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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: PERNIX IRELAND PAIN
    Approval date: October 25, 2013
    Strength(s): 10MG [RLD], 15MG, 20MG, 30MG, 40MG, 50MG

Has a generic version of Zohydro ER been approved?

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

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: 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.

  • Multiparticulate modified release composition
    Patent 6,228,398
    Issued: May 8, 2001
    Inventor(s): Devane; John G. & Stark; Paul & Fanning; Niall M. M.
    Assignee(s): Elan Corporation, PLC
    The invention relates to a multiparticulate modified release composition that in operation delivers an active ingredient in a pulsed or bimodal manner. The multiparticulate modified release composition comprises an immediate release component and a modified release component; the immediate release component comprising a first population of active ingredient containing particles and the modified release component compnsimg a second population of active ingredient containing particles coated with a controlled release coating; wherein the combination of the immediate release and modified release components in operation deliver the active ingredient in a pulsed or a bimodal manner. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition. The plasma profile achieved by the multiparticulate modified release composition is advantageous in reducing patient tolerance to the active ingredient and in increasing patient compliance by reducing dosage frequency.
    Patent expiration dates:
    • November 1, 2019
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      Drug product
  • Multiparticulate modified release composition
    Patent 6,902,742
    Issued: June 7, 2005
    Inventor(s): Devane; John G. & Stark; Paul & Fanning; Niall M. M. & Rekhi; Gurvinder Singh
    Assignee(s): Elan Corporation, plc
    The invention relates to a multiparticulate modified release composition that in operation delivers an active ingredient in a pulsed or bimodal manner. The multiparticulate modified release composition comprises an immediate release component and a modified release component; the immediate release component comprising a first population of active ingredient containing particles and the modified release component comprising a second population of active ingredient containing particles coated with a controlled release coating; wherein the combination of the immediate release and modified release components in operation deliver the active ingredient in a pulsed or a bimodal manner. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition. The plasma profile achieved by the multiparticulate modified release composition is advantageous in reducing patient tolerance to the active ingredient and in increasing patient compliance by reducing dosage frequency.
    Patent expiration dates:
    • November 1, 2019
      ✓ 
      Drug product
  • 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
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      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
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      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

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • October 25, 2016 - NEW PRODUCT

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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