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Last Updated: July 15, 2024

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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 eighty-two patent family members in thirty-eight 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

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Summary for FETROJA
International Patents:82
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 4
Clinical Trials: 5
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 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

SponsorPhase
Rambam Health Care CampusPhase 4
Pisa University HospitalPhase 4
Sheba Medical CenterPhase 4

See all FETROJA clinical trials

Pharmacology for FETROJA

US Patents and Regulatory Information for FETROJA

FETROJA is protected by five US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FETROJA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Cephalosporin having catechol group
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING BACTERIAL INFECTIONS

Cephalosporin having catechol group
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING COMPLICATED URINARY TRACT INFECTIONS (CUTI), INCLUDING PYELONEPHRITIS, COMPRISING ADMINISTERING CEFIDEROCOL SULFATE TOSYLATE

Cephalosporin having catechol group
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting FETROJA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Shionogi Inc FETROJA cefiderocol sulfate tosylate POWDER;INTRAVENOUS 209445-001 Nov 14, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Shionogi Inc FETROJA cefiderocol sulfate tosylate POWDER;INTRAVENOUS 209445-001 Nov 14, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Shionogi Inc FETROJA cefiderocol sulfate tosylate POWDER;INTRAVENOUS 209445-001 Nov 14, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Shionogi Inc FETROJA cefiderocol sulfate tosylate POWDER;INTRAVENOUS 209445-001 Nov 14, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Patent: Salt of cephalosporin derivative, crystalline solid form of same and method for producing same
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2017004166
Patent: sal de derivado de cefalosporina, forma sólida cristalina do mesmo e método para produzir o mesmo
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 59295
Patent: SEL DE DERIVE DE CEPHALOSPORINE, FORME SOLIDE CRISTALLINE DE CELUI-CI ET SON PROCEDE DE PRODUCTION (A SALT OF CEPHALOSPORIN DERIVATIVE, ITS CRYSTALLINE SOLID AND A METHOD OF MANUFACTURING THEREOF)
Estimated Expiration: ⤷  Sign Up

China

Patent: 6795176
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0211524
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 24838
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 90115
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 5845
Patent: СОЛЬ ПРОИЗВОДНОГО ЦЕФАЛОСПОРИНА, ЕЕ КРИСТАЛЛИЧЕСКОЕ ТВЕРДОЕ ВЕЩЕСТВО И СПОСОБ ЕЕ ПОЛУЧЕНИЯ (SALT OF CEPHALOSPORIN DERIVATIVE, CRYSTALLINE SOLID FORM THEREOF AND METHOD FOR PRODUCING SAME)
Estimated Expiration: ⤷  Sign Up

Patent: 1790522
Patent: СОЛЬ ПРОИЗВОДНОГО ЦЕФАЛОСПОРИНА, ЕЕ КРИСТАЛЛИЧЕСКОЕ ТВЕРДОЕ ВЕЩЕСТВО И СПОСОБ ЕЕ ПОЛУЧЕНИЯ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 90115
Patent: SEL DE DÉRIVÉ DE CÉPHALOSPORINE, FORME SOLIDE CRISTALLINE DE CELUI-CI ET SON PROCÉDÉ DE PRODUCTION (SALT OF CEPHALOSPORIN DERIVATIVE, CRYSTALLINE SOLID FORM OF SAME AND METHOD FOR PRODUCING SAME)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 56038
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 2016035845
Patent: セファロスポリン誘導体の塩、その結晶性固体およびその製造方法
Estimated Expiration: ⤷  Sign Up

