Viewing data from:

AYGESTIN

NDA

NORETHINDRONE ACETATE | N018405 | DURAMED RESEARCH 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

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 Aygestin (2023)

Total Spending

$7K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$6.52

Spending Trend

$6K(2019)→$6K(2020)→$4K(2021)→$7K(2022)→$7K(2023)

YoY Change:-0.3%

5yr CAGR:+6.9%

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

API Supply Chain5 active DMFs3 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

BAYER AGNORETHINDRONE ACETATE

DMF 20331972

ASPEN OSS BVNORETHINDRONE ACETATE

DMF 101851993

LUPIN LTDNORETHINDRONE ACETATE USP

DMF 225072009

VALDEPHARMNORETHINDRONE ACETATE

DMF 249132011

NAARI PTE LTDNORETHINDRONE ACETATE

DMF 360632021

SYNTEX USA INCInactiveNORETHINDRONE ACETATE

DMF 10841967

ROUSSEL CORPInactiveNORETHINDRONE ACETATE

DMF 18461971

NOVO NORDISK ASInactiveNORETHINDRONE ACETATE

DMF 63531986

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 10, 2007	SUPPL -23	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 21, 1982

No patent or exclusivity listings for this strength.