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Megestrol acetate - Generic Drug Details
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, 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.There are eighteen drug master file entries for megestrol acetate. Twenty-three suppliers are listed for this compound.
Summary for megestrol acetate
| US Patents: | 6 |
| Tradenames: | 3 |
| Applicants: | 13 |
| NDAs: | 18 |
| Drug Master File Entries: | 18 |
| Suppliers / Packagers: | 23 |
| Bulk Api Vendors: | 70 |
| Clinical Trials: | 49 |
| Patent Applications: | 7,110 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for megestrol acetate |
| 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
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Barr | MEGESTROL ACETATE | megestrol acetate | TABLET;ORAL | 074621-002 | Aug 16, 1996 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Teva | MEGESTROL ACETATE | megestrol acetate | TABLET;ORAL | 074745-001 | Feb 27, 1998 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| 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 | ||||
| West-ward Pharms Int | MEGESTROL ACETATE | megestrol acetate | TABLET;ORAL | 074458-001 | Sep 29, 1995 | AB | RX | No | No | ➤ 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 |
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 |
International Patents for megestrol acetate
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1490025 | ➤ Sign Up |
| Israel | 207893 | ➤ Sign Up |
| Australia | 2003230692 | ➤ Sign Up |
| Germany | 60309300 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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