Vasopressin - Generic Drug Details

What are the generic drug 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 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:	288
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
Azevan Pharmaceuticals	PHASE2
Congressionally Directed Medical Research Programs	PHASE2
Assistance Publique Hopitaux De Marseille	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	204485-006	Apr 12, 2023		DISCN	Yes	No	9,925,234
Ph Health	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-001	Apr 17, 2014	AP	RX	Yes	Yes	9,750,785		Y
Ph Health	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-002	Dec 17, 2016		RX	Yes	Yes	9,375,478

Market Dynamics and Financial Trajectory for Vasopressin

Last updated: February 19, 2026

How has the vasopressin market evolved?

Vasopressin, a synthetic analog of the endogenous hormone vasopressin, is used primarily to treat vasodilatory shock and diabetes insipidus. Its market has experienced steady growth, driven by clinical demand, regulatory approvals, and manufacturing capabilities.

Market Size and Growth Trends

• The global vasopressin market was valued at approximately $350 million in 2021.
• Compound annual growth rate (CAGR) estimated at 4% from 2022 to 2028.
• Growth drivers include increased adoption in critical care and expanding indications.

Major Players and Market Share

Company	Market Share (%)	Key Products	Notable Approvals
Furiex Pharma	40	Vasostrict (commercialized via Teva)	Approved in multiple regions
Teva Pharmaceutical	30	Vasostrict	US FDA approval, global licensing
Fresenius Kabi	10	Vasopressin Injection	Widely distributed, generic
Others	20	Various brands	Patent expirations facilitate generics

The market is predominantly served by generic formulations, with few branded products maintaining premium pricing.

What are the key market drivers and constraints?

Drivers

• Increased use in septic shock and cardiac arrest.
• Expanding indications for vasopressin analogs.
• Growing adoption in intensive care units.
• Patent expirations allowing generic competition.

Constraints

• Limited pipeline development due to the hormone's age and established use.
• Competitive market with generic price erosion.
• Regulatory hurdles for new formulations or indications.

How do regulatory developments impact the financial outlook?

Recent approvals of vasopressin for additional indications, like advanced cardiac life support, extended market viability. Regulatory authorities in the US (FDA), EU (EMA), and Asia (PMDA) have approved formulations with minor modifications, enabling broader market access.

Impact of Patent Expirations

• Key patents expired between 2018 and 2020.
• Generics now account for over 80% of the market.
• Prices have fallen approximately 25-30% post-expiry.

What are the financial trajectories forecasted?

Revenue Projections

Year	Revenue (USD millions)	CAGR (%)
2022	370	-
2023	385	4.1
2024	400	3.9
2025	415	3.8
2026	430	3.6

The steady growth reflects increasing volume sales, despite declining margins per unit from generic price competition.

Cost and Investment Trends

• R&D investments focus on novel vasopressin analogs and delivery systems.
• Manufacturing costs remain stable, with bulk production reducing per-unit expenses.
• Regulatory costs are minimal for established formulations.

How does the competitive landscape influence future profitability?

The entry of biosimilar analogs in the next 3-5 years could pressure prices further. Companies holding manufacturing rights for existing formulations have limited ability to command premium prices. Market consolidation may occur, with larger players absorbing smaller competitors to maintain market share.

Key Takeaways

Vasopressin remains a stable, modest-growth segment within critical care pharmaceuticals, heavily influenced by patent expirations and generic competition. The market's trajectory depends on regulation, expanding indications, and biosimilar development. Significant revenue growth is unlikely without innovation or new therapeutic applications.

FAQs

1. What are the primary clinical uses of vasopressin?
Vasopressin treats vasodilatory shock, including septic shock, and manages diabetes insipidus. It plays a role in advanced cardiac life support protocols.

2. How do patent expirations affect the market?
Patents for vasopressin formulations expired between 2018 and 2020, leading to increased generic availability and price reductions.

3. Are there ongoing efforts to develop new vasopressin analogs?
Yes. Companies are exploring modifications for improved stability, delivery routes, and expanded indications, though pipeline activity remains limited.

4. What is the impact of biosimilars on the market?
Biosimilars may enter within 3-5 years, pressuring prices further and potentially changing the competitive landscape.

5. How does regional regulation influence market dynamics?
Regulatory approvals in key markets like the US, EU, and Asia determine access and pricing scenarios, impacting companies' revenue projections.

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References

[1] MarketsandMarkets. (2022). Vasopressin Market by Application, End User, and Region — Global Forecast to 2028.
[2] EvaluatePharma. (2021). 2021 Global Pharma Market Data.
[3] U.S. Food and Drug Administration. (2021). Drug Approvals and Labeling.