VASOPRESSIN - Generic Drug Details

What are the generic drug sources for vasopressin and what is the scope of freedom to operate?

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 are nine drug master file entries for vasopressin. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for VASOPRESSIN

US Patents:	16
Tradenames:	5
Applicants:	13
NDAs:	13
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	16
Clinical Trials:	285
Drug Prices:	Drug price trends for VASOPRESSIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VASOPRESSIN
What excipients (inactive ingredients) are in VASOPRESSIN?	VASOPRESSIN excipients list
DailyMed Link:	VASOPRESSIN at DailyMed

See drug prices for VASOPRESSIN

Recent Clinical Trials for VASOPRESSIN

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

Sponsor	Phase
Assistance Publique Hopitaux De Marseille	PHASE3
Prisma Health-Upstate	PHASE4
Centre Hospitalier Universitaire Dijon	PHASE3

See all VASOPRESSIN clinical trials

Generic filers with tentative approvals for VASOPRESSIN

Applicant	Application No.	Strength	Dosage Form
		200UNITS/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.

Pharmacology for VASOPRESSIN

Physiological Effect

Decreased Diuresis Vasoconstriction

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
Ph Health	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-002	Dec 17, 2016		RX	Yes	Yes
Ph Health	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-002	Dec 17, 2016		RX	Yes	Yes
Baxter Hlthcare Corp	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	vasopressin	SOLUTION;INTRAVENOUS	217569-002	Sep 29, 2023		RX	Yes	Yes			Y
Ph Health	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-004	Apr 15, 2020		DISCN	Yes	No			Y
Long Grove Pharms	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	vasopressin	SOLUTION;INTRAVENOUS	217766-002	Jul 11, 2024		RX	Yes	Yes

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Vasopressin

Last updated: September 9, 2025

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Introduction

Vasopressin, also known as antidiuretic hormone (ADH), is a synthetic or natural peptide hormone pivotal in regulating water retention and vascular tone. Its clinical utility spans conditions such as vasodilatory shock, diabetes insipidus, and bleeding abnormalities. As the healthcare industry continues to evolve, understanding the market dynamics and financial trajectory of vasopressin offers crucial insights for pharmaceutical companies, investors, and healthcare providers.

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Historical Context and Current Market Landscape

Vasopressin has long been established as a critical drug in intensive care units and emergency medicine. Its earliest formulations date back to the 20th century, with synthetic versions commercialized primarily under brand names like Vasostrict (manufactured by Fresenius Kabi) and Pitressin (Pfizer). Over the decades, its usage has been driven by the need for rapid hemodynamic stabilization in septic shock and cardiac arrest.

Despite its longstanding clinical application, the market remains relatively specialized. Several factors—such as limited therapeutic alternatives, drug-specific regulatory pathways, and the critical nature of its indications—contribute to a stable yet modest growth trajectory. The global vasopressin market was valued at approximately USD 250 million in 2022, with projections estimating a compound annual growth rate (CAGR) between 4-6% through 2030 [1].

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Market Drivers

1. Rising Incidence of Critical Care Cases

An increase in sepsis, septic shock, and cardiovascular emergencies globally propels demand for vasopressin. The World Health Organization (WHO) reports that sepsis affects more than 30 million people annually, with mortality rates exceeding 25% [2]. The growing burden of critical illnesses sustains demand for vasopressors like vasopressin, which are essential in these care protocols.

2. Advances in Critical Care Protocols

Recent clinical guidelines underscore vasopressin's role as an adjunct in vasodilatory shock management, especially in combination with catecholamines such as norepinephrine. The Surviving Sepsis Campaign recommends vasopressin as a second-line agent, which reinforces its clinical importance [3].

3. Market Expansion through New Formulations

Emerging formulations, such as inhalational vasopressin or combination therapies, expand the utility spectrum. Strategic R&D efforts by big pharma and biotech firms aim to develop novel delivery mechanisms, potentially enhancing efficacy and safety profiles.

4. Regulatory Approvals and Patent Opportunities

While the original formulations are off-patent, recent efforts to develop biosimilars and new analogs open lucrative opportunities. The regulatory landscape, including pathways to fast-track approvals in certain jurisdictions, influences market dynamics markedly.

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Challenges and Limitations

1. Limited Market Penetration Beyond Critical Care

Vasopressin's niche application constrains substantial market expansion. Its use is predominantly confined to intensive care settings, limiting widespread outpatient application.

2. Competition with Alternative Vasopressors

Agents like norepinephrine, epinephrine, and dopamine compete with vasopressin, often being first-line therapies. The relative cost, efficacy, and safety profiles influence clinician choice, thereby impacting vasopressin's market share [4].

