FETROJA Drug Patent Profile
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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 seventy-nine patent family members in thirty-six 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 will be eligible for patent challenges on November 14, 2023. 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 September 3, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for FETROJA
International Patents: | 79 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Clinical Trials: | 4 |
Patent Applications: | 31 |
Drug Prices: | Drug price information for FETROJA |
What excipients (inactive ingredients) are in FETROJA? | FETROJA excipients list |
DailyMed Link: | FETROJA at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity 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 three US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of FETROJA is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Cephalosporin having catechol group
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING BACTERIAL INFECTIONS
Preparation containing cephalosporin having a catechol moiety
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting FETROJA
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
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: See Plans and Pricing
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: See Plans and Pricing
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:
China
Patent: 6687116
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 89841
Estimated Expiration: See Plans and Pricing
Japan
Patent: 2016035846
Estimated Expiration: See Plans and Pricing
Patent: 18204
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1935186
Estimated Expiration: See Plans and Pricing
Patent: 170048511
Estimated Expiration: See Plans and Pricing
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 |
---|---|---|---|
China | 106795176 | 头孢菌素衍生物的盐、其结晶固体及其制造方法 (Salt of cephalosporin derivative, crystalline solid form of same and method for producing same) | See Plans and Pricing |
Japan | WO2010050468 | カテコール基を有するセファロスポリン類 | See Plans and Pricing |
Serbia | 62449 | SO DERIVATA CEFALOSPORINA, NJEN KRISTALNI ČVRST OBLIK I POSTUPAK NJENE PROIZVODNJE (SALT OF CEPHALOSPORIN DERIVATIVE, CRYSTALLINE SOLID FORM OF SAME AND METHOD FOR PRODUCING SAME) | See Plans and Pricing |
Spain | 2602969 | See Plans and Pricing | |
New Zealand | 591728 | CEPHALOSPORIN HAVING CATECHOL GROUP | See Plans and Pricing |
Netherlands | 301067 | See Plans and Pricing | |
European Patent Office | 2960244 | CÉPHALOSPORINE COMPRENANT UN GROUPE CATÉCHOL (CEPHALOSPORIN HAVING CATECHOL GROUP) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FETROJA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2960244 | 122020000060 | Germany | See Plans and Pricing | PRODUCT NAME: CEFIDEROCOL; REGISTRATION NO/DATE: EU/1/20/1434 20200423 |
2960244 | 132020000000136 | Italy | See Plans and Pricing | 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 |
2960244 | 2020/044 | Ireland | See Plans and Pricing | 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 | CA 2020 00049 | Denmark | See Plans and Pricing | PRODUCT NAME: CEFIDEROCOL, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT; REG. NO/DATE: EU/1/20/1434 20200424 |
2960244 | LUC00179 | Luxembourg | See Plans and Pricing | PRODUCT NAME: CEFIDEROCOL, EVENTUELLEMENT SOUS LA FORME D'UN SEL OU D'UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/20/1434 20200424 |
2960244 | 20C1050 | France | See Plans and Pricing | PRODUCT NAME: CEFIDEROCOL, EVENTUELLEMENT SOUS FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU D'UN SOLVATE; REGISTRATION NO/DATE: EU/1/20/1434 20200424 |
2960244 | 43/2020 | Austria | See Plans and Pricing | PRODUCT NAME: CEFIDEROCOL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/20/1434 (MITTEILUNG) 20200424 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |