Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
UBS
Healthtrust
Fuji
Baxter
Accenture
AstraZeneca
Chinese Patent Office
Citi

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021778

« Back to Dashboard

NDA 021778 describes MEGACE ES, which is a drug marketed by Endo Pharms Inc and is included in one NDA. It is available from five 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-four 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
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 Atlantic Biologicals Corps 17856-0949 N 17856-0949-5
MEGACE ES megestrol acetate SUSPENSION;ORAL 021778 NDA AUTHORIZED GENERIC Par Pharmaceutical, Inc. 49884-230 N 49884-230-69

Profile for product number 001

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Boehringer Ingelheim
Healthtrust
Deloitte
Farmers Insurance
UBS
Teva
Moodys
Julphar

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.