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Last Updated: October 23, 2021

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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, Akorn, Breckenridge, Hikma Pharms, Par Pharm, Pharm Assoc, 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 eighteen drug master file entries for megestrol acetate. Fifteen 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:	18
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	63
Patent Applications:	6,442
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
Wake Forest University Health Sciences	Phase 3
University Health Network, Toronto	Phase 1
Huashan Hospital	Phase 2/Phase 3

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

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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
Par Pharm	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	072423-001	Aug 8, 1988	AB	RX	No	Yes	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Usl Pharma	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	070647-001	Oct 2, 1987		DISCN	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Akorn	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	203960-001	Jun 9, 2017	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Endo Pharms Inc	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	AB	RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free	Y			⤷ Try it Free
Par Pharm	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	072422-001	Aug 8, 1988	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
>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
Bristol Myers Squibb	MEGACE	megestrol acetate	SUSPENSION;ORAL	020264-001	Sep 10, 1993	⤷ Try it Free	⤷ Try it Free
Endo Pharms Inc	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	⤷ Try it Free	⤷ Try it Free
Endo Pharms Inc	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	⤷ Try it Free	⤷ Try it Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for megestrol acetate

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Country	Patent Number	Estimated Expiration
Slovenia	1494649	⤷ Try it Free
Japan	2005527584	⤷ Try it Free
Australia	2003231071	⤷ Try it Free
World Intellectual Property Organization (WIPO)	03086354	⤷ Try it Free
Mexico	2008000396	⤷ Try it Free
>Country	>Patent Number	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.