Ethinylestradiol / Norethisterone — Competitive Intelligence Brief

Ethinylestradiol / Norethisterone (Ethinylestradiol / Norethisterone) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Combined oral contraceptive. Area: Contraception / Reproductive Health.

marketed Combined oral contraceptive Estrogen receptor and progesterone receptor Contraception / Reproductive Health Small molecule

Target snapshot

Ethinylestradiol / Norethisterone (Ethinylestradiol / Norethisterone) — University of Edinburgh. Ethinylestradiol and norethisterone work together as a combined oral contraceptive by suppressing ovulation through hormonal feedback on the hypothalamic-pituitary-ovarian axis.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Ethinylestradiol / Norethisterone TARGET	Ethinylestradiol / Norethisterone	University of Edinburgh	marketed	Combined oral contraceptive	Estrogen receptor and progesterone receptor
ETHINYL ESTRADIOL AND LEVOGESTREL	ETHINYL ESTRADIOL AND LEVOGESTREL	FHI 360	marketed	Combined oral contraceptive	Estrogen receptor and progesterone receptor
OCR	OCR	Hoffmann-La Roche	marketed	Combined oral contraceptive	Estrogen receptor and progesterone receptor
placebo + ethinylestradiol/levonorgestrel	placebo + ethinylestradiol/levonorgestrel	HRA Pharma	marketed	Combined oral contraceptive	Estrogen receptor and progesterone receptor
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
ethinyl estradiol/etonogestrel vaginal ring	ethinyl estradiol/etonogestrel vaginal ring	University of Pittsburgh	marketed	Combined hormonal contraceptive	Estrogen receptor and progesterone receptor
Estradiol valerate / dienogest	Estradiol valerate / dienogest	Helsinki University Central Hospital	marketed	Oral contraceptive (combined estrogen-progestin)	Estrogen receptor and progesterone 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 (Combined oral contraceptive class)

1. University of Palermo · 3 drugs in this class
2. Teva Branded Pharmaceutical Products R&D, Inc. · 2 drugs in this class
3. Organon and Co · 2 drugs in this class
4. HRA Pharma · 1 drug in this class
5. Hansoh BioMedical R&D Company · 1 drug in this class
6. Helsinki University Central Hospital · 1 drug in this class
7. Hoffmann-La Roche · 1 drug in this class
8. IVI Madrid · 1 drug in this class
9. Leiden University Medical Center · 1 drug in this class
10. Massachusetts General Hospital · 1 drug in this class