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 four branded drugs marketed by Am Regent, Amneal, Amphastar Pharms Inc, Cipla, Dr Reddys, Eagle Pharms, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Baxter Hlthcare Corp, Long Grove Pharms, Endo Operations, and Parke Davis, and is included in thirteen NDAs. There are fourteen 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. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for vasopressin

US Patents:	14
Tradenames:	4
Applicants:	13
NDAs:	13
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	14
Clinical Trials:	251
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
University Hospital, Basel, Switzerland	Phase 2
Kingman Regional Medical Center	Phase 4
University of Alberta	Phase 1

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
Long Grove Pharms	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	vasopressin	SOLUTION;INTRAVENOUS	217766-003	Jul 11, 2024		RX	Yes	Yes
Long Grove Pharms	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	vasopressin	SOLUTION;INTRAVENOUS	217766-002	Jul 11, 2024		RX	Yes	Yes
Amphastar Pharms Inc	VASOPRESSIN	vasopressin	SOLUTION;INTRAVENOUS	211857-001	Jul 18, 2022	AP	RX	No	No
Endo Operations	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-005	Apr 21, 2021	AP	RX	Yes	Yes	10,010,575
Long Grove Pharms	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	vasopressin	SOLUTION;INTRAVENOUS	217766-001	Jul 11, 2024		RX	Yes	Yes
Endo Operations	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-006	Apr 12, 2023		DISCN	Yes	No	9,925,234

Vasopressin Market Analysis and Financial Projection Experimental

Vasopressin Market Dynamics and Financial Trajectory

Market Size and Forecast

The vasopressin market is poised for significant growth over the next few years. As of 2024, the market size was valued at USD 889.9 million and is projected to reach USD 2656.9 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 13.8% during the forecast period[1][3][4].

Key Drivers

Several factors are driving the growth of the vasopressin market:

Growing Prevalence of Diabetes Insipidus

The increasing incidence of diabetes insipidus, a condition treated with vasopressin, is a major driver. As more people are diagnosed with this condition, the demand for vasopressin therapies increases[1].

Cardiovascular Diseases

Vasopressin is used in treating various cardiovascular conditions such as cardiac arrest and septic shock. The rising incidence of these cardiovascular diseases contributes to the market's growth[1].

Growing Senior Population

The ageing population is more prone to disorders like hypotension and cardiovascular diseases, for which vasopressin is often prescribed. This demographic trend is expanding the market[1].

Enhanced Knowledge and Diagnosis

Earlier and more accurate diagnoses of diseases treatable with vasopressin have increased the demand for the medication. Advances in diagnostic techniques and awareness among healthcare professionals are key factors here[1].

Technological Developments in Manufacturing

Improvements in biotechnology and pharmaceutical manufacturing processes have made vasopressin more widely available and affordable. These advancements have enhanced production efficiency and quality[1].

Research and Development Initiatives

Ongoing studies and clinical trials exploring new therapeutic uses for vasopressin are expanding its potential market. Positive research findings could lead to additional indications and increased adoption[1].

Market Segmentation

The vasopressin market is segmented based on several criteria:

By Application

• Anti-Diuretic Hormone Deficiency: This is one of the primary applications, given vasopressin's role in treating diabetes insipidus.
• Vasodilatory Shock: Vasopressin is used to treat septic shock and other forms of vasodilatory shock.
• Gastrointestinal Bleeding: It is also used in cases of gastrointestinal bleeding, particularly in conditions like esophageal varices.
• Ventricular Tachycardia & Fibrillation: Vasopressin can be used in the management of these cardiac arrhythmias[1][3][4].

By Product

• Intravenous Injection: This is a common method of administration, especially in critical care settings.
• Intramuscular Injection: Used for less urgent conditions.
• Subcutaneous Injection: Another mode of administration, particularly for chronic conditions[3].

