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Generic Xepi Availability

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

XEPI (ozenoxacin - cream;topical)

  • Manufacturer: FERRER INTERNACIONAL
    Approval date: December 11, 2017
    Strength(s): 1% [RLD]

Has a generic version of Xepi been approved?

No. There is currently no therapeutically equivalent version of Xepi available in the United States.

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

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.

  • Quinolonecarboxylic acid derivatives or salts thereof
    Patent 6,335,447
    Issued: January 1, 2002
    Inventor(s): Kazuya; Hayashi & Tokunori; Kito & Junichi; Mitsuyama & Tetsumi; Yamakawa & Hiroshi; Kuroda & Hiroyo; Kawafuchi
    Assignee(s): Toyama Chemical Co., Ltd.
    Novel quinolonecarboxylic acid derivatives of general formula (1) or salts thereof which have potent antibacterial effects on gram-positive bacteria in particular Propionibacterium acnes (wherein R1 represents a hydrogen atom or a carboxyl-protective group; R2 represents an optionally substituted cycloalkyl group; R3 represents a hydrogen atom, a halogen atom, an optionally substituted alkyl, alkoxy or alkylthio group, an optionally protected hydroxyl or amino group, or a nitro group; R4 represents an optionally substituted alkyl or alkoxy group; and Z represents a pyridin-4-yl or pyridin-3-yl group which is optionally substituted with at least one group selected from a halogen atom, an optionally substituted alkyl, alkenyl, cycloalkyl, alkoxy, alkylthio or amino group and an optionally protected hydroxyl or amino group).
    Patent expiration dates:
    • April 6, 2019
      ✓ 
      Drug substance
  • Pharmaceutical topical compositions
    Patent 9,180,200
    Issued: November 10, 2015
    Assignee(s): FERRER INTERNATIONAL, S.A.
    The invention provides pharmaceutical stable semisolid topical compositions comprising between 0.2 to 5% of a des-fluoroquinolone compound, and a suitable carrier to manufacture an ointment or a cream.
    Patent expiration dates:
    • January 29, 2032
      ✓ 
      Patent use: TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES
      ✓ 
      Drug product
  • Pharmaceutical topical compositions
    Patent 9,399,014
    Issued: July 26, 2016
    Assignee(s): FERRER INTERNACIONAL, S.A.
    The invention provides pharmaceutical stable semisolid topical compositions comprising between 0.2 to 5% of a des-fluoroquinolone compound, and a suitable carrier to manufacture an ointment or a cream.
    Patent expiration dates:
    • December 15, 2029
      ✓ 
      Patent use: TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES

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:
    • December 11, 2022 - NEW CHEMICAL ENTITY
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.
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