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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 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.

Summary for megestrol acetate

International Patents:	197
US Patents:	6
Tradenames:	3
Applicants:	13
NDAs:	18
Drug Master File Entries:	18
Suppliers / Packagers:	25
Bulk Api Vendors:	69
Clinical Trials:	49
Patent Applications:	7,128
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for megestrol acetate
DailyMed Link:	megestrol acetate at DailyMed

Pharmacology for megestrol acetate

Ingredient-type	Progesterone Congeners
Drug Class	Progestin

Medical Subject Heading (MeSH) Categories for megestrol acetate

Antineoplastic Agents, Hormonal

Appetite Stimulants

Contraceptives, Oral, Synthetic

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
Par Pharm	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	072422-001	Aug 8, 1988	AB	RX	No	No
Breckenridge Pharm	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	204688-001	Dec 1, 2017	AB	RX	No	No
Endo Pharms Inc	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	AB	RX	Yes	Yes

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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
Endo Pharms Inc	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005

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
6,375,986	Solid dose nanoparticulate compositions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate
6,428,814	Bioadhesive nanoparticulate compositions having cationic surface stabilizers
6,811,767	Liquid droplet aerosols of nanoparticulate drugs

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International Patents for megestrol acetate

Country	Document Number	Estimated Expiration
Germany	60019774
Denmark	1128814
World Intellectual Property Organization (WIPO)	03080027
Japan	2002525311