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Last Updated: December 22, 2024

PROTAMINE SULFATE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Protamine Sulfate

A generic version of PROTAMINE SULFATE was approved as protamine sulfate by FRESENIUS KABI USA on April 7th, 1987.

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Summary for PROTAMINE SULFATE
Drug patent expirations by year for PROTAMINE SULFATE
Recent Clinical Trials for PROTAMINE SULFATE

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

SponsorPhase
St. Antonius HospitalPhase 4
St. Antonius Research FundPhase 4
National Institute of Cardiovascular Diseases, KarachiPhase 2/Phase 3

See all PROTAMINE SULFATE clinical trials

Pharmacology for PROTAMINE SULFATE
Drug ClassHeparin Reversal Agent
Mechanism of ActionHeparin Binding Activity
Physiological EffectReversed Anticoagulation Activity
Anatomical Therapeutic Chemical (ATC) Classes for PROTAMINE SULFATE

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

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.

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