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Generic Primsol Availability

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

PRIMSOL (trimethoprim hydrochloride - solution;oral)

  • Manufacturer: AYTU BIOSCIENCE INC
    Approval date: January 24, 2000
    Strength(s): EQ 50MG BASE/5ML [RLD]
  • Manufacturer: AYTU PHARMS
    Approval date: June 23, 1995
    Strength(s): EQ 25MG BASE/5ML

Has a generic version of Primsol been approved?

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

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

  • Pleasant-tasting aqueous liquid composition of a bitter-tasting drug
    Patent 5,763,449
    Issued: June 9, 1998
    Inventor(s): Anaebonam; Aloysius O. & Clemente; Emmett & Fawzy; Abdel A.
    Assignee(s): Ascent Pediatrics, Inc.
    A liquid pharmaceutical composition is contemplated that comprises a pharmaceutically effective amount of a bitter tasting drug dissolved or dispersed in an aqueous medium that is free of ethanol. That aqueous medium consists essentially of water, about 5 to about 30 weight percent polyvinylpyrrolidone, about 45 to about 55 weight percent of a C.sub.3 -C.sub.6 polyol, about 0.01 to about 0.5 weight percent ammonium glycyrrhizinate and one or more flavorants. The liquid composition is transparent and has a pleasant taste.
    Patent expiration dates:
    • August 7, 2016
  • Pleasant-tasting aqueous liquid composition of a bitter-tasting drug
    Patent 5,962,461
    Issued: October 5, 1999
    Inventor(s): Anaebonam; Aloysius O. & Clemente; Emmett & Fawzy; Abdel A.
    Assignee(s): Ascent Pediatrics, Inc.
    A liquid pharmaceutical composition is contemplated that comprises a pharmaceutically effective amount of a bitter tasting drug dissolved or dispersed in an aqueous medium that is free of ethanol. That aqueous medium consists essentially of water, about 5 to about 30 weight percent polyvinylpyrrolidone, about 35 to about 55 weight percent of a C.sub.3 -C.sub.6 polyol, about 0.01 to about 0.5 weight percent ammonium glycyrrhizinate and one or more flavorants. The liquid composition is transparent and has a pleasant taste. The bitter tasting drugs claimed herein are vitamin and mineral preparations, trimethoprim, and guaifenesin.
    Patent expiration dates:
    • August 7, 2016

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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