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NORETHINDRONE ACETATE

ANDA

NORETHINDRONE ACETATE | A075951 | BARR LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Norethindrone Acetate (2023)

Total Spending

$3.2M

Total Claims

55,454

Beneficiaries

15,646

Avg Cost/Unit

$0.90

Spending Trend

$3.2M(2019)→$3.2M(2020)→$3.2M(2021)→$3.4M(2022)→$3.2M(2023)

YoY Change:-15.7%

5yr CAGR:-9.3%

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
May 25, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 25, 2001

No patent or exclusivity listings for this strength.