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Last Updated: March 28, 2024

ELAGOLIX SODIUM - Generic Drug Details


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What are the generic drug sources for elagolix sodium and what is the scope of patent protection?

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

Elagolix sodium has ninety-eight patent family members in twenty-six countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ELAGOLIX SODIUM
Generic Entry Date for ELAGOLIX SODIUM*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 ORIAHNN (COPACKAGED) elagolix sodium,estradiol,norethindrone acetate; elagolix sodium CAPSULE;ORAL 213388-001 May 29, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie ORIAHNN (COPACKAGED) elagolix sodium,estradiol,norethindrone acetate; elagolix sodium CAPSULE;ORAL 213388-001 May 29, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Abbvie ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie ORIAHNN (COPACKAGED) elagolix sodium,estradiol,norethindrone acetate; elagolix sodium CAPSULE;ORAL 213388-001 May 29, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>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 ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ELAGOLIX SODIUM

Country Patent Number Title Estimated Expiration
Israel 280135 הרכבי נתרן אלאגוליקס ותהליכים (Elagolix sodium compositions and processes) ⤷  Try a Trial
Canada 3104902 COMPOSITIONS D'ELAGOLIX SODIQUE ET PROCEDES ASSOCIES (ELAGOLIX SODIUM COMPOSITIONS AND PROCESSES) ⤷  Try a Trial
Brazil PI0412314 derivados de pirimidina-2,4-diona como antagonistas de receptor de hormÈnio liberador de gonadotropina ⤷  Try a Trial
Taiwan 201919632 Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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