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Last Updated: December 22, 2024

Heparin sodium; taurolidine - Generic Drug Details

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What are the generic sources for heparin sodium; taurolidine and what is the scope of freedom to operate?

Heparin sodium; taurolidine is the generic ingredient in one branded drug marketed by Cormedix and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Heparin sodium; taurolidine has fourteen patent family members in eight countries.

One supplier is listed for this compound.

Summary for heparin sodium; taurolidine

International Patents:	14
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	heparin sodium; taurolidine at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for heparin sodium; taurolidine

Generic Entry Date for heparin sodium; taurolidine^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: GENERATING ANTIBIOTIC INCENTIVES NOW 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 heparin sodium; taurolidine

Drug Class	Anti-coagulant Unfractionated Heparin

Anatomical Therapeutic Chemical (ATC) Classes for heparin sodium; taurolidine

US Patents and Regulatory Information for heparin sodium; taurolidine

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Glossary

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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	⤷ Subscribe	⤷ Subscribe	Y	Y		⤷ Subscribe
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y	Y		⤷ Subscribe
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y	Y		⤷ Subscribe
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y	Y		⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for heparin sodium; taurolidine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023	⤷ Subscribe	⤷ Subscribe
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023	⤷ Subscribe	⤷ Subscribe
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023	⤷ Subscribe	⤷ Subscribe
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for heparin sodium; taurolidine

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Country	Patent Number	Title	Estimated Expiration
Japan	2013090933	ANTIMICROBIAL LOCKING SOLUTION COMPRISING TAURINAMIDE DERIVATIVE AND BIOLOGICALLY ACCEPTABLE SALT AND ACID, WITH ADDITION OF SMALL CONCENTRATION OF HEPARIN	⤷ Subscribe
Japan	2008518739		⤷ Subscribe
Spain	2951567		⤷ Subscribe
World Intellectual Property Organization (WIPO)	2006049813		⤷ Subscribe
Germany	202005022124		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Heparin sodium; taurolidine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Taurolidine and Heparin Sodium

Introduction

Taurolidine and heparin sodium, combined in the catheter lock solution known as Defencath, are crucial in the management of patients undergoing chronic hemodialysis. This article delves into the market dynamics, financial trajectory, and regulatory aspects of this drug combination.

Market Drivers

Increasing Demand for Anticoagulants and Antimicrobials

The global demand for anticoagulants like heparin sodium is on the rise, driven by the increasing prevalence of cardiovascular diseases and the need to prevent thromboembolic events. This trend is expected to continue, with the heparin sodium market projected to grow from USD 5.76 billion in 2024 to USD 9.72 billion by 2031, at a CAGR of 4.2%[4].

Growing Healthcare Expenditure

Increasing healthcare spending, particularly in emerging economies, is making advanced medical therapies more accessible. This trend supports the expansion of the market for taurolidine and heparin sodium, as more patients gain access to these treatments[4].

Regulatory Support and Approval

Strict regulatory guidelines ensure the safety and quality of pharmaceuticals, including taurolidine and heparin sodium. Recent approvals, such as the FDA approval for Defencath, have bolstered market confidence and facilitated wider adoption[5].

Regulatory Framework

Transitional Drug Add-on Payment Adjustment (TDAPA)

The Centers for Medicare and Medicaid Services (CMS) has included taurolidine and heparin sodium in the TDAPA program, effective July 1, 2024, through June 30, 2026. This program provides a transitional payment adjustment for new renal dialysis drugs and biological products that do not fall within existing End-Stage Renal Disease Prospective Payment System (ESRD PPS) functional categories. The payment is based on 100% of the average sales price (ASP) or wholesale acquisition cost (WAC) if ASP is not available[1][2].

ESRD Prospective Payment System (PPS)

Taurolidine and heparin sodium fall within the existing ESRD PPS functional category of anti-infectives. This categorization ensures that these drugs are included in the bundled payment for ESRD services, which helps in streamlining reimbursement processes for healthcare providers[1][2].

