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Last Updated: May 29, 2024

Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium - Generic Drug Details


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What are the generic sources for elagolix sodium,estradiol,norethindrone acetate; elagolix sodium and what is the scope of patent protection?

Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium has fifty-seven patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for elagolix sodium,estradiol,norethindrone acetate; elagolix sodium
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for elagolix sodium,estradiol,norethindrone acetate; elagolix sodium
Generic Entry Date for elagolix sodium,estradiol,norethindrone acetate; elagolix sodium*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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.

Paragraph IV (Patent) Challenges for ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ORIAHNN (COPACKAGED) Capsules elagolix sodium,estradiol,norethindrone acetate; elagolix sodium 300 mg/1 mg/ 0.5 mg; 300 mg 213388 1 2022-11-03

US Patents and Regulatory Information for elagolix sodium,estradiol,norethindrone acetate; 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 ⤷  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 Y Y ⤷  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 Y ⤷  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 Y Y ⤷  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 Y Y ⤷  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 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,estradiol,norethindrone acetate; elagolix sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie ORIAHNN (COPACKAGED) elagolix sodium,estradiol,norethindrone acetate; elagolix sodium CAPSULE;ORAL 213388-001 May 29, 2020 ⤷  Sign Up ⤷  Sign Up
Abbvie ORIAHNN (COPACKAGED) elagolix sodium,estradiol,norethindrone acetate; elagolix sodium CAPSULE;ORAL 213388-001 May 29, 2020 ⤷  Sign Up ⤷  Sign Up
Abbvie ORIAHNN (COPACKAGED) elagolix sodium,estradiol,norethindrone acetate; elagolix sodium CAPSULE;ORAL 213388-001 May 29, 2020 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for elagolix sodium,estradiol,norethindrone acetate; elagolix sodium

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2009062087 ⤷  Sign Up
New Zealand 731834 Compositions for use in treating heavy menstrual bleeding and uterine fibroids ⤷  Sign Up
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) ⤷  Sign Up
Japan 2007521309 ⤷  Sign Up
Japan 5226760 ⤷  Sign Up
European Patent Office 4223298 COMPOSITIONS POUR LE TRAITEMENT DES SAIGNEMENTS MENSTRUELS LOURDS (COMPOSITIONS FOR USE IN TREATING HEAVY MENSTRUAL BLEEDING) ⤷  Sign Up
South Korea 20060031851 PYRIMIDINE-2,4-DIONE DERIVATIVES AS GONADOTROPIN-RELEASING HORMONE RECEPTOR ANTAGONISTS ⤷  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.