Viewing data from:

PREFEST

NDA

ESTRADIOL; NORGESTIMATE | N021040 | TEVA WOMENS HEALTH 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 Prefest (2023)

Total Spending

$157K

Total Claims

363

Beneficiaries

100

Avg Cost/Unit

$6.56

Spending Trend

$220K(2019)→$207K(2020)→$200K(2021)→$186K(2022)→$157K(2023)

YoY Change:+8.2%

5yr CAGR:+9.2%

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Feb 16, 2024	SUPPL -15	View Letter (PDF)
Jul 21, 2004	SUPPL -12	View Letter (PDF)
Jun 10, 2004	SUPPL -10	View Letter (PDF)
Dec 23, 2003	SUPPL -9	View Letter (PDF)
Dec 23, 2003	SUPPL -2	View Letter (PDF)
Dec 23, 2003	SUPPL -5	View Letter (PDF)
Dec 23, 2003	SUPPL -7	View Letter (PDF)
Dec 23, 2003	SUPPL -1	View Letter (PDF)
Oct 22, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 22, 1999

No patent or exclusivity listings for this strength.