By Geography

• North America: A significant market due to high healthcare spending and advanced medical infrastructure.
• Europe: Strong government investments in R&D and the launch of novel therapeutics are driving growth.
• Asia Pacific: Emerging economies with increasing numbers of manufacturers are contributing to the market's expansion.
• Rest of the World: Includes Latin America, Middle East, and Africa, where the market is growing due to increasing prevalence of heart disorders and other conditions[1][3][4].

Competitive Landscape

The global vasopressin market is competitive, with several key players:

• Endo International Plc.: Holds a significant market share, particularly in the U.S. market.
• AMOMED Pharma: Known for its novel arginine-vasopressin products.
• Novartis, Pfizer, Fresenius Kabi Canada, Par Pharmaceutical, Ferring Pharmaceuticals, Astellas Pharma: Other major players with a strong presence in the market[3][4].

Challenges and Restraints

Despite the growth potential, the vasopressin market faces several challenges:

Adverse Side Effects

Vasopressin can cause serious side effects such as hyponatremia, headaches, nausea, and abdominal cramping, which can limit its use[1][4].

High Treatment Cost

The cost of vasopressin therapy and its formulations can be prohibitive, especially in developing countries[1].

Strict Regulatory Approvals

The stringent regulatory approval process can delay product introductions and impede market expansion[1].

Availability of Alternative Therapies

The presence of alternative therapies can reduce the demand for vasopressin[1].

Limited Knowledge

Incomplete knowledge among patients and healthcare professionals about vasopressin can hinder its widespread adoption[1].

Supply Chain Disruptions

Issues such as production difficulties and raw material shortages can affect the availability of vasopressin products[1].

Patent Expirations

The expiration of patents can lead to the introduction of generic versions, increasing competition and potentially reducing the market share of original manufacturers[1].

Financial Trajectory

The financial trajectory of the vasopressin market is promising, with significant growth projected:

• North America: The market in this region was valued at USD 561.3 million in 2019 and is expected to grow substantially due to the increasing prevalence of sepsis and the growing number of cardiac surgeries[4].
• Europe: Strong government investments in R&D and the launch of novel therapeutics are expected to drive growth in this region[4].
• Asia Pacific: The market here is anticipated to show considerable growth due to the increasing number of manufacturers entering the region[4].

Key Takeaways

• The vasopressin market is expected to grow significantly, driven by increasing prevalence of diabetes insipidus and cardiovascular diseases.
• Technological advancements and enhanced diagnostic capabilities are boosting market growth.
• The market faces challenges such as adverse side effects, high treatment costs, and strict regulatory approvals.
• Key players are focusing on R&D and the launch of novel therapeutics to maintain market dominance.

FAQs

Q: What is the projected market size of the vasopressin market by 2031? A: The vasopressin market is projected to reach USD 2656.9 million by 2031[1].

Q: What are the main applications of vasopressin? A: The main applications include anti-diuretic hormone deficiency, vasodilatory shock, gastrointestinal bleeding, and ventricular tachycardia & fibrillation[1][3][4].

Q: Which region is expected to show significant growth in the vasopressin market? A: The Asia Pacific region is anticipated to show considerable growth due to the increasing number of manufacturers entering the region[4].

Q: What are some of the challenges facing the vasopressin market? A: Challenges include adverse side effects, high treatment costs, strict regulatory approvals, and the availability of alternative therapies[1].

Q: Who are the key players in the vasopressin market? A: Key players include Endo International Plc., AMOMED Pharma, Novartis, Pfizer, and others[3][4].

Sources

1. Verified Market Research: Vasopressin Market Size & Forecast[1].
2. MDPI: Vasopressin in Sepsis and Other Shock States: State of the Art[2].
3. Market Research Intellect: Vasopressin Market Size and Forecast[3].
4. Fortune Business Insights: Vasopressin for Vasoplegic Shock Market Size & Growth[4].
5. Market Research Intellect: Global Vasopressin Antagonists Market Size, Trends and Projections[5].