MEGACE ES Drug Patent Profile
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Which patents cover Megace Es, and when can generic versions of Megace Es launch?
Megace Es is a drug marketed by Endo Operations and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has thirty-six patent family members in nineteen countries.
The generic ingredient in MEGACE ES is megestrol acetate. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Megace Es
A generic version of MEGACE ES was approved as megestrol acetate by STRIDES PHARMA on August 8th, 1988.
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Summary for MEGACE ES
International Patents: | 36 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 90 |
Clinical Trials: | 35 |
Patent Applications: | 3,043 |
Drug Prices: | Drug price information for MEGACE ES |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MEGACE ES |
What excipients (inactive ingredients) are in MEGACE ES? | MEGACE ES excipients list |
DailyMed Link: | MEGACE ES at DailyMed |
Recent Clinical Trials for MEGACE ES
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 1/Phase 2 |
Sunnybrook Health Sciences Centre | Phase 1 |
Ontario Institute for Cancer Research | Phase 1 |
Paragraph IV (Patent) Challenges for MEGACE ES
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 MEGACE ES
MEGACE ES is protected by five US patents.
Patents protecting MEGACE ES
Nanoparticulate megestrol formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ANOREXIA, CACHEXIA, OR AN UNEXPLAINED, SIGNIFICANT WEIGHT LOSS IN PATIENTS WITH A DIAGNOSIS OF ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)
Nanoparticulate megestrol formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ANOREXIA, CACHEXIA, OR AN UNEXPLAINED, SIGNIFICANT WEIGHT LOSS IN PATIENTS WITH A DIAGNOSIS OF ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)
Nanoparticulate megestrol formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ANOREXIA, CACHEXIA, OR AN UNEXPLAINED, SIGNIFICANT WEIGHT LOSS IN PATIENTS WITH A DIAGNOSIS OF ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)
Nanoparticulate megestrol formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ANOREXIA, CACHEXIA, OR AN UNEXPLAINED, SIGNIFICANT WEIGHT LOSS IN PATIENTS WITH A DIAGNOSIS OF ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)
Nanoparticulate megestrol formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ANOREXIA, CACHEXIA, OR AN UNEXPLAINED, SIGNIFICANT WEIGHT LOSS IN PATIENTS WITH A DIAGNOSIS OF ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Endo Operations | MEGACE ES | megestrol acetate | SUSPENSION;ORAL | 021778-001 | Jul 5, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Endo Operations | MEGACE ES | megestrol acetate | SUSPENSION;ORAL | 021778-001 | Jul 5, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Endo Operations | MEGACE ES | megestrol acetate | SUSPENSION;ORAL | 021778-001 | Jul 5, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 MEGACE ES
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Endo Operations | MEGACE ES | megestrol acetate | SUSPENSION;ORAL | 021778-001 | Jul 5, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Endo Operations | MEGACE ES | megestrol acetate | SUSPENSION;ORAL | 021778-001 | Jul 5, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Endo Operations | 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 MEGACE ES
See the table below for patents covering MEGACE ES around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 1471887 | ⤷ Sign Up | |
Greece | 3032059 | ⤷ Sign Up | |
Japan | 4611641 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |