Fetroja is a drug owned by Shionogi Inc. It is protected by 3 US drug patents filed in 2019 out of which none have expired yet. Fetroja's patents will be open to challenges from 14 November, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 03, 2035. Details of Fetroja'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. | |||
| US10004750 | Salt of cephalosporin derivative, its crystalline solid and a method of manufacturing thereof |
Sep, 2035
(10 years from now) | Active |
| US9238657 | Cephalosporin having catechol group |
Nov, 2033
(8 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9949982 | Preparation containing cephalosporin having a catechol moiety |
Sep, 2035
(10 years from now) | Active |
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 Fetroja's patents.
Latest Legal Activities on Fetroja's Patents
Given below is the list of recent legal activities going on the following patents of Fetroja.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Jul, 2023 | US9238657 |
| Patent Term Extension Certificate Critical | 25 Oct, 2022 | US9238657 |
| Email Notification Critical | 26 Sep, 2022 | US9238657 |
| Change in Power of Attorney (May Include Associate POA) Critical | 26 Sep, 2022 | US9238657 |
| Correspondence Address Change Critical | 23 Sep, 2022 | US9238657 |
| Notice of Final Determination -Eligible | 14 Jul, 2022 | US9238657 |
| FDA Final Eligibility Letter Critical | 17 Feb, 2022 | US9238657 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Dec, 2021 | US10004750 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 06 Oct, 2021 | US9949982 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jun, 2021 | US9238657 |
FDA has granted several exclusivities to Fetroja. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Fetroja, 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 Fetroja.
Exclusivity Information
Fetroja holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Fetroja's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-844) | Sep 25, 2023 |
| New Chemical Entity Exclusivity(NCE) | Nov 14, 2024 |
| Generating Antibiotic Incentives Now(GAIN) | Nov 14, 2029 |
US patents provide insights into the exclusivity only within the United States, but Fetroja 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 Fetroja's family patents as well as insights into ongoing legal events on those patents.
Fetroja's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fetroja's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 03, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fetroja Generics:
There are no approved generic versions for Fetroja as of now.
About Fetroja
Fetroja is a drug owned by Shionogi Inc. It is used for treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Fetroja uses Cefiderocol Sulfate Tosylate as an active ingredient. Fetroja was launched by Shionogi Inc in 2019.
Approval Date:
Fetroja was approved by FDA for market use on 14 November, 2019.
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 Fetroja is 14 November, 2019, its NCE-1 date is estimated to be 14 November, 2028.
Active Ingredient:
Fetroja uses Cefiderocol Sulfate Tosylate as the active ingredient. Check out other Drugs and Companies using Cefiderocol Sulfate Tosylate ingredient
Treatment:
Fetroja is used for treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
Dosage:
Fetroja is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1GM BASE/VIAL | POWDER | Prescription | INTRAVENOUS |