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. There are five patents protecting this drug.

The generic ingredient in MEGACE is megestrol acetate. There are eighteen drug master file entries for this compound. Seventeen 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 on August 8^th, 1988.

Summary for MEGACE

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	35
Patent Applications:	4,217
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
National Cancer Institute (NCI)	Phase 1/Phase 2
Ontario Institute for Cancer Research	Phase 1
Sunnybrook Health Sciences Centre	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	AB	RX	Yes	Yes
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	AB	RX	Yes	Yes
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	AB	RX	Yes	Yes

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
Spain	2091977
Canada	2071141
Hungary	213511	PROCESS FOR PRODUCING PHARMACEUTICAL COMPOSITION CONTAINING MEGESTROL ACETATE
Israel	102198	Pharmaceutical composition containing megestrol acetate

MEGACE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Megestrol Acetate (Megace)

Overview of Megestrol Acetate (Megace)

Megestrol acetate, marketed under the brand name Megace among others, is a progestin medication primarily used as an appetite stimulant to treat wasting syndromes such as cachexia, particularly in patients with AIDS or cancer. It also has applications in the treatment of breast cancer, endometrial cancer, and other conditions[4].

Market Size and Forecast

The global megestrol acetate market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent from its current valuation. This growth is projected over the forecast period of 2024-2031, with the market size expected to increase significantly during this time frame[1].

Segmentation of the Market

The megestrol acetate market is segmented based on several key factors:

By Application

• Hospital: A significant portion of the market, given the frequent use of megestrol acetate in hospital settings for treating patients with severe weight loss and cachexia.
• Clinic: Clinics also play a crucial role, especially for outpatient treatment and follow-up care.
• Other: This includes home care, nursing homes, and other healthcare facilities where megestrol acetate may be administered[1].

By Product

• Suspension: The oral suspension form is a dominant product type, known for its ease of administration and bioavailability.
• Tablets: While less common, tablets are also available and may be preferred in certain cases due to patient compliance or specific clinical needs[1].

By Geography

• North America: A major market due to the high prevalence of conditions requiring megestrol acetate treatment and advanced healthcare infrastructure.
• Europe: Another significant market with a strong healthcare system and high demand for the drug.
• Asia-Pacific: This region is expected to show substantial growth due to increasing healthcare spending and a large patient population.
• South America and Middle-East & Africa: These regions also contribute to the market, though to a lesser extent compared to North America and Europe[1].

Key Companies and Market Competition

The market for megestrol acetate is competitive, with several key players:

• Par Pharmaceutical (Endo International): Known for developing the Megace ES oral suspension using Elan Corporation's NanoCrystal Dispersion (NCD) technology, which offers improved bioavailability and a more convenient dosing regimen[3].
• Teva Pharmaceuticals: Involved in a legal dispute with Par Pharmaceutical over patent infringement but eventually settled with a licensing agreement[3].
• Hikma (West-Ward Pharm): Another major player in the market, contributing to the availability of megestrol acetate formulations.
• Other Companies: Include Twi Pharmaceuticals, Hi-Tech Pharmacal (Akorn), Nanjing Cuccess Pharmaceutical, Xianju Pharma, Jiangsu Nhwa Pharmaceutical, and Qingdao Guohai Biological Pharmaceutical[1].

Clinical Efficacy and Usage

Megestrol acetate has been clinically proven to be effective in stimulating appetite and inducing weight gain in patients with cachexia associated with AIDS and cancer. Clinical trials have shown that high doses of megestrol acetate can significantly increase appetite and weight in these patients. For example, a multicenter, randomized, double-blind, placebo-controlled study demonstrated that 64% of patients receiving 800 mg/day of megestrol acetate gained five or more pounds over a 12-week period[2].

Pharmacokinetics and Pharmacodynamics

Megestrol acetate has a mean elimination half-life of 34 hours, with a range of 13 to 105 hours. It is metabolized in the liver and has high bioavailability. The drug exhibits progestogenic, antigonadotropic, and weak glucocorticoid activities, which contribute to its therapeutic effects[4].

Side Effects and Safety Profile

While effective, megestrol acetate can have significant side effects, including an increased risk of respiratory infections, decreased lymphocyte counts, and increased neutrophil counts. Long-term use may also lead to manifestations of glucocorticoid activity such as Cushing's syndrome and adrenal insufficiency[2][4].

Financial Trajectory

The financial trajectory of the megestrol acetate market is influenced by several factors:

Market Growth Drivers

• Increasing Prevalence of Chronic Diseases: The rising incidence of cancer, AIDS, and other conditions that lead to cachexia drives the demand for megestrol acetate.
• Advancements in Formulations: Improved formulations like the NanoCrystal Dispersion (NCD) technology enhance patient compliance and bioavailability, contributing to market growth[3].

Market Restraints

• Side Effects and Safety Concerns: The potential for serious side effects can limit the market growth.
• Legal and Patent Issues: Disputes over patent infringement, as seen between Par Pharmaceutical and Teva Pharmaceuticals, can impact market dynamics[3].

Pricing and Generic Availability

• Generic Versions: The availability of generic versions of megestrol acetate can reduce costs and increase accessibility, but may also reduce revenue for branded products[5].

Key Takeaways

• The global megestrol acetate market is expected to grow at a CAGR of 3 to 5 percent from 2024 to 2031.
• The market is segmented by application, product form, and geography, with North America and Europe being major contributors.
• Key companies include Par Pharmaceutical, Teva Pharmaceuticals, and Hikma, among others.
• Megestrol acetate is clinically effective in treating cachexia but comes with significant side effects.
• The financial trajectory is influenced by the increasing prevalence of chronic diseases, advancements in formulations, and legal and patent issues.

FAQs

What is megestrol acetate used for?

Megestrol acetate is primarily used as an appetite stimulant to treat wasting syndromes such as cachexia, particularly in patients with AIDS or cancer. It is also used in the treatment of breast cancer, endometrial cancer, and other conditions.

What are the common side effects of megestrol acetate?

Common side effects include an increased risk of respiratory infections, decreased lymphocyte counts, and increased neutrophil counts. Long-term use may lead to manifestations of glucocorticoid activity such as Cushing's syndrome and adrenal insufficiency.

How does the NanoCrystal Dispersion (NCD) technology improve megestrol acetate?

The NCD technology developed by Par Pharmaceutical improves the bioavailability of megestrol acetate, allows for a more rapid onset of action, and provides a more convenient dosing regimen compared to the original formulation.

What is the market segmentation for megestrol acetate?

The market is segmented by application (hospital, clinic, other), product form (suspension, tablets), and geography (North America, Europe, Asia-Pacific, South America, Middle-East & Africa).

Which companies are key players in the megestrol acetate market?

Key companies include Par Pharmaceutical (Endo International), Teva Pharmaceuticals, Hikma (West-Ward Pharm), Twi Pharmaceuticals, Hi-Tech Pharmacal (Akorn), and several others.

Sources

1. Market Research Intellect: Global Megestrol Acetate Megace Market Size And Forecast.
2. FDA: Megace® - accessdata.fda.gov.
3. PubMed: Megestrol acetate NCD oral suspension -- Par Pharmaceutical.
4. Wikipedia: Megestrol acetate.
5. Drugs.com: Megace Alternatives Compared.