DrugPatentWatch Database Preview
AXUMIN Drug Profile
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Which patents cover Axumin, and when can generic versions of Axumin launch?
This drug has thirty-three patent family members in thirteen 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: | 33 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 5 |
| Clinical Trials: | 2 |
| Patent Applications: | 16 |
| DailyMed Link: | AXUMIN at DailyMed |
Pharmacology for AXUMIN
| Drug Class | Radioactive Diagnostic Agent |
| Mechanism of Action | Positron Emitting Activity |
Synonyms for AXUMIN
| (18F)FACBC |
| (18F)Fluciclovine |
| (18F)Ge-148 |
| (1R,3R)-1-Amino-3(18f)fluorocyclobutane-1-carboxylic acid |
| [18F]-FACBC |
| [18F]FACBC |
| [18F]Fluciclovine |
| 1-amino-3-fluoranylcyclobutane-1-carboxylic acid |
| 18F fluciclovine |
| 18F-Ge-148 |
| 222727-39-1 |
| 38R1Q0L1ZE |
| AC1L9P1E |
| AKOS030238192 |
| anti-(18f)FABC |
| Anti-[18F]FACBC |
| anti-1-Amino-3-(18f)fluorocyclobutane-1-carboxylic acid |
| Anti-1-Amino-3-[18F]fluorocyclobutane-1-carboxylic acid |
| Anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic-acid |
| Anti-1-amino-3-F-18-fluorocyclobutane-1-carboxylic-acid |
| Anti-1-amino-3-fluorine-18-fluorocyclobutane-1-carboxylic acid |
| Anti-18-F-FACBC |
| Anti-18F-FABC |
| Anti-3-18F-FACBC |
| Anti-F-18-fluorocyclobutane-carboxylic-acid |
| AxuminCN FACBCCN Fluciclovine (18F)CN GE 148CN NMK 36 |
| CHEBI:134703 |
| CHEMBL254468 |
| CHEMBL447701 |
| D03QIP |
| D10860 |
| DB13146 |
| FACBC |
| FACBC F-18 |
| Fluciclovine |
| Fluciclovine ((sup 18)F) |
| Fluciclovine ((sup 18)F) [INN] |
| Fluciclovine (18F) |
| Fluciclovine (18F) (INN) |
| Fluciclovine (18F) [INN] |
| Fluciclovine F 18 |
| Fluciclovine F-18 |
| Fluciclovine F18 [USAN] |
| Fluciclovine-F-18 |
| GE-148 |
| Ge-148 (18F) |
| Ge-148 F-18 |
| Ge-148-18F |
| Ge-148-F-18 |
| MOLI001120 |
| NMK36 |
| SCHEMBL10017245 |
| SCHEMBL11939897 |
| SCHEMBL11939900 |
| syn-1-Amino-3-[18F]fluorocyclobutane-1-carboxylic acid |
| syn-3-[18F]FACBC |
| Trans-1-amino-3-18F-fluorocyclobutanecarboxylic-acid |
| UNII-38R1Q0L1ZE |
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 | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| 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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Non-Orange Book US Patents for AXUMIN
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 5,817,776 | Amino acid analogs for tumor imaging | ➤ Sign Up |
| 9,381,259 | Precursor compound of radioactive halogen-labeled organic compound | ➤ Sign Up |
| 8,758,724 | Unnatural amino acid radiolabeling precursor | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for AXUMIN
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2007063824 | ➤ Sign Up |
| South Korea | 101643991 | ➤ Sign Up |
| South Korea | 20080071146 | ➤ Sign Up |
| Japan | 2007246535 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