3. Supply Chain and Manufacturing Issues

Given the peptide nature of vasopressin, manufacturing complexities and stability concerns impact supply consistency. Disruptions may influence pricing and availability.

4. Regulatory and Ethical Concerns

Potential side effects, such as ischemia due to vasoconstriction, necessitate precise dosing and monitoring. Regulatory scrutiny over safety profiles can delay approvals or restrict usage.

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Financial Trajectory and Market Forecast

Market Growth Projections

The global vasopressin market is projected to grow at a CAGR of approximately 5% over the next eight years, driven chiefly by the expanding critical care burden and pipeline developments. The increasing adoption in emerging markets, such as China and India, which are witnessing rising healthcare infrastructure and critical care awareness, offers additional growth avenues.

Revenue Streams and Cost Dynamics

Revenue generation centers on formulation sales, biosimilar proliferation, and potential combination drug development. Pricing strategies are influenced by manufacturing costs, competitive dynamics, and reimbursement frameworks. Notably, patent expirations of pioneer products have led to the entry of biosimilars, intensifying price competition but also expanding market access.

Impact of Biosimilars

The advent of biosimilars, such as generic vasopressin analogs, has altered the profitability landscape. While biosimilar entry exerts downward pressure on prices, it simultaneously broadens access, spurring volume-based growth. Furthermore, ongoing clinical trials for new analogs aim to improve efficacy, safety, and delivery, fostering innovation-driven revenue streams.

Potential Disruptors

Emerging technologies, such as genetically engineered peptides or alternative vasopressors, could challenge vasopressin's dominance. Additionally, digital health and personalized medicine trends might influence clinician preferences and prescribing patterns.

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Regulatory and Market Entry Considerations

Navigating regulatory pathways remains paramount for new formulations or biosimilars. Agencies such as the FDA and EMA emphasize demonstrating biosimilarity, safety, and efficacy. Regulatory approvals often hinge on robust clinical trial data, which can be both time-consuming and costly, influencing the financial viability of new entrants.

Market entry strategies should focus on establishing manufacturing excellence, optimizing supply chains, and demonstrating clinical benefits to secure reimbursement and clinician acceptance.

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Conclusion

Vasopressin’s market remains characterized by stability amid incremental growth, driven by increasing critical care needs and pipeline innovations. Its niche positioning within vasodilatory shock management ensures steady demand, though competition and regulatory factors shape its financial trajectory. Future profitability hinges on technological advancements, biosimilar proliferation, and expanding critical care infrastructure in emerging economies.

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Key Takeaways

• Steady Growth, Niche Market: Vasopressin’s market is expected to grow modestly (~5% CAGR) due to ongoing critical care needs.

• Pipeline and Biosimilars: Entry of biosimilars and new formulations offers growth opportunities but also intensifies competition.

• Regulatory Landscape: Navigating biosimilar approval pathways remains pivotal for future market expansion.

• Market Drivers: Rising global incidence of sepsis and cardiovascular emergencies sustain demand, especially in emerging markets.

• Challenges: Limited application scope, competition with other vasopressors, and manufacturing complexities pose ongoing risks.

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FAQs

1. What defines vasopressin’s primary clinical applications?
Vasopressin is chiefly used for vasodilatory shock (including septic shock), diabetes insipidus, and certain bleeding disorders, functioning as a vasoconstrictor and antidiuretic hormone analog.

2. How are biosimilars expected to influence the vasopressin market?
Biosimilars are likely to reduce costs, expand access, and trigger price competition, potentially increasing overall market volume but reducing profit margins for original formulations.

3. What are the key challenges in developing new vasopressin formulations?
Developing novel formulations involves complex peptide synthesis, stability issues, regulatory hurdles, and demonstrating clinical benefits over existing therapies.

4. Which factors most significantly impact vasopressin's market growth?
Increasing critical illness incidence, clinical guideline endorsements, pipeline innovations, and healthcare infrastructure expansion in emerging markets are primary drivers.

5. What trends might disrupt vasopressin’s market in the future?
Emerging vasopressor alternatives, advancements in peptide engineering, personalized medicine approaches, and potential regulatory restrictions on safety could reshape its market landscape.

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References

[1] Market Research Future, "Vasopressin Market Analysis," 2022.
[2] WHO. "Sepsis Incidence and Mortality," 2021.
[3] Surviving Sepsis Campaign, "Guidelines on Vasopressor Use," 2021.
[4] Journal of Critical Care, "Comparison of Vasopressors," 2020.