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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Nextstellis (2023)

Total Spending

$78K

Total Claims

212

Beneficiaries

Avg Cost/Unit

$7.71

Spending Trend

$6K(2021)→$37K(2022)→$78K(2023)

YoY Change:+6.6%

5yr CAGR:+5.6%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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