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
Ontario Institute for Cancer Research	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
Usl Pharma	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	070646-001	Oct 2, 1987		DISCN	No	No	⤷ 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
Xttrium Labs Inc	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	076721-001	Nov 1, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	204688-001	Dec 1, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Barr	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	074621-002	Aug 16, 1996	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol Myers Squibb	MEGACE	megestrol acetate	SUSPENSION;ORAL	020264-001	Sep 10, 1993		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	072422-001	Aug 8, 1988	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
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
World Intellectual Property Organization (WIPO)	03086354		⤷ Sign Up
Israel	188322		⤷ Sign Up
South Africa	200800376	Nanoparticulate megestrol formulations	⤷ Sign Up
Eurasian Patent Organization	200800099	КОМПОЗИЦИИ НАНОЧАСТИЦ МЕГЕСТРОЛА	⤷ Sign Up
European Patent Office	1494649	PREPARATIONS DE MEGESTROL NANOPARTICULAIRES (NANOPARTICULATE MEGESTROL FORMULATIONS)	⤷ Sign Up
Slovenia	1494649		⤷ Sign Up
European Patent Office	1901713	FORMULATIONS DE MEGESTROL NANOPARTICULAIRE (NANOPARTICULATE MEGESTROL FORMULATIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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