Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Dow
Baxter
Johnson and Johnson
McKinsey
AstraZeneca

Last Updated: September 30, 2022

Elagolix sodium - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


What are the generic sources for elagolix sodium and what is the scope of freedom to operate?

Elagolix sodium is the generic ingredient in two branded drugs marketed by Abbvie Inc and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elagolix sodium has forty-three patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for elagolix sodium
International Patents:43
US Patents:8
Tradenames:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 79
Clinical Trials: 8
Patent Applications: 421
DailyMed Link:elagolix sodium at DailyMed
Recent Clinical Trials for elagolix sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AbbViePhase 3
AbbVie (prior sponsor, Abbott)Phase 2
AbbViePhase 2

See all elagolix sodium clinical trials

Paragraph IV (Patent) Challenges for ELAGOLIX SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ORILISSA Tablets elagolix sodium 150 mg and 200 mg 210450 9 2022-07-25

US Patents and Regulatory Information for elagolix sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Abbvie Inc ORIAHNN (COPACKAGED) elagolix sodium,estradiol,norethindrone acetate; elagolix sodium CAPSULE;ORAL 213388-001 May 29, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for elagolix sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018 See Plans and Pricing See Plans and Pricing
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 See Plans and Pricing See Plans and Pricing
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018 See Plans and Pricing See Plans and Pricing
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for elagolix sodium

Country Patent Number Title Estimated Expiration
Canada 2906894 COMPOSITIONS DESTINEES A L'UTILISATION DANS LE TRAITEMENT DE SAIGNEMENTSMENSTRUELS ABONDANTS ET FIBROMES UTERINS (COMPOSITIONS FOR USE IN TREATING HEAVY MENSTRUAL BLEEDING AND UTERINE FIBROIDS) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2005007165 See Plans and Pricing
China 1819829 Pyrimidine-2, 4-dione derivatives as gonadotropin-releasing hormone receptor antagonists See Plans and Pricing
Australia 2004257639 Pyrimidine-2, 4-dione derivatives as gonadotropin-releasing hormone receptor antagonists See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Harvard Business School
McKinsey
Boehringer Ingelheim
AstraZeneca
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.