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Generic Apadaz Availability

Last updated on June 8, 2021.

Apadaz is a brand name of acetaminophen/benzhydrocodone, approved by the FDA in the following formulation(s):

APADAZ (acetaminophen; benzhydrocodone hydrochloride - tablet;oral)

  • Manufacturer: KVK TECH INC
    Approval date: February 23, 2018
    Strength(s): 325MG;EQ 6.12MG BASE [RLD]
  • Manufacturer: KVK TECH INC
    Approval date: January 4, 2019
    Strength(s): 325MG;EQ 4.08MG BASE [RLD], 325MG;EQ 8.16MG BASE [RLD]

Has a generic version of Apadaz been approved?

An Authorized Generic version of Apadaz has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.

List of authorized generic versions:

  • Benzhydrocodone and Acetaminophen ORAL TABLET 4.08; 325 mg/1; mg
    KVK-Tech, Inc.
    NDC Code: 107020343
  • Benzhydrocodone and Acetaminophen ORAL TABLET 6.12; 325 mg/1; mg
    KVK-Tech, Inc.
    NDC Code: 107020344
  • Benzhydrocodone and Acetaminophen ORAL TABLET 8.16; 325 mg/1; mg
    KVK-Tech, Inc.
    NDC Code: 107020345

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

  • Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
    Patent 8,461,137
    Issued: June 11, 2013
    Assignee(s): KemPharm, Inc.

    The presently described technology provides compositions comprising aryl carboxylic acids chemically conjugated to hydrocodone (morphinan-6-one, 4,5-alpha-epoxy-3-methoxy-17-methyl) to form novel prodrugs/compositions of hydrocodone, including benzoates and heteroaryl carboxylic acids, which have a decreased potential for abuse of hydrocodone. The present technology also provides methods of treating patients, pharmaceutical kits and methods of synthesizing conjugates of the present technology.

    Patent expiration dates:

    • February 22, 2031
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  • Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
    Patent 8,748,413
    Issued: June 10, 2014
    Assignee(s): KemPharm, Inc.

    The presently described technology provides compositions comprising aryl carboxylic acids chemically conjugated to hydrocodone (morphinan-6-one, 4,5-alpha-epoxy-3-methoxy-17-methyl) to form novel prodrugs/compositions of hydrocodone, including benzoates and heteroaryl carboxylic acids, which have a decreased potential for abuse of hydrocodone. The present technology also provides methods of treating patients, pharmaceutical kits and methods of synthesizing conjugates of the present technology.

    Patent expiration dates:

    • July 10, 2030
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    • July 1, 2030
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  • Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
    Patent 8,828,978
    Issued: September 9, 2014
    Assignee(s): KemPharm, Inc.

    The presently described technology provides compositions comprising aryl carboxylic acids chemically conjugated to hydrocodone (morphinan-6-one, 4,5-alpha-epoxy-3-methoxy-17-methyl) to form novel prodrugs/compositions of hydrocodone, including benzoates and heteroaryl carboxylic acids, which have a decreased potential for abuse of hydrocodone. The present technology also provides methods of treating patients, pharmaceutical kits and methods of synthesizing conjugates of the present technology.

    Patent expiration dates:

    • July 1, 2030
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      Drug product
  • Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
    Patent 9,132,125
    Issued: September 15, 2015
    Assignee(s): KemPharm, Inc.

    The presently described technology provides compositions comprising aryl carboxylic acids chemically conjugated to hydrocodone (morphinan-6-one, 4,5-alpha-epoxy-3-methoxy-17-methyl) to form novel prodrugs/compositions of hydrocodone, including benzoates and heteroaryl carboxylic acids, which have a decreased potential for abuse of hydrocodone. The present technology also provides methods of treating patients, pharmaceutical kits and methods of synthesizing conjugates of the present technology.

    Patent expiration dates:

    • July 1, 2030
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      Patent use: MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE
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  • Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and uses thereof
    Patent 9,549,923
    Issued: January 24, 2017
    Assignee(s): KemPharm, Inc.

    The presently described technology provides compositions comprising aryl carboxylic acids chemically conjugated to hydrocodone (morphinan-6-one, 4,5-alpha-epoxy-3-methoxy-17-methyl) to form novel prodrugs/compositions of hydrocodone, including benzoates and heteroaryl carboxylic acids, which have a decreased potential for abuse of hydrocodone. The present technology also provides methods of treating patients, pharmaceutical kits and methods of synthesizing conjugates of the present technology.

    Patent expiration dates:

    • July 1, 2030
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      Drug substance
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      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.