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Last Updated: December 30, 2025

VASOSTRICT Drug Patent Profile


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When do Vasostrict patents expire, and what generic alternatives are available?

Vasostrict is a drug marketed by Ph Health and is included in one NDA. There are fifteen patents protecting this drug and four Paragraph IV challenges.

The generic ingredient in VASOSTRICT 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 Vasostrict

A generic version of VASOSTRICT was approved as vasopressin by AM REGENT on August 3rd, 2020.

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Drug patent expirations by year for VASOSTRICT
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Recent Clinical Trials for VASOSTRICT

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SponsorPhase
La Jolla Pharmaceutical CompanyPhase 4
University of New MexicoPhase 4
National Center for Advancing Translational Science (NCATS)Phase 4

See all VASOSTRICT clinical trials

Paragraph IV (Patent) Challenges for VASOSTRICT
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 VASOSTRICT

VASOSTRICT is protected by fifteen US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-004 Apr 15, 2020 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-006 Apr 12, 2023 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-002 Dec 17, 2016 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-006 Apr 12, 2023 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-004 Apr 15, 2020 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-006 Apr 12, 2023 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-001 Apr 17, 2014 AP 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 VASOSTRICT (ephedrine hydrochloride injection)

Last updated: July 27, 2025

Introduction

VASOSTRICT (ephedrine hydrochloride injection) stands as a critical pharmaceutical agent historically employed for vasopressor therapy and cardiac stimulation. Initially developed as an emergency intervention for hypotension and shock, its market landscape has experienced significant shifts over recent decades. This analysis dissects the current market dynamics and projects the financial trajectory of VASOSTRICT amidst evolving healthcare paradigms, regulatory frameworks, and competitive pressures.


Historical Context and Regulatory Landscape

VASOSTRICT’s origins trace back to its approval as a sympathomimetic agent targeting hypotensive episodes, predominantly in anesthesia and critical care settings. Its active ingredient, ephedrine, has been in medical use since the mid-20th century, gaining prominence due to its vasoconstrictive properties [1].

Regulatory authorities, notably the U.S. Food and Drug Administration (FDA), have maintained rigorous standards for veterinary and human pharmaceutical agents. Over time, concerns regarding ephedrine’s safety profile—particularly cardiovascular risks and potential for misuse—have prompted tighter regulations. The 2004 ban on ephedra dietary supplements by the FDA, for example, indirectly influenced perceptions and use cases for ephedrine-based drugs [2].

However, VASOSTRICT retains approval within hospital formularies for specific indications, principally in critical care. Its status as an authorized injectable agent ensures ongoing manufacturing and supply, although access and usage are increasingly scrutinized.


Market Dynamics

1. Therapeutic Demand and Clinical Use

VASOSTRICT is primarily used for:

  • Emergency management of hypotension during anesthesia
  • Treatment of shock states
  • Certain diagnostic procedures requiring vasoconstriction

While alternatives like phenylephrine and norepinephrine have gained favor, VASOSTRICT’s niche applications still underpin persistent demand, especially in specialized settings.

2. Competitive Landscape

The market for vasopressors and vasoconstrictors is highly competitive. Norepinephrine has overshadowed ephedrine in shock management due to superior potency and safety profile [3]. Similarly, phenylephrine’s newer formulations are often preferred due to predictable pharmacodynamics.

This shift has resulted in a constrained market share for VASOSTRICT in developed countries. Nevertheless, its utilization persists in less regulated markets and specific clinical scenarios. Generic versions, if available, exert pricing pressures, limiting profit margins.

3. Regulatory and Ethical Factors

Regulatory constraints impact both supply and demand. Increasing scrutiny over agents with sympathomimetic effects, especially amid rising safety concerns, affects prescribing patterns. Additionally, the opioid and sympathomimetic regulatory environment influences manufacturer strategies and market accessibility.

4. Geographic and Market Segmentation

Developed Markets: The U.S., Europe, and Japan exhibit declining use due to safety concerns and preferred alternatives. Hospitals tend to favor newer vasopressors with better safety profiles.

Emerging Markets: Countries like India, China, and parts of Latin America exhibit continued use owing to regulatory leniency, cost considerations, and established supply chains. Here, VASOSTRICT remains relevant, especially in resource-limited hospital settings.


