Generic Embeda Availability

Embeda is a brand name of morphine/naltrexone, approved by the FDA in the following formulation(s):

EMBEDA (morphine sulfate; naltrexone hydrochloride - capsule, extended release;oral)

  • Manufacturer: ALPHARMA PHARMS
    Approval date: August 13, 2009
    Strength(s): 20MG;0.8MG, 30MG;1.2MG, 50MG;2MG, 60MG;2.4MG [RLD], 80MG;3.2MG, 100MG;4MG

Has a generic version of Embeda been approved?

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

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

  • Pharmaceutical composition
    Patent 7,682,633
    Issued: March 23, 2010
    Inventor(s): Matthews; Frank & Boehm; Garth & Tang; Lijuan & Liang; Alfred
    Assignee(s): Alpharma Pharmaceuticals, LLC
    Provided herein is a pharmaceutical composition comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, wherein the antagonist, agonist, seal coat and at least one sequestering polymer are all components of a single unit, and wherein the seal coat forms a layer physically separating the antagonist from the agonist from one another. Methods for manufacturing such a pharmaceutical composition are also provided.
    Patent expiration dates:
    • June 19, 2027
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOD TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
  • Pharmaceutical compositions
    Patent 7,682,634
    Issued: March 23, 2010
    Inventor(s): Matthews; Frank & Boehm; Garth & Tang; Lijuan & Liang; Alfred
    Assignee(s): Alpharma Pharmaceuticals, LLC
    Provided herein is a pharmaceutical composition comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, wherein the antagonist, agonist, seal coat and at least one sequestering polymer are all components of a single unit, and wherein the seal coat forms a layer physically separating the antagonist from the agonist from one another. Methods for manufacturing such a pharmaceutical composition are also provided.
    Patent expiration dates:
    • June 19, 2027
      ✓ 
      Drug product
  • Sequestering subunit and related compositions and methods
    Patent 7,815,934
    Issued: October 19, 2010
    Inventor(s): Boehm; Garth
    Assignee(s): Alpharma Pharmaceuticals, LLC
    A sequestering subunit comprising an aversive agent and a blocking agent, wherein the blocking agent substantially prevents release of the aversive agent from the sequestering subunit in the gastrointestinal tract for a time period that is greater than 24 hours; a composition comprising a sequestering subunit and a therapeutic agent in releasable form, wherein, optionally, the mechanical fragility of the sequestering subunit is the same as the mechanical fragility of the therapeutic agent in releasable form; a capsule or tablet comprising a sequestering subunit and a therapeutic agent; and a method of preventing abuse of a therapeutic agent.
    Patent expiration dates:
    • December 12, 2027
      ✓ 
      Drug product
  • Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist
    Patent 8,158,156
    Issued: April 17, 2012
    Inventor(s): Matthews; Frank & Boehm; Garth & Tang; Lijuan & Liang; Alfred
    Assignee(s): Alpharma Pharmaceuticals, LLC
    Provided herein is a pharmaceutical composition comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, wherein the antagonist, agonist, seal coat and at least one sequestering polymer are all components of a single unit, and wherein the seal coat forms a layer physically separating the antagonist from the agonist from one another. Methods for manufacturing such a pharmaceutical composition are also provided.
    Patent expiration dates:
    • June 19, 2027
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOD TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
  • Sequestering subunit and related compositions and methods
    Patent 8,685,443
    Issued: April 1, 2014
    Assignee(s): Alpharma Pharmaceuticals LLC
    A sequestering subunit comprising an aversive agent and a blocking agent, wherein the blocking agent substantially prevents release of the aversive agent from the sequestering subunit in the gastrointestinal tract for a time period that is greater than 24 hours; a composition comprising a sequestering subunit in releasable form, wherein, optionally, the mechanical fragility of the sequestering subunit is the same as the mechanical fragility of the therapeutic agent in releasable form; a capsule or tablet comprising a sequestering subunit and a therapeutic agent; and a method of preventing abuse of a therapeutic agent.
    Patent expiration dates:
    • July 3, 2025
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
  • Sequestering subunit and related compositions and methods
    Patent 8,685,444
    Issued: April 1, 2014
    Assignee(s): Alpharma Pharmaceuticals LLC
    A sequestering subunit comprising an aversive agent and a blocking agent, wherein the blocking agent substantially prevents release of the aversive agent from the sequestering subunit in the gastrointestinal tract for a time period that is greater than 24 hours; a composition comprising a sequestering subunit in releasable form, wherein, optionally, the mechanical fragility of the sequestering subunit is the same as the mechanical fragility of the therapeutic agent in releasable form; a capsule or tablet comprising a sequestering subunit and a therapeutic agent; and a method of preventing abuse of a therapeutic agent.
    Patent expiration dates:
    • July 3, 2025
      ✓ 
      Drug 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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