Financial Impact

Reimbursement and Payment Adjustments

The inclusion of taurolidine and heparin sodium in the TDAPA program and the ESRD PPS ensures that healthcare facilities receive adequate reimbursement for these drugs. The payment adjustments under TDAPA are calculated based on the ASP or WAC, which helps in maintaining financial stability for providers offering these treatments[1][2].

Economic Impact of ESRD QIP

The overall economic impact of the ESRD Quality Incentive Program (QIP) for 2027 is estimated to be approximately $145.1 million. While this figure includes various components, the inclusion of new drugs like taurolidine and heparin sodium under the TDAPA and ESRD PPS contributes to the financial dynamics of the program[2].

Clinical and Economic Benefits

Reduction in Catheter-Related Bloodstream Infections (CRBSI)

Defencath has been shown to reduce the incidence of CRBSI by 71% compared to heparin alone, which significantly improves patient outcomes and reduces healthcare costs associated with treating these infections[5].

Cost Savings

By reducing the incidence of CRBSI, Defencath can lead to substantial cost savings for healthcare systems. The reduction in infections decreases the need for additional treatments, hospitalizations, and other medical interventions, thereby lowering overall healthcare expenditure.

Market Size and Forecast

Heparin Sodium Market

The heparin sodium market, which includes the component of Defencath, is expected to grow significantly. The market size was valued at USD 5.76 billion in 2024 and is projected to reach USD 9.72 billion by 2031, indicating a robust growth trajectory[4].

Specifics of Defencath

Defencath, the specific product containing taurolidine and heparin sodium, benefits from this broader market trend. Its approval and inclusion in reimbursement programs further solidify its market position.

Challenges and Considerations

Heparin-Induced Thrombocytopenia (HIT)

One of the cautionary aspects of using heparin sodium is the risk of HIT, which was reported at an incidence rate of 0.3% in clinical trials. This necessitates careful monitoring and appropriate management strategies[3].

Manufacturing and Quality Control

Ensuring the quality and safety of the drug product is crucial. The FDA has scrutinized the manufacturing facilities and processes for Defencath, highlighting the importance of stringent quality control measures[5].

Key Takeaways

Market Growth: The market for heparin sodium and taurolidine is driven by increasing demand for anticoagulants and antimicrobials, growing healthcare expenditure, and regulatory support.
Regulatory Framework: The inclusion of taurolidine and heparin sodium in the TDAPA program and ESRD PPS ensures adequate reimbursement and streamlines payment processes.
Clinical Benefits: Defencath significantly reduces CRBSI, improving patient outcomes and reducing healthcare costs.
Financial Impact: The drug contributes to the economic dynamics of the ESRD QIP and is expected to grow as part of the broader heparin sodium market.

FAQs

What is the primary use of taurolidine and heparin sodium in Defencath?

Taurolidine and heparin sodium in Defencath are used to reduce the incidence of catheter-related bloodstream infections (CRBSI) in patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC)[3][5].

How is Defencath administered?

Defencath is instilled into the lumens of the hemodialysis catheter after each dialysis session and withdrawn before the next session. It is not intended for systemic administration[3][5].

What are the potential risks associated with using heparin sodium in Defencath?

One of the potential risks is heparin-induced thrombocytopenia (HIT), which requires careful monitoring and management[3].

How does the TDAPA program affect the reimbursement for Defencath?

The TDAPA program provides a transitional payment adjustment for Defencath, ensuring that healthcare facilities receive reimbursement based on 100% of the ASP or WAC, if ASP is not available[1][2].

What is the projected market growth for heparin sodium?

The heparin sodium market is projected to grow from USD 5.76 billion in 2024 to USD 9.72 billion by 2031, at a CAGR of 4.2%[4].

Sources

CMS Manual System - Pub 100-04 Medicare Claims Processing. CMS, 2024.
Federal Register - 2024-14359.pdf. Federal Register, 2024.
Taurolidine and Heparin Sodium. American Journal of Health-System Pharmacy, Volume 81, Issue 10, 2024.
Heparin Sodium Market Size, Forecast. Verified Market Research, 2024.
Center for Drug Evaluation and Research - Defencath. FDA, 2023.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.