MEGESTROL ACETATE - Generic Drug Details
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What are the generic drug sources for megestrol acetate and what is the scope of freedom to operate?
Megestrol acetate
is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Endo Pharms Inc, Chartwell, Hikma, Novitium Pharma, Strides Pharma, Teva Pharms, Twi Pharms, Xttrium Labs Inc, Barr, Teva, and Usl Pharma, and is included in eighteen NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Megestrol acetate has thirty-six patent family members in nineteen countries.
There are seventeen drug master file entries for megestrol acetate. Fourteen suppliers are listed for this compound.
Summary for MEGESTROL ACETATE
International Patents: | 36 |
US Patents: | 5 |
Tradenames: | 3 |
Applicants: | 12 |
NDAs: | 18 |
Drug Master File Entries: | 17 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 90 |
Clinical Trials: | 73 |
Patent Applications: | 7,290 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for MEGESTROL ACETATE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MEGESTROL ACETATE |
What excipients (inactive ingredients) are in MEGESTROL ACETATE? | MEGESTROL ACETATE excipients list |
DailyMed Link: | MEGESTROL ACETATE at DailyMed |
Recent Clinical Trials for MEGESTROL ACETATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 1/Phase 2 |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Phase 2 |
Sunnybrook Health Sciences Centre | Phase 1 |
Pharmacology for MEGESTROL ACETATE
Drug Class | Progestin |
Medical Subject Heading (MeSH) Categories for MEGESTROL ACETATE
Anatomical Therapeutic Chemical (ATC) Classes for MEGESTROL ACETATE
Paragraph IV (Patent) Challenges for MEGESTROL ACETATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
MEGACE ES | Oral Suspension | megestrol acetate | 125 mg/mL | 021778 | 1 | 2011-04-27 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Strides Pharma | MEGESTROL ACETATE | megestrol acetate | TABLET;ORAL | 072423-001 | Aug 8, 1988 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bristol Myers Squibb | MEGACE | megestrol acetate | TABLET;ORAL | 016979-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Endo Pharms Inc | MEGACE ES | megestrol acetate | SUSPENSION;ORAL | 021778-001 | Jul 5, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Strides Pharma | MEGESTROL ACETATE | megestrol acetate | TABLET;ORAL | 072422-001 | Aug 8, 1988 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for MEGESTROL ACETATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Endo Pharms Inc | MEGACE ES | megestrol acetate | SUSPENSION;ORAL | 021778-001 | Jul 5, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | MEGACE | megestrol acetate | SUSPENSION;ORAL | 020264-001 | Sep 10, 1993 | ⤷ Sign Up | ⤷ Sign Up |
Endo Pharms Inc | MEGACE ES | megestrol acetate | SUSPENSION;ORAL | 021778-001 | Jul 5, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Endo Pharms Inc | MEGACE ES | megestrol acetate | SUSPENSION;ORAL | 021778-001 | Jul 5, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MEGESTROL ACETATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 2008000396 | FORMULACIONES DE MEGESTROL EN NANOPARTICULA. (NANOPARTICULATE MEGESTROL FORMULATIONS.) | ⤷ Sign Up |
Japan | 2008546796 | ⤷ Sign Up | |
Portugal | 1494649 | ⤷ Sign Up | |
Brazil | PI0612665 | formulações nanoparticuladas de megestrol | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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