Polymyxin b sulfate; trimethoprim sulfate - Generic Drug Details

What are the generic drug sources for polymyxin b sulfate; trimethoprim sulfate and what is the scope of freedom to operate?

Polymyxin b sulfate; trimethoprim sulfate is the generic ingredient in two branded drugs marketed by Allergan, Bausch And Lomb, Epic Pharma Llc, Sandoz, and Somerset Theraps Llc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Thirteen suppliers are listed for this compound.

Summary for polymyxin b sulfate; trimethoprim sulfate

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	13
DailyMed Link:	polymyxin b sulfate; trimethoprim sulfate at DailyMed

Pharmacology for polymyxin b sulfate; trimethoprim sulfate

Drug Class	Dihydrofolate Reductase Inhibitor Antibacterial Polymyxin-class Antibacterial
Mechanism of Action	Cytochrome P450 2C8 Inhibitors Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for polymyxin b sulfate; trimethoprim sulfate

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

J01EA	Trimethoprim and derivatives
J01E	SULFONAMIDES AND TRIMETHOPRIM
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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; trimethoprim sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	064211-001	Apr 13, 1998	AT	RX	No	Yes
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
Allergan	POLYTRIM	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	050567-001	Oct 20, 1988		DISCN	Yes	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
Bausch And Lomb	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	064120-001	Feb 14, 1997	AT	RX	No	No

Polymyxin b sulfate; trimethoprim sulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Polymyxin B Sulfate and Trimethoprim Sulfate

Introduction

Polymyxin B sulfate and trimethoprim sulfate ophthalmic solution, commonly known as Polytrim, is a widely used medication for treating surface ocular bacterial infections, including bacterial conjunctivitis. This article delves into the market dynamics and financial trajectory of this drug, exploring factors such as demand, supply chain issues, regulatory challenges, and financial implications.

Market Demand

The demand for Polytrim eye drops is driven by the prevalence of bacterial eye infections. Conditions like bacterial conjunctivitis, which affects a significant portion of the population, particularly children and individuals in close living environments, contribute to the steady demand for this medication[4].

Seasonal Variations

Demand for Polytrim can vary seasonally, with higher demand during periods when respiratory and ocular infections are more common, such as during the winter months. This seasonal fluctuation can impact the financial trajectory of the drug, with manufacturers and distributors needing to adjust production and inventory accordingly.

Demographic Factors

The demographic makeup of the patient population also influences demand. For instance, schools and daycare centers are common breeding grounds for bacterial conjunctivitis, leading to increased demand among pediatric populations[4].

Supply Chain Issues

Production Disruptions

Recent years have seen disruptions in the production of Polytrim eye drops, contributing to shortages. For example, Akorn ceased operations in February 2023, leading to the discontinuation of their Polytrim products. This has forced patients and healthcare providers to seek alternative treatments or sources[3][4].

Regulatory Challenges

Regulatory requirements and changes can also impact the supply chain. Compliance with regulatory standards can lead to delays in the availability of the medication, affecting both the manufacturers and the end-users. Ensuring that the production process meets all regulatory requirements is crucial but can be time-consuming and costly[4].

Availability and Alternatives

Current Availability

Despite the discontinuation of some products, other manufacturers like Bausch Health and Sandoz continue to produce Polytrim eye drops, ensuring some level of availability. However, the reduced number of manufacturers can lead to price fluctuations and supply chain vulnerabilities[3].

Alternative Treatments

In cases of shortages, healthcare providers may recommend alternative treatments such as Tobramycin-Dexamethasone eye drops. These alternatives can mitigate the impact of shortages but may not offer the exact same efficacy or patient preference as Polytrim[4].

Financial Implications

Revenue Impact

Shortages and production disruptions can significantly impact the revenue of manufacturers. The discontinuation of products by key manufacturers like Akorn has led to a shift in market share, with other companies like Bausch Health and Sandoz potentially benefiting from the increased demand for their versions of Polytrim[3].

