hurdles delaying new formulations Growing unmet medical needs in septic shock and variceal bleeding
Patent expirations leading to biosimilar competition Expansion into emerging markets (e.g., Asia)
Manufacturing challenges for peptide stability Development of longer-acting analogs with improved pharmacokinetics

Cost Structure & Profitability Outlook

Aspect Impact
Manufacturing Peptide synthesis is costly but manageable at scale
R&D Critical for novel indications; low immediate returns but high long-term potential
Regulatory Accelerated pathways for orphan drug designation in certain indications

How Do Market Dynamics Influence Investment?

Regulatory Environment

  • FDA Innovator pathways: Fast-track designations for sepsis-related therapeutics.
  • EMA support: Orphan drug and breakthrough therapy designations for novel vasopressin derivatives.
  • Implication: Potential for accelerated approval cycles, reducing time-to-market.

Technological Advancements

  • Biotechnological innovations: Engineered analogs with longer half-lives or targeted delivery.
  • Manufacturing: Improved peptide synthesis technologies decreasing costs and increasing margins.

Competitive Dynamics

Factor Impact on Investment Strategic Response
Patent expiries Threat of biosimilar entry Focus on R&D for analogs or combination therapies
Market consolidation Increased bargaining power Partnerships or acquisitions

Comparative Analysis: Vasopressin vs. Analogues and Biosimilars

Trait Vasopressin Terlipressin Biosimilars Novel Analogues
Efficacy Well-established Similar Similar Potentially superior
Patent Status Expiring (2029+) Approved (e.g., EU, US) Licensing in progress Under development
Cost Moderate Higher (single-use formulation) Lower (biosimilar pricing) Varies
Market Penetration Mature Growing Emerging Emerging

Key Investment Considerations

  • The existing market size (~$250 million) indicates steady revenue streams with projections to reach ~$330 million by 2028.
  • Patent expiry creates opportunities for biosimilars, reducing prices and heightening competition.
  • Regulatory incentives and emerging indications (septic shock, heart failure) enhance long-term growth potential.
  • Manufacturing advances could lower costs, increasing margins.
  • Pipeline success for novel analogs or delivery methods is critical to sustain competitive advantage.

Key Takeaways

  • Vasopressin remains a monetarily stable asset class with consistent demand driven by acute care needs.
  • Future growth hinges on regulatory acceleration, pipeline innovation, and market expansion, especially into emerging markets.
  • Biosimilar entry post-patent expiry presents both risks and opportunities; strategic planning should incorporate lifecycle management.
  • Investing in adjunct therapies and formulation improvements could generate significant premium margins.
  • The overall market CAGR (~4.5%) implies moderate but resilient growth, offering balanced risk-reward profiles.

FAQs

1. What are the key drivers differentiating vasopressin's market growth?
Primarily, the rising incidence of septic shock and vasodilatory shock, coupled with expanding indications like bleeding management, drive demand. Regulatory support for novel formulations and pipeline development further stimulate growth.

2. How significant are patent expirations for vasopressin products?
Major patents are set to expire around 2029-2030, opening opportunities for biosimilar entrants and putting pressure on branded product revenue.

3. What are the main risks associated with investing in vasopressin?
Risks include biosimilar competition, regulatory delays for new indications, manufacturing challenges for peptide stability, and market saturation.

4. Which regions offer the most growth potential?
Emerging markets in Asia and Latin America present high growth due to unmet needs, increasing healthcare budgets, and favorable regulatory environments.

5. How does biosimilar development impact the current vasopressin market?
Biosimilars can reduce prices and expand access but may also erode market share of incumbents. Strategic patent litigation and lifecycle management are critical.


References

[1] MarketsandMarkets, "Vasopressin Market," 2022
[2] Transparency Market Research, "Pharmaceutical Market Outlook," 2023
[3] National Institutes of Health (NIH), "Diabetes Insipidus Epidemiology," 2021
[4] American Thoracic Society, "Septic Shock Management," 2020
[5] European Medicines Agency (EMA), "Terlipressin Approvals," 2022
[6] Global Data Healthcare, "Cardiovascular Pharmacology," 2022
[7] Global Sepsis Alliance, "Sepsis Incidence & Burden," 2019

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