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
(5 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
(13 days 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
(13 days 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.
Latest 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 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 Critical | 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 Critical | 29 Aug, 2023 | US11738120 |
| Email Notification Critical | 29 Aug, 2023 | US11738120 |
| Electronic Review Critical | 10 Aug, 2023 | US11738120 |
| Email Notification Critical | 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 |
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
Explore Our Curated Drug Screens
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 |