Question 1

Is there a generic for Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium?

Accepted Answer

ORIAHNN (COPACKAGED) (NDA 213388, ABBVIE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium?

Accepted Answer

The Orange Book lists 7 patents against Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium are approved?

Accepted Answer

Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium is approved in the following dosage form: capsule.

Patent	Expires	In	Type
11459305	Nov 07, 2028	in 2 yr 5 mo	ProductU-2842
7419983	Jul 06, 2029	in 3 yr 1 mo	SubstanceProduct
10881659	Mar 14, 2034	in 7 yr 10 mo	U-2842
11045470	Mar 14, 2034	in 7 yr 10 mo	U-2842
12083227	Aug 20, 2038	in 12 yr 4 mo	ProductU-2842
11542239	Jul 23, 2039	in 13 yr 3 mo	SubstanceProduct
11690845	Aug 27, 2040	in 14 yr 5 mo	U-3655

Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium

Brand (NDA) products · capsule

Listed patents (7)

Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium — frequently asked questions

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