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Megestrol acetate - Generic Drug Details

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What are the generic drug sources for megestrol acetate and what is the scope of patent protection?

Megestrol acetate is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Endo Pharms Inc, Breckenridge, Hi Tech, Hikma, Par Pharm, Pharm Assoc, Teva Pharms, Twi Pharms, Wockhardt Bio Ag, Barr, Teva, and Usl Pharma, and is included in eighteen NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Megestrol acetate has one hundred and ninety-eight patent family members in twenty-eight countries.

There are eighteen drug master file entries for megestrol acetate. Seventeen suppliers are listed for this compound.

Summary for megestrol acetate

International Patents:	198
US Patents:	6
Tradenames:	3
Applicants:	13
NDAs:	18
Drug Master File Entries:	18
Suppliers / Packagers:	17
Bulk Api Vendors:	80
Clinical Trials:	58
Patent Applications:	5,023
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for megestrol acetate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for megestrol acetate
DailyMed Link:	megestrol acetate at DailyMed

See drug prices for megestrol acetate

Recent Clinical Trials for megestrol acetate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Zagazig University	Phase 2/Phase 3
Children's Hospital of Fudan University	Phase 4
University of Kansas Medical Center	Phase 4

See all megestrol acetate clinical trials

Pharmacology for megestrol acetate

Drug Class

Progestin

Medical Subject Heading (MeSH) Categories for megestrol acetate

Antineoplastic Agents, Hormonal

Appetite Stimulants

Contraceptives, Oral, Synthetic

Paragraph IV (Patent) Challenges for MEGESTROL ACETATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
MEGACE ES	SUSPENSION;ORAL	megestrol acetate	021778	2011-04-27
MEGACE	SUSPENSION;ORAL	megestrol acetate	020264

US Patents and Regulatory Information for megestrol acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	075681-001	May 5, 2003		DISCN	No	No
Barr	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	074621-002	Aug 16, 1996	AB	RX	No	No
Barr	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	074621-001	Nov 30, 1995	AB	RX	No	No
Teva	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	074745-001	Feb 27, 1998		DISCN	No	No
Bristol Myers Squibb	MEGACE	megestrol acetate	SUSPENSION;ORAL	020264-001	Sep 10, 1993		DISCN	Yes	No
Wockhardt Bio Ag	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	076721-001	Nov 1, 2004	AB	RX	No	No
Endo Pharms Inc	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	AB	RX	Yes	Yes

Expired US Patents for megestrol acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	MEGACE	megestrol acetate	SUSPENSION;ORAL	020264-001	Sep 10, 1993
Endo Pharms Inc	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005
Endo Pharms Inc	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005

International Patents for megestrol acetate

Country	Patent Number	Estimated Expiration
Austria	556702
Canada	2386782
Japan	2005527584
World Intellectual Property Organization (WIPO)	0018374
Japan	2011037876
European Patent Office	1471887
Japan	2003533465