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Generic Hysingla ER Availability

Medically reviewed by Drugs.com. Last updated on May 11, 2021.

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

HYSINGLA ER (hydrocodone bitartrate - tablet, extended release;oral)

Has a generic version of Hysingla ER been approved?

A generic version of Hysingla 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 Hysingla ER and have been approved by the FDA:

hydrocodone bitartrate tablet, extended release;oral

  • Manufacturer: ALVOGEN PINE BROOK
    Approval date: March 1, 2021
    Strength(s): 20MG [AB], 30MG [AB], 40MG [AB], 60MG [AB], 80MG [AB], 100MG [AB], 120MG [AB]

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

  • Abuse-proofed dosage form
    Patent 10,130,591
    Issued: November 20, 2018
    Assignee(s): GRÜNENTHAL GMBH

    The present invention relates to an abuse-proofed, thermoformed dosage form containing, in addition to one or more active ingredients with abuse potential optionally together with physiologically acceptable auxiliary substances, at least one synthetic or natural polymer with a breaking strength of at least 500 N and to a process for the production thereof.

    Patent expiration dates:

    • November 20, 2023
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
      ✓ 
      Drug product
  • Patent 10,369,109

    Patent expiration dates:

    • June 16, 2023
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      Drug product
  • Controlled release hydrocodone formulations
    Patent 6,733,783
    Issued: May 11, 2004
    Inventor(s): Benjamin; Oshlack & John K.; Masselink & Hua-Pin; Huang & Alfred P.; Tonelli
    Assignee(s): Euro-Celtique S.A.

    A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.

    Patent expiration dates:

    • October 30, 2021
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
      ✓ 
      Drug product
  • Abuse-proofed dosage form
    Patent 8,309,060
    Issued: November 13, 2012
    Inventor(s): Bartholomaus; Johannes & Kugelmann; Heinrich & Arkenau-Marić; Elisabeth
    Assignee(s): Grunenthal GmbH

    An abuse-proofed, thermoformed dosage form containing, in addition to one or more active ingredients with abuse potential optionally together with physiologically acceptable auxiliary substances, at least one synthetic or natural polymer with a breaking strength of at least 500 N and to a process for the production thereof.

    Patent expiration dates:

    • November 20, 2023
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
      ✓ 
      Drug product
  • Controlled release hydrocodone formulations
    Patent 8,361,499
    Issued: January 29, 2013
    Assignee(s): Purdue Pharma L.P.

    A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.

    Patent expiration dates:

    • October 30, 2021
      ✓ 
      Drug product
  • Pharmaceutical formulation containing gelling agent
    Patent 8,529,948
    Issued: September 10, 2013
    Assignee(s): Purdue Pharma L.P. The P.F. Laboratories, Inc. Purdue Pharmaceuticals L.P.

    Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.

    Patent expiration dates:

    • August 6, 2022
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      Drug product
  • Controlled release hydrocodone
    Patent 8,551,520
    Issued: October 8, 2013
    Assignee(s): Purdue Pharma L.P.

    A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.

    Patent expiration dates:

    • October 30, 2021
      ✓ 
      Drug product
  • Controlled release hydrocodone formulations
    Patent 8,647,667
    Issued: February 11, 2014
    Assignee(s): Purdue Pharma, L.P.

    A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.

    Patent expiration dates:

    • October 30, 2021
      ✓ 
      Drug product
  • Encased tamper resistant controlled release dosage forms
    Patent 8,808,740
    Issued: August 19, 2014
    Assignee(s): Purdue Pharma L.P.

    In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 C.

    Patent expiration dates:

    • December 21, 2031
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
      ✓ 
      Drug product
  • Tamper resistant dosage forms
    Patent 9,084,816
    Issued: July 21, 2015
    Assignee(s): PURDUE PHARMA L.P. PURDUE PHARMACEUTICALS L.P.

    The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

    Patent expiration dates:

    • August 24, 2027
      ✓ 
      Drug product
  • Tamper resistant dosage forms
    Patent 9,095,614
    Issued: August 4, 2015
    Assignee(s): PURDUE PHARMA L.P. PURDUE PHARMACEUTICALS L.P.

    The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

    Patent expiration dates:

    • August 24, 2027
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
  • Tamper resistant dosage forms
    Patent 9,095,615
    Issued: August 4, 2015
    Assignee(s): PURDUE PHARMA L.P. PURDUE PHARMACEUTICALS L.P.

