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Generic Cubicin Availability

See also: Generic Cubicin RF

Cubicin is a brand name of daptomycin, approved by the FDA in the following formulation(s):

CUBICIN (daptomycin - powder;intravenous)

  • Manufacturer: CUBIST PHARMS LLC
    Approval date: September 12, 2003
    Strength(s): 500MG/VIAL [RLD] [AP]

CUBICIN (daptomycin - powder;iv (infusion))

  • Manufacturer: CUBIST PHARMS LLC
    Approval date: September 12, 2003
    Strength(s): 250MG/VIAL

Has a generic version of Cubicin been approved?

A generic version of Cubicin has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Cubicin and have been approved by the FDA:

daptomycin powder;intravenous

  • Manufacturer: CRANE PHARMS LLC
    Approval date: June 15, 2016
    Strength(s): 500MG/VIAL [AP]
  • Manufacturer: HOSPIRA INC
    Approval date: September 12, 2014
    Strength(s): 500MG/VIAL [AP]
  • Manufacturer: TEVA PARENTERAL
    Approval date: March 25, 2016
    Strength(s): 500MG/VIAL [AP]

Note: No generic formulation of the following product is available.

  • daptomycin - powder;iv (infusion)

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Cubicin. 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.

Related Patents

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.

  • Daptomycin for the treatment of biofilm and catheter salvage
    Patent 8,003,673
    Issued: August 23, 2011
    Inventor(s): Alder; Jeffrey & Silverman; Jared & Mortin; Lawrence & Van Praagh; Andrew
    Assignee(s): Cubist Pharmaceuticals, Inc.
    Daptomycin can be used for biofilm treatment (particularly central venous catheter salvage for S. epidermidis infected catheters). Catheter salvage with daptomycin shows rapid cidality, activity against stationary phase bacteria, and penetration and activity in biofilms. The present inventions provide formulations, methods, and articles of manufacture useful for biofilm treatment or catheter salvage involving daptomycin. Particular formulations include daptomycin in lactated Ringer's solution having a rapid kill curve against the bacteria of the biofilm.
    Patent expiration dates:
    • September 4, 2028
      ✓ 
      Patent use: TREATMENT OF THE FOLLOWING INFECTIONS: COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS

Related Exclusivities

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

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
APInjectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.
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