➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Harvard Business School
Colorcon
Johnson and Johnson
McKinsey

Last Updated: July 10, 2020

DrugPatentWatch Database Preview

AXUMIN Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

Which patents cover Axumin, and what generic alternatives are available?

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 was eligible for patent challenges on May 27, 2020.

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

< Available with Subscription >

  Start Trial

Summary for AXUMIN
International Patents:39
US Patents:4
Applicants:1
NDAs:1
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:
NDA:
Dosage:
SOLUTION;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 AXUMIN

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

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Harvard Business School
Colorcon
Johnson and Johnson
McKinsey

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.