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Last Updated: January 23, 2020

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AXUMIN Drug Profile

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Which patents cover Axumin, and when can generic versions of Axumin launch?

Axumin is a drug marketed by Blue Earth and is included in one NDA. There are four patents protecting this drug.

This drug has thirty-nine patent family members in sixteen countries.

The generic ingredient in AXUMIN is fluciclovine f-18. One supplier is listed for this compound. Additional details are available on the fluciclovine f-18 profile page.

US ANDA Litigation and Generic Entry Outlook for Axumin

Axumin will be eligible for patent challenges on May 27, 2020. 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 November 28, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for AXUMIN
International Patents:39
US Patents:4
Suppliers / Packagers: 1
Bulk Api Vendors: 6
Clinical Trials: 9
DailyMed Link:AXUMIN at DailyMed
Drug patent expirations by year for AXUMIN
Generic Entry Opportunity Date for AXUMIN
Generic Entry Date for AXUMIN*:
Constraining patent/regulatory exclusivity:

*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 AXUMIN

Identify potential brand extensions & 505(b)(2) entrants

Tulane UniversityPhase 2
M.D. Anderson Cancer CenterPhase 4
National Cancer Institute (NCI)Phase 4

See all AXUMIN clinical trials

Pharmacology for AXUMIN

US Patents and Regulatory Information for AXUMIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Blue Earth AXUMIN fluciclovine f-18 SOLUTION;INTRAVENOUS 208054-001 May 27, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Blue Earth AXUMIN fluciclovine f-18 SOLUTION;INTRAVENOUS 208054-001 May 27, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Blue Earth AXUMIN fluciclovine f-18 SOLUTION;INTRAVENOUS 208054-001 May 27, 2016 RX Yes Yes   Start Trial   Start Trial   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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