ELAGOLIX SODIUM - Generic Drug Details

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What are the generic drug sources for elagolix sodium and what is the scope of freedom to operate?

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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Anatomical Therapeutic Chemical (ATC) Classes for ELAGOLIX SODIUM

H01CC	Anti-gonadotropin-releasing hormones
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018		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	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				⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	210450-002	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

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Country	Patent Number	Title	Estimated Expiration
South Korea	20060031851	PYRIMIDINE-2,4-DIONE DERIVATIVES AS GONADOTROPIN-RELEASING HORMONE RECEPTOR ANTAGONISTS	⤷ Sign Up
Canada	3073247	FORMULATIONS PHARMACEUTIQUES SOLIDES POUR LE TRAITEMENT DE L'ENDOMETRIOSE, DE FIBROMES UTERINS, DU SYNDROME DES OVAIRES POLYKYSTIQUES ET DE L'ADENOMYOSE (SOLID PHARMACEUTICAL FORMULATIONS FOR TREATING ENDOMETRIOSIS, UTERINE FIBROIDS, POLYCYSTIC OVARY SYNDROME AND ADENOMYOSIS)	⤷ Sign Up
Japan	2021531303	エラゴリクスナトリウム組成物及び方法	⤷ Sign Up
Portugal	1646389		⤷ Sign Up
Mexico	2020001874	FORMULACIONES FARMACÉUTICAS SÓLIDAS PARA TRATAR LA ENDOMETRIOSIS, LOS FIBROMAS UTERINOS, EL SÍNDROME DE OVARIO POLIQUÍSTICO Y LA ADENOMIOSIS. (SOLID PHARMACEUTICAL FORMULATIONS FOR TREATING ENDOMETRIOSIS, UTERINE FIBROIDS, POLYCYSTIC OVARY SYNDROME AND ADENOMYOSIS.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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