oral contraceptives — Competitive Intelligence Brief

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

marketed Hormonal contraceptive Estrogen receptor, Progesterone receptor Contraception / Reproductive Health Small molecule

Target snapshot

oral contraceptives (oral contraceptives) — FHI 360. Oral contraceptives prevent pregnancy by suppressing ovulation through hormonal inhibition of the hypothalamic-pituitary-gonadal axis.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
oral contraceptives TARGET	oral contraceptives	FHI 360	marketed	Hormonal contraceptive	Estrogen receptor, Progesterone 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
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)
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
oral contraceptive pills	oral contraceptive pills	Kayseri Education and Research Hospital	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
Oral contraceptives cyclic	Oral contraceptives cyclic	University of Athens	marketed	Hormonal 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 (Hormonal contraceptive class)

1. Penn State University · 2 drugs in this class
2. Italfarmaco · 1 drug in this class
3. Kayseri Education and Research Hospital · 1 drug in this class
4. TherapeuticsMD · 1 drug in this class
5. University of Alabama at Birmingham · 1 drug in this class
6. University of Athens · 1 drug in this class
7. FHI 360 · 1 drug in this class
8. University of Pittsburgh · 1 drug in this class