Generic Zohydro ER Availability
Last updated on Apr 10, 2025.
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)
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Manufacturer: RECRO GAINESVILLE
Approval date: October 25, 2013
Strength(s): 10MG (discontinued) [RLD], 15MG (discontinued) [RLD], 20MG (discontinued) [RLD], 30MG (discontinued) [RLD], 40MG (discontinued) [RLD], 50MG (discontinued) [RLD]
All of the above formulations have been discontinued.
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 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.
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Treating pain in patients with hepatic impairment
Patent 10,028,946
Issued: July 24, 2018
Inventor(s): Hartman Andrew & Rubino Christopher M. & Robinson Cynthia Y.
Assignee(s): Pernix Ireland Pain Designated Activity CompanyAn 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✓
- July 25, 2033
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Abuse resistant pharmaceutical compositions
Patent 10,092,559
Issued: October 9, 2018
Inventor(s): Rekhi Gurvinder Singh & Sidwell Richard
Assignee(s): Recro Gainesville LLCThe 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✓
- September 12, 2034
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Treating pain in patients with hepatic impairment
Patent 10,322,120
Issued: June 18, 2019
Inventor(s): Hartman Andrew & Rubino Christopher M. & Robinson Cynthia Y.
Assignee(s): Persion Pharmaceuticals LLCAn 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✓
- July 25, 2033
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Treating pain in patients with hepatic impairment
Patent 10,456,393
Issued: October 29, 2019
Inventor(s): Hartman Andrew & Rubino Christopher M. & Robinson Cynthia Y.
Assignee(s): Persion Pharmaceuticals LLCAn 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✓
- July 25, 2033
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Treating pain in patients with hepatic impairment
Patent 10,722,511
Issued: July 28, 2020
Inventor(s): Hartman Andrew & Rubino Christopher M. & Robinson Cynthia Y.
Assignee(s): Persion Pharmaceuticals LLCAn 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 hydroccodone 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✓
- July 25, 2033
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Abuse resistant pharmaceutical compositions
Patent 9,132,096
Issued: September 15, 2015
Inventor(s): Rekhi Gurvinder Singh & Sidwell Richard
Assignee(s): Alkermes Pharma Ireland LimitedThe 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✓
- September 12, 2034
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Treating pain in patients with hepatic impairment
Patent 9,265,760
Issued: February 23, 2016
Inventor(s): Hartman Andrew & Rubino Christopher M. & Robinson Cynthia Y.
Assignee(s): Pemix Ireland Pain LimitedAn 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✓
- July 25, 2033
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Treating pain in patients with hepatic impairment
Patent 9,326,982
Issued: May 3, 2016
Inventor(s): Hartman Andrew & Rubino Christopher M. & Robinson Cynthia Y.
Assignee(s): Pemix Ireland Pain LimitedAn 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✓
- July 25, 2033
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Treating pain in patients with hepatic impairment
Patent 9,333,201
Issued: May 10, 2016
Inventor(s): Hartman Andrew & Rubino Christopher M. & Robinson Cynthia Y.
Assignee(s): Pernix Ireland Pain LimitedAn 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✓
- July 25, 2033
-
Treating pain in patients with hepatic impairment
Patent 9,339,499
Issued: May 17, 2016
Inventor(s): Hartman Andrew & Rubino Christopher M. & Robinson Cynthia Y.
Assignee(s): Pernix Ireland Pain LimitedAn 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✓
- July 25, 2033
-
Treating pain in patients with hepatic impairment
Patent 9,421,200
Issued: August 23, 2016
Inventor(s): Hartman Andrew & Rubino Christopher M. & Robinson Cynthia Y.
Assignee(s): Pernix Ireland Pain LimitedAn 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✓
- July 25, 2033
-
Treating pain in patients with hepatic impairment
Patent 9,433,619
Issued: September 6, 2016
Inventor(s): Hartman Andrew & Rubino Christopher M. & Robinson Cynthia Y.
Assignee(s): Pemix Ireland Pain LimitedAn 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✓
- July 25, 2033
-
Abuse resistant pharmaceutical compositions
Patent 9,452,163
Issued: September 27, 2016
Inventor(s): Rekhi Gurvinder Singh & Sidwell Richard
Assignee(s): Recro Gainesville LLCThe 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✓
- September 12, 2034
-
Abuse resistant pharmaceutical compositions
Patent 9,486,451
Issued: November 8, 2016
Inventor(s): Rekhi Gurvinder S. & Sidwell Richard
Assignee(s): Recro Gainesville LLCThe 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✓
- September 12, 2034
-
Treating pain in patients with hepatic impairment
Patent 9,610,286
Issued: April 4, 2017
Inventor(s): Hartman Andrew & Rubino Christopher M. & Robinson Cynthia Y.
Assignee(s): Pernix Ireland Pain LimitedAn 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✓
- July 25, 2033
-
Abuse resistant pharmaceutical compositions
Patent 9,713,611
Issued: July 25, 2017
Inventor(s): Rekhi Gurvinder Singh & Sidwell Richard
Assignee(s): Recro Gainesville, LLCThe 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✓✓
- September 12, 2034
More about Zohydro ER (hydrocodone)
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- Drug class: Opioids (narcotic analgesics)
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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
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