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Generic Clorotekal Availability

Last updated on Sep 8, 2021.

Clorotekal is a brand name of chloroprocaine, approved by the FDA in the following formulation(s):

CLOROTEKAL (chloroprocaine hydrochloride - solution;intrathecal)

  • Manufacturer: B BRAUN MEDICAL INC
    Approval date: September 26, 2017
    Strength(s): 50MG/5ML (10MG/ML) [RLD]

Has a generic version of Clorotekal been approved?

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

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

  • Use for a composition comprising chloroprocaine HCL, a new composition comprising chloroprocaine HCL and a method for its manufacture
    Patent 8,969,412
    Issued: March 3, 2015
    Assignee(s): Sintetica S.A.

    The present invention concerns a new use for a composition containing chloroprocaine HCl, and in particular its use for the manufacture of a drug for intrathecal narcosis. The present invention also concerns a new composition containing chloroprocaine HCl, being particularly suited to this new use, as well as a new method for manufacturing the composition.

    Patent expiration dates:

    • September 5, 2026
      ✓ 
      Patent use: A METHOD FOR INDUCING A REGIONAL ANAESTHESIA VIA INTRATHECAL ADMINISTRATION OF A PATENTED PRESERVATIVE FREE SOLUTION FOR INJECTION (WITH A SPECIFIC COMPOSITION, PH, OSMOLALITY AND DENSITY) CONTAINING 9-11 MG/ML CHLOROPROCAINE HCL
      ✓ 
      Drug product
  • Chloroprocaine-based pharmaceutical composition for repeated intrathecal administration
    Patent 9,504,666
    Issued: November 29, 2016
    Assignee(s): SINTETICA S.A.

    This invention relates to an injectable pharmaceutical composition based on chloroprocaine or salts and/or derivatives thereof for use in central loco-regional anesthesia by intrathecal administration in repeated doses. Unexpectedly, the intrathecal administration in repeated doses of chloroprocaine does not increase the neurotoxicity of this drug in statistically significant manner.

    Patent expiration dates:

    • December 11, 2033
      ✓ 
      Drug product

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.