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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for FETROJA?
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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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FETROJA
*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 |
|---|---|
| Sheba Medical Center | Phase 4 |
| Monaldi Hospital | Phase 4 |
| Rutgers Robert Wood Johnson Medical School | Phase 4 |
Pharmacology for FETROJA
| Drug Class | Cephalosporin Antibacterial |
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 | ||||
| >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 |
|---|---|---|---|
| Serbia | 55365 | CEFALOSPORIN SA KATEHOLSKOM GRUPOM (CEPHALOSPORIN HAVING CATECHOL GROUP) | ⤷ Sign Up |
| Taiwan | I535727 | ⤷ Sign Up | |
| Netherlands | 301067 | ⤷ 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 |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FETROJA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | PA2020530,C2960244 | Lithuania | ⤷ Sign Up | PRODUCT NAME: CEFIDEROKOLAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1434 20200423 |
| 2960244 | PA2020530 | Lithuania | ⤷ Sign Up | PRODUCT NAME: CEFIDEROKOLAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1434 20200423 |
| 2960244 | SPC/GB20/053 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: CEFIDEROCOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE; REGISTERED: UK EU/1/20/1434 (NI) 20200424; UK PLGB 50999/0009 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.
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