MEGESTROL ACETATE - Generic Drug Details

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 Operations, Chartwell, Hikma, Novitium Pharma, Pharmobedient, Strides Pharma Intl, Teva Pharms, Twi Pharms, Barr, Teva, and Usl Pharma, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for megestrol acetate. Fifteen suppliers are listed for this compound.

Summary for MEGESTROL ACETATE

US Patents:	0
Tradenames:	3
Applicants:	12
NDAs:	18
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	88
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
Changchun GeneScience Pharmaceutical Co., Ltd.	PHASE1
Tongji Hospital	PHASE3
The First Affiliated Hospital of Xinxiang Medical College	PHASE3

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

Anatomical Therapeutic Chemical (ATC) Classes for MEGESTROL ACETATE

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03DB	Pregnadien derivatives
G03D	PROGESTOGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

L02AB	Progestogens
L02A	HORMONES AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Usl Pharma	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	070646-001	Oct 2, 1987		DISCN	No	No
Strides Pharma Intl	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	072422-001	Aug 8, 1988	AB	RX	No	No
Bristol Myers Squibb	MEGACE	megestrol acetate	SUSPENSION;ORAL	020264-001	Sep 10, 1993		DISCN	Yes	No
Twi Pharms	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	203139-001	Aug 27, 2014		RX	No	Yes
Strides Pharma Intl	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	072423-001	Aug 8, 1988	AB	RX	No	Yes

Expired US Patents for MEGESTROL ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005
Bristol Myers Squibb	MEGACE	megestrol acetate	SUSPENSION;ORAL	020264-001	Sep 10, 1993
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005

Market Dynamics and Financial Trajectory for Megestrol Acetate

Last updated: November 21, 2025

Introduction

Megestrol acetate, a synthetic progestin, has been pivotal in the treatment of cachexia, anorexia, and certain hormone-responsive cancers. As a regulatory-approved therapy, its market landscape is shaped by evolving medical needs, regulatory policies, and competitive innovations. This analysis explores the current market dynamics, future financial trajectory, and strategic implications for stakeholders invested in or considering the development and commercialization of megestrol acetate.

Pharmacological Profile and Clinical Applications

Megestrol acetate’s primary clinical indication includes the management of cachexia and appetite stimulation in cancer and AIDS patients. It also holds palliative uses for hormone-sensitive tumors. Its efficacy in improving nutritional status and quality of life has cemented its role in supportive cancer care [1].

Recent advancements incorporate its off-label potential for weight management and as an adjuvant in hormone therapy, although regulatory approvals remain limited to specific indications. Solidifying its position within oncology and palliative care paradigms, megestrol acetate’s clinical utility supports steady demand amid evolving treatment guidelines.

Market Size and Segmentation

The global megestrol acetate market was valued at approximately USD 200 million in 2022, with projections indicating a compound annual growth rate (CAGR) of about 4-6% over the next five years [2].

Segments include:

• Oncology Supportive Care: comprising cachexia and anorexia management.
• HIV/AIDS Treatment: appetite stimulation.
• Off-label Uses: weight gain and ancillary cancer therapies.

North America currently dominates the market due to high prevalence rates of cancer and HIV/AIDS, coupled with widespread healthcare infrastructure. Europe maintains significant market shares, bolstered by aging populations. Emerging markets in Asia-Pacific and Latin America show promising growth potential fueled by increasing healthcare access and chronic disease burdens.

Market Drivers

Growing Prevalence of Cancer and HIV/AIDS

Cancer incidence is projected to reach 28.4 million new cases globally by 2040, amplifying demand for supportive care agents like megestrol acetate [3]. Concurrently, HIV/AIDS remains prevalent in regions such as Sub-Saharan Africa, where appetite stimulants are essential to management protocols.

Advancements in Supportive Oncology Care

Oncology guidelines increasingly endorse supportive therapies targeting cachexia, a condition affecting up to 80% of advanced cancer patients [4]. Megestrol acetate’s proven efficacy fuels its continued routine use.

Regulatory Approvals and Evolving Indications

Regulatory clearances in key markets affirm its medical utility, encouraging wider adoption. However, off-label use persists, sometimes limiting formal market expansion.

Patent and Pricing Landscape

Patent expirations have led to the proliferation of generic formulations, significantly reducing drug prices and increasing affordability. Market competition from generics positively influences uptake but constrains revenue potential for branded versions.

