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Megestrol acetate - Generic Drug Details

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Megestrol acetate is the generic ingredient in three branded drugs marketed by Apotex Inc, Wockhardt, Barr, Par Pharm, Twi Pharms Inc, Teva, Usl Pharma, Roxane, Bristol Myers Squibb, Endo Pharms Inc, and Teva Pharms, and is included in sixteen NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and eighty-five patent family members in twenty-seven countries.

There are eighteen drug master file entries for megestrol acetate. Twenty-five suppliers are listed for this compound.

Summary for Generic Name: megestrol acetate

Tradenames:3
Patents:6
Applicants:11
NDAs:16
Drug Master File Entries: see list18
Suppliers / Packaging: see list25
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: megestrol acetate

Ingredient-typeProgesterone Congeners
Drug ClassProgestin
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roxane
MEGESTROL ACETATE
megestrol acetate
TABLET;ORAL074458-001Sep 29, 1995RXNo► subscribe► subscribe
Bristol Myers Squibb
MEGACE
megestrol acetate
SUSPENSION;ORAL020264-001Sep 10, 1993RXYes► subscribe► subscribe
Teva
MEGESTROL ACETATE
megestrol acetate
TABLET;ORAL074745-001Feb 27, 1998DISCNNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: 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;ORAL020264-001Sep 10, 19935,338,732► subscribe
Endo Pharms Inc
MEGACE ES
megestrol acetate
SUSPENSION;ORAL021778-001Jul 5, 20055,145,684► subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
7,850,995Bioadhesive nanoparticulate compositions having cationic surface stabilizers► subscribe
7,998,507Nanoparticulate compositions of mitogen-activated protein (MAP) kinase inhibitors► subscribe
7,931,917Nanoparticulate fibrate formulations► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: megestrol acetate

Country Document Number Estimated Expiration
European Patent Office2263652► subscribe
Japan2006510726► subscribe
TaiwanI347198► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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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