DEFENCATH Drug Patent Profile
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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 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in DEFENCATH? | DEFENCATH excipients list |
| DailyMed Link: | DEFENCATH at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DEFENCATH
Generic Entry Date for DEFENCATH*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW NDA:
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 |
Anatomical Therapeutic Chemical (ATC) Classes for DEFENCATH
US Patents and Regulatory Information for DEFENCATH
DEFENCATH is protected by four US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of DEFENCATH is ⤷ Try a Trial.
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.
Patents protecting DEFENCATH
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A CATHETER LOCK SOLUTION TO REDUCE CATHETER-RELATED BLOODSTREAM INFECTIONS IN ADULT PATIENTS RECEIVING HEMODIALYSIS THROUGH A CENTRAL VENOUS CATHETER
Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A CATHETER LOCK SOLUTION TO REDUCE CATHETER-RELATED BLOODSTREAM INFECTIONS IN ADULT PATIENTS RECEIVING HEMODIALYSIS THROUGH A CENTRAL VENOUS CATHETER
Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting DEFENCATH
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Cormedix | DEFENCATH | heparin sodium; taurolidine | SOLUTION;N/A | 214520-002 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Cormedix | DEFENCATH | heparin sodium; taurolidine | SOLUTION;N/A | 214520-001 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Cormedix | DEFENCATH | heparin sodium; taurolidine | SOLUTION;N/A | 214520-002 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Cormedix | DEFENCATH | heparin sodium; taurolidine | SOLUTION;N/A | 214520-002 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Cormedix | DEFENCATH | heparin sodium; taurolidine | SOLUTION;N/A | 214520-001 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for DEFENCATH
When does loss-of-exclusivity occur for DEFENCATH?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
China
Patent: 1094679
Estimated Expiration: ⤷ Try a Trial
Patent: 3083353
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 14562
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 14562
Estimated Expiration: ⤷ Try a Trial
Patent: 42945
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2005022124
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 05617
Estimated Expiration: ⤷ Try a Trial
Patent: 08518739
Estimated Expiration: ⤷ Try a Trial
Patent: 13090933
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 14562
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 56946
Estimated Expiration: ⤷ Try a Trial
Patent: 51567
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering DEFENCATH around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 103083353 | Antimicrobial Locking Solutions Comprising Taurinamide Derivatives And Biologically Acceptable Salts And Acids, With The Addition Of Small Concentrations Of Heparin | ⤷ Try a Trial |
| Germany | 202005022124 | ⤷ Try a Trial | |
| Japan | 2013090933 | ANTIMICROBIAL LOCKING SOLUTION COMPRISING TAURINAMIDE DERIVATIVE AND BIOLOGICALLY ACCEPTABLE SALT AND ACID, WITH ADDITION OF SMALL CONCENTRATION OF HEPARIN | ⤷ Try a Trial |
| China | 101094679 | Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin | ⤷ Try a Trial |
| Japan | 2008518739 | ⤷ Try a Trial | |
| Japan | 5805617 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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