Protamine sulfate - Generic Drug Details

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

Protamine sulfate is the generic ingredient in one branded drug marketed by Fresenius Kabi Usa, Hikma, Lilly, and Pharmacia And Upjohn, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for protamine sulfate. Two suppliers are listed for this compound.

Summary for protamine sulfate

US Patents:	0
Tradenames:	1
Applicants:	4
NDAs:	5
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	2
Clinical Trials:	17
What excipients (inactive ingredients) are in protamine sulfate?	protamine sulfate excipients list
DailyMed Link:	protamine sulfate at DailyMed

Recent Clinical Trials for protamine sulfate

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

Sponsor	Phase
St. Antonius Research Fund	Phase 4
St. Antonius Hospital	Phase 4
National Institute of Cardiovascular Diseases, Karachi	Phase 2/Phase 3

See all protamine sulfate clinical trials

Pharmacology for protamine sulfate

Drug Class	Heparin Reversal Agent
Mechanism of Action	Heparin Binding Activity
Physiological Effect	Reversed Anticoagulation Activity

Anatomical Therapeutic Chemical (ATC) Classes for protamine sulfate

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for protamine sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	PROTAMINE SULFATE	protamine sulfate	INJECTABLE;INJECTION	006460-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pharmacia And Upjohn	PROTAMINE SULFATE	protamine sulfate	INJECTABLE;INJECTION	007413-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Fresenius Kabi Usa	PROTAMINE SULFATE	protamine sulfate	INJECTABLE;INJECTION	089454-001	Apr 7, 1987		RX	No	Yes
Hikma	PROTAMINE SULFATE	protamine sulfate	INJECTABLE;INJECTION	089475-001	Nov 5, 1986		DISCN	No	No
Pharmacia And Upjohn	PROTAMINE SULFATE	protamine sulfate	INJECTABLE;INJECTION	007413-002	Aug 2, 1984		DISCN	No	No
Hikma	PROTAMINE SULFATE	protamine sulfate	INJECTABLE;INJECTION	089474-001	Nov 5, 1986		DISCN	No	No

Protamine sulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Protamine Sulfate

Market Overview

The protamine sulfate market is experiencing significant growth, driven by several key factors. As of 2023, the global protamine sulfate market was valued at USD 350 million and is projected to reach USD 520 million by 2031, growing at a compound annual growth rate (CAGR) of 4.3% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Cardiovascular Procedures

The rise in cardiovascular surgeries and complex medical procedures that require efficient anticoagulant reversal is a major driver of the protamine sulfate market. Protamine sulfate is the only clinically approved antidote for unfractionated heparin (UFH), making it indispensable in cardiopulmonary surgery and other extracorporeal circulation situations[2][5].

Growing Prevalence of Cardiovascular Diseases

The increasing incidence of cardiovascular diseases such as deep vein thrombosis and atrial fibrillation, which require anticoagulant medication, is another significant factor. The growing geriatric population, who are more susceptible to these conditions, further fuels the demand for protamine sulfate[1].

Advancements in Healthcare and Surgical Methods

Improvements in surgical techniques and the implementation of advanced treatments by healthcare systems worldwide are also driving the market. The need for efficient anticoagulant management solutions is becoming more critical, contributing to the market's expansion[1].

Market Segmentation

By Application

The protamine sulfate market is segmented based on its applications, including anticoagulant reversal, pharmaceuticals, medical procedures, and cardiovascular treatment. The anticoagulant reversal segment is particularly significant due to the drug's role in reversing heparin overdoses during surgical procedures[1][3].

By Product

The market is also segmented by product type, which includes protamine sulfate injection, powder, solution, tablets, and concentrates. Protamine sulfate injection is a key product, widely used in clinical settings to reverse the effects of heparin[1][5].

Geographical Regions

Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America and Europe are significant markets due to their advanced healthcare systems and high demand for cardiovascular treatments[1][5].

Financial Trajectory

Market Size and Projections

The global protamine sulfate market is expected to grow from USD 350 million in 2023 to USD 520 million by 2031. This growth is driven by the increasing demand for anticoagulant reversal agents and the expanding use of protamine sulfate in various medical procedures[1].

CAGR and Growth Rate

The market is projected to grow at a CAGR of 4.3% from 2024 to 2031. This steady growth rate indicates a stable and increasing demand for protamine sulfate over the forecast period[1].

