Generic DaTscan Availability
DATSCAN (ioflupane i-123 - solution;intravenous)
Manufacturer: GE HLTHCARE INC
Approval date: January 14, 2011
Strength(s): 5MCI/2.5ML (2MCI/ML) [RLD]
Has a generic version of DaTscan been approved?
No. There is currently no therapeutically equivalent version of DaTscan available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of DaTscan. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Iodinated neuroprobe for mapping monoamine reuptake sites
Issued: May 10, 1994
Inventor(s): Neumeyer; John L. & Milius; Richard A. & Innis; Robert B.
Assignee(s): Research Biochemicals Limited Partnership
An iodinated neuroprobe is provided for mapping monoamine reuptake sites. The iodinated neuroprobe is of the formula: ##STR1## wherein R=a C.sub.n H.sub.2n+1 group where n=0-6, an alkenyl group, a monofluoroalkyl group including .sup.n F where n=18 or 19, or a .sup.m C.sub.n H.sub.2n+1 group where n=1-6 and where m=11 or 14 for at least one .sup.m C; R'=a C.sub.n H.sub.2n+1 group where n=0-6, a p-iodophenylmethyl group, a p-iodophenylethyl group, a phenylmethyl group, or a phenylethyl group; X=an isotope of F, an isotope of Cl, an isotope of Br, an isotope of I, CH.sub.3, or Sn(R".sub.1 R".sub.2 R".sub.3); R".sub.1 =a C.sub.n H.sub.2n+1 group where n=1-6, or an aryl group; R".sub.2 =a C.sub.n H.sub.2n+1 group where n=1-6, or an aryl group; R".sub.3 =a C.sub.n H.sub.2n+1 group where n=1-6, or an aryl group; and Y=H only if X is an isotope of I, or R' is a p-iodophenylmethyl group, or R' is a p-iodophenylethyl group, else Y=an isotope of I. Related analogs are also provided. Additionally, a precursor of a radiolabled neuroprobe and a kit for preparing the iodinated neuroprobe are provided.Patent expiration dates:
- February 25, 2013✓
- February 25, 2013
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
- Exclusivity expiration dates:
- January 14, 2016 - NEW CHEMICAL ENTITY
- DaTscan Consumer Information (Drugs.com)
- DaTscan Consumer Information (Cerner Multum)
- DaTscan Advanced Consumer Information (Micromedex)
- Ioflupane I-123 Consumer Information (Cerner Multum)
- Ioflupane i 123 Intravenous Advanced Consumer Information (Micromedex)
|Drug Patent||A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.|
|Drug Exclusivity||Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.|
|RLD||A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.|