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Generic Tessalon Availability

Last updated on Nov 9, 2021.

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

TESSALON (benzonatate - capsule;oral)

  • Manufacturer: PFIZER
    Approved Prior to Jan 1, 1982
    Strength(s): 100MG [RLD] [AA]
  • Manufacturer: PFIZER
    Approval date: June 25, 1999
    Strength(s): 200MG (discontinued) [RLD]

Has a generic version of Tessalon been approved?

Yes. The following products are equivalent to Tessalon:

benzonatate capsule;oral

  • Manufacturer: ALEMBIC LABS
    Approval date: July 30, 2007
    Strength(s): 100MG [AA]
  • Manufacturer: APOTEX INC
    Approval date: January 16, 2015
    Strength(s): 100MG [AA]
  • Manufacturer: ASCENT PHARMS INC
    Approval date: February 22, 2019
    Strength(s): 100MG [AA]
  • Manufacturer: BIONPHARMA INC
    Approval date: January 29, 1993
    Strength(s): 100MG [AA]
  • Manufacturer: CSPC-NBP PHARM
    Approval date: August 25, 2017
    Strength(s): 100MG [AA]
  • Manufacturer: MIKART
    Approval date: November 9, 2009
    Strength(s): 100MG [AA]
  • Manufacturer: PURACAP PHARM LLC
    Approval date: December 19, 2018
    Strength(s): 100MG [AA]
  • Manufacturer: QINGDAO BAHEAL PHARM
    Approval date: November 9, 2018
    Strength(s): 100MG [AA]
  • Manufacturer: STRIDES PHARMA
    Approval date: July 30, 2015
    Strength(s): 100MG [AA]
  • Manufacturer: THEPHARMANETWORK LLC
    Approval date: March 30, 2007
    Strength(s): 100MG [AA]
  • Manufacturer: ZYDUS PHARMS USA
    Approval date: June 8, 2007
    Strength(s): 100MG [AA]

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

More about Tessalon (benzonatate)

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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.
AA Products in conventional dosage forms not presenting bioequivalence problems. Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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