low-dose estradiol/noresterone — Competitive Intelligence Brief

low-dose estradiol/noresterone (low-dose estradiol/noresterone) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Oral contraceptive (combined estrogen-progestin). Area: Contraception / Women's Health.

marketed Oral contraceptive (combined estrogen-progestin) Estrogen receptors (ER-α, ER-β) and progesterone receptors (PR) Contraception / Women's Health Small molecule

Target snapshot

low-dose estradiol/noresterone (low-dose estradiol/noresterone) — Organon and Co. Low-dose estradiol and noresterone work together as hormonal contraceptives by suppressing ovulation and altering cervical mucus and endometrial conditions to prevent pregnancy.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
low-dose estradiol/noresterone TARGET	low-dose estradiol/noresterone	Organon and Co	marketed	Oral contraceptive (combined estrogen-progestin)	Estrogen receptors (ER-α, ER-β) and progesterone receptors (PR)
Ethinyl Estradiol / Norgestimate Oral Tablet	Ethinyl Estradiol / Norgestimate Oral Tablet	University of Colorado, Denver	marketed	Oral contraceptive (combined estrogen-progestin)	Estrogen receptor and progesterone receptor
YAZ®	YAZ®	Teva Pharmaceuticals USA	marketed	Oral contraceptive (combined estrogen-progestin)	Progesterone receptor, estrogen receptor, mineralocorticoid receptor
Microgestin®	Microgestin®	Ironwood Pharmaceuticals, Inc.	marketed	Oral contraceptive (combined estrogen-progestin)	Estrogen receptor, progesterone receptor
Estradiol valerate / dienogest	Estradiol valerate / dienogest	Helsinki University Central Hospital	marketed	Oral contraceptive (combined estrogen-progestin)	Estrogen receptor and progesterone receptor
FEMCON® Fe	FEMCON® Fe	Teva Pharmaceuticals USA	marketed	Oral contraceptive (combined estrogen-progestin)	Estrogen and progesterone receptors; LH/FSH suppression
All participants (Aviane)	All participants (Aviane)	Oregon Health and Science University	marketed	Oral contraceptive (combined estrogen-progestin)	Progesterone receptor, estrogen receptor

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 (Oral contraceptive (combined estrogen-progestin) class)

1. Bayer · 3 drugs in this class
2. Organon and Co · 2 drugs in this class
3. Teva Pharmaceuticals USA · 2 drugs in this class
4. University of Colorado, Denver · 1 drug in this class
5. Oregon Health and Science University · 1 drug in this class
6. Helsinki University Central Hospital · 1 drug in this class
7. Ironwood Pharmaceuticals, Inc. · 1 drug in this class