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Last Updated: November 19, 2019

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Megestrol acetate - Generic Drug Details

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What are the generic drug sources for megestrol acetate and what is the scope of patent protection?

Megestrol acetate is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Endo Pharms Inc, Breckenridge, Hi Tech, Par Pharm, Pharm Assoc, Teva Pharms, Twi Pharms, West-ward Pharms Int, Wockhardt Bio Ag, Barr, Teva, and Usl Pharma, and is included in eighteen NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Megestrol acetate has one hundred and ninety-eight patent family members in twenty-eight countries.

There are eighteen drug master file entries for megestrol acetate. Nineteen suppliers are listed for this compound.

Summary for megestrol acetate

International Patents:	198
US Patents:	6
Tradenames:	3
Applicants:	13
NDAs:	18
Drug Master File Entries:	18
Suppliers / Packagers:	19
Bulk Api Vendors:	74
Clinical Trials:	53
Patent Applications:	7,116
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for megestrol acetate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for megestrol acetate
DailyMed Link:	megestrol acetate at DailyMed

See drug prices for megestrol acetate

Recent Clinical Trials for megestrol acetate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Children's Hospital of Fudan University	Phase 4
University of Kansas Medical Center	Phase 4
City of Hope Medical Center	Phase 2

See all megestrol acetate clinical trials

Recent Litigation for megestrol acetate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Par Pharmaceutical Inc. v. Breckenridge Pharmaceutical Inc.	2015-11-11
Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc.	2015-07-30
Par Pharmaceutical, Inc. v. Twi Pharmaceuticals, Inc.	2014-04-01

See all megestrol acetate litigation

Pharmacology for megestrol acetate

Drug Class	Progestin

Medical Subject Heading (MeSH) Categories for megestrol acetate

Antineoplastic Agents, Hormonal
Appetite Stimulants
Contraceptives, Oral, Synthetic

