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Last Updated: May 26, 2022

Elagolix sodium - Generic Drug Details


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What are the generic 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 Inc and is included in two NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elagolix sodium has thirty-six patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for elagolix sodium
International Patents:36
US Patents:7
Tradenames:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 68
Clinical Trials: 8
Patent Applications: 391
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

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 210450-001 Jul 23, 2018 RX Yes No See Plans and Pricing See Plans and Pricing 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 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 See Plans and Pricing
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 RX Yes No 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 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
Abbvie Inc ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y Y 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

International Patents for elagolix sodium

Country Patent Number Title Estimated Expiration
Denmark 1646389 See Plans and Pricing
Brazil PI0412314 derivados de pirimidina-2,4-diona como antagonistas de receptor de horm├łnio liberador de gonadotropina See Plans and Pricing
Germany 602004016516 See Plans and Pricing
Canada 3002791 METHODES D'ADMINISTRATION D'ELAGOLIX (METHODS OF ADMINISTERING ELAGOLIX) See Plans and Pricing
Canada 2531508 DERIVES DE PYRIMIDINE-2, 4-DIONE UTILISES COMME ANTAGONISTESDU RECEPTEUR D'HORMONE LIBERANT DE LA GONADOTROPHINE (PYRIMIDINE-2, 4-DIONE DERIVATIVES AS GONADOTROPIN-RELEASING HORMONE RECEPTOR ANTAGONISTS) See Plans and Pricing
Spain 2314448 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

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