Viewing data from:

MEGACE

NDA

MEGESTROL ACETATE | N016979 | BRISTOL MYERS SQUIBB

2 strengths0 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

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers NCT05538897	Phase 1/2	Active	National Cancer Institute (NCI)	96	2023-03-31 → 2027-01-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain7 active DMFs7 inactive

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

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCMEGESTROL ACETATE USP

DMF 18171971

FARMABIOS SPAMEGESTROL ACETATE

DMF 126621997

TAPI NL BVMEGESTROL ACETATE

DMF 126871997

TAIZHOU TAIFA PHARMACEUTICALS CO LTDMEGESTROL ACETATE

DMF 245832011

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDMEGESTROL ACETATE USP (NON-STERILE BULK DRUG SUBSTANCE)

DMF 245922011

JIANGSU GRAND XIANLE PHARMACEUTICAL CO LTDMEGESTROL ACETATE

DMF 275962013

ZHEJIANG XIANJU YANGGUANG BIOPRODUCTS CO LTDMEGESTROL ACETATE

DMF 356012021

SYNTEX USA INCInactiveMEGESTROL ACETATE

DMF 17381971

GLAXO LABORATORIES SAInactiveMEGESTROL ACETATE

DMF 24941975

DIOSYNTH BVInactiveMEGESTROL ACETATE MICRO

DMF 38691980

BAYER SCHERING PHARMA AGInactiveMEGESTROL ACETATE

DMF 52961984

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveMEGESTROL ACETATE

DMF 66731986

DIOSYNTH BVInactiveMEGESTROL ACETATE FROM GRANULATE

DMF 70121987

NV ORGANONInactiveMEGESTROL ACETATE

DMF 121571996

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 27, 2002	SUPPL -51	View Letter (PDF)
Jan 6, 2002	SUPPL -52	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982