Phase 3 NOMAC-E2 "Batch A" — Competitive Intelligence Brief

Phase 3 NOMAC-E2 "Batch A" (Phase 3 NOMAC-E2 "Batch A") 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

Phase 3 NOMAC-E2 "Batch A" (Phase 3 NOMAC-E2 "Batch A") — Organon and Co. NOMAC-E2 is a combined oral contraceptive containing norethisterone acetate (progestin) and ethinyl estradiol (estrogen) that prevents pregnancy through ovulation suppression and cervical mucus thickening.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Phase 3 NOMAC-E2 "Batch A" TARGET	Phase 3 NOMAC-E2 "Batch A"	Organon and Co	marketed	Combined oral contraceptive	Progesterone receptor, estrogen receptor
Drospirenone and Ethinyl Estradiol tablets	Drospirenone and Ethinyl Estradiol tablets	Hansoh BioMedical R&D Company	marketed	Combined oral contraceptive	Progesterone receptor, estrogen receptor
Continuous OC (EE/DROS)	Continuous OC (EE/DROS)	University of North Carolina, Chapel Hill	marketed	Oral contraceptive	Progesterone receptor, estrogen receptor
Drospirenone / Estetrol	Drospirenone / Estetrol	University of Palermo	marketed	Combined oral contraceptive	Progesterone receptor, estrogen receptor
Female Contraceptive	Female Contraceptive	Italfarmaco	marketed	Hormonal 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
Etonogestrel/ethinyl estradiol vaginal ring	Etonogestrel/ethinyl estradiol vaginal ring	Andrea Roe, MD, MPH	marketed	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