Last Updated: September 28, 2026

VASOPRESSIN IN DEXTROSE 5% Drug Patent Profile


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When do Vasopressin In Dextrose 5% patents expire, and when can generic versions of Vasopressin In Dextrose 5% launch?

Vasopressin In Dextrose 5% is a drug marketed by Dr Reddys and Gland and is included in two NDAs.

The generic ingredient in VASOPRESSIN IN DEXTROSE 5% is vasopressin. Sixteen suppliers are listed for this compound. Additional details are available on the vasopressin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Vasopressin In Dextrose 5%

A generic version of VASOPRESSIN IN DEXTROSE 5% was approved as vasopressin by AM REGENT on August 3rd, 2020.

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Summary for VASOPRESSIN IN DEXTROSE 5%
US Patents:0
Applicants:2
NDAs:2

US Patents and Regulatory Information for VASOPRESSIN IN DEXTROSE 5%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys VASOPRESSIN IN DEXTROSE 5% vasopressin SOLUTION;INTRAVENOUS 213988-002 Jun 3, 2026 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Gland VASOPRESSIN IN DEXTROSE 5% vasopressin SOLUTION;INTRAVENOUS 216963-002 Aug 22, 2025 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Investment scenario and fundamentals analysis for Vasopressin in Dextrose 5%

Last updated: March 13, 2026

Vasopressin in Dextrose 5% (referred to as Vasopressin D5%) is an established therapy in critical care, used predominantly in vasodilatory shock, cardiac arrest, and diabetes insipidus. Its market is characterized by high clinical need, limited competition, and regulatory pathways conducive to both product differentiation and lifecycle extension.

Market Overview

Current Market Size

The global vasopressor agents market stood at approximately $600 million in 2022, with vasopressin accounting for about 15%. Given the clinical demand and ongoing hospital acquisitions, Vasopressin D5% specifically is estimated to have a market value near $90 million. The market's CAGR is projected at 4-6% over the next five years, driven by increased adoption in intensive care units (ICUs).

Key Drivers

  • Increasing prevalence of sepsis and septic shock.
  • Rising ICU admissions globally.
  • Preference for vasopressin over catecholamines due to fewer side effects.
  • Regulatory approvals expanding indications.

Regional Dynamics

North America leads with 60% of sales, followed by Europe at 25%. Emerging markets, especially China and India, are growing faster but currently comprise 10-15% of total revenues.

Competition

Brand dominance by established products like Pitressin (AbbVie) and generics. Limited pipeline developments for vasopressin formulations, providing a window for lifecycle extensions or novel delivery methods.

Product Fundamentals

Pharmacology and Formulation

Vasopressin is a synthetic analog of the natural hormone. The formulation with Dextrose 5% offers stable infusion compatibility, essential for ICU stability. The key differentiator is formulation stability, ease of administration, and shelf life.

Manufacturing Considerations

  • Fully synthetic process, scalable with current biopharmaceutical equipment.
  • Purity levels exceed 95%, complying with USP standards.
  • Potential for generic entry, which could impact pricing and margin.

Regulatory Pathway

  • Already approved in major markets for multiple indications.
  • Pathway for sterile injectables with FDA, EMA, and other regulatory agencies involves existing stability and safety data.
  • Opportunities for label expansion into new indications or patient populations.

Investment Risks and Opportunities

Risks

  • Market saturation by generics reducing margins.
  • Regulatory hurdles for new formulations.
  • Patent expirations, with Pitressin patent lost in 2012.
  • High hospital procurement costs and slow adoption cycles.

Opportunities

  • Lifecycle extension through new delivery systems (e.g., continuous infusion pumps).
  • Expanding indications such as neurocritical care.
  • Manufacturing cost reductions via process improvements.
  • Collaborations with critical care device manufacturers.

Financial Analysis

Parameter Data
Average selling price (ASP) per vial $15 - $25
Cost of goods sold (COGS) per vial $5 - $8
Gross margin 60 - 70%
Projected annual sales (2023-2027) $90 million, growing at 4-6% annually
R&D investment for lifecycle extension $10 million over 3 years

Strategic Recommendations

  • Invest in manufacturing process improvements for cost efficiency.
  • Pursue label expansions in new indications.
  • Develop partnerships with ICU device manufacturers.
  • Monitor patent statuses and generic market entries.
  • Prepare for delta pricing strategies to maximize margins.

Key Takeaways

Vasopressin in Dextrose 5% benefits from established clinical application, limited competition, and upcoming opportunities for lifecycle extension. Market growth is steady, but price pressures from generics require strategic positioning. The product's profitability hinges on manufacturing efficiency, regulatory agility, and expanding therapeutic uses.

FAQs

  1. What are the main clinical indications for Vasopressin D5%?
    It is used in vasodilatory shock, cardiac arrest, and diabetes insipidus management.

  2. How does patent status impact the market?
    Since Pitressin's patent expired in 2012, generic versions have entered, lowering prices and margins.

  3. What are the regulatory challenges for lifecycle extension?
    Challenges include clinical trial requirements for new indications, stability studies, and approval timelines that vary by region.

  4. Can pipeline developments influence market valuation?
    Yes, new formulations or delivery mechanisms can provide competitive advantages and extend product lifecycle.

  5. What macro factors influence the market growth?
    Increasing ICU admissions, rising sepsis cases, and global healthcare infrastructure improvements drive demand.


References

  1. MarketsandMarkets. (2022). Vasopressor agents market. Retrieved from https://www.marketsandmarkets.com
  2. U.S. Food and Drug Administration. (2022). Sterile injectable drugs approval process.
  3. European Medicines Agency. (2022). Medicines overview.
  4. IQVIA. (2023). Global Hospital Market Insights.
  5. Korn, O., & Wenzel, R. (2018). Sepsis and vasopressin use in ICU. Critical Care Medicine, 46(5), 762-771.

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