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Serving leading biopharmaceutical companies globally:

Cerilliant
Merck
UBS
Colorcon
QuintilesIMS
Deloitte
Queensland Health
Fish and Richardson
Julphar
US Department of Justice

Generated: November 17, 2017

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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 Apotex Inc, Wockhardt, Barr, Par Pharm, Twi Pharms Inc, Teva, Usl Pharma, West-ward Pharms Int, Hi-tech Pharmacal, Bristol Myers Squibb, Endo Pharms Inc, and Teva Pharms, and is included in seventeen 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-six patent family members in twenty-seven countries.

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

Pharmacology for megestrol acetate

Ingredient-typeProgesterone Congeners
Drug ClassProgestin

Medical Subject Heading (MeSH) Categories 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
Usl Pharma
MEGESTROL ACETATE
megestrol acetate
TABLET;ORAL070646-001Oct 2, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Endo Pharms Inc
MEGACE ES
megestrol acetate
SUSPENSION;ORAL021778-001Jul 5, 2005ABRXYesYes► Subscribe► Subscribe ► Subscribe
Par Pharm
MEGESTROL ACETATE
megestrol acetate
TABLET;ORAL072422-001Aug 8, 1988ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
MEGESTROL ACETATE
megestrol acetate
SUSPENSION;ORAL075681-001May 5, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
MEGESTROL ACETATE
megestrol acetate
SUSPENSION;ORAL077404-001Feb 16, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Usl Pharma
MEGESTROL ACETATE
megestrol acetate
TABLET;ORAL070647-001Oct 2, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Endo Pharms Inc
MEGACE ES
megestrol acetate
SUSPENSION;ORAL021778-001Jul 5, 2005ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Endo Pharms Inc
MEGACE ES
megestrol acetate
SUSPENSION;ORAL021778-001Jul 5, 2005ABRXYesYes► Subscribe► Subscribe ► Subscribe
West-ward Pharms Int
MEGESTROL ACETATE
megestrol acetate
TABLET;ORAL074458-002Sep 29, 1995ABRXNoNo► Subscribe► Subscribe► Subscribe
West-ward Pharms Int
MEGESTROL ACETATE
megestrol acetate
TABLET;ORAL074458-001Sep 29, 1995ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: megestrol acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
MEGACE
megestrol acetate
SUSPENSION;ORAL020264-001Sep 10, 1993► Subscribe► Subscribe
Endo Pharms Inc
MEGACE ES
megestrol acetate
SUSPENSION;ORAL021778-001Jul 5, 2005► Subscribe► 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
7,244,451Methods of making nanoparticulate drug compositions comprising copolymers of vinyl pyrrolidone and vinyl acetate as surface stabilizers► Subscribe
8,236,352Glipizide compositions► Subscribe
6,316,029 Rapidly disintegrating solid oral dosage form► Subscribe
8,652,464Method of treatment using nanoparticulate compositions having lysozyme as a surface stabilizer► Subscribe
6,811,767 Liquid droplet aerosols of nanoparticulate drugs► Subscribe
7,931,917Nanoparticulate fibrate formulations► Subscribe
7,320,802Methods of treatment using nanoparticulate fenofibrate compositions► Subscribe
8,309,136In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate or nanoparticulate active agent compositions► Subscribe
7,521,068Dry powder aerosols of nanoparticulate drugs► Subscribe
8,293,277Controlled-release nanoparticulate 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 Ingredient: megestrol acetate

Country Document Number Estimated Expiration
Japan2013100359► Subscribe
World Intellectual Property Organization (WIPO)2004041250► Subscribe
Canada2481390► Subscribe
Japan2011093919► Subscribe
World Intellectual Property Organization (WIPO)03080027► Subscribe
Austria419834► Subscribe
Canada2479665► Subscribe
European Patent Office1341521► Subscribe
World Intellectual Property Organization (WIPO)0027363► Subscribe
Canada2487054► 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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Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
McKesson
Chubb
Johnson and Johnson
Teva
Accenture
Harvard Business School
Baxter
Fish and Richardson

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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