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Generated: July 26, 2017
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 seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 3 |
| Patents: | 7 |
| Applicants: | 12 |
| NDAs: | 17 |
| Drug Master File Entries: see list | 18 |
| Suppliers / Packagers: see list | 27 |
| Bulk Api Vendors: see list | 55 |
| Clinical Trials: see list | 915 |
| Patent Applications: see list | 6,277 |
| Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers) |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | megestrol acetate at DailyMed |
| Ingredient-type | Progesterone Congeners |
| Drug Class | Progestin |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Twi Pharms Inc | MEGESTROL ACETATE | megestrol acetate | SUSPENSION;ORAL | 203139-001 | Aug 27, 2014 | 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 | Y | ► Subscribe | ||||||||||||||||
Par Pharm | MEGESTROL ACETATE | megestrol acetate | TABLET;ORAL | 072422-001 | Aug 8, 1988 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Bristol Myers Squibb | MEGACE | megestrol acetate | TABLET;ORAL | 016979-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 | |||||||||||||||||
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| 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 | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,198,795 | In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate of nanoparticulate active agent compositions | ► Subscribe | |||||||||||||||||||||||||||
| 7,695,739 | In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate or nanoparticulate active agent compositions | ► Subscribe | |||||||||||||||||||||||||||
| 8,309,136 | In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate or nanoparticulate active agent compositions | ► Subscribe | |||||||||||||||||||||||||||
| 8,323,641 | Nanoparticulate compositions having lysozyme as a surface stabilizer | ► Subscribe | |||||||||||||||||||||||||||
| 7,459,283 | Nanoparticulate compositions having lysozyme as a surface stabilizer | ► 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cyprus | 1111344 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2317874 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1531799 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2487054 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 4838514 | ► 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 500+ biopharmaceutical companies globally:
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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