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Generic Xtoro Availability

Xtoro is a brand name of finafloxacin otic, approved by the FDA in the following formulation(s):

XTORO (finafloxacin - suspension/drops;otic)

  • Manufacturer: ALCON RES LTD
    Approval date: December 17, 2014
    Strength(s): 0.3% [RLD]

Has a generic version of Xtoro been approved?

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

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

  • Use of 7-(2-oxa-5,8-diazabicyclo[4.3.0]non-8-yl)-quinolone carboxylic acid and naphthyridon carboxylic acid derivatives for the treatment of Helicobacter pylori infections and associated gastroduodenal diseases
    Patent 6,133,260
    Issued: October 17, 2000
    Inventor(s): Matzke; Michael & Petersen; Uwe & Jaetsch; Thomas & Bartel; Stephan & Schenke; Thomas & Himmler; Thomas & Baasner; Bernd & Werling; Hans-Otto & Schaller; Klaus & Labischinski; Harald
    Assignee(s): Bayer Aktiengesellschaft
    The invention relates to the use of quinolone- and naphthyridonecarboxylic acid derivatives which are substituted in the 7-position by a 2-oxa-5,8-diazabicyclo[4.3.0]-non-8-yl) radical, and their pharmaceutically utilizable hydrates and/or salts for the therapy of Helicobacter pylori infections and the gastroduodenal disorders associated therewith.
    Patent expiration dates:
    • April 12, 2017
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      Drug substance
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      Drug product
  • USE OF 7-(2-OXA-5,8-DIAZABICYLCO[4.3.0]NON-8-YL)-QUINOLONE CARBOXYLIC ACID AND NAPHTHYRIDON CARBOXYLIC ACID DERIVATIVES FOR THE TREATMENT OF HELIOBACTER PYLORI INFECTIONS AND ASSOCIATED GASTRODUODENAL DISEASES
    Patent 6,432,948
    Issued: August 13, 2002
    Inventor(s): Michael; Matzke & Uwe; Petersen & Thomas; Jaetsch & Stephan; Bartel & Thomas; Schénke & Thomas; Himmler & Bernd; Baasner & Hans-Otto; Werling & Klaus; Schaller & Harald; Labischinski
    Assignee(s): Bayer Aktiengesellschaft
    The invention relates to the use of quinolone- and naphthyridonecarboxylic acid derivatives, which are substituted in the 7-position by a 2-oxa-5,8-diazabicyclo[4.3.0]-non-8-yl) radical, and their pharmaceutically utilizable hydrates and/or salts for the therapy of Helicobacter pylori infections and the gastroduodenal disorders associated therewith.
    Patent expiration dates:
    • April 12, 2017
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      Drug substance
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      Drug product
  • Methods for treating ophthalmic, otic, or nasal infections
    Patent 8,536,167
    Issued: September 17, 2013
    Assignee(s): Alcon Research, Ltd.
    The present invention relates to methods for treating an ophthalmic, otic, or nasal infection comprising treating the infected tissue with a composition comprising finafloxacin or a finafloxacin derivative. The present invention also relates to antimicrobial compositions comprising finafloxacin or a finafloxacin derivative. The compositions are suitable for the treatment of ophthalmic, otic, or nasal infections.
    Patent expiration dates:
    • August 8, 2031
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      Patent use: TREATMENT OF ACUTE OTITIS EXTERNA
  • Methods for treating otic infections
    Patent 9,119,859
    Issued: September 1, 2015
    Assignee(s): Alcon Research, Ltd.
    The present invention relates to methods for treating an ophthalmic, otic, or nasal infection comprising treating the infected tissue with a composition comprising finafloxacin or a finafloxacin derivative. The present invention also relates to antimicrobial compositions comprising finafloxacin or a finafloxacin derivative. The compositions are suitable for the treatment of ophthalmic, otic, or nasal infections.
    Patent expiration dates:
    • July 2, 2030
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      Patent use: TREATMENT OF ACUTE OTITIS EXTERNA

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 17, 2019 - NEW CHEMICAL ENTITY
    • June 17, 2020 - PEDIATRIC EXCLUSIVITY

More about Xtoro (finafloxacin otic)

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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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