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Last Updated: August 11, 2022

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

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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
Drug patent expirations by year for FETROJA
Drug Prices for FETROJA

See drug prices for FETROJA

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

SponsorPhase
University of TexasPhase 4
Keystone Bioanalytical, Inc.Phase 4
University of Pittsburgh Medical CenterPhase 4

See all FETROJA clinical trials

Pharmacology 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

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Shionogi Inc FETROJA cefiderocol sulfate tosylate POWDER;INTRAVENOUS 209445-001 Nov 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Shionogi Inc FETROJA cefiderocol sulfate tosylate POWDER;INTRAVENOUS 209445-001 Nov 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Shionogi Inc FETROJA cefiderocol sulfate tosylate POWDER;INTRAVENOUS 209445-001 Nov 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Shionogi Inc FETROJA cefiderocol sulfate tosylate POWDER;INTRAVENOUS 209445-001 Nov 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Shionogi Inc FETROJA cefiderocol sulfate tosylate POWDER;INTRAVENOUS 209445-001 Nov 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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:

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

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Serving leading biopharmaceutical companies globally:

McKesson
Dow
Harvard Business School
Moodys
Medtronic
Mallinckrodt

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.