Patent: 20429
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 90115
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 8017
Patent: A SALT OF CEPHALOSPORIN DERIVATIVE, ITS CRYSTALLINE SOLID AND A METHOD OF MANUFACTURING THEREOF
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 17002790
Patent: SAL DE UN DERIVADO DE CEFALOSPORINA, FORMA SOLIDA CRISTALINA DEL MISMO Y METODO PARA SU PRODUCCION. (SALT OF CEPHALOSPORIN DERIVATIVE, CRYSTALLINE SOLID FORM OF SAME AND METHOD FOR PRODUCING SAME.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 585
Patent: SEL DE DÉRIVÉ DE CÉPHALOSPORINE, FORME SOLIDE CRISTALLINE DE CELUI-CI ET SON PROCÉDÉ DE PRODUCTION
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 017500435
Patent: A SALT OF CEPHALOSPORIN DERIVATIVE, ITS CRYSTALLINE SOLID AND A METHOD OF MANUFACTURING THEREOF
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 90115
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 90115
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 449
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 90115
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2284990
Estimated Expiration: ⤷  Sign Up

Patent: 170043663
Patent: 세팔로스포린 유도체의 염, 그의 결정성 고체 및 그의 제조 방법 (SALT OF CEPHALOSPORIN DERIVATIVE CRYSTALLINE SOLID FORM OF SAME AND METHOD FOR PRODUCING SAME)
Estimated Expiration: ⤷  Sign Up

Patent: 180088750
Patent: 세팔로스포린 유도체의 염, 그의 결정성 고체 및 그의 제조 방법 (SALT OF CEPHALOSPORIN DERIVATIVE CRYSTALLINE SOLID FORM OF SAME AND METHOD FOR PRODUCING SAME)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 93424
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 93690
Estimated Expiration: ⤷  Sign Up

Patent: 1609753
Patent: Salts of a cephalosporin derivative or its crystalline solids and processes for producing them
Estimated Expiration: ⤷  Sign Up

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
Canada 2959295 SEL DE DERIVE DE CEPHALOSPORINE, FORME SOLIDE CRISTALLINE DE CELUI-CI ET SON PROCEDE DE PRODUCTION (A SALT OF CEPHALOSPORIN DERIVATIVE, ITS CRYSTALLINE SOLID AND A METHOD OF MANUFACTURING THEREOF) ⤷  Sign Up
Lithuania 3190115 ⤷  Sign Up
Israel 211720 תרכובות של צפאלוספורין המכילה קבוצת קטקול, אסטר, מלח תרופתי קביל או סולבט שלהן ו תכשירי רוקחות והשימוש בהם (Compounds of cephalosporin having a catechol group , an ester, a pharmaceutically acceptable salt or a solvate thereof and pharmaceutical compositions thereof and their use as medicaments) ⤷  Sign Up
Hungary E031802 ⤷  Sign Up
Brazil PI0921701 cefarosporinas tendo um grupo catecol ⤷  Sign Up
Eurasian Patent Organization 035845 СОЛЬ ПРОИЗВОДНОГО ЦЕФАЛОСПОРИНА, ЕЕ КРИСТАЛЛИЧЕСКОЕ ТВЕРДОЕ ВЕЩЕСТВО И СПОСОБ ЕЕ ПОЛУЧЕНИЯ (SALT OF CEPHALOSPORIN DERIVATIVE, CRYSTALLINE SOLID FORM THEREOF AND METHOD FOR PRODUCING SAME) ⤷  Sign Up
Denmark 3190115 ⤷  Sign Up
>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 ⤷  Sign Up PRODUCT NAME: CEFIDEROCOL; REGISTRATION NO/DATE: EU/1/20/1434 20200423
2960244 20C1050 France ⤷  Sign Up 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 ⤷  Sign Up PRODUCT NAME: CEFIDEROCOL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/20/1434 (MITTEILUNG) 20200424
2960244 2020/044 Ireland ⤷  Sign Up 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 PA2020530,C2960244 Lithuania ⤷  Sign Up PRODUCT NAME: CEFIDEROKOLAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1434 20200423
2960244 2020C/541 Belgium ⤷  Sign Up PRODUCT NAME: CEFIDEROCOL, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH ZOUT OF SOLVAAT; AUTHORISATION NUMBER AND DATE: EU/1/20/1434 20200424
2960244 301067 Netherlands ⤷  Sign Up PRODUCT NAME: CEFIDEROCOL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/20/1434 20200424
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.