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Generic Hycodan Availability

Hycodan is a brand name of homatropine/hydrocodone, approved by the FDA in the following formulation(s):

HYCODAN (homatropine methylbromide; hydrocodone bitartrate - syrup;oral)

  • Manufacturer: GENUS
    Approval date: July 26, 1988
    Strength(s): 1.5MG/5ML;5MG/5ML [RLD] [AA]

HYCODAN (homatropine methylbromide; hydrocodone bitartrate - tablet;oral)

  • Manufacturer: GENUS
    Approval date: July 26, 1988
    Strength(s): 1.5MG;5MG (discontinued) [RLD]

Has a generic version of Hycodan been approved?

Yes. The following products are equivalent to Hycodan:

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (homatropine methylbromide; hydrocodone bitartrate syrup;oral)

  • Manufacturer: ABHAI LLC
    Approval date: February 21, 2017
    Strength(s): 1.5MG/5ML;5MG/5ML [AA]
  • Manufacturer: ACTAVIS MID ATLANTIC
    Approval date: July 5, 1983
    Strength(s): 1.5MG/5ML;5MG/5ML [AA]
  • Manufacturer: HI TECH PHARMA
    Approval date: February 8, 2008
    Strength(s): 1.5MG/5ML;5MG/5ML [AA]
  • Manufacturer: NOVEL LABS INC
    Approval date: February 13, 2017
    Strength(s): 1.5MG/5ML;5MG/5ML [AA]
  • Manufacturer: PADDOCK LLC
    Approval date: February 15, 2017
    Strength(s): 1.5MG/5ML;5MG/5ML [AA]
  • Manufacturer: WOCKHARDT BIO AG
    Approval date: March 3, 1983
    Strength(s): 1.5MG/5ML;5MG/5ML [AA]

Note: No generic formulation of the following product is available.

  • homatropine methylbromide; hydrocodone bitartrate - tablet;oral

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

Further information

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

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.