POLYMYXIN B SULFATE - Generic Drug Details

What are the generic drug sources for polymyxin b sulfate and what is the scope of patent protection?

Polymyxin b sulfate is the generic ingredient in five branded drugs marketed by Glaxosmithkline, Adrastea Pharma, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Rising, Xellia Pharms Aps, X Gen Pharms, Paddock Llc, Allergan, Bausch And Lomb, Epic Pharma Llc, Sandoz, and Somerset Theraps Llc, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for polymyxin b sulfate. Seven suppliers are listed for this compound.

Summary for POLYMYXIN B SULFATE

US Patents:	0
Tradenames:	5
Applicants:	15
NDAs:	15
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	6
What excipients (inactive ingredients) are in POLYMYXIN B SULFATE?	POLYMYXIN B SULFATE excipients list
DailyMed Link:	POLYMYXIN B SULFATE at DailyMed

Recent Clinical Trials for POLYMYXIN B SULFATE

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

Sponsor	Phase
Madonna Magdy Fahmy	Early Phase 1
Bascom Palmer Eye Institute	N/A
University of Miami	N/A

See all POLYMYXIN B SULFATE clinical trials

Pharmacology for POLYMYXIN B SULFATE

Drug Class

Polymyxin-class Antibacterial

Medical Subject Heading (MeSH) Categories for POLYMYXIN B SULFATE

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for POLYMYXIN B SULFATE

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

J01XB	Polymyxins
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for POLYMYXIN B SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Somerset Theraps Llc	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	211572-001	Aug 5, 2024	AT	RX	No	No
Sandoz	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	064211-001	Apr 13, 1998	AT	RX	No	Yes
Fresenius Kabi Usa	POLYMYXIN B SULFATE	polymyxin b sulfate	INJECTABLE;INJECTION	065372-001	Jan 10, 2008	AP	RX	No	No
Epic Pharma Llc	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	065006-001	Dec 17, 1998	AT	RX	No	No
Gland	POLYMYXIN B SULFATE	polymyxin b sulfate	INJECTABLE;INJECTION	207322-001	Apr 14, 2016	AP	RX	No	No

POLYMYXIN B SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Polymyxin B Sulfate

Introduction to Polymyxin B Sulfate

Polymyxin B sulfate is an antibiotic derived from the bacterium Bacillus polymyxa, known for its efficacy against Gram-negative bacteria. It is used in various medical applications, including the treatment of urinary tract, meningeal, and bloodstream infections, as well as surface ocular bacterial infections[2][3].

Market Size and Growth Projections

The global Polymyxin B Sulfate Market has experienced significant growth in recent years and is expected to continue this upward trend. As of 2023, the market size was valued at approximately USD 320 million. Projections indicate that the market will expand to reach around USD 520 million by 2032[4].

Historical and Forecast Periods

The market analysis spans from 2021 to 2031, with 2023 serving as the base year. The historical period from 2021 to 2023 has shown a rapid and substantial upswing, and this growth is anticipated to continue through the forecast period from 2024 to 2031[1].

Segmentation of the Market

The Polymyxin B Sulfate Market is segmented based on several key factors:

By Type

• Tablets: Used for oral administration, often in cases of less severe infections.
• Injections: Administered intravenously or intramuscularly for more severe infections[1].

By Application

• Hospitals: A major segment due to the frequent use of polymyxin B sulfate in treating severe infections.
• Private Clinics: Also a significant segment, especially for outpatient treatments.
• Others: Includes other healthcare facilities and home care settings[1].

By Geography

• North America: A significant market due to advanced healthcare infrastructure and high demand.
• Europe: Another major market with a strong healthcare system.
• Asia-Pacific: Rapidly growing due to increasing healthcare needs and infrastructure development.
• South America: Growing steadily with improving healthcare access.
• Middle-East and Africa: Emerging markets with increasing demand for advanced antibiotics[1].

Market Drivers and Restraints

Drivers

• Increasing Resistance to Other Antibiotics: The rise in antibiotic-resistant bacteria has increased the demand for polymyxin B sulfate as a last-resort treatment[3].
• Advancements in Healthcare Infrastructure: Improved healthcare facilities and access to advanced treatments in various regions drive the market growth.
• Growing Prevalence of Infections: The increasing incidence of infections, particularly those caused by Gram-negative bacteria, fuels the demand for polymyxin B sulfate[1].

