Defencath Patent Expiration

Defencath is a drug owned by Cormedix Inc. It is protected by 4 US drug patents filed in 2023. Out of these, 2 drug patents are active and 2 have expired. Defencath's patents will be open to challenges from 15 November, 2032. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 15, 2042. Details of Defencath's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US11738120 Synthesis of taurolidine, purity profiles and polymorphs
Apr, 2042

(17 years from now)

Active
US7696182 Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin
May, 2025

(4 months from now)

Active
US9339036 Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin
Nov, 2024

(a month ago)

Expired
US8541393 Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin
Nov, 2024

(a month ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Defencath's patents.

Given below is the list of recent legal activities going on the following patents of Defencath.

Activity Date Patent Number
Patent litigations
Patent Term Extension Application under 35 USC 156 Filed 08 Jan, 2024 US7696182
Payment of Maintenance Fee, 8th Yr, Small Entity 04 Oct, 2023 US9339036
Recordation of Patent Grant Mailed 29 Aug, 2023 US11738120
Patent eGrant Notification 29 Aug, 2023 US11738120
Mail Patent eGrant Notification 29 Aug, 2023 US11738120
Recordation of Patent eGrant 29 Aug, 2023 US11738120
Patent Issue Date Used in PTA Calculation 29 Aug, 2023 US11738120
Email Notification 29 Aug, 2023 US11738120
Electronic Review 10 Aug, 2023 US11738120
Email Notification 10 Aug, 2023 US11738120


FDA has granted several exclusivities to Defencath. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Defencath, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Defencath.

Exclusivity Information

Defencath holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2033. Details of Defencath's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Nov 15, 2028
Generating Antibiotic Incentives Now(GAIN) Nov 15, 2033

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US patents provide insights into the exclusivity only within the United States, but Defencath is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Defencath's family patents as well as insights into ongoing legal events on those patents.

Defencath's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Defencath's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 15, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Defencath Generics:

There are no approved generic versions for Defencath as of now.





About Defencath

Defencath is a drug owned by Cormedix Inc. It is used for preventing catheter-related bloodstream infections in hemodialysis patients. Defencath uses Heparin Sodium; Taurolidine as an active ingredient. Defencath was launched by Cormedix in 2023.

Approval Date:

Defencath was approved by FDA for market use on 15 November, 2023.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Defencath is 15 November, 2023, its NCE-1 date is estimated to be 15 November, 2032.

Active Ingredient:

Defencath uses Heparin Sodium; Taurolidine as the active ingredient. Check out other Drugs and Companies using Heparin Sodium; Taurolidine ingredient

Treatment:

Defencath is used for preventing catheter-related bloodstream infections in hemodialysis patients.

Dosage:

Defencath is available in solution form for n/a use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) SOLUTION Prescription N/A
5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) SOLUTION Prescription N/A