Levonorgestrel and ethinylestradiol — Competitive Intelligence Brief

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

marketed Combined oral contraceptive Progesterone receptor (levonorgestrel); estrogen receptor (ethinylestradiol) Contraception / Reproductive Health Small molecule

Target snapshot

Levonorgestrel and ethinylestradiol (Levonorgestrel and ethinylestradiol) — IVI Madrid. Levonorgestrel and ethinylestradiol is a combined oral contraceptive that prevents ovulation by suppressing gonadotropin hormones and altering cervical mucus and endometrial conditions.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Levonorgestrel and ethinylestradiol TARGET	Levonorgestrel and ethinylestradiol	IVI Madrid	marketed	Combined oral contraceptive	Progesterone receptor (levonorgestrel); estrogen receptor (ethinylestradiol)
norelgestromin + ethinyl estradiol	norelgestromin + ethinyl estradiol	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	marketed	Combined oral contraceptive (progestin + estrogen)	Progesterone receptor, estrogen receptor
Nomegestrol Acetate / Estradiol	Nomegestrol Acetate / Estradiol	University of Palermo	marketed	Combined oral contraceptive	Progesterone receptor, Estrogen 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
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
Ethinyl estradiol / dienogest	Ethinyl estradiol / dienogest	Helsinki University Central Hospital	marketed	Combined oral contraceptive	Estrogen receptor, progesterone receptor
OC - Drospirenone plus Ethynylestradiol	OC - Drospirenone plus Ethynylestradiol	Federico II University	marketed	Combined oral contraceptive	Estrogen receptor, progesterone receptor, mineralocorticoid 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