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Last Updated: December 11, 2024

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

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

International Patents for elagolix sodium

Country Patent Number Title Estimated Expiration
Canada 3073229 FORMULATIONS PHARMACEUTIQUES POUR LE TRAITEMENT DE L'ENDOMETRIOSE, DE FIBROMES UTERINS, DU SYNDROME DES OVAIRES POLYKYSTIQUES OU DE L'ADENOMYOSE (PHARMACEUTICAL FORMULATIONS FOR TREATING ENDOMETRIOSIS, UTERINE FIBROIDS, POLYCYSTIC OVARY SYNDROME OR ADENOMYOSIS) ⤷  Sign Up
Australia 2004257639 Pyrimidine-2, 4-dione derivatives as gonadotropin-releasing hormone receptor antagonists ⤷  Sign Up
Hong Kong 1258062 給予惡拉戈利的方法 (METHODS OF ADMINISTERING ELAGOLIX) ⤷  Sign Up
Denmark 1646389 ⤷  Sign Up
Norway 20056251 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2014143669 ⤷  Sign Up
Australia 2018419533 Methods of treating heavy menstrual bleeding ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.