MEGACE Drug Patent Profile

Which patents cover Megace, and when can generic versions of Megace launch?

Megace is a drug marketed by Bristol Myers Squibb and Endo Operations and is included in three NDAs.

The generic ingredient in MEGACE is megestrol acetate. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Megace

A generic version of MEGACE was approved as megestrol acetate by STRIDES PHARMA INTL on August 8^th, 1988.

Summary for MEGACE

US Patents:	0
Applicants:	2
NDAs:	3

US Patents and Regulatory Information for MEGACE

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
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005		DISCN	Yes	No
Bristol Myers Squibb	MEGACE	megestrol acetate	TABLET;ORAL	016979-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Bristol Myers Squibb	MEGACE	megestrol acetate	TABLET;ORAL	016979-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

International Patents for MEGACE

See the table below for patents covering MEGACE around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	9202944	FORMULACION DE ACETATO DE MEGESTEROL.
Denmark	0519351
Israel	102198	Pharmaceutical composition containing megestrol acetate
Hungary	9202029
Greece	3021072

MEGACE Market Analysis and Financial Projection

Last updated: February 3, 2026

What is the market status of MEGACE (megestrol acetate)?

MEGACE, a brand name for megestrol acetate, is primarily indicated for palliative management of advanced or metastatic endometrial or breast carcinoma. It also treats appetite stimulation in AIDS-related cachexia. Although its patent protection expired in the early 2000s, the drug remains available in generic form, with ongoing demand driven largely by niche indications.

How does MEGACE perform in terms of market size and sales?

The global market for megestrol acetate, including MEGACE, is modest, estimated at approximately $50-$70 million annually. The United States accounts for over half the sales, driven by its approved use for appetite stimulation in cachexia. Sales have declined marginally with the availability of alternative therapies and increased off-label use of other agents.

Metric	Data
Estimated global sales	$50-$70 million
US market share	>50%
Growth rate (past 3 years)	~2-3% annual decline

The generic landscape intensifies price competition, pressuring margins for manufacturers.

What are the regulatory and patent considerations?

MEGACE's primary patent expired around 2002. No major patents prevent generic entry, which has led to the widespread availability of generic megestrol acetate. No recent regulatory barriers are reported; it is FDA-approved for its labeled indications.

However, off-label uses, such as for certain cancers and weight gain in chronic disease, are not formally approved but contribute to ongoing demand.

What are the key clinical attributes influencing demand?

• Efficacy: Demonstrated effectiveness for appetite stimulation and palliation in advanced cancers.
• Safety profile: Well-characterized but with risks such as thromboembolic events and adrenal suppression.
• On- and off-label uses: Limited approvals focus on cachexia, but off-label use in other cachexia-associated conditions sustains sales.

What is the competitive environment?

Generic megestrol acetate faces competition from alternatives such as dendritic hormone therapies, corticosteroids, and other appetite stimulants. New agents like anamorelin and other ghrelin receptor agonists are entering the market but have not superseded MEGACE in the niche indications.

What investment considerations arise from the fundamentals?

• The mature, generic status of MEGACE indicates limited revenue growth prospects.
• The stable demand from clinicians managing cachexia maintains baseline sales.
• Price erosion from generics constrains profit margins for manufacturers.
• Potential off-label use expands market, but not reliably.
• No active patent protections or exclusivity blocks competing generic manufacturers.

Overall, MEGACE's investment case depends on market penetration stability in niche indications and potential for new off-label applications rather than growth driven by innovation.

Key takeaways

• MEGACE remains on the market as a generic drug with stable but modest sales.
• Its patent expired more than two decades ago, resulting in a highly competitive generic landscape.
• Demand is sustained primarily by cachexia associated with terminal illnesses.
• Market growth is limited; price competition curtails profitability.
• Off-label uses provide some additional demand but lack regulatory backing for expansion.

FAQs

1. Is MEGACE a high-growth investment?
No, MEGACE’s sales are stable but flat, driven by niche indications and generic competition.

2. Are there any patent protections remaining?
No, primary patent protections expired around 2002, allowing widespread generic production.

3. What are the risks for investors?
Market saturation by generics, limited pipeline, and constrained growth prospects elevate risk.

4. Could new indications revive sales?
Potential off-label growth could occur, but it relies on physician acceptance and peer-reviewed evidence.

5. Are regulatory changes a concern?
Currently, no significant regulatory barriers exist; however, future approval of alternative therapies could impact MEGACE’s market share.

References

[1] IQVIA. (2022). Global Oncology Market Reports.
[2] FDA. (2023). Drug Approval and Patent History for Megestrol Acetate.
[3] MarketWatch. (2023). Appetite Stimulants Market Analysis.