MEGACE ES Drug Patent Profile

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

Megace Es is a drug marketed by Endo Operations and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Megace Es

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

Summary for MEGACE ES

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	36
Patent Applications:	4,619
Drug Prices:	Drug price information for MEGACE ES
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MEGACE ES
What excipients (inactive ingredients) are in MEGACE ES?	MEGACE ES excipients list
DailyMed Link:	MEGACE ES at DailyMed

See drug prices for MEGACE ES

Recent Clinical Trials for MEGACE ES

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 ES clinical trials

Paragraph IV (Patent) Challenges for MEGACE ES

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 MEGACE ES

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005		DISCN	Yes	No

Expired US Patents for MEGACE ES

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
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
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

International Patents for MEGACE ES

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

Country	Patent Number	Title	Estimated Expiration
Spain	2298270
Japan	2010111685	NANOPARTICLE COMPOSITION INCLUDING COPOLYMER AS SURFACE STABILIZER
Singapore	159391	NANOPARTICULATE FIBRATE FORMULATIONS
China	1063630
Taiwan	247275
Australia	2003230885	NANOPARTICULATE MEGESTROL FORMULATIONS
World Intellectual Property Organization (WIPO)	03066021

Market Dynamics and Financial Trajectory for Megace ES

Last updated: July 29, 2025

Introduction

Megace ES, an injectable formulation of megestrol acetate, addresses critical oncological and nutritional indications, notably cachexia management in cancer patients. Regulatory approvals, clinical efficacy, patent landscapes, and competitive forces shape its market dynamics. This analysis evaluates factors influencing Megace ES's market evolution and financial trajectory, providing stakeholders and investors with strategic insights.

---

Regulatory Landscape and Market Penetration

Megace ES benefits from regulatory approvals primarily in developed markets, including the U.S. and Europe. The drug's approval by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) prioritizes its therapeutic role in palliation of anorexia-cachexia syndrome associated with malignancies. Its injectable form offers advantages over oral counterparts, such as improved bioavailability and convenience for patients unable to tolerate oral medications, fostering broader clinical adoption.

However, regulatory pathways face scrutiny concerning safety profile and side effects, notably thromboembolic events. Post-marketing surveillance influences ongoing approval and prescribing practices, thereby impacting market penetration.

---

Clinical Efficacy and Competitive Landscape

Megace ES's clinical efficacy in managing cachexia has broad acceptance, yet alternative therapies, including corticosteroids and emerging agents like anamorelin and other ghrelin receptor agonists, are gaining ground. The competitive landscape is shaped by these agents' recent approvals, with some demonstrating superior efficacy or longer-lasting effects.

Manufacturers face the imperative of demonstrating incremental benefits, especially in the context of personalized medicine and patient-centric treatments. The emergence of biosimilars and generics further intensifies price competition, constraining revenue growth.

---

Patent Status and Intellectual Property Rights

Patent protections form a cornerstone of Megace ES's financial outlook. While the original formulation may be nearing patent expiry, secondary patents on delivery mechanisms or formulation specifics can extend exclusivity. Patent litigation or challenges in various jurisdictions influence market exclusivity timelines.

In regions where patent protections lapse, biosimilar and generic manufacturers may introduce competing products, diluting market share and compressing pricing power.

---

Manufacturing and Cost Considerations

Manufacturing of Megace ES involves complex processes to maintain drug stability and sterility, impacting production costs. Advances in manufacturing technology can lower costs, enhancing margins or enabling competitive pricing strategies.

Supply chain reliability, raw material availability, and regulatory compliance in manufacturing are critical factors influencing the financial stability of product supply and revenue streams.

---

Market Trends and Demographic Drivers

The global oncology patient population is expanding due to aging demographics and increased cancer prevalence, fostering demand for supportive care agents like Megace ES. Hospitals and cancer centers are primary channels for administration, with rising outpatient infusion services further broadening potential access points.

