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Last Updated: April 26, 2024

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 Pharms Inc, Bionpharma, 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. Thirteen 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:	13
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	73
Patent Applications:	7,364
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

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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
Bristol Myers Squibb	MEGACE	megestrol acetate	SUSPENSION;ORAL	020264-001	Sep 10, 1993		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Pharms	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	075681-001	May 5, 2003		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	074458-002	Sep 29, 1995		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Xttrium Labs Inc	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	076721-001	Nov 1, 2004		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bristol Myers Squibb	MEGACE	megestrol acetate	TABLET;ORAL	016979-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Usl Pharma	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	070647-001	Oct 2, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Barr	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	074621-001	Nov 30, 1995	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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 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
Endo Pharms Inc	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	⤷ Try a Trial	⤷ Try a Trial
Bristol Myers Squibb	MEGACE	megestrol acetate	SUSPENSION;ORAL	020264-001	Sep 10, 1993	⤷ 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
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

International Patents for MEGESTROL ACETATE

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Country	Patent Number	Title	Estimated Expiration
Japan	2010248220	NANOPARTICULATE MEGESTROL FORMULATION	⤷ Try a Trial
South Africa	200800376	Nanoparticulate megestrol formulations	⤷ Try a Trial
Austria	539737		⤷ Try a Trial
Denmark	1494649		⤷ Try a Trial
European Patent Office	1494649	PREPARATIONS DE MEGESTROL NANOPARTICULAIRES (NANOPARTICULATE MEGESTROL FORMULATIONS)	⤷ Try a Trial
Japan	2005527584		⤷ Try a Trial
European Patent Office	1935407	Formules de dosage de liquide à faible viscosité (Low viscosity liquid dosage forms)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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