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Generic Relistor Availability

Last updated on Sep 8, 2021.

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

RELISTOR (methylnaltrexone bromide - solution;subcutaneous)

  • Manufacturer: SALIX PHARMS
    Approval date: April 24, 2008
    Strength(s): 12MG/0.6ML (12MG/0.6ML) [RLD]
  • Manufacturer: SALIX PHARMS
    Approval date: September 27, 2010
    Strength(s): 8MG/0.4ML (8MG/0.4ML) [RLD], 12MG/0.6ML (12MG/0.6ML) [RLD]

RELISTOR (methylnaltrexone bromide - tablet;oral)

  • Manufacturer: SALIX
    Approval date: July 19, 2016
    Strength(s): 150MG [RLD]

Has a generic version of Relistor been approved?

An Authorized Generic version of Relistor has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.

List of authorized generic versions:

  • Methylnaltrexone bromide SUBCUTANEOUS INJECTION, SOLUTION 8 mg/.4mL
    Salix Pharmaceuticals, Inc.
    NDC Code: 656490552

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

  • Oral formulations and lipophilic salts of methylnaltrexone
    Patent 10,307,417
    Issued: June 4, 2019
    Assignee(s): Wyeth, LLC

    The present invention provides compositions comprising methylnaltrexone or a salt thereof, and compositions and formulations thereof, for oral administration.

    Patent expiration dates:

    • March 10, 2031
      ✓ 
      Drug product
  • Patent 10,376,505

    Patent expiration dates:

    • March 10, 2031
      ✓ 
      Drug product
  • Patent 10,376,584

    Patent expiration dates:

    • April 8, 2024
      ✓ 
      Patent use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
      ✓ 
      Drug product
  • Peripheral opioid receptor antagonists and uses thereof
    Patent 8,247,425
    Issued: August 21, 2012
    Inventor(s): Bazhina; Nataliya & Donato, III; George Joseph & Fabian; Steven R. & Lokhnauth; John & Megati; Sreenivasulu & Melucci; Charles & Ofslager; Christian & Patel; Niketa & Radebaugh; Galen & Shah; Syed M. & Szeliga; Jan & Zhang; Huyi & Zhu; Tianmin
    Assignee(s): Wyeth

    The present invention provides a compound of formula I: wherein X−, R1, and R2 are as defined herein, and compositions thereof.

    Patent expiration dates:

    • December 31, 2030
      ✓ 
      Patent use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
  • Peripheral opioid receptor antagonists and uses thereof
    Patent 8,420,663
    Issued: April 16, 2013
    Assignee(s): Wyeth

    The present invention provides a compound of formula I: wherein X−, R1, and R2 are as defined herein, and compositions thereof.

    Patent expiration dates:

    • September 30, 2029
      ✓ 
      Patent use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
  • Oral formulations and lipophilic salts of methylnaltrexone
    Patent 8,524,276
    Issued: September 3, 2013
    Assignee(s): Wyeth, LLC

    The present invention provides compositions comprising methylnaltrexone or a salt thereof, and compositions and formulations thereof, for oral administration.

    Patent expiration dates:

    • March 10, 2031
      ✓ 
      Drug product
  • Stable methylnaltrexone preparation
    Patent 8,552,025
    Issued: October 8, 2013
    Assignee(s): Progenics Pharmaceuticals, Inc.

    Stable pharmaceutical compositions useful for administering methylnaltrexone are described, as are methods for making the same. Kits, including these pharmaceutical compositions, also are provided.

    Patent expiration dates:

    • April 8, 2024
      ✓ 
      Drug product
  • Peripheral opioid receptor antagonists and uses thereof
    Patent 8,822,490
    Issued: September 2, 2014
    Assignee(s): Wyeth LLC

    The present invention provides a compound of formula I: wherein X−, R1, and R2 are as defined herein, and compositions thereof.

    Patent expiration dates:

    • September 30, 2029
      ✓ 
      Patent use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
      ✓ 
      Drug product
  • Oral formulations and lipophilic salts of methylnal trexone
    Patent 8,956,651
    Issued: February 17, 2015
    Assignee(s): Wyeth, LLC

    The present invention provides compositions comprising methylnaltrexone or a salt thereof, and compositions and formulations thereof, for oral administration.

    Patent expiration dates:

    • March 10, 2031
      ✓ 
      Drug product
  • Peripheral opioid receptor antagonists and uses thereof
    Patent 9,180,125
    Issued: November 10, 2015
    Assignee(s): Wyeth, LLC

    The present invention provides a compound of formula I: wherein X−, R1, and R2 are as defined herein, and compositions thereof.

    Patent expiration dates:

    • September 30, 2029
      ✓ 
      Patent use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
      ✓ 
      Drug product
  • Oral formulations and lipophilic salts of methylnaltrexone
    Patent 9,314,461
    Issued: April 19, 2016
    Assignee(s): Wyeth, LLC

    The present invention provides compositions comprising methylnaltrexone or a salt thereof, and compositions and formulations thereof, for oral administration.

    Patent expiration dates:

    • March 10, 2031
      ✓ 
      Drug product
  • Peripheral opioid receptor antagonists and uses thereof
    Patent 9,492,445
    Issued: November 15, 2016
    Assignee(s): Wyeth, LLC

    The present invention provides a compound of formula I: wherein X−, R1, and R2 are as defined herein, and compositions thereof.

    Patent expiration dates:

    • September 30, 2029
      ✓ 
      Patent use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
      ✓ 
      Drug product
  • Stable pharmaceutical formulations of methylnaltrexone
    Patent 9,669,096
    Issued: June 6, 2017
    Assignee(s): Progenics Pharmaceuticals, Inc.

    Stable pharmaceutical compositions useful for administering methylnaltrexone are described, as are methods for making the same. Kits, including these pharmaceutical compositions, also are provided.

    Patent expiration dates:

    • April 8, 2024
      ✓ 
      Drug product
  • Peripheral opioid receptor antagonists and uses thereof
    Patent 9,724,343
    Issued: August 8, 2017
    Assignee(s): Wyeth, LLC

    The present invention provides a compound of formua I: wherein X−, R1, and R2 are as defined herein, and compositions thereof.

    Patent expiration dates:

    • September 30, 2029
      ✓ 
      Patent use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
      ✓ 
      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.

Further information

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

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