Market Challenges

Safety and Side Effect Concerns

Adverse effects like thromboembolic events, fluid retention, and weight gain impact prescribing patterns. Stringent safety profiles necessitate monitoring and limit widespread off-label use.

Regulatory and Reimbursement Barriers

Variability in approval status across countries hampers unified market growth. Reimbursement policies favor high-cost drugs, restricting access in resource-limited settings.

Emergence of Alternative Therapies

Development of novel appetite stimulants, such as ghrelin mimetics and cannabinoids, introduces competition, potentially dampening megestrol acetate’s market share.

Future Financial Trajectory

Key Market Drivers

• Persistent Clinical Need: The ongoing burden of cachexia in cancer management sustains demand. According to recent clinical studies, supportive care remains integral to comprehensive cancer treatment, ensuring steady utilization of megestrol acetate.

• Market Expansion in Emerging Economies: Growing healthcare infrastructure, increased cancer burden, and government health initiatives in Asia-Pacific and Latin America bolster future market size.

• Generic Competition: Price erosion from generics will continue, reducing margins but expanding access, possibly increasing the volume of prescriptions.

Projected Revenue Trends

While global revenues plateaued at around USD 200 million in 2022, the pathway forward suggests modest growth. The overall CAGR is anticipated to hover around 4-5% (2023-2028), driven by incremental demand and expanding patient populations in emerging markets.

Strategic Opportunities

Stakeholders can capitalize on clinical research to broaden indications or optimize formulations to improve safety profiles. Additionally, partnerships with regional distributors may facilitate market penetration.

Regulatory Outlook and Strategic Implications

Regulatory agencies in the US, Europe, and Asia maintain conservative stances pending further safety data, influencing market stability. Companies must prioritize post-market surveillance and advocate for expanded indications, particularly in supportive oncology care.

Innovative formulations—such as long-acting injectables or combination therapies—could differentiate offerings and command premium pricing.

Concluding Perspectives

Megestrol acetate’s market remains characterized by steady demand rooted in its clinical prominence for cachexia and appetite stimulation. The future financial trajectory hinges on optimizing clinical utility, overcoming safety concerns, expanding geographical reach, and competing with emerging therapies. Its journey will be shaped by regulatory pathways, patent landscapes, and evolving treatment standards.

Key Takeaways

• The global megestrol acetate market is expected to grow at a CAGR of approximately 4-6% through 2028, underpinned by the persistent need for supportive care in oncology and HIV/AIDS.
• Generic formulations dominate, exerting downward price pressure but broadening access, especially in emerging markets.
• Safety concerns and emerging therapeutic alternatives present significant challenges; strategic innovations and expanded indications are key to sustaining growth.
• Regulatory and reimbursement landscapes influence market uptake; proactive engagement can facilitate market expansion.
• Stakeholders should prioritize research, formulation improvements, and regional partnerships to enhance market presence and profitability.

FAQs

1. What are the primary clinical indications of megestrol acetate?
   Megestrol acetate is primarily approved for appetite stimulation and weight gain in cancer and AIDS patients, and for palliation of hormone-responsive tumors.

2. How does the patent landscape impact the market for megestrol acetate?
   Patent expirations have led to increased generic competition, reducing prices but expanding accessibility, thereby influencing overall revenue prospects.

3. What are the main safety concerns associated with megestrol acetate?
   Thromboembolic events, fluid retention, and weight fluctuations are notable adverse effects that can limit its off-label use.

4. Which regions offer the most growth potential for megestrol acetate?
   Emerging markets in Asia-Pacific and Latin America present substantial growth opportunities due to increasing cancer prevalence and healthcare infrastructure.

5. Are there emerging therapies that threaten megestrol acetate’s market share?
   Yes, newer appetite stimulants, including ghrelin mimetics and cannabinoids, are emerging alternatives that could challenge megestrol acetate’s dominance in supportive care.

---

References

[1] National Comprehensive Cancer Network. (2022). Supportive Care Guidelines.
[2] MarketWatch. (2023). Global Megestrol Acetate Market Size and Forecast.
[3] WHO. (2022). Global Cancer Observatory Data.
[4] Argilés, J., et al. (2020). Cachexia in Cancer Patients: An Overview. The Lancet Oncology.