Drospirenone and Ethinyl Estradiol tablets — Competitive Intelligence Brief

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

marketed Combined oral contraceptive Progesterone receptor, estrogen receptor Contraception / Gynecology Small molecule

Target snapshot

Drospirenone and Ethinyl Estradiol tablets (Drospirenone and Ethinyl Estradiol tablets) — Hansoh BioMedical R&D Company. Drospirenone and ethinyl estradiol is a combined oral contraceptive that prevents pregnancy by suppressing ovulation through progestin and estrogen activity.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Drospirenone and Ethinyl Estradiol tablets TARGET	Drospirenone and Ethinyl Estradiol tablets	Hansoh BioMedical R&D Company	marketed	Combined oral contraceptive	Progesterone receptor, estrogen receptor
Etonogestrel/ethinyl estradiol vaginal ring	Etonogestrel/ethinyl estradiol vaginal ring	Andrea Roe, MD, MPH	marketed	Combined hormonal contraceptive	Progesterone receptor, estrogen receptor
YAZ®	YAZ®	Teva Pharmaceuticals USA	marketed	Oral contraceptive (combined estrogen-progestin)	Progesterone receptor, estrogen receptor, mineralocorticoid receptor
norelgestromin + ethinyl estradiol	norelgestromin + ethinyl estradiol	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	marketed	Combined oral contraceptive (progestin + estrogen)	Progesterone receptor, estrogen receptor
Phase 3 NOMAC-E2 "Batch A"	Phase 3 NOMAC-E2 "Batch A"	Organon and Co	marketed	Combined oral contraceptive	Progesterone receptor, estrogen receptor
Ortho Tri-Cyclen LO	Ortho Tri-Cyclen LO	Bristol-Myers Squibb	marketed	Oral contraceptive (combined hormonal contraceptive)	Progesterone receptor, estrogen receptor
Kariva®	Kariva®	Teva Branded Pharmaceutical Products R&D, Inc.	marketed	Oral contraceptive (combined hormonal contraceptive)	Progesterone receptor, estrogen 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