Impact of COVID-19

The COVID-19 pandemic had a temporary impact on the market, causing supply chain disruptions and production stagnation. However, the market is expected to recover as the pandemic's effects diminish and healthcare systems return to normal operations[5].

Competitive Landscape

Key Players

Major players in the protamine sulfate market include Pfizer, Merck, Sanofi, Amgen, Novartis, Johnson & Johnson, Mylan, Teva Pharmaceuticals, Hospira, and Baxter. These companies are focusing on expanding their product portfolios and improving their market presence through strategic initiatives[1].

Market Share

Fresenius-Kabi is one of the leading companies in the protamine sulfate injection market, holding a significant market share. Other notable players include EIPICO, Fada Pharma, and Sanofi-Aventis[5].

Technological and Innovative Trends

Nanopharmaceuticals

Protamine sulfate is being explored in nanopharmaceuticals for its potential in drug delivery systems. It is used to create nanoparticles that can deliver drugs more effectively, particularly in cancer treatment. This innovative use is expected to further expand the market for protamine sulfate[4].

Gene Delivery

Protamine sulfate is also used in gene delivery systems, enhancing the efficiency of gene transfer to specific cells. This application highlights the versatility and growing importance of protamine sulfate in advanced medical treatments[2].

Challenges and Restraints

Side Effects and Alternatives

Despite its widespread use, protamine sulfate is associated with severe side effects, including anaphylactic reactions. Research into safer alternatives, such as the novel peptide compound R15S, is ongoing to address these concerns[2].

Raw Material Shortages

The COVID-19 pandemic highlighted issues with raw material supply chains, particularly for fish sperm, which is a key source of protamine sulfate. This shortage has led to price increases and production challenges[5].

Regional Analysis

North America and Europe

These regions are significant markets due to their advanced healthcare infrastructure and high demand for cardiovascular treatments. The United States, in particular, holds a substantial share of the protamine sulfate injection market[5].

Asia-Pacific

The Asia-Pacific region is also experiencing growth, driven by increasing healthcare expenditures and technological advancements in medication formulation. Countries like China, Japan, and India are key markets in this region[1].

Key Takeaways

• The protamine sulfate market is valued at USD 350 million in 2023 and is expected to reach USD 520 million by 2031.
• The market is driven by the increasing need for anticoagulant reversal agents in cardiovascular surgeries and other medical procedures.
• Key players include Pfizer, Merck, Sanofi, and Fresenius-Kabi.
• The market faces challenges such as side effects and raw material shortages but is also seeing innovative applications in nanopharmaceuticals and gene delivery.

FAQs

Q: What is the primary use of protamine sulfate in medical procedures? A: Protamine sulfate is primarily used as an antidote to reverse the effects of heparin and low molecular weight heparin during surgical procedures, especially in cardiovascular surgeries[5].

Q: How is the COVID-19 pandemic affecting the protamine sulfate market? A: The COVID-19 pandemic has caused supply chain disruptions, production stagnation, and raw material shortages, which have temporarily slowed market growth. However, the market is expected to recover as the pandemic's effects diminish[5].

Q: What are the key drivers of the protamine sulfate market growth? A: The market growth is driven by the increasing prevalence of cardiovascular diseases, advancements in healthcare and surgical methods, and the growing geriatric population[1].

Q: Which regions are the most significant markets for protamine sulfate? A: North America and Europe are the most significant markets due to their advanced healthcare infrastructure and high demand for cardiovascular treatments. The Asia-Pacific region is also growing rapidly[1][5].

Q: Are there any innovative applications of protamine sulfate beyond its traditional use? A: Yes, protamine sulfate is being explored in nanopharmaceuticals for drug delivery systems and in gene delivery, highlighting its potential in advanced medical treatments[4].

Cited Sources:

1. Market Research Intellect: Global Protamine Sulfate Market Size and Forecast.
2. Science.gov: Protamine sulfate precipitation: Topics by Science.gov.
3. Cognitive Market Research: Global Protamine Sulfate Market Report 2024 Edition.
4. MDPI: Use of Protamine in Nanopharmaceuticals—A Review.
5. Market Research: Global Protamine Sulfate Injection Market Research Report 2023.