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Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Merck
Daiichi Sankyo
Colorcon
Fuji
Argus Health
Cantor Fitzgerald
Farmers Insurance
Medtronic

Generated: January 17, 2018

DrugPatentWatch Database Preview

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, Hi-tech Pharmacal, Par Pharm, Teva Pharms, Twi Pharms Inc, West-ward Pharms Int, Wockhardt, Barr, Teva, and Usl Pharma, 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-seven patent family members in twenty-eight countries.

There are eighteen drug master file entries for megestrol acetate. Twenty-six suppliers are listed for this compound.
Summary for megestrol acetate
Pharmacology for megestrol acetate
Ingredient-typeProgesterone Congeners
Drug ClassProgestin
Medical Subject Heading (MeSH) Categories for megestrol acetate

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 016979-001 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Usl Pharma MEGESTROL ACETATE megestrol acetate TABLET;ORAL 070647-001 Oct 2, 1987 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bristol Myers Squibb MEGACE megestrol acetate SUSPENSION;ORAL 020264-001 Sep 10, 1993 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Wockhardt MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 076721-001 Nov 1, 2004 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
West-ward Pharms Int MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 075997-001 Feb 15, 2002 AB RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hi-tech Pharmacal MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 203960-001 Jun 9, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Pharms MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 075681-001 May 5, 2003 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Pharm MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 075671-001 Jul 25, 2001 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Pharm MEGESTROL ACETATE megestrol acetate TABLET;ORAL 072423-001 Aug 8, 1988 AB RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Subscribe ➤ Subscribe
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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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
6,969,529 Nanoparticulate compositions comprising copolymers of vinyl pyrrolidone and vinyl acetate as surface stabilizers ➤ Subscribe
7,459,283 Nanoparticulate compositions having lysozyme as a surface stabilizer ➤ Subscribe
8,236,352 Glipizide compositions ➤ Subscribe
6,316,029 Rapidly disintegrating solid oral dosage form ➤ Subscribe
8,323,641 Nanoparticulate compositions having lysozyme as a surface stabilizer ➤ Subscribe
8,293,277 Controlled-release nanoparticulate compositions ➤ Subscribe
7,276,249 Nanoparticulate fibrate formulations ➤ Subscribe
7,927,627 Nanoparticulate fibrate formulations ➤ Subscribe
7,850,995 Bioadhesive nanoparticulate compositions having cationic surface stabilizers ➤ Subscribe
7,521,068 Dry powder aerosols of nanoparticulate drugs ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for megestrol acetate

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Serving leading biopharmaceutical companies globally:

Teva
Chubb
AstraZeneca
QuintilesIMS
Mallinckrodt
Farmers Insurance
Merck
McKinsey
Fuji

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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