Viewing data from:

MIRCETTE

NDA

DESOGESTREL; ETHINYL ESTRADIOL | N020713 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC

1 strength0 unique patents0 unique exclusivities

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 Mircette (2023)

Total Spending

$6K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$7.40

Spending Trend

$11K(2019)→$7K(2020)→$6K(2021)→$6K(2022)→$6K(2023)

YoY Change:+24.4%

5yr CAGR:+11.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jan 5, 2023	SUPPL -13	View Letter (PDF)
May 3, 2022	SUPPL -12	View Letter (PDF)
Aug 15, 2017	SUPPL -11	View Letter (PDF)
Jul 20, 2012	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.15MG,N/A;0.02MG,0.01MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL-28 | Approved: Apr 22, 1998

No patent or exclusivity listings for this strength.