By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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FETROJA Drug 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 sixty-seven 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: | 67 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 1 |
| 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 |
|---|---|
| Shionogi | Phase 2 |
Pharmacology for FETROJA
| Drug Class | Cephalosporin Antibacterial |
US Patents and Regulatory Information for FETROJA
| 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 | Get Started Free | Get Started Free | Y | Y | Get Started Free | ||
| Shionogi Inc | FETROJA | cefiderocol sulfate tosylate | POWDER;INTRAVENOUS | 209445-001 | Nov 14, 2019 | RX | Yes | Yes | Get Started Free | Get Started Free | Get Started Free | ||||
| Shionogi Inc | FETROJA | cefiderocol sulfate tosylate | POWDER;INTRAVENOUS | 209445-001 | Nov 14, 2019 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Y | Get Started Free | ||
| Shionogi Inc | FETROJA | cefiderocol sulfate tosylate | POWDER;INTRAVENOUS | 209445-001 | Nov 14, 2019 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Shionogi Inc | FETROJA | cefiderocol sulfate tosylate | POWDER;INTRAVENOUS | 209445-001 | Nov 14, 2019 | RX | Yes | Yes | Get Started Free | Get Started Free | Get Started Free | ||||
| Shionogi Inc | FETROJA | cefiderocol sulfate tosylate | POWDER;INTRAVENOUS | 209445-001 | Nov 14, 2019 | RX | Yes | Yes | Get Started Free | Get Started Free | Get Started Free | ||||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 6218204 | Get Started Free |
| Mexico | 2017002790 | Get Started Free |
| South Africa | 201102024 | Get Started Free |
| Japan | WO2016035846 | Get Started Free |
| Hungary | E031802 | Get Started Free |
| Netherlands | 301067 | Get Started Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FETROJA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2960244 | PA2020530 | Lithuania | Get Started Free | PRODUCT NAME: CEFIDEROKOLAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1434 20200423 |
| 2960244 | 301067 | Netherlands | Get Started Free | PRODUCT NAME: CEFIDEROCOL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/20/1434 20200424 |
| 2960244 | 2020C/541 | Belgium | Get Started Free | PRODUCT NAME: CEFIDEROCOL, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH ZOUT OF SOLVAAT; AUTHORISATION NUMBER AND DATE: EU/1/20/1434 20200424 |
| 2960244 | LUC00179 | Luxembourg | Get Started Free | 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 | 122020000060 | Germany | Get Started Free | PRODUCT NAME: CEFIDEROCOL; REGISTRATION NO/DATE: EU/1/20/1434 20200423 |
| 2960244 | CA 2020 00049 | Denmark | Get Started Free | PRODUCT NAME: CEFIDEROCOL, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT; REG. NO/DATE: EU/1/20/1434 20200424 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
