Ethinylestradiol/levonorgestrel — Competitive Intelligence Brief

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

phase 3 Combined oral contraceptive Estrogen receptor (ER), Progesterone receptor (PR) Contraception / Reproductive Health Small molecule

Target snapshot

Ethinylestradiol/levonorgestrel (Ethinylestradiol/levonorgestrel) — Leiden University Medical Center. Ethinylestradiol/levonorgestrel is a combined oral contraceptive that suppresses ovulation by inhibiting gonadotropin-releasing hormone (GnRH) and preventing the luteinizing hormone (LH) surge required for egg release.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Ethinylestradiol/levonorgestrel TARGET	Ethinylestradiol/levonorgestrel	Leiden University Medical Center	phase 3	Combined oral contraceptive	Estrogen receptor (ER), Progesterone receptor (PR)
ethinyl estradiol and cyproterone acetate	ethinyl estradiol and cyproterone acetate	S.C.B. Medical College and Hospital	marketed	Combined oral contraceptive with anti-androgenic activity	Estrogen receptor, progesterone receptor, androgen receptor
Ethinyl Estradiol + Desogestrel	Ethinyl Estradiol + Desogestrel	Massachusetts General Hospital	marketed	Combined oral contraceptive	Estrogen receptor, progesterone receptor
Levonorgestrel/Ethinyl Estradiol	Levonorgestrel/Ethinyl Estradiol	Wyeth is now a wholly owned subsidiary of Pfizer	marketed	Combined oral contraceptive	Progesterone receptor, estrogen receptor alpha and beta
Ethinylestradiol / Norethisterone	Ethinylestradiol / Norethisterone	University of Edinburgh	marketed	Combined oral contraceptive	Estrogen receptor and progesterone receptor
Estradiol+Drospirenone	Estradiol+Drospirenone	Brigham and Women's Hospital	marketed	Combined oral contraceptive	Estrogen receptors (ER-α, ER-β) and progesterone receptors (PR); mineralocorticoid receptor antagonism
Estetrol and Drospirenone	Estetrol and Drospirenone	Ospedale Policlinico San Martino	marketed	Combined oral contraceptive	Estrogen receptor; 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