DEFENCATH Drug Patent Profile

When do Defencath patents expire, and when can generic versions of Defencath launch?

Defencath is a drug marketed by Cormedix and is included in one NDA. There are four patents protecting this drug.

This drug has fourteen patent family members in eight countries.

The generic ingredient in DEFENCATH is heparin sodium; taurolidine. There are seventy-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the heparin sodium; taurolidine profile page.

DrugPatentWatch^® Generic Entry Outlook for Defencath

Defencath will be eligible for patent challenges on November 15, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 15, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DEFENCATH

International Patents:	14
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for DEFENCATH
What excipients (inactive ingredients) are in DEFENCATH?	DEFENCATH excipients list
DailyMed Link:	DEFENCATH at DailyMed

See drug prices for DEFENCATH

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DEFENCATH

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

214520

Dosage:

SOLUTION;N/A

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for DEFENCATH

Drug Class

Anti-coagulant Unfractionated Heparin

US Patents and Regulatory Information for DEFENCATH

DEFENCATH is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023		RX	Yes	Yes	8,541,393		Y	Y
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023		RX	Yes	Yes	8,541,393		Y	Y
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023		RX	Yes	Yes	9,339,036		Y	Y
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023		RX	Yes	Yes
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023		RX	Yes	Yes	7,696,182		Y	Y
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023		RX	Yes	Yes	7,696,182		Y	Y

Expired US Patents for DEFENCATH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023	8,541,393
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023	9,339,036
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023	9,339,036
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023	8,541,393

International Patents for DEFENCATH

See the table below for patents covering DEFENCATH around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	202005022124
Spain	2951567
Spain	2456946
China	103083353	Antimicrobial Locking Solutions Comprising Taurinamide Derivatives And Biologically Acceptable Salts And Acids, With The Addition Of Small Concentrations Of Heparin
Japan	2013090933	ANTIMICROBIAL LOCKING SOLUTION COMPRISING TAURINAMIDE DERIVATIVE AND BIOLOGICALLY ACCEPTABLE SALT AND ACID, WITH ADDITION OF SMALL CONCENTRATION OF HEPARIN
World Intellectual Property Organization (WIPO)	2023201019

Market Dynamics and Financial Trajectory for DefenCath

Introduction to DefenCath

DefenCath, developed by CorMedix Inc., is a groundbreaking therapeutic product designed to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients undergoing chronic hemodialysis through a central venous catheter. Approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) by the FDA on November 15, 2023, DefenCath has marked a significant milestone in the treatment of life-threatening infections associated with dialysis[1].

Commercialization and Market Expansion

The commercialization of DefenCath has been a pivotal event for CorMedix Inc., particularly with its recent launch in outpatient dialysis centers. This expansion taps into a substantial portion of the renal care market, allowing CorMedix to access a wider customer base and potentially increase its market share. The outpatient sector, being more accessible and less resource-intensive than inpatient settings, facilitates more scalable growth[1].

Outpatient Availability and CMS Reimbursement

Effective July 1, 2024, DefenCath became eligible for CMS reimbursement for outpatient use, a crucial factor in its market potential. This reimbursement has directly impacted the revenue stream, making the product more viable for healthcare providers and patients alike. CorMedix has commenced shipping orders to dialysis operators and is anticipating additional customer agreements, which are expected to drive further market penetration[1].

Financial Performance and Revenue Growth

In the third quarter of 2024, CorMedix reported substantial revenue growth, with net revenue reaching $11.5 million, primarily driven by the successful rollout of DefenCath. This represents a significant increase, reflecting a 2107.4% growth in revenue over the last twelve months as of Q2 2024. The company has secured agreements with dialysis operators to provide access to approximately 60% of U.S. dialysis clinics, with purchases expected by the end of Q4 2024[2].

Operational Expenses and Cash Position

Despite the impressive revenue growth, CorMedix reported a net loss of $2.8 million for Q3 2024. However, this loss is an improvement from the previous year. The company's operating expenses increased to $14.1 million, driven primarily by new personnel and costs to support the commercial launch of DefenCath. CorMedix maintains a robust cash position of $46 million, sufficient for 12 months of operation, which provides a stable financial foundation for ongoing operations and future growth[2].

