Oriahnn (copackaged) - (300 mg, 1mg, and 0.5mg; 300 mg. Capsule, Oral)

Generic Name	Elagolix sodium, estradiol and norethindrone acetate; Elagolix sodium	Innovator	Abbvie
Dosage	300 mg, 1mg, and 0.5mg; 300 mg. Capsule, Oral	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	None	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	ORIAHNN is a combination of elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin, indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
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Chronology Of Events