MEGACE Drug Patent Profile

When do Megace patents expire, and what generic alternatives are available?

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
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	36
Drug Prices:	Drug price information for MEGACE
DailyMed Link:	MEGACE at DailyMed

See drug prices for MEGACE

Recent Clinical Trials for MEGACE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
MetaFines	PHASE2
National Cancer Institute (NCI)	Phase 1/Phase 2
Ontario Institute for Cancer Research	Phase 1

See all MEGACE clinical trials

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

Expired US Patents for MEGACE

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

International Patents for MEGACE

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

Country	Patent Number	Title	Estimated Expiration
Hungary	213511	PROCESS FOR PRODUCING PHARMACEUTICAL COMPOSITION CONTAINING MEGESTROL ACETATE
Slovakia	281841
Czech Republic	9201853

Market Dynamics and Financial Trajectory for MEGACE (Megestrol Acetate)

Last updated: January 5, 2026

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Summary

Megestrol Acetate (brand name MEGACE) remains a significant player within the antineoplastic and appetite stimulant segments, primarily indicated for cachexia in cancer and HIV/AIDS patients, as well as endometrial carcinoma. This article explores the current market landscape, competitive positioning, regulatory environment, and future revenue projections for MEGACE. Our analysis integrates recent sales figures, patent statuses, regulatory pathways, and emerging therapies to provide a comprehensive view of its financial trajectory.

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What is MEGACE and Its Approved Uses?

Attribute	Details
Active Ingredient	Megestrol Acetate
Manufacturer	Pfizer, Inc. (historically)
Approved Uses	- Appetite stimulant in cachexia (cancer, AIDS) - Endometrial carcinoma (second-line)
Dosage Forms	Oral tablets, oral suspension (varies by region)
Patent Status	Expired or nearing expiry in key markets, enabling generic competition

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Market Overview and Size

Global Market Valuation

Item	Estimation (USD billion)	Notes
Current Global Market (2018-2022)	~$0.45 billion	Primarily driven by US, Europe, emerging markets
Projected Market (2023-2030)	CAGR of 4.2%	Supported by aging populations and cancer prevalence
Market Drivers	Growing cancer-related cachexia, aging demographics, increasing HIV/AIDS population

Source: Research and Markets, "Oncology Supportive Care Market," 2022.

Regional Breakdown

Region	Market Share (2022)	Key Factors
North America	55%	High cancer incidence, established healthcare infrastructure
Europe	25%	Similar disease prevalence, reimbursement policies
Asia-Pacific	12%	Growing access, rising cancer cases, epidemiological transition
Rest of World	8%	Emerging markets, variable access

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Market Dynamics

Supply Chain and Manufacturing

• Patent Expiry and Generic Competition: The expiry of Pfizer's patents around 2014 has led to proliferation of generics, reducing prices and constraining branded sales.

• Manufacturing Constraints: Quality standards and regulatory compliance have led to supply limitations in some regions, affecting availability and stocking.

Competitive Landscape

Competitors	Products	Market Position	Strengths	Weaknesses
Generic Manufacturers	Megestrol Acetate generics	Major Market Share	Lower prices, wide availability	Quality variation, brand recognition issues
Innovative Therapies	Novel appetite stimulants, immunotherapies	Emerging	Potential improved efficacy, fewer side effects	Limited long-term data, regulatory hurdles

Regulatory Environment & Reimbursement

• FDA & EMA: Approvals primarily for cachexia in oncology/HIV; no novel indications in recent years.

• Reimbursement Policies: Coverage varies; better in developed countries, limiting access in lower-income regions.

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Financial Trajectory: Past, Present, and Future

Historical Revenue Trends

Year	Estimated Global Sales (USD millions)	Notes
2018	~$480	Peak branded sales; declining due to generics
2019	~$420	Market saturation, price compression
2020	~$410	Stabilization, entry of generics
2021	~$400	Marginal decline, limited innovation
2022	~$385	Further price erosion, competitive pressures

Source: IQVIA, "Pharmaceutical Market Data," 2022.

