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Generic Zohydro ER Availability

Zohydro ER is a brand name of hydrocodone, approved by the FDA in the following formulation(s):

ZOHYDRO ER (hydrocodone bitartrate - capsule, extended release;oral)

  • Manufacturer: PERSION
    Approval date: October 25, 2013
    Strength(s): 10MG [RLD] [AB], 15MG [RLD] [AB], 20MG [RLD] [AB], 30MG [RLD] [AB], 40MG [RLD] [AB], 50MG [RLD] [AB]

Has a generic version of Zohydro ER been approved?

A generic version of Zohydro ER has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Zohydro ER and have been approved by the FDA:

hydrocodone bitartrate capsule, extended release;oral

  • Manufacturer: ALVOGEN
    Approval date: January 21, 2020
    Strength(s): 10MG [AB], 15MG [AB], 20MG [AB], 30MG [AB], 40MG [AB], 50MG [AB]

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

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.

  • Treating pain in patients with hepatic impairment
    Patent 10,028,946
    Issued: July 24, 2018
    Assignee(s): Pernix Ireland Pain Designated Activity Company

    An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.

    Patent expiration dates:

    • July 25, 2033
      ✓ 
      Patent use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
  • Abuse resistant pharmaceutical compositions
    Patent 10,092,559
    Issued: October 9, 2018
    Assignee(s): Recro Gainesville LLC

    The present invention relates to a composition comprising pharmaceutical active ingredients which are susceptible to, or have potential for, abuse. The invention provides an oral pharmaceutical composition comprising a first population of beads and a second population of beads. The first bead population comprises a pharmaceutically active ingredient susceptible to, or having the potential for, abuse. The second bead population comprises a gelling agent and a coating substantially surrounding the gelling agent, but containing no pharmaceutically active ingredient. The first bead population and the second bead population are physically separable, but visually indistinguishable to the naked eye. Upon ingress of water into the second population of beads, the gelling agent is caused to swell forming a viscous mass inhibiting or preventing the extraction of the active ingredient.

    Patent expiration dates:

    • September 12, 2034
      ✓ 
      Patent use: TREATMENT OF PAIN
  • Treating pain in patients with hepatic impairment
    Patent 10,322,120
    Issued: June 18, 2019
    Assignee(s): Persion Pharmaceuticals LLC

    An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.

    Patent expiration dates:

    • July 25, 2033
      ✓ 
      Drug product
  • Patent 10,456,393

    Patent expiration dates:

    • July 25, 2033
      ✓ 
      Patent use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
  • Abuse resistant pharmaceutical compositions
    Patent 9,132,096
    Issued: September 15, 2015
    Assignee(s): Alkermes Pharma Ireland Limited

    The present invention relates to a composition comprising pharmaceutical active ingredients which are susceptible to, or have potential for, abuse. The invention provides an oral pharmaceutical composition comprising a first population of beads and a second population of beads. The first bead population comprises a pharmaceutically active ingredient susceptible to, or having the potential for, abuse. The second bead population comprises a gelling agent and a coating substantially surrounding the gelling agent, but containing no pharmaceutically active ingredient. The first bead population and the second bead population are physically separable, but visually indistinguishable to the naked eye. Upon ingress of water into the second population of beads, the gelling agent is caused to swell forming a viscous mass inhibiting or preventing the extraction of the active ingredient.

    Patent expiration dates:

    • September 12, 2034
      ✓ 
      Drug product
  • Treating pain in patients with hepatic impairment
    Patent 9,265,760
    Issued: February 23, 2016
    Assignee(s): Pemix Ireland Pain Limited

    An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.

    Patent expiration dates:

    • July 25, 2033
      ✓ 
      Patent use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
  • Treating pain in patients with hepatic impairment
    Patent 9,326,982
    Issued: May 3, 2016
    Assignee(s): Pemix Ireland Pain Limited

    An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.

    Patent expiration dates:

    • July 25, 2033
      ✓ 
      Patent use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
  • Treating pain in patients with hepatic impairment
    Patent 9,333,201
    Issued: May 10, 2016
    Assignee(s): Pernix Ireland Pain Limited

    An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.

