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Last Updated: July 13, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021778


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NDA 021778 describes MEGACE ES, which is a drug marketed by Endo Pharms Inc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MEGACE ES profile page.

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.
Summary for 021778
Tradename:MEGACE ES
Applicant:Endo Pharms Inc
Ingredient:megestrol acetate
Patents:6
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021778
Suppliers and Packaging for NDA: 021778
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEGACE ES megestrol acetate SUSPENSION;ORAL 021778 NDA AUTHORIZED GENERIC Par Pharmaceutical, Inc. 49884-230 49884-230-69 150 mL in 1 BOTTLE (49884-230-69)
Paragraph IV (Patent) Challenges for 021778
Tradename Dosage Ingredient NDA Submissiondate
MEGACE ES SUSPENSION;ORAL megestrol acetate 021778 2011-04-27

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength125MG/ML
Approval Date:Jul 5, 2005TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Sep 21, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 22, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ANOREXIA, CACHEXIA, OR AN UNEXPLAINED, SIGNIFICANT WEIGHT LOSS IN PATIENTS WITH A DIAGNOSIS OF ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)
Patent:  Start TrialPatent Expiration:Apr 22, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ANOREXIA, CACHEXIA, OR AN UNEXPLAINED, SIGNIFICANT WEIGHT LOSS IN PATIENTS WITH A DIAGNOSIS OF ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)

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