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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
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 |
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
| Sponsor | Phase |
|---|---|
| Tulane University | Phase 2 |
| M.D. Anderson Cancer Center | Phase 4 |
| National Cancer Institute (NCI) | Phase 4 |
Pharmacology for AXUMIN
| Drug Class | Radioactive Diagnostic Agent |
| Mechanism of Action | Positron Emitting Activity |
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 |
International Patents for AXUMIN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | 200800869 | Start Trial |
| Japan | 3992736 | Start Trial |
| Japan | 2011207901 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