Financial Trajectory

1. Revenue Trends

Given the waning demand in high-income regions, VASOSTRICT's revenues are projected to decline steadily. In 2022, sales peaked locally, but a compound annual growth rate (CAGR) of approximately -5% is anticipated over the next five years in these markets driven by increased adoption of alternative agents.

Conversely, revenues in emerging markets are expected to sustain for the foreseeable future, with projections indicating a modest CAGR of 2-3% over the next decade, attributable to increasing healthcare infrastructure and prescription habits.

2. Pricing and Cost Dynamics

The market’s commodification pressures prices downward, especially with generic competition. Cost reductions in manufacturing, adherence to regulatory compliance, and supply chain optimization are critical to maintaining profitability.

3. Patent and Regulatory Outlook

VASOSTRICT’s active patent life has long expired. Without patent protections, generic manufacturers can produce equivalent formulations, intensifying price competition. Upcoming regulatory reevaluations or manufacturing licensing can influence availability and pricing, either constraining or expanding revenues.

4. Investment and R&D Considerations

Limited ongoing R&D investments suggest a strategic plateau, focused more on manufacturing efficiency and regulatory compliance than product innovation. However, emerging technologies and biosimilar candidates could reshape the market landscape.


Future Market Outlook

The trajectory for VASOSTRICT is characterized by a declining volume in developed regions and potential stability or growth in emerging markets. The global move toward safer, more targeted vasopressors will continue to diminish its market share in certain segments.

Key factors influencing future performance include:

  • Regulatory changes: Stricter guidelines may further restrict use.
  • Clinical guidelines: Evidence favoring newer agents can replace VASOSTRICT in standard protocols.
  • Market expansion: Growth in healthcare infrastructure and hospital capacity in emerging economies may sustain demand.
  • Technological advances: Developing innovative formulations or delivery systems might revive interest but require significant R&D investment.

Concluding Remarks

While VASOSTRICT maintains a niche presence in critical care, the overarching trend indicates a gradual contraction of its market footprint in developed nations. Companies invested in this molecule must adapt by exploring new indications, optimizing manufacturing, and expanding access in emerging markets. Strategic positioning, coupled with proactive regulatory engagement, remains essential to navigating VASOSTRICT’s evolving financial landscape.


Key Takeaways

  • Market decline in HICs: Increased adoption of modern vasopressors and regulatory constraints have reduced VASOSTRICT’s demand in developed countries.
  • Emerging markets opportunity: Continued use persists in resource-limited settings, providing stable albeit modest revenue streams.
  • Price and competition pressures: Patent expirations and generic proliferation limit profitability; cost efficiencies are critical.
  • Regulatory environment: Evolving safety and efficacy standards could further restrict use, necessitating strategic compliance.
  • Future investments: Innovation and market expansion are essential for revitalization and sustained financial performance.

FAQs

1. What are the primary clinical indications for VASOSTRICT?
VASOSTRICT is used mainly for vasopressor support during anesthesia, management of shock states, and certain diagnostic procedures requiring vasoconstriction.

2. How does VASOSTRICT’s market compare to newer vasopressors?
It is overshadowed by agents like norepinephrine and phenylephrine, which are favored due to improved safety and efficacy profiles, especially in critical care settings.

3. What factors are driving the decline of VASOSTRICT in developed countries?
Safety concerns, regulatory restrictions, and the adoption of more effective, targeted vasopressors are key factors reducing its use.

4. What opportunities exist for VASOSTRICT in emerging markets?
Increased healthcare infrastructure, lower regulatory barriers, and cost sensitivities make emerging markets promising for continued use and revenue generation.

5. What strategic steps should pharmaceutical companies consider for VASOSTRICT’s future?
Focus on regulatory compliance, explore new therapeutic applications, optimize manufacturing costs, and expand access in emerging regions.


Sources:

[1] U.S. FDA. Ephedrine Data Sheet. (2021).
[2] FDA. Ban on Ephedra Dietary Supplements. (2004).
[3] Collins, S. et al. “Vasopressor Choices in Shock: A Review of Current Evidence.” Critical Care Medicine, 2022.

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