VASOPRESSIN Drug Patent Profile

Which patents cover Vasopressin, and when can generic versions of Vasopressin launch?

Vasopressin is a drug marketed by Am Regent, Amneal, Amphastar Pharms Inc, Cipla, Dr Reddys, Eagle Pharms, Eugia Pharma, Fresenius Kabi Usa, Gland, Baxter Hlthcare Corp, and Long Grove Pharms. and is included in eleven NDAs. There is one patent protecting this drug.

The generic ingredient in VASOPRESSIN 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

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

Summary for VASOPRESSIN

US Patents:	0
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	12
Clinical Trials:	288
Drug Prices:	Drug price information 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

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
Am Regent	VASOPRESSIN	vasopressin	SOLUTION;INTRAVENOUS	212593-001	Aug 3, 2020		RX	Yes	Yes
Eagle Pharms	VASOPRESSIN	vasopressin	SOLUTION;INTRAVENOUS	211538-001	Dec 15, 2021	AP	RX	No	No
Amphastar Pharms Inc	VASOPRESSIN	vasopressin	SOLUTION;INTRAVENOUS	211857-001	Jul 18, 2022	AP	RX	No	No
Baxter Hlthcare Corp	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	vasopressin	SOLUTION;INTRAVENOUS	217569-001	Sep 29, 2023		RX	Yes	Yes			Y
Eugia Pharma	VASOPRESSIN	vasopressin	SOLUTION;INTRAVENOUS	214314-001	Aug 15, 2022	AP	RX	No	No
Long Grove Pharms	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	vasopressin	SOLUTION;INTRAVENOUS	217766-003	Jul 11, 2024		DISCN	Yes	No
Long Grove Pharms	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	vasopressin	SOLUTION;INTRAVENOUS	217766-001	Jul 11, 2024		RX	Yes	Yes

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.