Synonyms for megestrol acetate

(8R,9S,10R,13S,14S,17R)-17-acetyl-6,10,13-trimethyl-3-oxo-2,3,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-17-yl acetate
[(8R,9S,10R,13S,14S,17R)-17-acetyl-6,10,13-trimethyl-3-oxo-2,8,9,11,12,14,15,16-octahydro-1H-cyclopenta[a]phenanthren-17-yl] acetate
14365-EP2311464A1
14365-EP2316836A1
17-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione
17-Acetoxy-6-methylpregna-4,20-dione
17-Acetoxy-6-methylpregna-4,6-diene-3,20-dione
17-alpha-Acetoxy-6-dehydro-6-methylprogesterone
17-Hydroxy-6-methylpregna-4,20-dione acetate
17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione 17-acetate
17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate
17.alpha.-Acetoxy-6-dehydro-6-methylprogesterone
17.alpha.-Acetoxy-6-methyl-4,20-dione
17.alpha.-Acetoxy-6-methylpregna-4,20-dione
17alpha-Acetoxy-6-dehydro-6-methylprogesterone
17alpha-Acetoxy-6-methylpregna-4,6-diene-3,20-dione
17alpha-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate
595-33-5
595M335
6-Dehydro-6-methyl-17-alpha-acetoxyprogesterone
6-Dehydro-6-methyl-17.alpha.-acetoxyprogesterone
6-Dehydro-6-methyl-17alpha-acetoxyprogesterone
6-Methyl-17-alpha-acetoxypregna-4,6-diene-3,20-dione
6-Methyl-17-alpha-hydroxy-delta(sup 6)-progesterone acetate
6-Methyl-17.alpha.-hydroxy-.delta.(sup 6)-progesterone acetate
6-Methyl-17alpha-hydroxy-delta(sup 6)-progesterone acetate
6-Methyl-3,20-dioxopregna-4,6-dien-17-yl acetate
6-Methyl-6-dehydro-17-alpha-acetoxyprogesterone
6-Methyl-6-dehydro-17.alpha.-acetoxyprogesterone
6-Methyl-6-dehydro-17.alpha.-acetylprogesterone
6-Methyl-6-dehydro-17alpha-acetoxyprogesterone
6-Methyl-delta(sup 4,6)-pregnadien-17-alpha-ol-3,20-dione acetate
6-Methyl-delta(sup 6)-dehydro-17-alpha-acetoxyprogesterone
6-Methyl-delta4,6-pregnadien-17alpha-ol-3,20-dione acetate
AB00383046_16
AB00383046-13
AB00383046-14
AB00383046-15
AB00490013
AB2000040
AC-24570
AC1L1XW9
AJ-47998
AK145584
AKOS015894927
AN-21566
ANW-43468
API0003279
AS-13384
B1377
BCP29265
BCP9000904
BCPP000168
BDH 1298
BDH-1298
BDH-1298, NSC-71423
BPBio1_001048
BRD-K19507340-001-03-1
BSPBio_000952
C08151
CAS-595-33-5
CCG-100899
CCRIS 372
CHEMBL1201139
CS-2065
CTK5B0088
D00952
DB00351
DSSTox_CID_20683
DSSTox_GSID_40683
DSSTox_RID_79539
DTXSID9040683
EINECS 209-864-5
HMS1570P14
HMS2051I20
HMS2090N04
HMS2097P14
HMS2235D16
HMS3714P14
HY-13676
I040
LMST02030118
LS-118489
Magestin
Megace
Megace ES
Megace;Megace ES
Megeron
Megesgtrol Acetate, Pharmaceutical Secondary Standard; Certified Reference Material
Megestat
Megestrol (Acetate)
Megestrol acetate (USAN)
Megestrol acetate [USAN:USP]
Megestrol acetate [USAN]
Megestrol acetate for peak identification, European Pharmacopoeia (EP) Reference Standard
Megestrol acetate for system suitability, European Pharmacopoeia (EP) Reference Standard
Megestrol acetate, analytical standard, for drug analysis
Megestrol acetate, European Pharmacopoeia (EP) Reference Standard
Megestrol acetate, United States Pharmacopeia (USP) Reference Standard
Megestrol acetate, VETRANAL(TM), analytical standard
Megestrol acetole
Megestrol acetole [Progestins]
Megestrol-17-acetate
Megestryl acetate
MLS000028633
MLS000759501
MLS001074091
MLS001424055
MolPort-005-934-820
NC00149
NCGC00016516-01
NCGC00024196-03
NCGC00024196-05
NCGC00255456-01
Niagestin
NSC-71423
NSC71423
Opera_ID_1511
Ovaban
Ovaban (Veterinary)
Ovarid
Pallace
par-100,2
Pregna-4,20-dione, 17-(acetyloxy)-6-methyl-
Pregna-4,20-dione, 17-hydroxy-6-methyl-, acetate
Pregna-4,6-diene-3,20-dione, 17-(acetyloxy)-6-methyl-
Pregna-4,6-diene-3,20-dione, 17-hydroxy-6-methyl-, acetate
Prestwick0_000956
Prestwick1_000956
Prestwick2_000956
Prestwick3_000956
Q-201346
RQZAXGRLVPAYTJ-GQFGMJRRSA-N
s1304
SC 10363
SC-10363
SC-16134
SC10363
SCHEMBL745
SMR000058691
SPBio_003101
SR-01000000258
SR-01000000258-4
TJ2M0FR8ES
Tox21_110469
Tox21_110469_1
Tox21_302360
TR-031797
UNII-TJ2M0FR8ES
WLN: L E5 B666 OV KU MUTJ A1 E1 FV1 FOV1 L1
ZINC4097467

Paragraph IV (Patent) Challenges for MEGESTROL ACETATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
MEGACE ES	SUSPENSION;ORAL	megestrol acetate	021778	2011-04-27
MEGACE	SUSPENSION;ORAL	megestrol acetate	020264

US Patents and Regulatory Information for megestrol acetate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Pharm	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	072423-001	Aug 8, 1988	AB	RX	No	Yes	Start Trial	Start Trial				Start Trial
Teva Pharms	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	075681-001	May 5, 2003	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Endo Pharms Inc	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	AB	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Barr	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	074621-002	Aug 16, 1996	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Usl Pharma	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	070647-001	Oct 2, 1987		DISCN	No	No	Start Trial	Start Trial				Start Trial
Barr	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	074621-001	Nov 30, 1995	AB	RX	No	No	Start Trial	Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for megestrol acetate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	MEGACE	megestrol acetate	SUSPENSION;ORAL	020264-001	Sep 10, 1993	Start Trial	Start Trial
Endo Pharms Inc	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for megestrol acetate

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Country	Patent Number	Estimated Expiration
Slovenia	1494649	Start Trial
South Africa	200410209	Start Trial
Canada	2487054	Start Trial
World Intellectual Property Organization (WIPO)	2004050059	Start Trial
Australia	2003245313	Start Trial
European Patent Office	1551457	Start Trial
>Country	>Patent Number	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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