Estradiol/norethindrone acetate — Competitive Intelligence Brief

Estradiol/norethindrone acetate (Estradiol/norethindrone acetate) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Hormone replacement therapy (HRT). Area: Women's Health / Endocrinology.

marketed Hormone replacement therapy (HRT) Estrogen receptor alpha and beta; progesterone receptor Women's Health / Endocrinology Small molecule

Target snapshot

Estradiol/norethindrone acetate (Estradiol/norethindrone acetate) — Myovant Sciences GmbH. Estradiol and norethindrone acetate work together as a hormone replacement therapy, with estradiol providing estrogen and norethindrone acetate providing progestin to supplement declining hormones.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Estradiol/norethindrone acetate TARGET	Estradiol/norethindrone acetate	Myovant Sciences GmbH	marketed	Hormone replacement therapy (HRT)	Estrogen receptor alpha and beta; progesterone receptor
Estradiol+MPA	Estradiol+MPA	Brigham and Women's Hospital	marketed	Hormone replacement therapy (HRT)	Estrogen receptor alpha and beta; progesterone receptor
Estradiol + Medroxy Progesterone Acetate	Estradiol + Medroxy Progesterone Acetate	Erasmus Medical Center	marketed	Hormone replacement therapy (HRT)	Estrogen receptor alpha (ERα), Estrogen receptor beta (ERβ), Progesterone receptor (PR)
Estracomb TTS	Estracomb TTS	Anna Posadzy-Małaczyńska	marketed	Hormone replacement therapy (HRT)	Estrogen receptor (ER-α, ER-β) and progesterone receptor (PR)
EVOREL® CONTI	EVOREL® CONTI	Royal Brompton & Harefield NHS Foundation Trust	marketed	Hormone replacement therapy (HRT) — combined estrogen/progestin	Estrogen receptors (ER-α, ER-β) and progesterone receptor (PR)
estradiol plus progesterone	estradiol plus progesterone	Peking Union Medical College Hospital	marketed	Hormone replacement therapy (HRT)	Estrogen receptor alpha (ERα), Estrogen receptor beta (ERβ), Progesterone receptor (PR)
estradiol and progesterone	estradiol and progesterone	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	marketed	Hormone replacement therapy (HRT)	Estrogen receptor alpha (ERα), Estrogen receptor beta (ERβ), Progesterone receptor (PR)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Hormone replacement therapy (HRT) class)

1. Anna Posadzy-Małaczyńska · 1 drug in this class
2. Beni-Suef University · 1 drug in this class
3. Brigham and Women's Hospital · 1 drug in this class
4. El Shatby University Hospital for Obstetrics and Gynecology · 1 drug in this class
5. Erasmus Medical Center · 1 drug in this class
6. Massachusetts General Hospital · 1 drug in this class
7. Myovant Sciences GmbH · 1 drug in this class
8. Peking Union Medical College Hospital · 1 drug in this class
9. Scientific Research Institute of Public Health, Russian Federation · 1 drug in this class
10. Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · 1 drug in this class