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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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Frommer Lawrence & Haug, LLP FDA-2006-P-0393 · 7 docket documents Frommer Lawrence & Haug, LLP filed this citizen petition on behalf of Par Pharmaceutical, Inc. requesting that the FDA require all applicants seeking approval of generic formulations of the reference listed drug Megace ES (megestrol acetate oral suspension 625 mg/5 ml) to conduct and successfully co	505(q)	2009-01-16	Partially Denied	Frommer Lawrence & Haug, LLP

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

54 trials from ClinicalTrials.gov, 1 active, 37 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy NCT03671811	Phase 2	Active	City of Hope Medical Center	44	2019-01-21 → 2027-02-28
Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting NCT00004664	N/A	Completed	National Center for Research Resources (NCRR)	69	1995-06
Study to Evaluate the Effect of Megestrol Acetate in Severe Chronic Obstructive Pulmonary Disease With Loss of Weight NCT00507949	Phase 2	Completed	Rottapharm Spain	40	2006-10 → 2009-09
Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite NCT00031707	Phase 3	Completed	Alliance for Clinical Trials in Oncology	429	2000-03 → 2004-01
A Pre-operative Window Study of Letrozole Plus PR Agonist (Megestrol Acetate) Versus Letrozole Alone in Post-menopausal Patients With ER-positive Breast Cancer NCT03306472	Phase 2	Completed	Cambridge University Hospitals NHS Foundation Trust	198	2017-07-20 → 2023-10-31
Comparison Between Mirtazapine and Megestrol for the Control of Anorexia-cachexia in Cancer Patients in Palliative Care.NCT03283488	Phase 2	Completed	University of Sao Paulo	52	2019-03-26 → 2022-02-02
Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer NCT00006799	Phase 3	Completed	Wake Forest University Health Sciences	13	2000-10-01 → 2002-09-06
The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer NCT00910091	Phase 2	Completed	Ipsen	73	2009-08 → 2013-07
Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss NCT00004912	Phase 2	Completed	Northwestern University	—	2000-01 → 2003-11
Megestrol Acetate Plus LNG-IUS in Young Women With Endometrial Atypical Hyperplasia NCT03241888	Phase 2/3	Completed	Fudan University	180	2017-07-04 → 2020-06-18

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