Generic Orilissa Availability

Last updated on Apr 10, 2025.

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

ORILISSA (elagolix sodium - tablet;oral)

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

Is there a generic version of Orilissa available?

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.

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.

Methods of administering elagolix
Patent 10,537,572
Issued: January 21, 2020
Inventor(s): Goss Sandra L. & Klein Cheri E. & Ng Juki Wing-Keung & Salem Ahmed
Assignee(s): AbbVie Inc.
The present disclosure relates to the use of GnRH receptor antagonists used in the treatment of endometriosis or uterine fibroids. In particular, the present disclosure describes a method of treating endometriosis or uterine fibroids, where the method involves the administration of elagolix, and where the method may further involve the co-administration of rifampin or ketoconazole.
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
Methods of administering elagolix
Patent 10,682,351
Issued: June 16, 2020
Inventor(s): Goss Sandra L. & Klein Cheri E. & Ng Juki Wing-Keung & Salem Ahmed
Assignee(s): ABBVIE INC.
The present disclosure relates to the use of GnRH receptor antagonists used in the treatment of endometriosis or uterine fibroids. In particular, the present disclosure describes a method of treating endometriosis or uterine fibroids, where the method involves the administration of elagolix, and where the method may further involve the co-administration of rifampin or ketoconazole.
Patent expiration dates:
- September 1, 2036
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  Patent use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG ELAGOLIX WHILE CO-ADMINISTERING KETOCONAZOLE
Methods of treating heavy menstrual bleeding
Patent 11,344,551
Issued: May 31, 2022
Inventor(s): Chwalisz; Kristof et al.
Assignee(s): AbbVie Inc. (North Chicago, IL)
The present invention relates to the method of treating heavy menstrual bleeding in a subject with or without uterine fibroids and in need of treatment by administering an effective amount of 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino)-butyric acid or a pharmaceutically acceptable salt thereof, in combination with estrogens and progestogens.
Patent expiration dates:
- March 14, 2034
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  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
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  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
Elagolix sodium compositions and processes
Patent 11,542,239
Issued: January 3, 2023
Inventor(s): Chauhan; Niharika et al.
Assignee(s): AbbVie Inc. (North Chicago, IL)
The present invention relates to compositions of elagolix sodium, and process and intermediates for the preparation thereof.
Patent expiration dates:
- July 23, 2039
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Methods of administering elagolix
Patent 11,690,845
Issued: July 4, 2023
Inventor(s): Ali; Farah N. et al.
Assignee(s): AbbVie Inc. (North Chicago, IL)
The present disclosure relates to the use of GnRH receptor antagonists for the treatment of endometriosis, uterine fibroids, polycystic ovary syndrome (PCOS), or adenomyosis. In particular, the present disclosure describes methods for treating such gynecological disorders, where the methods involve administration of elagolix and may further involve co-administration of a CYP2B6 substrate (e.g., bupropion) or a CYP2C19 substrate (e.g., omeprazole).
Patent expiration dates:
- August 27, 2040
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  Patent use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG OR 200 MG ELAGOLIX WHILE CO-ADMINISTERING OMEPRAZOLE
Methods of treating heavy menstrual bleeding
Patent 11,690,854
Issued: July 4, 2023
Inventor(s): Ng; Juki Wing-Keung et al.
Assignee(s): AbbVie Inc. (North Chicago, IL)
The present invention relates to the method of treating heavy menstrual bleeding in a subject with or without uterine fibroids and in need of treatment by administering an effective amount of 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino)-butyric acid or a pharmaceutically acceptable salt thereof, in combination with estrogens and progestogens.
Patent expiration dates:
- April 19, 2038
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  Patent use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS IN A PATIENT WITH MODERATE HEPATIC IMPAIRMENT
Methods of treating heavy menstrual bleeding
Patent 11,707,464
Issued: July 25, 2023
Inventor(s): Chwalisz; Kristof et al.
Assignee(s): AbbVie Inc. (North Chicago, IL)
The present invention relates to the method of treating heavy menstrual bleeding in a subject with or without uterine fibroids and in need of treatment by administering an effective amount of 4((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino)-butyric acid or a pharmaceutically acceptable salt thereof, in combination with estrogens and progestogens.
Patent expiration dates:
- March 14, 2034
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  Patent use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG ELAGOLIX FOR UP TO 24 MONTHS
Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis
Patent 12,102,637
Issued: October 1, 2024
Inventor(s): Jayanth; Jayanthy et al.
Assignee(s): AbbVie Inc. (North Chicago, IL); Neurocrine Biosciences, Inc. (San Diego, CA)
The present disclosure relates to pharmaceutical compositions comprising a gonadotropin-releasing hormone (GnRH) antagonist and methods of preparing and using such compositions. The disclosure also relates to methods of facilitating release of a GnRH antagonist from a pharmaceutical composition.
Patent expiration dates:
- August 20, 2038
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Gonadotropin-releasing hormone receptor antagonists and methods related thereto
Patent 7,419,983
Issued: September 2, 2008
Inventor(s): Guo; Zhiqiang et al.
Assignee(s): Neurocrine Biosciences, Inc. (San Diego, CA)
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: ##STR00001## wherein R.sub.1a, R.sub.1b, R.sub.1c, R.sub.2a, R.sub.2b, R.sub.3, R.sub.4, R.sub.5, R.sub.6 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, 2029
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  Patent use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS
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More about Orilissa (elagolix)

Patient resources

Orilissa drug information

Professional resources

Related treatment guides

Endometriosis

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.

Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

User Reviews & Ratings

5.4 / 10

128 Reviews

Images

Pill EL 150 is Orilissa 150 mg — Orilissa 150 mg (EL 150)