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Last Updated: August 13, 2020

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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

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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
Drug patent expirations by year for FETROJA
Drug Prices for FETROJA

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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

SponsorPhase
ShionogiPhase 2

See all FETROJA clinical trials

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

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Serving leading biopharmaceutical companies globally:

McKesson
Dow
Harvard Business School
Moodys
Medtronic
Mallinckrodt

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.