Generic Xepi Availability
Last updated on Sep 11, 2024.
Xepi is a brand name of ozenoxacin topical, approved by the FDA in the following formulation(s):
XEPI (ozenoxacin - cream;topical)
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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 FAQ.
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.
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Pharmaceutical topical compositions
Patent 9,180,200
Issued: November 10, 2015
Inventor(s): Tarragó Cristina & Santos Benjamin & Raga Manuel & Guglietta Antonio
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✓✓
- January 29, 2032
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Pharmaceutical topical compositions
Patent 9,399,014
Issued: July 26, 2016
Inventor(s): Tarrago Cristina & Santos Benjamin & Raga Manuel & Guglietta Antonio
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✓
- December 15, 2029
More about Xepi (ozenoxacin topical)
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- Reviews (1)
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: topical antibiotics
- Breastfeeding
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Patient resources
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Glossary
| Term | Definition |
|---|---|
| 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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.