Megestrol acetate - Generic Drug Details

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What are the generic drug sources for megestrol acetate and what is the scope of freedom to operate?

Megestrol acetate is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Endo Operations, Chartwell, Hikma, Novitium Pharma, Strides Pharma, Teva Pharms, Twi Pharms, Xttrium Labs Inc, 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. Sixteen suppliers are listed for this compound.

Summary for megestrol acetate

International Patents:	36
US Patents:	5
Tradenames:	3
Applicants:	12
NDAs:	18
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	73
Patent Applications:	7,435
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

Anatomical Therapeutic Chemical (ATC) Classes for megestrol acetate

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xttrium Labs Inc	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	076721-001	Nov 1, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol Myers Squibb	MEGACE	megestrol acetate	TABLET;ORAL	016979-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	074745-001	Feb 27, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	203960-001	Jun 9, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	075671-001	Jul 25, 2001	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Twi Pharms	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	203139-001	Aug 27, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for megestrol acetate

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

International Patents for megestrol acetate

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1494649	PREPARATIONS DE MEGESTROL NANOPARTICULAIRES (NANOPARTICULATE MEGESTROL FORMULATIONS)	⤷ Sign Up
European Patent Office	1613276	FORMES POSOLOGIQUES LIQUIDES A FAIBLE VISCOSITE (LOW VISCOSITY LIQUID DOSAGE FORMS)	⤷ Sign Up
Mexico	2008000396	FORMULACIONES DE MEGESTROL EN NANOPARTICULA. (NANOPARTICULATE MEGESTROL FORMULATIONS.)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	03086354		⤷ Sign Up
Spain	2380318		⤷ Sign Up
Canada	2613466	FORMULATIONS DE MEGESTROL NANOPARTICULAIRE (NANOPARTICULATE MEGESTROL FORMULATIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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