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Generic Kovanaze Availability

Kovanaze is a brand name of oxymetazoline/tetracaine nasal, approved by the FDA in the following formulation(s):

KOVANAZE (oxymetazoline hydrochloride; tetracaine hydrochloride - spray, metered;nasal)

  • Manufacturer: ST RENATUS
    Approval date: June 29, 2016
    Strength(s): 0.1MG/SPRAY;6MG/SPRAY [RLD]

Has a generic version of Kovanaze been approved?

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

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

  • Methods and kits for maxillary dental anesthesia by means of a nasal deliverable anesthetic
    Patent 6,413,499
    Issued: July 2, 2002
    Inventor(s): Bryan M.; Clay
    Methods and systems for anesthetizing a portion or all of a patient's maxillary dental arch using a nasal delivered anesthetizing composition. The process generates anesthesia sufficient for facilitation of operative dentistry, endodontics, periodontics or oral surgery for teeth of the maxillary arch. The dental nasal spray process consists of inserting one or more dispensing devices through the patient's nostril and delivering metered dosages of anesthetic solution or gel into the nasal cavity. The process may utilize a single solution which is a mixture of anesthetic agents, vasoconstricting agents and other physiological inert agents or two separate solutions, wherein one solution contains the vasoconstricting agents and the other solution contains the anesthetic agents. Anesthetic diffusion through the thin walls of the nasal cavity allows for the blocking of nerve impulses originating from the maxillary dentition and surrounding tissues. Anesthesia of specific oral regions such as right versus left sides of the dental arch, anterior versus posterior teeth, and soft tissue anesthesia may be controlled through modification of the dosage volume and the selection of right or left nostril insertion and agent delivery.
    Patent expiration dates:
    • March 20, 2020
      ✓ 
      Patent use: METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH
  • Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration
    Patent 8,580,282
    Issued: November 12, 2013
    Assignee(s): St. Renatus, LLC
    The present invention relates to tetracaine based anesthetic formulations and methods of use thereof. The invention further relates to topical formulations of tetracaine and methods of topically anesthetizing body tissues. The present invention also relates to tetracaine based dental anesthetic formulations and methods for anesthetizing the maxillary dental arch using these formulations.
    Patent expiration dates:
    • April 2, 2030
      ✓ 
      Patent use: METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH
      ✓ 
      Drug product
  • Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration
    Patent 9,308,191
    Issued: April 12, 2016
    Assignee(s): St. Renatus, LLC
    The present invention relates to tetracaine based anesthetic formulations and methods of use thereof. The invention further relates to topical formulations of tetracaine and methods of topically anesthetizing body tissues. The present invention also relates to tetracaine based dental anesthetic formulations and methods for anesthetizing the maxillary dental arch using these formulations.
    Patent expiration dates:
    • April 2, 2030
      ✓ 
      Patent use: METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH
      ✓ 
      Drug product

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:
    • June 29, 2019 - NEW COMBINATION

More about Kovanaze (oxymetazoline / tetracaine nasal)

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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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