    Patent expiration dates:

    • July 25, 2033
      ✓ 
      Patent use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
  • Treating pain in patients with hepatic impairment
    Patent 9,339,499
    Issued: May 17, 2016
    Assignee(s): Pernix Ireland Pain Limited

    An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.

    Patent expiration dates:

    • July 25, 2033
      ✓ 
      Patent use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
  • Treating pain in patients with hepatic impairment
    Patent 9,421,200
    Issued: August 23, 2016
    Assignee(s): Pernix Ireland Pain Limited

    An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.

    Patent expiration dates:

    • July 25, 2033
      ✓ 
      Patent use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
  • Treating pain in patients with hepatic impairment
    Patent 9,433,619
    Issued: September 6, 2016
    Assignee(s): Pemix Ireland Pain Limited

    An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.

    Patent expiration dates:

    • July 25, 2033
      ✓ 
      Patent use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
  • Abuse resistant pharmaceutical compositions
    Patent 9,452,163
    Issued: September 27, 2016
    Assignee(s): Recro Gainesville LLC

    The present invention relates to a composition comprising pharmaceutical active ingredients which are susceptible to, or have potential for, abuse. The invention provides an oral pharmaceutical composition comprising a first population of beads and a second population of beads. The first bead population comprises a pharmaceutically active ingredient susceptible to, or having the potential for, abuse. The second bead population comprises a gelling agent and a coating substantially surrounding the gelling agent, but containing no pharmaceutically active ingredient. The first bead population and the second bead population are physically separable, but visually indistinguishable to the naked eye. Upon ingress of water into the second population of beads, the gelling agent is caused to swell forming a viscous mass inhibiting or preventing the extraction of the active ingredient.

    Patent expiration dates:

    • September 12, 2034
      ✓ 
      Patent use: TREATMENT OF PAIN
  • Abuse resistant pharmaceutical compositions
    Patent 9,486,451
    Issued: November 8, 2016
    Assignee(s): Recro Gainesville LLC

    The present invention relates to a composition comprising pharmaceutical active ingredients which are susceptible to, or have potential for, abuse. The invention provides an oral pharmaceutical composition comprising a first population of beads and a second population of beads. The first bead population comprises a pharmaceutically active ingredient susceptible to, or having the potential for, abuse. The second bead population comprises a gelling agent and a coating substantially surrounding the gelling agent, but containing no pharmaceutically active ingredient. The first bead population and the second bead population are physically separable, but visually indistinguishable to the naked eye. Upon ingress of water into the second population of beads, the gelling agent is caused to swell forming a viscous mass inhibiting or preventing the extraction of the active ingredient.

    Patent expiration dates:

    • September 12, 2034
      ✓ 
      Patent use: TREATMENT OF PAIN
  • Treating pain in patients with hepatic impairment
    Patent 9,610,286
    Issued: April 4, 2017
    Assignee(s): Pernix Ireland Pain Limited

    An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.

    Patent expiration dates:

    • July 25, 2033
      ✓ 
      Patent use: TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
  • Abuse resistant pharmaceutical compositions
    Patent 9,713,611
    Issued: July 25, 2017
    Assignee(s): Recro Gainesville, LLC

    The present invention relates to a composition comprising pharmaceutical active ingredients which are susceptible to, or have potential for, abuse. The invention provides an oral pharmaceutical composition comprising a first population of beads and a second population of beads. The first bead population comprises a pharmaceutically active ingredient susceptible to, or having the potential for, abuse. The second bead population comprises a gelling agent and a coating substantially surrounding the gelling agent, but containing no pharmaceutically active ingredient. The first bead population and the second bead population are physically separable, but visually indistinguishable to the naked eye. Upon ingress of water into the second population of beads, the gelling agent is caused to swell forming a viscous mass inhibiting or preventing the extraction of the active ingredient.

    Patent expiration dates:

    • September 12, 2034
      ✓ 
      Patent use: TREATMENT OF PAIN
      ✓ 
      Drug product

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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.