FETROJA Drug Patent Profile
✉ Email this page to a colleague
When do Fetroja patents expire, and what generic alternatives are available?
Fetroja is a drug marketed by Shionogi Inc and is included in one NDA. There are three patents protecting this drug.
This drug has eighty-one patent family members in thirty-seven countries.
The generic ingredient in FETROJA is cefiderocol sulfate tosylate. One supplier is listed for this compound. Additional details are available on the cefiderocol sulfate tosylate profile page.
DrugPatentWatch® Generic Entry Outlook for Fetroja
Fetroja was eligible for patent challenges on November 14, 2023.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 3, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for FETROJA
International Patents: | 81 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Clinical Trials: | 4 |
Drug Prices: | Drug price information for FETROJA |
What excipients (inactive ingredients) are in FETROJA? | FETROJA excipients list |
DailyMed Link: | FETROJA at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FETROJA
Generic Entry Date for FETROJA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS |
*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.
Recent Clinical Trials for FETROJA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Texas | Phase 4 |
Keystone Bioanalytical, Inc. | Phase 4 |
University of Pittsburgh Medical Center | Phase 4 |
Pharmacology for FETROJA
Drug Class | Cephalosporin Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for FETROJA
US Patents and Regulatory Information for FETROJA
FETROJA is protected by five US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of FETROJA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ 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.
Patents protecting FETROJA
Salt of cephalosporin derivative, its crystalline solid and a method of manufacturing thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Cephalosporin having catechol group
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING BACTERIAL INFECTIONS
Cephalosporin having catechol group
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING COMPLICATED URINARY TRACT INFECTIONS (CUTI), INCLUDING PYELONEPHRITIS, COMPRISING ADMINISTERING CEFIDEROCOL SULFATE TOSYLATE
Cephalosporin having catechol group
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP) COMPRISING ADMINISTERING CEFIDEROCOL SULFATE TOSYLATE
Preparation containing cephalosporin having a catechol moiety
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting FETROJA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
INDICATED IN PATIENTS 18 YEARS OF AGE AND OLDER FOR THE TREATMENT OF HOSPITAL ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP) CAUSED BY THE FOLLOWING SUSCEPTIBLE GRAM-NEGATIVE MICROORGANISMS: ACINETOBACTER BAUMANNII COMPLEX, ESCHERICHIA COLI, ENTEROBACTER CLOACAE COMPLEX, KLEBSIELLA PNEUMONIAE, PSEUDOMONAS AERUGINOSA, AND SERRATIA MARCESCENS
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Shionogi Inc | FETROJA | cefiderocol sulfate tosylate | POWDER;INTRAVENOUS | 209445-001 | Nov 14, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Shionogi Inc | FETROJA | cefiderocol sulfate tosylate | POWDER;INTRAVENOUS | 209445-001 | Nov 14, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Shionogi Inc | FETROJA | cefiderocol sulfate tosylate | POWDER;INTRAVENOUS | 209445-001 | Nov 14, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Shionogi Inc | FETROJA | cefiderocol sulfate tosylate | POWDER;INTRAVENOUS | 209445-001 | Nov 14, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 FETROJA
When does loss-of-exclusivity occur for FETROJA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 15312828
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2017004166
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 59295
Estimated Expiration: ⤷ Try a Trial
China
Patent: 6795176
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0211524
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 24838
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 90115
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 5845
Estimated Expiration: ⤷ Try a Trial
Patent: 1790522
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 90115
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 56038
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 2016035845
Estimated Expiration: ⤷ Try a Trial
Patent: 20429
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 90115
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 8017
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 17002790
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 585
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 017500435
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 90115
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 90115
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 449
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 90115
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2284990
Estimated Expiration: ⤷ Try a Trial
Patent: 170043663
Estimated Expiration: ⤷ Try a Trial
Patent: 180088750
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 93424
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 93690
Estimated Expiration: ⤷ Try a Trial
Patent: 1609753
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 FETROJA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 2020035 | ⤷ Try a Trial | |
European Patent Office | 2341053 | CÉPHALOSPORINE POSSÉDANT UN GROUPE CATÉCHOL (CEPHALOSPORIN HAVING CATECHOL GROUP) | ⤷ Try a Trial |
Eurasian Patent Organization | 201170632 | ЦЕФАЛОСПОРИНЫ, СОДЕРЖАЩИЕ КАТЕХОЛЬНУЮ ГРУППУ | ⤷ Try a Trial |
Canada | 2736953 | CEPHALOSPORINE POSSEDANT UN GROUPE CATECHOL (CEPHAROSPORINS HAVING A CATECHOL GROUP) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FETROJA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2960244 | 2090041-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: CEFIDEROKOL; REG. NO/DATE: EU/1/20/1434 20200424 |
2960244 | C202030051 | Spain | ⤷ Try a Trial | PRODUCT NAME: CEFIDEROCOL, OPCIONALMENTE EN FORMA DE UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE.; NATIONAL AUTHORISATION NUMBER: EU/1/20/1434; DATE OF AUTHORISATION: 20200423; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1434; DATE OF FIRST AUTHORISATION IN EEA: 20200423 |
2960244 | 2020/044 | Ireland | ⤷ Try a Trial | PRODUCT NAME: CEFIDEROCOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE; NAT REGISTRATION NO/DATE: EU/1/20/1434 20200424; FIRST REGISTRATION NO/DATE: EU/1/20/1434 20200424 |
2960244 | 132020000000136 | Italy | ⤷ Try a Trial | PRODUCT NAME: CEFIDEROCOL, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE O SOLVATO(FETCROJA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1434, 20200424 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |