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. There are five 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. Fourteen 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:	5
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 021778

Antineoplastic Agents, Hormonal
Appetite Stimulants
Contraceptives, Oral, Synthetic

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	125MG/ML
Approval Date:	Jul 5, 2005	TE:	AB	RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Apr 22, 2024	Product 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 Trial	Patent Expiration:	Apr 22, 2024	Product 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 Trial	Patent Expiration:	Apr 22, 2024	Product Flag?	Y	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 US Patents for NDA 021778

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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	⤷ Try a Trial	⤷ Try a Trial
Endo Pharms Inc	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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 verification 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.