Generic Bactroban Availability

Bactroban is a brand name of mupirocin topical, approved by the FDA in the following formulation(s):

BACTROBAN (mupirocin - ointment;topical)

BACTROBAN (mupirocin calcium - cream;topical)

BACTROBAN (mupirocin calcium - ointment;nasal)

  • Manufacturer: GLAXOSMITHKLINE
    Approval date: September 18, 1995
    Strength(s): EQ 2% BASE [RLD]

Has a generic version of Bactroban been approved?

A generic version of Bactroban 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 Bactroban and have been approved by the FDA:

mupirocin ointment;topical

  • Manufacturer: FOUGERA PHARMS
    Approval date: November 30, 2005
    Strength(s): 2% [AB]
  • Manufacturer: GLENMARK PHARMS
    Approval date: June 8, 2011
    Strength(s): 2% [AB]
  • Manufacturer: PERRIGO NEW YORK
    Approval date: November 7, 2003
    Strength(s): 2% [AB]
  • Manufacturer: TARO
    Approval date: September 23, 2005
    Strength(s): 2% [AB]
  • Manufacturer: TEVA
    Approval date: November 7, 2003
    Strength(s): 2% [AB]

MUPIROCIN (mupirocin calcium cream;topical)

  • Manufacturer: GLENMARK GENERICS
    Approval date: January 24, 2013
    Strength(s): EQ 2% BASE [AB]

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

  • mupirocin calcium - ointment;nasal

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

  • Compounds
    Patent 5,569,672
    Issued: October 29, 1996
    Inventor(s): Baker; Geoffrey H. & Beal; Merle
    Assignee(s): Beecham Group p.l.c.
    Crystalline calcium pseudomonate or a hydrate thereof, in particular the dihydrate. Processes for the preparation of these salts and their use in human and veterinary medicine and as a growth promoter in animals are described.
    Patent expiration dates:
    • October 29, 2013
      ✓ 
      Patent use: TREATMENT OF BACTERIAL INFECTIONS IN THE NASAL PASSAGE OF ADULT PATIENTS AND HEALTH CARE WORKERS WITH METHICILLIN RESISTANT S. AUREUS
  • Pharmaceutical and veterinary compositions of mupirocin and methods for their preparation
    Patent 6,025,389
    Issued: February 15, 2000
    Inventor(s): Zimmerman; Harvey Lee
    Assignee(s): SmithKline Beecham Corporation
    The invention is directed to a pharmaceutical composition comprising a cream base which comprises mupiricin dihydrate, a mineral oil, one or more fatty alcohols or fatty esters, a polyoxyethylene ether or ester surfactant, xanthan gum, water and a method for treating a bacterial infection using said composition.
    Patent expiration dates:
    • October 20, 2014
      ✓ 
      Patent use: TREATMENT OF SECONDARILY INFECTED TRAUMATIC SKIN LESIONS DUE TO S. AUREUS AND S. PYOGENES
      ✓ 
      Drug product

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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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