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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-one patent family members in thirty-four 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.
US ANDA Litigation and 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: | 61 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Drug Prices: | Drug price information for FETROJA |
| DailyMed Link: | FETROJA at DailyMed |
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 |
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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Shionogi Inc | FETROJA | cefiderocol sulfate tosylate | POWDER;INTRAVENOUS | 209445-001 | Nov 14, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Shionogi Inc | FETROJA | cefiderocol sulfate tosylate | POWDER;INTRAVENOUS | 209445-001 | Nov 14, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >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 |
|---|---|---|
| Poland | 2960244 | Start Trial |
| Croatia | P20161408 | Start Trial |
| Montenegro | 02666 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
