Generic Cubicin RF Availability
See also: Generic Cubicin
CUBICIN RF (daptomycin - powder;intravenous)
Manufacturer: CUBIST PHARMS LLC
Approval date: July 6, 2016
Strength(s): 500MG/VIAL [RLD]
Has a generic version of Cubicin RF been approved?
An Authorized Generic version of Cubicin RF has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance, and unlike a generic, the Authorized Generic has exactly the same inactive ingredients.
List of authorized generic versions:
- Daptomycin INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg/10mL
Teva Parenteral Medicines, Inc.
NDC Code: 007030125
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Cubicin RF. 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: Generic Drug FAQs.
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.
Lipopeptide compositions and related methods
Issued: September 22, 2015
Assignee(s): Cubist Pharmaceuticals LLC
The present disclosure provides novel powder daptomycin formulations which have improved chemical stability and faster reconstitution times when in the solid state. Some examples of the compositions comprise daptomycin and sucrose.Patent expiration dates:
- November 23, 2030✓
- November 23, 2030
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:
- March 29, 2020 - NEW PATIENT POPULATION
- September 1, 2020 - PROVIDES FOR LABELING CHANGES REGARDING THE USE OF DAPTOMYCIN IN THE PEDIATRIC POPULATION FOR STAPHYLOCOCCUS AUREUS BACTEREMIA (SAB) BASED ON RESULTS OF A TRIAL IN PEDIATRIC PATIENTS 1 TO 17 YEARS OF AGE
More about Cubicin RF (daptomycin)
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Other brands: Cubicin
Related treatment guides
|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.|