Furthermore, growing awareness of cachexia's impact on treatment outcomes incentivizes early intervention, positioning Megace ES favorably should clinicians prefer injectable options for their rapid onset and predictable pharmacokinetics.

---

Pricing Strategy and Reimbursement Landscape

Pricing strategies for Megace ES reflect its positioning as a premium supportive cancer therapy. Reimbursement policies from Medicare, Medicaid, and private insurers significantly influence market uptake.

Given healthcare cost-containment pressures, payers favor cost-effective options. Accordingly, demonstrations of clinical benefit and pharmacoeconomic analyses are pivotal to secure favorable reimbursement terms.

---

Emerging Opportunities and Risks

Innovative formulations, combination therapies, and targeted delivery platforms represent opportunities to enhance Megace ES's market appeal. Conversely, safety concerns, regulatory changes, and the advent of novel cachexia treatments pose ongoing risks.

Furthermore, geopolitical factors, patent disputes, and market access barriers can distort financial trajectories, requiring robust monitoring and strategic flexibility.

---

Financial Trajectory: Projections and Investment Outlook

Current market data suggest a cautious growth pattern for Megace ES’s revenues, influenced by clinical competition, patent protections, and reimbursement policies. Optimistic projections depend on successful market penetration, clinical endorsements, and expansion into new geographic markets.

Forecast models estimate a compound annual growth rate (CAGR) in the low single digits over the next five years, emphasizing the importance of differentiating factors like dosing convenience, safety profile improvements, and cost management to uphold profitability.

Investors should consider patent expiration timelines, pipeline developments, and competitive entry as critical variables shaping future financial performance. Strategic alliances and licensing agreements might sustain market relevance amid patent expirations.

---

Key Takeaways

• Megace ES's market growth hinges on clinical positioning, regulatory support, and competitive differentiation from emerging cachexia therapies.
• Patent protections and regulatory stability are pivotal in sustaining revenue streams; expirations pose significant risks of generic competition.
• Demographics and rising cancer incidences favor increased demand, especially with shifts towards outpatient and home infusion services.
• Cost-effective reimbursement strategies and pharmacoeconomic evidence bolster market access and profitability.
• Innovation and strategic partnering remain essential to extend product life cycle and capitalize on emerging markets.

---

FAQs

1. How does Megace ES compare to oral megestrol acetate formulations?
Megace ES offers improved bioavailability and a rapid onset of action, making it suitable for patients who cannot tolerate oral medications or require quick symptom management. Its injectable form provides consistent dosing, which can be advantageous in clinical settings.

2. What are the key patent considerations for Megace ES?
The original patents on Megace ES cover its formulation and delivery method. Once these patents expire, biosimilar and generic competitors may enter, impacting pricing and market share unless secondary patents or exclusive rights are maintained.

3. How does the safety profile influence Megace ES’s market adoption?
Safety concerns, particularly thromboembolic risks and metabolic effects, can limit prescribing. Clinicians weigh benefits against risks, emphasizing the importance of post-marketing safety data to support broader adoption.

4. What are upcoming patent expirations or regulatory changes that could affect Megace ES?
Patent expirations are anticipated within the next 2–5 years, varying by jurisdiction. Regulatory shifts favoring or restricting supportive cancer therapies can influence market dynamics, especially if new data emerges.

5. Can emerging cachexia treatments threaten Megace ES's market?
Yes. Emerging therapies like anamorelin, which target specific pathways in cachexia, may offer superior efficacy or fewer side effects, potentially capturing market share if they gain regulatory approval and clinician acceptance.

---

References
[1] U.S. Food and Drug Administration. Megestrol Acetate Drug Label. 2022.
[2] European Medicines Agency. Megace ES Summary of Product Characteristics. 2021.
[3] Market Research Future. Global Cachexia Treatment Market Analysis. 2022.
[4] ClinicalTrials.gov. Studies on Megestrol Acetate and Cachexia. 2023.
[5] IQVIA. Oncology Supportive Care Market Report. 2022.