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Generated: December 15, 2017

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 six suppliers. 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. Twenty-six suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.

Summary for 021778

Tradename:1
Applicant:1
Ingredient:1
Patents:6
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 021778

Ingredient-typeProgesterone Congeners

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 Stat Rx USA 16590-254 16590-254-33 150 mL in 1 BOTTLE (16590-254-33)
MEGACE ES megestrol acetate SUSPENSION;ORAL 021778 NDA Atlantic Biologicals Corps 17856-0949 17856-0949-5 5 mL in 1 CUP (17856-0949-5)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength125MG/ML
Approval Date:Jul 5, 2005TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Sep 21, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent 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:► SubscribePatent 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)

Expired Orange Book Patents for NDA: 021778

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms IncMEGACE ESmegestrol acetateSUSPENSION;ORAL021778-001Jul 5, 2005► Subscribe► Subscribe
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Moodys

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