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Last Updated: April 18, 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 patent protection?

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
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

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
Hikma	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	075997-001	Feb 15, 2002		DISCN	No	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
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
Strides Pharma	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	072422-001	Aug 8, 1988	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
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
>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
Canada	2508301	FORMES POSOLOGIQUES LIQUIDES A FAIBLE VISCOSITE (LOW VISCOSITY LIQUID DOSAGE FORMS)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2007002315		⤷ Try a Trial
South Africa	200800376	Nanoparticulate megestrol formulations	⤷ Try a Trial
Japan	2005527584		⤷ Try a Trial
>Country	>Patent Number	>Title	>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.