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Last Updated: April 26, 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 thirteen 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.

Summary for elagolix sodium

International Patents:	101
US Patents:	13
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	8
Patent Applications:	106
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for elagolix sodium
DailyMed Link:	elagolix sodium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for elagolix sodium

Generic Entry Date for elagolix sodium^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

Sponsor	Phase
AbbVie	Phase 3
AbbVie	Phase 2
AbbVie (prior sponsor, Abbott)	Phase 2

See all elagolix sodium clinical trials

Pharmacology for elagolix sodium

Drug Class	Gonadotropin Releasing Hormone Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A Inducers Gonadotropin Releasing Hormone Receptor Antagonists P-Glycoprotein Inhibitors
Physiological Effect	Decreased GnRH Secretion

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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018		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				⤷ Try a Trial
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ 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				⤷ 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
>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

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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	210450-001	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	210450-001	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for elagolix sodium

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Country	Patent Number	Title	Estimated Expiration
Israel	272723	פורמולציות רוקחיות לטיפול באנדומטריוסיס, פיברואידים ברחם וסינדרום שחלות פוליציסטיות ואדנומיוזיס (Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis)	⤷ Try a Trial
Brazil	112020021276	métodos de tratamento de sangramento menstrual intenso	⤷ Try a Trial
Japan	7350715		⤷ Try a Trial
European Patent Office	3826638	COMPOSITIONS D'ÉLAGOLIX SODIQUE ET PROCÉDÉS ASSOCIÉS (ELAGOLIX SODIUM COMPOSITIONS AND PROCESSES)	⤷ Try a Trial
Japan	2007521309		⤷ Try a Trial
Mexico	2023002450	FORMULACIONES FARMACEUTICAS PARA TRATAR LA ENDOMETRIOSIS, LOS FIBROMAS UTERINOS, EL SINDROME DE OVARIO POLIQUISTICO O LA ADENOMIOSIS. (PHARMACEUTICAL FORMULATIONS FOR TREATING ENDOMETRIOSIS, UTERINE FIBROIDS, POLYCYSTIC OVARY SYNDROME OR ADENOMYOSIS.)	⤷ Try a Trial
Canada	2977938	FORMULATIONS PHARMACEUTIQUES DESTINEES AU TRAITEMENT DE L'ENDOMETRIOSE ET DES FIBROMES UTERINS (PHARMACEUTICAL FORMULATIONS FOR TREATING ENDOMETRIOSIS AND UTERINE FIBROIDS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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