FETROJA Drug Patent Profile
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Which patents cover Fetroja, and when can generic versions of Fetroja launch?
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
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: | 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
*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 Pittsburgh Medical Center | Phase 4 |
| Indiana University Health Methodist Hospital | Phase 4 |
| Hartford Hospital | 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 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
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2017004166
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 59295
Estimated Expiration: ⤷ Sign Up
China
Patent: 6795176
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
Estimated Expiration: ⤷ Sign Up
Patent: 1790522
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 90115
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 56038
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 2016035845
Estimated Expiration: ⤷ Sign Up
Patent: 20429
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 90115
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 8017
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 17002790
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 585
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 017500435
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 90115
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 90115
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 449
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 90115
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2284990
Estimated Expiration: ⤷ Sign Up
Patent: 170043663
Estimated Expiration: ⤷ Sign Up
Patent: 180088750
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 93424
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 93690
Estimated Expiration: ⤷ Sign Up
Patent: 1609753
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 |
|---|---|---|---|
| Japan | WO2016035846 | カテコール基を有するセファロスポリン類を含有する製剤 | ⤷ Sign Up |
| South Korea | 102284990 | ⤷ Sign Up | |
| Colombia | 6331443 | CEFAROSPORINAS QUE TIENEN UN GRUPO CATECOL | ⤷ 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 |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FETROJA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2960244 | 2020035 | Norway | ⤷ Sign Up | PRODUCT NAME: CEFIDEROKOL, EVENTUELT PA FORMEN AV ET FARMASOEYTISK AKSEPTABELT SALT ELLER SOLVAT; REG. NO/DATE: EU/1/20/1434 20200508 |
| 2960244 | LUC00179 | Luxembourg | ⤷ Sign Up | 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 | CR 2020 00049 | Denmark | ⤷ Sign Up | PRODUCT NAME: CEFIDEROCOL, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT; REG. NO/DATE: EU/1/20/1434 20200424 |
| 2960244 | C20200033 00355 | Estonia | ⤷ Sign Up | PRODUCT NAME: TSEFIDEROKOOL;REG NO/DATE: EU/1/20/1434 24.04.2020 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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