Viewing data from:

NEXTSTELLIS

NDA

DROSPIRENONE; ESTETROL | N214154 | MAYNE PHARMA LLC

1 strength7 unique patents1 unique exclusivity

Patent Timeline

7 unique patents, 1 exclusivity by expiration date

Active (7)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

2044

Today

Jan. 15, 2028

Jun. 17, 2036

Jun. 17, 2036

Jun. 17, 2036

Feb. 9, 2043

Jun. 17, 2036

Oct. 1, 2043

NCE

Apr. 15, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

6 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
E4/DRSP Ovarian Function Inhibition Study NCT03091595	Phase 2	Completed	Estetra	82	2017-02-07 → 2018-06-08
E4/DRSP Single and Multiple Dose PK and Early QT Study NCT02874248	Phase 1	Completed	Estetra	55	2016-05 → 2016-11-21
"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"NCT02957630	Phase 1/2	Completed	Estetra	101	2016-09 → 2017-10-09
E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study NCT02817841	Phase 3	Completed	Estetra	2,148	2016-08-30 → 2018-11-16
Effect of Food on the Bioavailability of 15 mg Estetrol/3 mg Drospirenone Tablets in Healthy Female Volunteers NCT02852681	Phase 1	Completed	Estetra	28	2015-08 → 2016-04
E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - EU/Russia Study NCT02817828	Phase 3	Completed	Estetra	1,577	2016-06 → 2018-04-26

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$7.67

per ea

Lowest NADAC/Unit

$7.67

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
51862025801NEXTSTELLIS 3-14.2 MG TABLET	$7.67	EA	Brand	—	2026-06-01

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$139.29

Highest Price

$139.29

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
51862-0258-01NEXTSTELLIS TAB,28	$139.29	FSS	Mayne Pharma Commercial LLC	07/14/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Nextstellis (2024)

Total Spending

$94K

Total Claims

267

Beneficiaries

Avg Cost/Unit

$7.20

Spending Trend

$6K(2021)→$37K(2022)→$78K(2023)→$94K(2024)

YoY Change:-6.7%

5yr CAGR:+1.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 3, 2022	SUPPL -2	View Letter (PDF)
Apr 16, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3MG;14.2MG

RLD

7 patents1 exclusivity▴

TABLET;ORAL | Approved: Apr 15, 2021

Patents (7) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7732430	Jan 15, 2028	—	—	Yes		—
11793760	Jun 17, 2036	—	—	Yes	—	—
11957694	Jun 17, 2036	—	—	Yes	—	—
11964055	Jun 17, 2036	—	—	Yes	—	—
12233074	Feb 9, 2043	—	—	Yes		—
12427114	Jun 17, 2036	—	—	Yes		—
12458649	Oct 1, 2043	—	—	—		—

Exclusivities (1)

Code	Date	Status
NCE	Apr 15, 2026	Expired