Restraints

• Nephrotoxicity and Other Adverse Effects: Polymyxin B sulfate can cause nephrotoxicity and other adverse effects, which can limit its use and impact market growth[3].
• Regulatory Challenges: Strict regulatory environments and the need for careful monitoring of side effects can slow market expansion.
• High Cost: The drug's high cost can be a barrier to access, especially in developing regions[1].

Competitive Landscape

The Polymyxin B Sulfate Market is characterized by a mix of established and emerging players. Key companies profiled in the market include:

• AKORN
• Allergan
• BAUSCH AND LOMB
• FRESENIUS KABI USA
• SANDOZ INC
• XELLIA PHARMS APS
• Concord Biotech
• AuroMedics[1].

These companies are profiled based on their product offerings, market entry year, and other relevant market-related factors.

Market Outlook and Trends

Porter's 5 Forces Framework

The market analysis includes an in-depth examination using Porter's 5 Forces Framework, which considers the threat of new entrants, the threat of substitute products, the bargaining power of buyers, the bargaining power of suppliers, and the intensity of competitive rivalry. This framework helps in understanding the competitive dynamics and potential future trends[1].

Macroeconomic Evaluation

The report also includes a macroeconomic evaluation, scrutinizing the economic, political, and social landscapes of various countries. This helps in predicting how external factors might influence the market[1].

Value Chain Analysis

A comprehensive value chain analysis is conducted to understand the flow of goods and services from raw materials to end consumers. This analysis highlights critical areas that can be optimized to enhance market performance[1].

Financial Performance and Projections

Revenue Growth

The market is expected to grow significantly, with revenue projected to increase from USD 320 million in 2023 to USD 520 million by 2032. This growth is driven by increasing demand, advancements in healthcare, and the expanding reach of the drug into new markets[4].

Pricing Analysis

The report includes a detailed pricing analysis, which considers the pricing strategies of key players, the extent of product penetration at national and regional levels, and the impact of pricing on market dynamics. This analysis helps in understanding how pricing influences the financial trajectory of the market[1].

Key Takeaways

• Rapid Market Growth: The Polymyxin B Sulfate Market is experiencing rapid growth due to increasing demand and limited alternatives.
• Segmentation: The market is segmented by type, application, and geography, each contributing to its overall growth.
• Drivers and Restraints: The market is driven by antibiotic resistance and healthcare advancements but restrained by nephrotoxicity and regulatory challenges.
• Competitive Landscape: The market features a mix of established and emerging players, with key companies playing significant roles.
• Financial Projections: The market is projected to reach USD 520 million by 2032, driven by revenue growth and expanding market reach.

FAQs

What are the primary uses of Polymyxin B Sulfate?

Polymyxin B sulfate is primarily used to treat infections caused by Gram-negative bacteria, including urinary tract, meningeal, and bloodstream infections, as well as surface ocular bacterial infections[2][3].

Which regions are driving the growth of the Polymyxin B Sulfate Market?

North America, Europe, and the Asia-Pacific region are significant drivers of the market growth due to their advanced healthcare infrastructure and high demand for antibiotics[1].

What are the major challenges facing the Polymyxin B Sulfate Market?

The market faces challenges such as nephrotoxicity, high cost, and regulatory hurdles, which can limit its growth and adoption[1][3].

Who are the key players in the Polymyxin B Sulfate Market?

Key players include AKORN, Allergan, BAUSCH AND LOMB, FRESENIUS KABI USA, SANDOZ INC, XELLIA PHARMS APS, Concord Biotech, and AuroMedics[1].

What is the projected market size of Polymyxin B Sulfate by 2032?

The market is projected to reach approximately USD 520 million by 2032[4].

Sources

1. Market Research Intellect: Global Polymyxin B Sulfate Market Size, Scope And Forecast Report.
2. DailyMed: Polymyxin B sulfate and trimethoprim sulfate solution/drops.
3. DrugBank: Polymyxin B: Uses, Interactions, Mechanism of Action.
4. Dataintelo: Global Polymyxin B Sulfate Market Research Report 2032.