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Generated: May 28, 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, Bristol Myers Squibb, Endo Pharms Inc, and Teva Pharms, and is included in sixteen 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: | 11 |
| NDAs: | 16 |
| Drug Master File Entries: see list | 18 |
| Suppliers / Packagers: see list | 26 |
| Bulk Api Vendors: see list | 55 |
| Clinical Trials: see list | 442 |
| 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
West-ward Pharms Int | MEGESTROL ACETATE | megestrol acetate | TABLET;ORAL | 074458-002 | Sep 29, 1995 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Endo Pharms Inc | MEGACE ES | megestrol acetate | SUSPENSION;ORAL | 021778-001 | Jul 5, 2005 | AB | RX | Yes | Yes | 9,101,540 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Par Pharm | MEGESTROL ACETATE | megestrol acetate | TABLET;ORAL | 072423-001 | Aug 8, 1988 | AB | RX | No | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Bristol Myers Squibb | MEGACE | megestrol acetate | TABLET;ORAL | 016979-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Endo Pharms Inc | MEGACE ES | megestrol acetate | SUSPENSION;ORAL | 021778-001 | Jul 5, 2005 | AB | RX | Yes | Yes | 7,101,576 | ► Subscribe | ► Subscribe | |||||||||||||||||
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Expired Orange Book Patents
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Paragraph IV Activity
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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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