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. Fourteen 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 on August 8^th, 1988.

Summary for MEGACE ES

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	35
Patent Applications:	4,472
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
National Cancer Institute (NCI)	Phase 1/Phase 2
Sunnybrook Health Sciences Centre	Phase 1
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	AB	RX	Yes	Yes

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	5,145,684
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	9,101,549
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	9,040,088
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	6,592,903
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	9,101,540
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	7,101,576

International Patents for MEGACE ES

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

Country	Patent Number	Title	Estimated Expiration
Australia	1014792
Hungary	9301917
Japan	2010248220	NANOPARTICULATE MEGESTROL FORMULATION
Portugal	499299
South Korea	101216853
World Intellectual Property Organization (WIPO)	03066021

Market Dynamics and Financial Trajectory for MEGACE ES

Overview of MEGACE ES

MEGACE ES, a formulation of megestrol acetate, is a medication primarily used to treat anorexia, cachexia, and significant, unexplained weight loss in patients with conditions such as AIDS, cancer, and other chronic diseases. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Segmentation

By Drug

The global appetite stimulant market is dominated by the Megestrol Acetate segment, which includes MEGACE ES. This segment is expected to experience significant growth due to the increasing number of patients suffering from chronic diseases like cancer and AIDS[1].

By Distribution Channel

The retail pharmacy segment is the primary distribution channel for MEGACE ES, driven by consumer preference for established brick-and-mortar pharmacies. This segment is anticipated to continue its dominance as emerging economies see an expansion in their pharmaceutical retail sectors[1].

By End-User

Hospitals are the major end-users of MEGACE ES, given their large consumer base and role in in-patient care. The expansion of healthcare infrastructure in emerging economies further boosts the demand for this medication in hospitals[1].

Market Drivers

Increasing Prevalence of Chronic Diseases

The rising number of patients with chronic diseases such as cancer, AIDS, and other conditions drives the demand for appetite stimulants like MEGACE ES. These patients often suffer from anorexia and weight loss, making MEGACE ES a critical treatment option[1].

Economic Development in Emerging Economies

Economic growth and improved healthcare infrastructure in emerging markets like India, China, Brazil, and several African nations are key drivers. These regions are experiencing an increase in the use of Megestrol Acetate due to better access to healthcare and a growing middle class with higher purchasing power[1].

Financial Performance

Sales and Revenue

As of 2015, the total annual sales of MEGACE ES in the U.S. were approximately $44 million. This figure indicates a significant market presence and revenue generation for the drug[3].

Pricing and Affordability

The cost of MEGACE ES oral suspension can vary, with a supply of 150 milliliters costing around $691. However, generic versions are available at lower prices, such as $280.47 for 100 milliliters, making the medication more affordable for a broader range of patients[5].

Generic Competition

The launch of generic versions of MEGACE ES by companies like TWi Pharmaceuticals has introduced competition, which can impact the pricing and market share of the branded product. TWi Pharmaceuticals was granted 180-day generic market exclusivity by the US FDA, which can influence the financial trajectory of the drug[3].

Clinical Efficacy and Mechanism of Action

Clinical Trials

MEGACE ES has been clinically proven to be effective in treating anorexia and cachexia. In clinical trials, patients treated with MEGACE ES showed significant weight gain and improvements in appetite and overall well-being compared to the placebo group[2].

Mechanism of Action

Although the precise mechanism by which megestrol acetate stimulates appetite is unknown, it is believed to involve the regulation of hormones that control hunger and satiety. This makes MEGACE ES a valuable treatment option for patients suffering from appetite loss and weight loss associated with chronic diseases[2].

Pharmacokinetics and Safety

Pharmacokinetic Studies

Pharmacokinetic studies have shown that the plasma concentrations of megestrol acetate are linear in the dosing range between 150 mg and 675 mg, regardless of meal conditions. However, a high-fat meal can increase the peak plasma concentration and area under the concentration-time curve[2][4].

Safety Profile

Long-term treatment with MEGACE ES may increase the risk of respiratory infections. However, clinical trials have shown that the drug is generally well-tolerated, with no significant differences in laboratory abnormalities or new opportunistic infections compared to the placebo group[2][4].

Expansion into Emerging Markets

Growth Opportunities

The Asia-Pacific region, with its large population and growing middle class, presents a significant growth opportunity for MEGACE ES. Pharmaceutical companies can invest in research, development, and marketing to capitalize on this market, although developing affordable and locally compliant medications remains a challenge[1].

Key Takeaways

• Market Dominance: MEGACE ES dominates the appetite stimulant market, driven by its effectiveness in treating anorexia and cachexia.
• Distribution Channels: Retail pharmacies are the primary distribution channels, with hospitals being major end-users.
• Financial Performance: The drug generates significant revenue, with annual sales in the U.S. reaching $44 million as of 2015.
• Generic Competition: The availability of generic versions impacts pricing and market share.
• Clinical Efficacy: MEGACE ES is clinically proven to improve appetite and weight in patients with chronic diseases.
• Pharmacokinetics and Safety: The drug has a favorable pharmacokinetic profile but may increase the risk of respiratory infections.

FAQs

What is MEGACE ES used for?

MEGACE ES is used to treat anorexia, cachexia, and significant, unexplained weight loss in patients with conditions such as AIDS, cancer, and other chronic diseases.

How does MEGACE ES work?

MEGACE ES works by stimulating the release of hormones that regulate hunger and satiety, although the precise mechanism is unknown.

What are the primary distribution channels for MEGACE ES?

The primary distribution channels for MEGACE ES are retail pharmacies and hospital pharmacies.

What is the financial impact of generic competition on MEGACE ES?

The introduction of generic versions of MEGACE ES can reduce the pricing and market share of the branded product, making the medication more affordable for patients.

What are the potential side effects of long-term MEGACE ES treatment?

Long-term treatment with MEGACE ES may increase the risk of respiratory infections.

How does economic development in emerging economies affect the demand for MEGACE ES?

Economic growth and improved healthcare infrastructure in emerging economies increase access to healthcare and drive the demand for MEGACE ES.

Sources

1. MarketResearch.biz: Appetite Stimulant Market Size, Share, Trends | Forecast 2032
2. FDA: Megace® ES Megestrol acetate 625 mg/5 mL oral suspension
3. TWi Pharmaceuticals: News - TWi Pharmaceuticals
4. FDA: Megace® ES (megestrol acetate, USP) Oral Suspension
5. Drugs.com: Megace ES Prices, Coupons, Copay Cards & Patient Assistance