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MEGESTROL ACETATE

ANDA

MEGESTROL ACETATE | A204688 | CHARTWELL LIFE MOLECULES LLC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Par Pharmaceutical Inc. et al v. Breckenridge Pharmaceutical Inc. 1:2015cv01039 6 patentsANDA 204688megestrol acetate	D. Del.	2015-11-11	Terminated 2016-01-25	—
PAR PHARMACEUTICAL, INC. et al v. BRECKENRIDGE PHARMACEUTICAL, INC. 1:2013cv04000 2 patentsANDA 204688megestrol acetate	D.N.J.	2013-06-27	Terminated 2013-09-06	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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.

Products (1)

#001 — 125MG/ML

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Dec 1, 2017

No patent or exclusivity listings for this strength.