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MEGACE ES Drug Profile

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Which patents cover Megace Es, and what substitute generic drugs are available?

Megace Es is a drug marketed by Endo Pharms Inc and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in MEGACE ES is megestrol acetate. There are eighteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.

Summary for Tradename: MEGACE ES

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list5
Bulk Api Vendors: see list56
Clinical Trials: see list9
Patent Applications: see list13,138
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:MEGACE ES at DailyMed

Pharmacology for Tradename: MEGACE ES

Ingredient-typeProgesterone Congeners
Drug ClassProgestin
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Pharms Inc
MEGACE ES
megestrol acetate
SUSPENSION;ORAL021778-001Jul 5, 2005RXYesYes7,101,576► Subscribe ► Subscribe
Endo Pharms Inc
MEGACE ES
megestrol acetate
SUSPENSION;ORAL021778-001Jul 5, 2005RXYesYes9,107,827► Subscribe ► Subscribe
Endo Pharms Inc
MEGACE ES
megestrol acetate
SUSPENSION;ORAL021778-001Jul 5, 2005RXYesYes9,101,540► SubscribeY ► Subscribe
Endo Pharms Inc
MEGACE ES
megestrol acetate
SUSPENSION;ORAL021778-001Jul 5, 2005RXYesYes9,101,549► Subscribe ► Subscribe
Endo Pharms Inc
MEGACE ES
megestrol acetate
SUSPENSION;ORAL021778-001Jul 5, 2005RXYesYes6,592,903► SubscribeY ► Subscribe
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Expired Patents for Tradename: MEGACE ES

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms Inc
MEGACE ES
megestrol acetate
SUSPENSION;ORAL021778-001Jul 5, 20055,145,684► Subscribe
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Paragraph IV activity for: MEGACE ES

Drugname Dosage Strength RLD Submissiondate
megestrol acetateOral Suspension125 mg/mLMegace ES

Non-Orange Book Patents for Tradename: MEGACE ES

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
7,931,917Nanoparticulate fibrate formulations► Subscribe
8,652,464Method of treatment using nanoparticulate compositions having lysozyme as a surface stabilizer► Subscribe
7,521,068Dry powder aerosols of nanoparticulate drugs► Subscribe
6,316,029 Rapidly disintegrating solid oral dosage form► Subscribe
7,320,802Methods of treatment using nanoparticulate fenofibrate compositions► 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 Tradename: MEGACE ES

Country Document Number Estimated Expiration
European Patent Office1471887► Subscribe
Spain2380318► Subscribe
Australia9501701► Subscribe
World Intellectual Property Organization (WIPO)2009114695► Subscribe
Eurasian Patent Organization023686► 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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