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Last Updated: December 9, 2019

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Fluciclovine f-18 - Generic Drug Details

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What are the generic drug sources for fluciclovine f-18 and what is the scope of freedom to operate?

Fluciclovine f-18 is the generic ingredient in one branded drug marketed by Blue Earth and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluciclovine f-18 has thirty-nine patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for fluciclovine f-18
International Patents:39
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 6
Clinical Trials: 18
Patent Applications: 16
DailyMed Link:fluciclovine f-18 at DailyMed
Recent Clinical Trials for fluciclovine f-18

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

SponsorPhase
James MountzEarly Phase 1
M.D. Anderson Cancer CenterPhase 4
National Cancer Institute (NCI)Phase 4

See all fluciclovine f-18 clinical trials

Pharmacology for fluciclovine f-18
Synonyms for fluciclovine f-18
(18F)FACBC
(18F)Fluciclovine
(18F)Ge-148
(1R,3R)-1-Amino-3(18f)fluorocyclobutane-1-carboxylic acid
[18F]FACBC
[18F]Fluciclovine
1-amino-3-fluoranylcyclobutane-1-carboxylic acid
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
AxuminCN FACBCCN Fluciclovine (18F)CN GE 148CN NMK 36
BCP24384
CHEBI:134703
CHEMBL254468
CHEMBL447701
D10860
DB13146
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 F18 [USAN]
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
UNII-38R1Q0L1ZE

US Patents and Regulatory Information for fluciclovine f-18

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   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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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
Express Scripts
McKesson
Medtronic
AstraZeneca

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