Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Colorcon
Citi
Boehringer Ingelheim
Baxter
Harvard Business School
Federal Trade Commission
AstraZeneca
Chinese Patent Office

Generated: July 19, 2018

DrugPatentWatch Database Preview

Megestrol acetate - Generic Drug Details

see a sample report or, see our see our flat-rate plans

« Back to Dashboard

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

Megestrol acetate
is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Endo Pharms Inc, Apotex Inc, Breckenridge Pharm, Hi-tech Pharmacal, Par Pharm, Teva Pharms, Twi Pharms Inc, 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-seven patent family members in twenty-eight countries.

There are eighteen drug master file entries for megestrol acetate. Twenty-five suppliers are listed for this compound.
Pharmacology for megestrol acetate
Ingredient-typeProgesterone Congeners
Drug ClassProgestin
Medical Subject Heading (MeSH) Categories for megestrol acetate
Synonyms for megestrol acetate
(1S,2R,10R,11S,14R,15S)-14-ACETYL-2,8,15-TRIMETHYL-5-OXOTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADECA-6,8-DIEN-14-YL 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
51154-23-5
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
Ambap595-33-5
AN-21566
ANW-43468
API0003279
AS-13384
B1377
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
DSSTox_CID_20683
DSSTox_GSID_40683
DSSTox_RID_79539
DTXSID9040683
EINECS 209-864-5
HMS1570P14
HMS2051I20
HMS2090N04
HMS2097P14
HMS2235D16
HY-13676
I040
LMST02030118
LS-118489
Magestin
Megace
Megace ES
Megace;Megace ES
Megeron
Megesgtrol Acetate, pharmaceutical secondary standard; traceable to USP, PhEur and BP
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
MegestrolAcetate
Megestryl acetate
MFCD00056470
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
PL057943
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
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

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
Bristol Myers Squibb MEGACE megestrol acetate TABLET;ORAL 016979-002 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Par Pharm MEGESTROL ACETATE megestrol acetate TABLET;ORAL 072422-001 Aug 8, 1988 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Breckenridge Pharm MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 204688-001 Dec 1, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

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 ➤ Sign Up ➤ Sign Up
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Non-Orange Book US Patents for megestrol acetate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,316,029 Rapidly disintegrating solid oral dosage form ➤ Sign Up
6,375,986 Solid dose nanoparticulate compositions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate ➤ Sign Up
6,428,814 Bioadhesive nanoparticulate compositions having cationic surface stabilizers ➤ Sign Up
6,811,767 Liquid droplet aerosols of nanoparticulate drugs ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Teva
Farmers Insurance
Express Scripts
Healthtrust
US Department of Justice
Daiichi Sankyo
Baxter
QuintilesIMS
Cerilliant

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.