DrugPatentWatch Database Preview
AXUMIN Drug Profile
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.
Summary for AXUMIN
| International Patents: | 39 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 6 |
| Clinical Trials: | 7 |
| 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 |
|---|---|
| Seyed Ali Nabavizadeh, MD | Phase 1 |
| Blue Earth Diagnostics | Phase 1 |
| Loma Linda University | Phase 2 |
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 | 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 | ||||
| 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 | ||||
| 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 |
|---|---|---|
| Japan | 5341136 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9717092 | Start Trial |
| Israel | 191184 | Start Trial |
| Australia | 1120497 | Start Trial |
| European Patent Office | 1978015 | Start Trial |
| Norway | 20082877 | Start Trial |
| Japan | 5684333 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
