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Last Updated: December 15, 2025

VASOPRESSIN IN SODIUM CHLORIDE 0.9% Drug Patent Profile


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When do Vasopressin In Sodium Chloride 0.9% patents expire, and when can generic versions of Vasopressin In Sodium Chloride 0.9% launch?

Vasopressin In Sodium Chloride 0.9% is a drug marketed by Baxter Hlthcare Corp and Long Grove Pharms and is included in two NDAs. There is one patent protecting this drug.

The generic ingredient in VASOPRESSIN IN SODIUM CHLORIDE 0.9% is vasopressin. There are nine drug master file entries for this compound. 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 Sodium Chloride 0.9%

A generic version of VASOPRESSIN IN SODIUM CHLORIDE 0.9% was approved as vasopressin by AM REGENT on August 3rd, 2020.

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Summary for VASOPRESSIN IN SODIUM CHLORIDE 0.9%
Drug patent expirations by year for VASOPRESSIN IN SODIUM CHLORIDE 0.9%
Recent Clinical Trials for VASOPRESSIN IN SODIUM CHLORIDE 0.9%

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

SponsorPhase
Assistance Publique Hopitaux De MarseillePHASE3
Prisma Health-UpstatePHASE4
Centre Hospitalier Universitaire DijonPHASE3

See all VASOPRESSIN IN SODIUM CHLORIDE 0.9% clinical trials

Pharmacology for VASOPRESSIN IN SODIUM CHLORIDE 0.9%
Physiological EffectDecreased Diuresis
Vasoconstriction

US Patents and Regulatory Information for VASOPRESSIN IN SODIUM CHLORIDE 0.9%

VASOPRESSIN IN SODIUM CHLORIDE 0.9% is protected by one US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare Corp VASOPRESSIN IN SODIUM CHLORIDE 0.9% vasopressin SOLUTION;INTRAVENOUS 217569-001 Sep 29, 2023 RX Yes Yes 12,447,190 ⤷  Get Started Free Y ⤷  Get Started Free
Long Grove Pharms VASOPRESSIN IN SODIUM CHLORIDE 0.9% vasopressin SOLUTION;INTRAVENOUS 217766-002 Jul 11, 2024 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare Corp VASOPRESSIN IN SODIUM CHLORIDE 0.9% vasopressin SOLUTION;INTRAVENOUS 217569-002 Sep 29, 2023 RX Yes Yes 12,447,190 ⤷  Get Started Free Y ⤷  Get Started Free
Long Grove Pharms VASOPRESSIN IN SODIUM CHLORIDE 0.9% vasopressin SOLUTION;INTRAVENOUS 217766-001 Jul 11, 2024 RX Yes Yes ⤷  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 Vasopressin in Sodium Chloride 0.9%

Last updated: July 30, 2025

Introduction

Vasopressin in Sodium Chloride 0.9% (also known as 0.9% NaCl solution combined with vasopressin) is a critical pharmaceutical agent used predominantly in critical care settings. Its primary indications include vasodilatory shock, diabetes insipidus, and other hemodynamic disorders. As a synthetic analog of the endogenous hormone vasopressin, it exerts vasoconstrictive effects, making it essential in emergency medicine and intensive care units (ICUs).

This analysis evaluates current market drivers, competitive landscape, regulatory influences, and financial outlooks shaping the trajectory of vasopressin in sodium chloride 0.9%. Strategic insights for stakeholders interested in manufacturing, investing, or expanding market share are also discussed.

Market Overview and Evolution

Historical Context and Market Penetration

Vasopressin was first introduced as a therapeutic agent in the 1950s. Its early application focused on diabetes insipidus and vasodilatory shock. The formulation involving sodium chloride 0.9%—a isotonic saline—became a standard delivery method for intravenous administration, especially in intensive care.

Over the decades, synthetic vasopressin products, such as Vasostrict (by Ferring Pharmaceuticals) and Pitressin (by Pfizer), gained widespread use due to their efficacy and established safety profiles. The global market expanded substantially with increased adoption in critical care protocols, notably in septic shock management.

Current Market Size and Forecast

The global hospital antiseptics and infusion solutions market, which includes vasopressin formulations, has been valued at approximately $4.5 billion USD in 2022. The segment dedicated to vasopressin is estimated to account for a niche but critical portion of this, driven by ICU demand and emergency applications.

Market forecasts project a compound annual growth rate (CAGR) of around 4-5% over the next five years, reaching approximately $6 billion by 2028 [1]. The growth is compounded by rising incidences of sepsis, cardiovascular emergencies, and advancements in critical care practices. Additionally, increased research in vasopressin analogs and optimized delivery systems could catalyze market expansion.

Key Market Drivers

Increasing Prevalence of Critical Care Conditions

The rising global burden of sepsis and septic shock significantly drives demand. According to the World Health Organization, sepsis affects approximately 31.5 million people annually, with mortality rates exceeding 20% [2]. Vasopressin, as a vasoconstrictor, is integral in resuscitation protocols, thus maintaining a steady demand in ICUs.