Cost-Effectiveness

The cost-effectiveness of Polytrim is another financial consideration. Studies have shown that moxifloxacin, another antibiotic eye drop, may be more cost-effective and efficacious in treating bacterial conjunctivitis, potentially affecting the market share of Polytrim[1].

Pricing Dynamics

Market Forces

Pricing for Polytrim is influenced by market forces such as competition, demand, and supply. The current shortage has led to pricing fluctuations, with some products becoming more expensive due to limited availability. This can affect the affordability of the medication for patients and impact the overall financial trajectory of the drug[4].

Regulatory Influence

Regulatory bodies can also influence pricing through policies and guidelines. For instance, regulations aimed at controlling prices or ensuring fair market practices can impact the profitability of Polytrim for manufacturers[4].

Logistical Challenges

Distribution Issues

Logistical issues such as transportation delays and distribution challenges can further exacerbate shortages. Ensuring timely delivery of Polytrim to pharmacies and healthcare facilities is crucial to maintaining a stable supply chain[4].

Pregnancy and Fertility Considerations

Teratogenic Effects

The potential teratogenic effects of trimethoprim and the unknown effects of polymyxin B sulfate on fetal development can influence prescribing practices and, by extension, market demand. While the topical application of Polytrim results in minimal systemic absorption, healthcare providers may still opt for alternative treatments in pregnant patients, affecting sales[2][4].

Conclusion

The market dynamics and financial trajectory of polymyxin B sulfate and trimethoprim sulfate ophthalmic solution are complex and multifaceted. Factors such as demand driven by the prevalence of bacterial eye infections, supply chain disruptions, regulatory challenges, and logistical issues all play significant roles. Understanding these dynamics is crucial for manufacturers, distributors, and healthcare providers to manage expectations and ensure the continuous availability of this essential medication.

Key Takeaways

• Demand and Seasonality: Demand for Polytrim is influenced by the prevalence of bacterial eye infections and seasonal variations.
• Supply Chain Issues: Production disruptions, regulatory challenges, and logistical issues contribute to shortages.
• Financial Implications: Shortages and production disruptions impact revenue, while alternative treatments and cost-effectiveness considerations affect market share.
• Pricing Dynamics: Market forces, regulatory influence, and logistical challenges influence pricing.
• Logistical Challenges: Distribution issues can exacerbate shortages.
• Pregnancy and Fertility: Potential teratogenic effects and unknown fertility impacts can influence prescribing practices.

FAQs

Q: What are the primary uses of Polytrim eye drops? A: Polytrim eye drops are used to treat bacterial conjunctivitis, manage and prevent eye infections caused by susceptible bacteria, and for post-operative care following eye surgeries[4].

Q: Why is there a current shortage of Polytrim eye drops? A: The shortage is due to factors such as increased demand, production issues, regulatory challenges, and logistical problems, including the discontinuation of products by some manufacturers[3][4].

Q: Are there alternative treatments for Polytrim eye drops? A: Yes, alternatives such as Tobramycin-Dexamethasone eye drops can be used to treat bacterial eye infections[4].

Q: How do regulatory changes affect the availability of Polytrim? A: Regulatory changes can lead to delays in production and distribution, impacting the availability of the medication[4].

Q: What are the potential risks of using Polytrim during pregnancy? A: While minimal systemic absorption occurs with topical use, there is a theoretical risk of adverse effects on the developing fetus, particularly with trimethoprim[2][4].

Sources

1. Multicenter comparison of polymyxin B sulfate/trimethoprim and moxifloxacin ophthalmic solution - PubMed[1]
2. Polymyxin B sulfate and trimethoprim ophthalmic solution - DailyMed[2]
3. Polymyxin B and Trimethoprim Sulfates Ophthalmic Solution - ASHP[3]
4. Understanding Polytrim Eye Drops - Inotek Corp[4]
5. Polymyxin B sulfate and trimethoprim ophthalmic solution - DailyMed[5]