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Generic Orilissa Availability

Last updated on Jan 11, 2023.

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

ORILISSA (elagolix sodium - tablet;oral)

  • Manufacturer: ABBVIE INC
    Approval date: July 23, 2018
    Strength(s): EQ 150MG BASE [RLD], EQ 200MG BASE [RLD]

Has a generic version of Orilissa been approved?

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

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

  • Patent 10,537,572

    Patent expiration dates:

    • September 1, 2036
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      Patent use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150MG ELAGOLIX WHILE CO-ADMINISTERING RIFAMPIN
  • Patent 10,682,351

    Patent expiration dates:

    • September 1, 2036
      ✓ 
      Patent use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG ELAGOLIX WHILE CO-ADMINISTERING KETOCONAZOLE
  • Patent 11,344,551

    Patent expiration dates:

    • March 14, 2034
      ✓ 
      Patent use: USE OF ELAGOLIX 200 MG BID FOR 6 MONTHS TO MANAGE MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS IN PREMENOPAUSAL WOMEN TO REDUCE DYSMENORRHEA AND NON-MENSTRUAL PELVIC PAIN
    • March 14, 2034
      ✓ 
      Patent use: USE OF ELAGOLIX 200 MG BID FOR 6 MONTHS TO MANAGE MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS IN PREMENOPAUSAL WOMEN HAVING DYSPAREUNIA ASSOCIATED WITH ENDOMETRIOSIS
  • Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
    Patent 7,056,927
    Issued: June 6, 2006
    Inventor(s): Guo; Zhiqiang & Chen; Yongsheng & Wu; Dongpei & Chen; Chen & Wade; Warren & Dwight; Wesley J. & Huang; Charles Q. & Tucci; Fabio C.
    Assignee(s): Neurocrine Biosciences, Inc.

    GnRH receptor antagonists are disclosed that have utility in the treatment of a variety of sex-hormone related conditions in both men and women. The compounds of this invention have the structure: wherein R1a, R1b, R1c, R2a, R2b, R3, R4, R5, R6 and X are as defined herein, including stereoisomers, prodrugs and pharmaceutically acceptable salts thereof. Also disclosed are compositions containing a compound of this invention in combination with a pharmaceutically acceptable carrier, as well as methods relating to the use thereof for antagonizing gonadotropin-releasing hormone in a subject in need thereof.

    Patent expiration dates:

    • September 10, 2024
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
    Patent 7,176,211
    Issued: February 13, 2007
    Inventor(s): Guo; Zhiqiang & Chen; Yongsheng & Wu; Dongpei & Chen; Chen & Wade; Warren & Dwight; Wesley J. & Huang; Charles Q. & Tucci; Fabio C.
    Assignee(s): Neurocrine Biosciences, Inc.

    GnRH receptor antagonists are disclosed that have utility in the treatment of a variety of sex-hormone related conditions in both men and women. The compounds of this invention have the structure: wherein R1a, R1b, R1c, R2a, R2b, R3, R4, R5, R6 and X are as defined herein, including stereoisomers, prodrugs and pharmaceutically acceptable salts thereof. Also disclosed are compositions containing a compound of this invention in combination with a pharmaceutically acceptable carrier, as well as methods relating to the use thereof for antagonizing gonadotropin-releasing hormone in a subject in need thereof.

    Patent expiration dates:

    • July 6, 2024
      ✓ 
      Patent use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS
  • Gonadotropin-releasing hormone receptor antagonists and methods related thereto
    Patent 7,419,983
    Issued: September 2, 2008
    Inventor(s): Guo; Zhiqiang & Chen; Yongsheng & Wu; Dongpei & Chen; Chen & Wade; Warren & Dwight; Wesley J. & Huang; Charles Q. & Tucci; Fabio C.
    Assignee(s): Neurocrine Biosciences, Inc.

    GnRH receptor antagonists are disclosed that have utility in the treatment of a variety of sex-hormone related conditions in both men and women. The compounds of this invention have the structure: wherein R1a, R1b, R1c, R2a, R2b, R3, R4, R5, R6 and X are as defined herein, including stereoisomers, prodrugs and pharmaceutically acceptable salts thereof. Also disclosed are compositions containing a compound of this invention in combination with a pharmaceutically acceptable carrier, as well as methods relating to the use thereof for antagonizing gonadotropin-releasing hormone in a subject in need thereof.

    Patent expiration dates:

    • July 6, 2024
      ✓ 
      Patent use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS
      ✓ 
      Drug substance
      ✓ 
      Drug product

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:

    • July 23, 2023 - NEW CHEMICAL ENTITY

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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