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Generic Xtampza ER Availability

Last updated on Sep 6, 2023.

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

XTAMPZA ER (oxycodone - capsule, extended release;oral)

  • Manufacturer: COLLEGIUM PHARM INC
    Approval date: April 26, 2016
    Strength(s): 9MG [RLD], 13.5MG [RLD], 18MG [RLD], 27MG [RLD], 36MG [RLD]

Has a generic version of Xtampza ER been approved?

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

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

  • Tamper-resistant pharmaceutical compositions of opioids and other drugs
    Patent 10,004,729
    Issued: June 26, 2018
    Assignee(s): COLLEGIUM PHARMACEUTICAL, INC.

    Tamper-resistant pharmaceutical compositions have been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. The tamper-resistant compositions retard the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.

    Patent expiration dates:

    • December 10, 2030
      ✓ 
      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
      ✓ 
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  • Patent 10,188,644

    Patent expiration dates:

    • September 2, 2036
      ✓ 
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    • July 7, 2023
      ✓ 
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    Patent expiration dates:

    • July 7, 2023
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    Patent expiration dates:

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      ✓ 
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    • December 10, 2030
      ✓ 
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    Patent expiration dates:

    • March 24, 2025
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    • March 21, 2025
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    Patent expiration dates:

    • June 10, 2025
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  • Patent 8,840,928

    Patent expiration dates:

    • July 7, 2023
      ✓ 
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  • Patent 9,044,398

    Patent expiration dates:

    • July 7, 2023
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  • Patent 9,248,195

    Patent expiration dates:

    • July 7, 2023
      ✓ 
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  • Patent 9,592,200

    Patent expiration dates:

    • July 7, 2023
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  • Patent 9,682,075

    Patent expiration dates:

    • December 10, 2030
      ✓ 
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  • Patent 9,737,530

    Patent expiration dates:

    • September 2, 2036
      ✓ 
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  • Patent 9,763,883

    Patent expiration dates:

    • July 7, 2023
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    Patent expiration dates:

    • September 2, 2036
      ✓ 
      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
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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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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