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NCE-1 Intelligence & Market Opportunity

Nextstellis

Drospirenone And Estetrol
Hormonal therapy
Oral Tablet

Nextstellis (drospirenone and estetrol) introduced a genuinely new estrogen into a category that had relied on the same one for decades.

It is the first birth control pill to use estetrol, an estrogen naturally produced during pregnancy and manufactured here from a plant source, paired with the progestin drospirenone. The combined tablet is taken once daily to prevent pregnancy.

Nextstellis faces no generic competition in a category otherwise dominated by low-cost generics, which is its central commercial challenge. Estetrol’s novelty is its principal asset, and its cardiovascular and hepatic profile relative to ethinyl estradiol is the key question shaping uptake in contraception.

Approval Date
15-Apr-21
NCE-1 Date
15-Apr-25
NCE Date
15-Apr-26
Commercial snapshot

Market performance & projections

Revenue ($M)
127
CAGR (%)
-25.56%
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
17
2027
24
2028
33
2029
39
2030
49
2031
51
2032
62
Molecule profile

Details & specifications

Molecule
Drospirenone And Estetrol
Innovator
MAYNE PHARMA
Dosage Form
Oral Tablet
Strength
3 mg
Therapeutic Category
Hormonal therapy
Usage
To prevent pregnancy
Good to know

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Verified regulatory data
Milestones tracked against primary FDA sources and refreshed continuously.
Analyst-built projections
Seven-year sales outlooks modeled by our pharma intelligence team.
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