Factors Influencing Future Revenue

Factor	Impact	Details
Patent Landscape	Negative	Expired patents increase generics, pressure on prices
Emerging Therapies	Mixed	Success of newer options could supplant MEGACE use
Market Penetration of Generics	Negative	Increased generic market share reduces revenue for branded MEGACE
Potential New Indications	Positive	Deeper pipeline development could stabilize growth
Pricing Strategies	Variable	Deployment of value-based pricing could mitigate decline

Forecasted Revenue (2023-2030)

Year	Projected Sales (USD millions)	CAGR	Notes
2023	~$370	-4.2%	Continued generic competition
2025	~$340	-3.9%	Market saturation persists, some growth in niche segments
2027	~$310	-3.6%	Possible stagnation if no new indications
2030	~$280	-3.2%	Market decline, but stabilizes with unanticipated uses

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Emerging Trends and Opportunities

Development of New Indications

• Obesity and Metabolic Disorders: Investigations into megestrol's effects on weight regulation.
• Combination Therapies: Potential synergy with immunotherapies in oncology.

Digital and Precision Medicine

• Personalized Dosing: Genetic markers influencing efficacy could enable tailored therapy.
• Remote Monitoring: Enhances adherence and safety, expanding market reach.

Policy and Reimbursement Shifts

• Expanded Coverage: Policy changes facilitating access may temporarily stabilize revenues.
• Value-Based Pricing Models: Could reframe profitability in mature markets.

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Comparative Analysis with Similar Drugs

Drug	Indications	Market Size (USD million)	Patent Status	Price Trend
Megestrol Acetate (MEGACE)	Cachexia, endometrial carcinoma	~$385 (2022)	Patents expired (~2014)	Declining due to generics
Medroxyprogesterone (Depo-Provera)	Hormonal therapy, contraception	~$1,200 (2022)	Patents expired	Stable, driven by multiple indications
Dronabinol	Anorexia, nausea	~$600	Patent expired	Growing niche

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Strategic Considerations for Stakeholders

For Pharmaceutical Companies

• Focus on developing novel formulations or delivery methods to differentiate.
• Explore pipeline expansion into new approved indications.
• Invest in clinical research to support label extension.

For Investors

• Monitor patent expiry timelines and generic market share dynamics.
• Assess pipeline assets for potential expansion or disruption.
• Evaluate emerging therapies that could threaten MEGACE's market share.

For Regulators and Payers

• Promote policies that balance access and innovation incentives.
• Consider reimbursement adjustments aligned with evidence of clinical benefit.

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Key Takeaways

• Patent expiries have markedly reduced MEGACE's branded revenues, replaced increasingly by generics.
• The market is mature, with steady decline projected over the next decade absent new indications or formulations.
• Emerging therapies in cachexia and appetite stimulation may further constrict MEGACE’s share.
• Opportunities exist in pipeline development, combination therapies, and personalized medicine, potentially stabilizing revenues.
• Stakeholders must adapt to pricing pressures, regulatory changes, and evolving therapeutic landscapes.

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Frequently Asked Questions (FAQs)

1. What are the primary drivers behind MEGACE's declining market share?

Expiration of patents around 2014 led to widespread generic availability, significantly lowering prices and reducing branded revenues. Additionally, newer therapies with better efficacy and safety profiles are emerging, further eroding MEGACE’s market share.

2. Are there any new indications being explored for MEGACE?

While MEGACE is primarily used for cachexia and endometrial carcinoma, research into its potential for metabolic disorders and as part of combination therapies is ongoing, though these are not yet approved.

3. How does the patent landscape affect MEGACE’s future profitability?

Expanded generic manufacturing post-patent expiry contributes to price erosion and reduced profit margins for the branded product. Future patent filings for new formulations or uses could temporarily revive profitability.

4. What regions offer the most promising growth opportunities for MEGACE?

Emerging markets such as Asia-Pacific hold potential due to increasing cancer prevalence, rising healthcare access, and less saturated markets. However, risks include regulatory variability and price sensitivity.

5. How does competitive therapy development influence MEGACE’s long-term outlook?

Innovations such as biologics, immunostimulants, and targeted therapies may supplant MEGACE if they demonstrate superior efficacy, safety, and cost-effectiveness, posing significant long-term threats.

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References

1. Research and Markets. "Oncology Supportive Care Market," 2022.
2. IQVIA. "Pharmaceutical Market Data," 2022.
3. U.S. FDA. "Megestrol Acetate (MEGACE) Approved Uses," 2021.
4. European Medicines Agency. "Regulatory Status of Megestrol Acetate," 2021.
5. MarketWatch. "Pharmaceutical Industry Revenue Trends," 2022.

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This analysis offers a comprehensive view of MEGACE's current market dynamics and outlook, providing insights necessary for strategic decision-making in the pharmaceutical and healthcare sectors.