Ethinyl estradiol / dienogest — Competitive Intelligence Brief

Ethinyl estradiol / dienogest (Ethinyl estradiol / dienogest) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Combined oral contraceptive. Area: Contraception / Gynecology.

marketed Combined oral contraceptive Estrogen receptor, progesterone receptor Contraception / Gynecology Small molecule

Target snapshot

Ethinyl estradiol / dienogest (Ethinyl estradiol / dienogest) — Helsinki University Central Hospital. Ethinyl estradiol and dienogest work together as a combined oral contraceptive, suppressing ovulation through hormonal feedback on the hypothalamic-pituitary-ovarian axis.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Ethinyl estradiol / dienogest TARGET	Ethinyl estradiol / dienogest	Helsinki University Central Hospital	marketed	Combined oral contraceptive	Estrogen receptor, progesterone receptor
Tibolone (Livial)	Tibolone (Livial)	Wyeth is now a wholly owned subsidiary of Pfizer	marketed	Selective tissue estrogenic activity regulator (STEAR); synthetic steroid	Estrogen receptor, progesterone receptor, androgen receptor
fenofibrate and tibolone	fenofibrate and tibolone	Keogh Institute for Medical Research	marketed	Fibrate + Selective Estrogen Receptor Modulator (SERM)	PPAR-α (fenofibrate); Estrogen receptor, progesterone receptor, androgen receptor (tibolone)
oral contraceptives	oral contraceptives	FHI 360	marketed	Hormonal contraceptive	Estrogen receptor, Progesterone receptor
EE20/DRSP (YAZ, BAY86-5300)	EE20/DRSP (YAZ, BAY86-5300)	Bayer	marketed	Oral contraceptive (combined estrogen-progestin)	Estrogen receptor, progesterone receptor, mineralocorticoid receptor
Tibolone plus Xiangshao granules	Tibolone plus Xiangshao granules	Peking Union Medical College Hospital	marketed	Hormone replacement therapy (HRT) / Selective tissue estrogenic activity regulator (STEAR)	Estrogen receptor, Progesterone receptor, Androgen receptor
Add back therapy 1 (tibolone)	Add back therapy 1 (tibolone)	University of Cagliari	marketed	Selective Tissue Estrogenic Activity Regulator (STEAR); Hormone Replacement Therapy	Estrogen receptor, Progesterone receptor, Androgen 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