Advancements in Intensive Care Protocols

The evolving guidelines by societies like the Surviving Sepsis Campaign recommend vasopressin as an adjunct vasopressor to norepinephrine in specific cases, especially for refractory vasodilatory shock. These updates support stable utilization rates across healthcare settings.

Regulatory Approvals and Off-label Use

Regulatory bodies, such as the FDA and EMA, continue to approve vasopressin in various formulations, enhancing its credibility. Off-label applications, including its use in hepatic cirrhosis and variceal bleeding, further broaden its therapeutic scope, indirectly bolstering market size.

Generic Competition and Patent Landscape

Patents protecting vasopressin formulations have mostly expired, paving the way for generics. This has increased accessibility and reduced prices but intensified competition among manufacturers, influencing revenue streams and profit margins.

Emerging Markets and Increasing Healthcare Expenditure

Growth in emerging markets—particularly in Asia-Pacific, Latin America, and Africa—augments demand for critical care drugs. Concurrently, rising healthcare expenditure improves access to advanced therapies like vasopressin.

Market Challenges

Pricing Pressures and Reimbursement Policies

Healthcare systems worldwide are increasingly cost-conscious. The availability of low-cost generics compresses profit margins for branded products, forcing manufacturers to innovate in delivery systems or expand indications.

Supply Chain Disruptions

Global supply chain constraints, intensified during the COVID-19 pandemic, have affected the procurement of raw materials and finished products, causing price volatility and shortages in some regions.

Regulatory Complexity

Different approval processes across jurisdictions require significant investment for continues compliance and approvals. Additionally, evolving standards for IV solutions and vasopressor agents necessitate ongoing R&D.

Competition from Novel Vasoconstrictors and Biologics

Emergence of alternative agents (e.g., terlipressin) and novel biologics could challenge vasopressin’s market dominance, especially if they demonstrate superior efficacy or safety profiles.

Financial Trajectory and Investment Outlook

Revenue Streams and Profitability

Established players like Ferring Pharmaceuticals and Pfizer maintain dominant positions due to their extensive manufacturing capabilities and global distribution networks. Their revenues are primarily fueled by volume-driven sales to hospitals and clinics.

Forecasting indicates moderate revenue growth aligned with the overall market CAGR of 4-5%. Margins are expected to be stable for patent-expired formulations due to economies of scale, but innovative combination formulations or delivery methods could command premium pricing.

Research & Development Investment

R&D efforts focus on new analogs with improved pharmacokinetics, combination therapies, and novel delivery systems such as pre-filled syringes and auto-injectors. Strategic partnerships between pharma companies and biotech firms are likely to accelerate innovation.

Market Expansion Strategies

Entering emerging markets with tailored pricing strategies and forming collaborations with healthcare providers can broaden reach. Also, developing alternative indications and supporting clinical trials can unlock new revenue streams.

Regulatory and Policy Impact

Regulators are increasingly emphasizing biosimilar and generic approvals to foster competition and reduce costs. This trend benefits market players willing to invest in bioequivalence studies and compliance. Conversely, stringent supply chain and manufacturing standards, including Good Manufacturing Practices (GMP), require continuous capital investment but ensure product quality and market access.

Conclusion

The market outlook for vasopressin in sodium chloride 0.9% remains cautiously optimistic, driven by expanding critical care needs and an aging population. Market players must navigate competitive pressures, regulatory landscapes, and supply chain complexities.

Brand differentiation, innovation in delivery, and geographic expansion are critical to sustaining growth. Meanwhile, the push toward cost-effective generic options implies that profitability margins may tighten unless manufacturers leverage operational efficiencies or develop differentiated formulations.


Key Takeaways

  • The vasopressin in sodium chloride 0.9% market is poised for steady growth (~4-5% CAGR) driven by rising critical care demands, especially in sepsis and vasodilatory shock management.
  • Market expansion into emerging economies, combined with ongoing R&D and regulatory support, will underpin future revenue streams.
  • Competition from generics necessitates innovation in delivery systems and new indications to sustain profitability.
  • Supply chain resilience and regulatory compliance are vital for maintaining market presence amid global disruptions.
  • Stakeholders should prioritize strategic partnerships, product differentiation, and geographic diversification to capitalize on growth opportunities.

FAQs

1. What are the primary indications for vasopressin in sodium chloride 0.9%?
Vasopressin is mainly used in vasodilatory shock, diabetes insipidus, and management of certain bleeding conditions, especially in critical care settings.

2. How does the expiration of patents affect the market for vasopressin formulations?
Patent expirations facilitate the entry of generics, increasing accessibility and lowering prices but reducing profit margins for branded manufacturers.

3. What emerging trends could influence the future of vasopressin in critical care?
Development of new analogs with improved safety/efficacy profiles, novel delivery devices, and expanded indications are key trends shaping the landscape.

4. How do regulatory policies impact the market trajectory?
Regulatory approvals, biosimilar pathways, and manufacturing standards influence market entry, quality assurance, and competitiveness.

5. What opportunities exist for market expansion?
Emerging markets, off-label uses, combination therapies, and innovative formulations present significant growth opportunities.


Sources:
[1] MarketsandMarkets. "Critical Care & Emergency Medicine Market." 2022.
[2] WHO. "Sepsis Fact Sheet." 2021.

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