Megestrol acetate - Generic Drug Details

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, Akorn, Breckenridge, Hikma, Pharm Assoc, Strides Pharma, Teva Pharms, Twi Pharms, Wockhardt Bio Ag, Barr, Teva, and Usl Pharma, and is included in eighteen NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Megestrol acetate has thirty-six patent family members in nineteen countries.

There are seventeen drug master file entries for megestrol acetate. Fourteen suppliers are listed for this compound.

Summary for megestrol acetate

International Patents:	36
US Patents:	5
Tradenames:	3
Applicants:	13
NDAs:	18
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	73
Patent Applications:	7,223
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
What excipients (inactive ingredients) are in megestrol acetate?	megestrol acetate excipients list
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
National Cancer Institute (NCI)	Phase 1/Phase 2
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Phase 2
Sunnybrook Health Sciences Centre	Phase 1

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	Strength	NDA	ANDAs Submitted	Submissiondate
MEGACE ES	Oral Suspension	megestrol acetate	125 mg/mL	021778	1	2011-04-27

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
Usl Pharma	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	070646-001	Oct 2, 1987		DISCN	No	No
Endo Pharms Inc	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	AB	RX	Yes	Yes
Endo Pharms Inc	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	AB	RX	Yes	Yes
Bristol Myers Squibb	MEGACE	megestrol acetate	TABLET;ORAL	016979-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Endo Pharms Inc	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	AB	RX	Yes	Yes
Strides Pharma	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	072423-001	Aug 8, 1988	AB	RX	No	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	Title	Estimated Expiration
Japan	2008546796
Mexico	2008000396	FORMULACIONES DE MEGESTROL EN NANOPARTICULA. (NANOPARTICULATE MEGESTROL FORMULATIONS.)
Denmark	1494649
Israel	188322
Canada	2481390	PREPARATIONS DE MEGESTROL NANOPARTICULAIRES (NANOPARTICULATE MEGESTROL FORMULATIONS)
Australia	2003230885	NANOPARTICULATE MEGESTROL FORMULATIONS
Slovenia	1494649