Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

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.

Drug Prices for megestrol acetate

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Recent Clinical Trials for megestrol acetate

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

SponsorPhase
Children's Hospital of Fudan UniversityPhase 4
University of Kansas Medical CenterPhase 4
City of Hope Medical CenterPhase 2

See all megestrol acetate clinical trials

Recent Litigation for megestrol acetate

Identify potential future generic entrants

District Court Litigation
Case NameDate
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 ClassProgestin
Medical Subject Heading (MeSH) Categories for megestrol acetate
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

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

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

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Serving leading biopharmaceutical companies globally:

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AstraZeneca

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