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)
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Manufacturer: ALPHARMA KING
Approval date: August 13, 2009
Strength(s): 100MG;4MG [RLD], 20MG;0.8MG, 30MG;1.2MG, 50MG;2MG, 60MG;2.4MG, 80MG;3.2MG
Has a generic version of Embeda been approved?
No. There is currently no therapeutically equivalent version of Embeda available.
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.
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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✓
- June 19, 2027
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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✓
- June 19, 2027
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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✓
- December 12, 2027
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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✓
- June 19, 2027
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:
- August 13, 2012 - NEW COMBINATION
See also...
- Embeda Consumer Information (Drugs.com)
- Embeda extended-release capsules Consumer Information (Wolters Kluwer)
- Embeda Consumer Information (Cerner Multum)
- Embeda Advanced Consumer Information (Micromedex)
- Morphine/naltrexone extended-release capsules Consumer Information (Wolters Kluwer)
- Morphine and naltrexone Consumer Information (Cerner Multum)
- Morphine and naltrexone Advanced Consumer Information (Micromedex)
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. |


