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Generic Sublocade Availability

Sublocade is a brand name of buprenorphine, approved by the FDA in the following formulation(s):

SUBLOCADE (buprenorphine - solution, extended release;subcutaneous)

  • Manufacturer: INDIVIOR INC
    Approval date: November 29, 2017
    Strength(s): 100MG/0.5ML (100MG/0.5ML) [RLD], 300MG/1.5ML (200MG/ML) [RLD]

Has a generic version of Sublocade been approved?

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

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

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.

  • Injectable flowable composition comprising buprenorphine
    Patent 8,921,387
    Issued: December 30, 2014
    Assignee(s): RB Pharmaceuticals Limited
    The present invention is directed to a buprenorphine sustained release delivery system capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 14 days to about 3 months. The buprenorphine sustained release delivery system includes a flowable composition and a solid implant for the sustained release of buprenorphine, a metabolite, or a prodrug thereof. The implant is produced from the flowable composition. The buprenorphine sustained release delivery system provides in situ 1-month and 3-month release profiles characterized by an exceptionally high bioavailability and minimal risk of permanent tissue damage and typically no risk of muscle necrosis.
    Patent expiration dates:
    • January 6, 2032
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      Patent use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
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      Drug product
    • January 6, 2032
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      Patent use: TREATING OPIOID DEPENDENCE BY ADMINISTERING BUPRENORPHINE
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      Drug product
  • Injectable flowable composition comprising buprenorphine
    Patent 8,975,270
    Issued: March 10, 2015
    Assignee(s): RB Pharmaceuticals Limited
    The present invention is directed to a buprenorphine sustained release delivery system capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 14 days to about 3 months. The buprenorphine sustained release delivery system includes a flowable composition and a solid implant for the sustained release of buprenorphine, a metabolite, or a prodrug thereof. The implant is produced from the flowable composition. The buprenorphine sustained release delivery system provides in situ 1-month and 3-month release profiles characterized by an exceptionally high bioavailability and minimal risk of permanent tissue damage and typically no risk of muscle necrosis.
    Patent expiration dates:
    • September 5, 2031
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      Patent use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE MONTHLY
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    • September 5, 2031
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      Patent use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
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  • Injectable flowable composition buprenorphine
    Patent 9,272,044
    Issued: March 1, 2016
    Assignee(s): Indivior UK Limited
    The present invention is directed to a buprenorphine sustained release delivery system capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 14 days to about 3 months. The buprenorphine sustained release delivery system includes a flowable composition and a solid implant for the sustained release of buprenorphine, a metabolite, or a prodrug thereof. The implant is produced from the flowable composition. The buprenorphine sustained release delivery system provides in situ 1-month and 3-month release profiles characterized by an exceptionally high bioavailability and minimal risk of permanent tissue damage and typically no risk of muscle necrosis.
    Patent expiration dates:
    • June 6, 2031
      ✓ 
      Patent use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
    • June 6, 2031
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      Patent use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
    • June 6, 2031
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      Patent use: TREATING OPIOID ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
    • June 6, 2031
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      Patent use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE COMPOSITION WITH 28 DAY DOSE DURATION
  • Injectable flowable composition comprising buprenorphine
    Patent 9,498,432
    Issued: November 22, 2016
    Assignee(s): Indivior UK Limited
    The present invention is directed to a buprenorphine sustained release delivery system capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 14 days to about 3 months. The buprenorphine sustained release delivery system includes a flowable composition and a solid implant for the sustained release of buprenorphine, a metabolite, or a prodrug thereof. The implant is produced from the flowable composition. The buprenorphine sustained release delivery system provides in situ 1-month and 3-month release profiles characterized by an exceptionally high bioavailability and minimal risk of permanent tissue damage and typically no risk of muscle necrosis.
    Patent expiration dates:
    • June 6, 2031
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      Patent use: IN SITU FORMATION OF SOLID BUPRENORPHINE COMPOSITION
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  • Injectable composition comprising buprenorphine
    Patent 9,782,402
    Issued: October 10, 2017
    Assignee(s): Indivior UK Limited
    The present invention is directed to a buprenorphine sustained release delivery system capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 14 days to about 3 months. The buprenorphine sustained release delivery system includes a flowable composition and a solid implant for the sustained release of buprenorphine, a metabolite, or a prodrug thereof. The implant is produced from the flowable composition. The buprenorphine sustained release delivery system provides in situ 1-month and 3-month release profiles characterized by an exceptionally high bioavailability and minimal risk of permanent tissue damage and typically no risk of muscle necrosis.
    Patent expiration dates:
    • June 6, 2031
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      Patent use: TREATING ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
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    • June 6, 2031
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      Patent use: TREATING ADDICTION WITH 100 MG OR 300 MG DOSE OF BUPRENORPHINE
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    • June 6, 2031
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      Patent use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
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    • June 6, 2031
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      Patent use: TREATING ADDICTION BY ONCE PER MONTH ADMINISTRATION OF BUPRENORPHINE
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  • Injectable flowable composition comprising buprenorphine
    Patent 9,827,241
    Issued: November 28, 2017
    Assignee(s): Indivior UK Limited
    The present invention is directed to a buprenorphine sustained release delivery system capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 14 days to about 3 months. The buprenorphine sustained release delivery system includes a flowable composition and a solid implant for the sustained release of buprenorphine, a metabolite, or a prodrug thereof. The implant is produced from the flowable composition. The buprenorphine sustained release delivery system provides in situ 1-month and 3-month release profiles characterized by an exceptionally high bioavailability and minimal risk of permanent tissue damage and typically no risk of muscle necrosis.
    Patent expiration dates:
    • June 6, 2031
      ✓ 
      Patent use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
      ✓ 
      Drug product
    • June 6, 2031
      ✓ 
      Patent use: TREATING OPIOID ADDICTION BY ADMINISTRATION OF BUPRENORPHINE
      ✓ 
      Drug product
    • June 6, 2031
      ✓ 
      Patent use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
      ✓ 
      Drug product
    • June 6, 2031
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      Patent use: TREATING OPIOID DEPENDENCY BY SUBCUTANEOUSLY ADMINISTERING BUPRENORPHINE
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      Drug product
    • June 6, 2031
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      Patent use: TREATING OPIOID ADDICTION BY 100 MG OR 300 MG DOSE BUPRENORPHINE
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      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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