    The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

    Patent expiration dates:

    • August 24, 2027
      ✓ 
      Drug product
  • Tamper resistant dosage forms
    Patent 9,486,412
    Issued: November 8, 2016
    Assignee(s): PURDUE PHARMA L.P. PURDUE PHARMACEUTICALS L.P.

    The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

    Patent expiration dates:

    • August 24, 2027
      ✓ 
      Drug product
  • Tamper resistant dosage forms
    Patent 9,486,413
    Issued: November 8, 2016
    Assignee(s): PURDUE PHARMA L.P. PURDUE PHARMACEUTICALS L.P.

    The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

    Patent expiration dates:

    • August 24, 2027
      ✓ 
      Drug product
  • Tamper resistant dosage forms
    Patent 9,492,389
    Issued: November 15, 2016
    Assignee(s): PURDUE PHARMA L.P. PURDUE PHARMACEUTICALS L.P.

    The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

    Patent expiration dates:

    • August 24, 2027
      ✓ 
      Drug product
  • Tamper resistant dosage forms
    Patent 9,492,390
    Issued: November 15, 2016
    Assignee(s): PURDUE PHARMA L.P. PURDUE PHARMACEUTICALS L.P.

    The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

    Patent expiration dates:

    • August 24, 2027
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
  • Tamper resistant dosage forms
    Patent 9,492,391
    Issued: November 15, 2016
    Assignee(s): PURDUE PHARMA L.P. PURDUE PHARMACEUTICALS L.P.

    The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

    Patent expiration dates:

    • August 24, 2027
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
  • Tamper resistant dosage forms
    Patent 9,545,380
    Issued: January 17, 2017
    Assignee(s): PURDUE PHARMA L.P. PURDUE PHARMACEUTICALS L.P.

    The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

    Patent expiration dates:

    • August 24, 2027
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
  • Encased tamper resistant controlled release dosage forms
    Patent 9,572,779
    Issued: February 21, 2017
    Assignee(s): Purdue Pharma L.P.

    In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 C.

    Patent expiration dates:

    • December 21, 2031
      ✓ 
      Drug product
  • Abuse-proofed dosage form
    Patent 9,675,610
    Issued: June 13, 2017
    Assignee(s): GRÜNENTHAL GMBH

    A solid administration form, protected from parenteral abuse and containing at least one viscosity-increasing agent in addition to one or more active substances that have parenteral abuse potential. The agent forms, when a necessary minimum amount of an aqueous liquid is added, on the basis of an extract obtained from the administration form, a preferably injectable gel that remains visually distinct when introduced into another quantity of an aqueous liquid.

    Patent expiration dates:

    • June 16, 2023
      ✓ 
      Drug product
  • Encased tamper resistant controlled release dosage forms
    Patent 9,750,703
    Issued: September 5, 2017
    Assignee(s): Purdue Pharma L.P.

    In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 C.

    Patent expiration dates:

    • December 21, 2031
      ✓ 
      Drug product
  • Tamper resistant dosage forms
    Patent 9,763,933
    Issued: September 19, 2017
    Assignee(s): PURDUE PHARMA L.P.

    The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

    Patent expiration dates:

    • August 24, 2027
      ✓ 
      Drug product
  • Tamper resistant dosage forms
    Patent 9,770,416
    Issued: September 26, 2017
    Assignee(s): PURDUE PHARMA L.P. PURDUE PHARMACEUTICALS L.P.

    The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

    Patent expiration dates:

    • August 24, 2027
      ✓ 
      Drug product
  • Tamper resistant dosage forms
    Patent 9,775,809
    Issued: October 3, 2017
    Assignee(s): PURDUE PHARMA L.P. PURDUE PHARMACEUTICALS L.P.

    The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

    Patent expiration dates:

    • August 24, 2027
      ✓ 
      Drug product
  • Tamper resistant controlled release dosage forms
    Patent 9,861,584
    Issued: January 9, 2018
    Assignee(s): Purdue Pharma L.P.

    In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 C.

    Patent expiration dates:

    • December 21, 2031
      ✓ 
      Drug product
  • Tamper resistant controlled release dosage forms
    Patent 9,872,837
    Issued: January 23, 2018
    Assignee(s): Purdue Pharma L.P.

    In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 C.

    Patent expiration dates:

    • December 21, 2031
      ✓ 
      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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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.

Further information

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