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Last Updated: December 22, 2024

CORMAX Drug Patent Profile


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Which patents cover Cormax, and when can generic versions of Cormax launch?

Cormax is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in CORMAX is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cormax

A generic version of CORMAX was approved as clobetasol propionate by COSETTE on February 16th, 1994.

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Summary for CORMAX
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 80
Patent Applications: 4,356
DailyMed Link:CORMAX at DailyMed
Drug patent expirations by year for CORMAX

US Patents and Regulatory Information for CORMAX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma CORMAX clobetasol propionate CREAM;TOPICAL 074220-001 May 16, 1997 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

CORMAX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CorMedix Inc.'s DefenCath (Not CORMAX)

Introduction

CorMedix Inc., a biopharmaceutical company, has been making significant strides in the healthcare industry, particularly with its product DefenCath. Although the query mentions "CORMAX," which does not correspond to any known product of CorMedix, we will focus on DefenCath, the company's flagship product.

Product Overview

DefenCath is a catheter lock solution designed to prevent catheter-related bloodstream infections (CRBSIs) in patients undergoing hemodialysis. It has been a key focus for CorMedix Inc. in their efforts to address life-threatening diseases and conditions.

Market Dynamics

Market Penetration

CorMedix has achieved substantial market penetration with DefenCath. As of the third quarter of 2024, the company reported commercial agreements covering approximately 60% of US outpatient dialysis centers. This includes agreements with four of the top five US dialysis providers, indicating strong acceptance and viability of the product[3].

Competitive Landscape

The dialysis market is competitive, but DefenCath's unique positioning as a catheter lock solution sets it apart. The successful implementation by a mid-sized dialysis operator as an anchor customer has demonstrated the product's effectiveness and market potential[3].

Regulatory and Clinical Initiatives

CorMedix is expanding DefenCath's indications beyond adult hemodialysis. Several clinical initiatives are planned for early 2025, including studies on Total Parenteral Nutrition and pediatric hemodialysis. These initiatives aim to significantly expand the addressable market for DefenCath[3].

Financial Trajectory

Revenue Growth

In the third quarter of 2024, CorMedix reported net revenue of $11.5 million, primarily driven by DefenCath sales. This marks the company's first full quarter of DefenCath sales since its outpatient launch in July 2024[3].

Cost Management and Profitability

Despite increasing operating expenses by 34% to $14.1 million, CorMedix managed to reduce its net loss to $2.8 million ($0.05 per share) in Q3 2024, compared to $9.7 million ($0.17 per share) in Q3 2023. This reduction in losses is a positive indicator of the company's financial health[3].

Cash Position

CorMedix's cash position stands at $46.0 million, which the company believes is sufficient for at least twelve months of operations. This cash reserve provides a buffer for ongoing operations and future expansion plans[3].

Market Trends and Growth Prospects

Increasing Demand

The demand for effective catheter lock solutions is increasing due to the growing need to prevent CRBSIs in dialysis patients. DefenCath's market entry has shown promising traction, with significant commercial agreements and successful implementations[3].

Expansion into New Markets

CorMedix is not only focusing on outpatient dialysis centers but also exploring inpatient facilities through P&T reviews. This multi-channel strategy is expected to open additional revenue streams and position the company for potential accelerated growth in 2025[3].

Competitor Insights

While CorMedix Inc. is a key player in the dialysis solutions market, the broader healthcare industry is highly competitive. Companies like Fresenius Medical Care and DaVita Inc. are major players in the dialysis sector, but CorMedix's focus on innovative solutions like DefenCath helps it maintain a competitive edge[3].

Challenges and Opportunities

Regulatory Challenges

The healthcare industry is heavily regulated, and CorMedix must navigate these regulations to expand DefenCath's indications and market reach. Stringent regulatory environments can pose challenges but also provide opportunities for differentiation through compliance and innovation[3].

Market Expansion Opportunities

The planned clinical initiatives and the expansion into new markets offer significant opportunities for growth. CorMedix's ability to secure commercial agreements with major dialysis providers and its ongoing clinical studies position the company for long-term success[3].

Key Takeaways

  • Strong Market Penetration: DefenCath has secured commercial agreements covering 60% of US outpatient dialysis centers.
  • Revenue Growth: Net revenue of $11.5 million in Q3 2024, driven by DefenCath sales.
  • Cost Management: Reduced net loss to $2.8 million in Q3 2024.
  • Cash Position: Sufficient cash reserves for at least twelve months of operations.
  • Expansion Plans: Clinical initiatives planned for early 2025 to expand DefenCath's indications.

FAQs

  1. What is DefenCath? DefenCath is a catheter lock solution designed to prevent catheter-related bloodstream infections (CRBSIs) in patients undergoing hemodialysis.

  2. How has DefenCath performed in the market? DefenCath has shown promising traction with commercial agreements covering approximately 60% of US outpatient dialysis centers and net revenue of $11.5 million in Q3 2024.

  3. What are the future expansion plans for DefenCath? CorMedix is planning several clinical initiatives for early 2025, including studies on Total Parenteral Nutrition and pediatric hemodialysis, to expand DefenCath's indications.

  4. How is CorMedix managing its financial health? CorMedix has reduced its net loss and maintains a cash position sufficient for at least twelve months of operations, indicating improved financial health.

  5. What are the regulatory challenges faced by CorMedix? CorMedix must navigate stringent regulatory environments to expand DefenCath's indications and market reach, but compliance and innovation can provide opportunities for differentiation.

Cited Sources:

  1. CorMedix Inc. Reports Third Quarter and Nine Month 2024 Financial Results and Provides Business Update - Stock Titan[3].

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