Gross Margins and Market Reception

The gross margins for DefenCath are expected to remain high through 2025, which is a positive indicator for the company's financial health. The successful implementation of DefenCath with U.S. Renal Care, accounting for over 90% of Q3 sales, underscores the strong market reception of the product. This high demand and the commitment to commercial agreements signify robust market acceptance and confidence in DefenCath[2].

Future Growth Prospects and Label Expansion

Analysts have maintained a positive outlook on CorMedix, with a Buy rating based on the potential market expansion for DefenCath. The anticipated label expansion into the adult Total Parenteral Nutrition (TPN) patient pool could significantly broaden the market for DefenCath, given the substantial number of TPN infusions annually. CorMedix plans to submit a refined clinical protocol for TPN to the FDA by mid-November 2024, with approval expected by late 2027 to 2028[4].

Strategic Manufacturing Expansion

To meet the increasing demand for DefenCath, CorMedix is planning to submit an NDA supplement for a new manufacturing site in Germany. If approved by the FDA, this strategic move will bolster the production capabilities, ensuring a steady supply of the product by the end of 2024[3].

Projected Profitability and Financial Stability

CorMedix anticipates achieving breakeven profitability by the end of December 2024, based on internal forecasts. This optimism is supported by a robust financial position and the assumption that the company can adhere to its base case assumptions for DefenCath's market uptake and pricing. The company expects to be EBITDA positive in Q4 2024, subject to order timing[3].

Market Engagement and Sales Trajectory

CorMedix is intensifying its market engagement by initiating discussions with healthcare systems and engaging with P&T committees to get DefenCath onto formularies. On the outpatient side, these discussions are expected to increase, indicating a proactive approach towards market penetration. The gradual sales increase anticipated as the company engages more deeply with the market is a promising indicator of future revenue streams[3].

Operational Cost Outlook

The operational costs for CorMedix have increased, driven by higher selling and marketing (S&M) and general and administrative (G&A) expenses. These increases are primarily due to the hiring of sales force, medical affairs, and marketing personnel in support of the commercial launch of DefenCath. However, research and development expenses have decreased significantly following the FDA approval of DefenCath[5].

Investor Insights and Market Reception

CorMedix's market capitalization of $584.54 million and the stock's strong performance, with a 306.58% price total return over the past year, indicate significant investor interest and positive market reception of DefenCath's rollout. Despite operating at a loss currently, the company's financial stability and projected profitability make it an attractive investment opportunity[2].

Key Takeaways

• Revenue Growth: DefenCath has driven substantial revenue growth for CorMedix, with Q3 2024 net revenue reaching $11.5 million.
• Market Expansion: The product's launch in outpatient dialysis centers has expanded its market potential, accessing a wider customer base.
• Financial Stability: CorMedix maintains a robust cash position and anticipates achieving breakeven profitability by the end of 2024.
• Future Prospects: Anticipated label expansion into the TPN market and strategic manufacturing expansion are key drivers for future growth.
• Market Reception: Strong market acceptance and high gross margins for DefenCath indicate a positive financial trajectory.

FAQs

Q: What is DefenCath, and what is its primary use? A: DefenCath is a therapeutic product designed to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients undergoing chronic hemodialysis through a central venous catheter.

Q: When did DefenCath receive FDA approval? A: DefenCath received FDA approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023.

Q: What is the current market reach of DefenCath? A: DefenCath has secured agreements with dialysis operators to provide access to approximately 60% of U.S. dialysis clinics.

Q: What are the financial projections for CorMedix Inc. in the near term? A: CorMedix anticipates achieving breakeven profitability by the end of December 2024 and expects to be EBITDA positive in Q4 2024.

Q: What are the future growth prospects for DefenCath? A: The anticipated label expansion into the adult Total Parenteral Nutrition (TPN) patient pool and strategic manufacturing expansion are key drivers for future growth.

Sources:

1. CorMedix Inc. Announces Outpatient Availability of DefenCath - Stock Titan
2. Earnings call: CorMedix Inc. reports Q3 financials, DefenCath drives growth - Investing.com
3. CRMD Q4-2023 Earnings Call - Alpha Spread
4. Expanding Markets and Anticipated Profitability: A Buy Rating for Cormedix on DefenCath’s Growth Prospects - Business Insider
5. CorMedix Inc. Reports Second Quarter AND SIX MONTH 2024 Financial Results AND Provides Business Update - CorMedix Inc.