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, Strides Pharma, Teva Pharms, Twi Pharms, Xttrium Labs Inc, Barr, Teva, and Usl Pharma, and is included in eighteen NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Megestrol acetate has thirty-six patent family members in nineteen countries.

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

Summary for megestrol acetate

International Patents:	36
US Patents:	5
Tradenames:	3
Applicants:	12
NDAs:	18
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	73
Patent Applications:	7,329
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
National Cancer Institute (NCI)	Phase 1/Phase 2
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Phase 2
Sunnybrook Health Sciences Centre	Phase 1

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
Bristol Myers Squibb	MEGACE	megestrol acetate	TABLET;ORAL	016979-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Xttrium Labs Inc	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	076721-001	Nov 1, 2004		DISCN	No	No
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	AB	RX	Yes	Yes	9,107,827
Strides Pharma	MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	072422-001	Aug 8, 1988	AB	RX	No	No
Twi Pharms	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	203139-001	Aug 27, 2014	AB	RX	No	No

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	9,040,088
Bristol Myers Squibb	MEGACE	megestrol acetate	SUSPENSION;ORAL	020264-001	Sep 10, 1993	5,338,732
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	9,101,540
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	7,101,576

International Patents for megestrol acetate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1494649	PREPARATIONS DE MEGESTROL NANOPARTICULAIRES (NANOPARTICULATE MEGESTROL FORMULATIONS)
Australia	2006262144	Nanoparticulate megestrol formulations
European Patent Office	2263651	Formulations de mégestrol nanoparticulaire (Low viscosity liquid dosage forms)
Eurasian Patent Organization	200800099	КОМПОЗИЦИИ НАНОЧАСТИЦ МЕГЕСТРОЛА
Japan	2006510726

Megestrol acetate Market Analysis and Financial Projection Experimental

Megestrol Acetate Market Dynamics and Financial Trajectory

Market Overview

Megestrol acetate, a synthetic progestin, is widely used for its therapeutic benefits in stimulating appetite in individuals with weight loss due to chronic illnesses such as cancer and HIV/AIDS, as well as for hormonal therapy in advanced endometrial and breast cancers. Here is a detailed look at the market dynamics and financial trajectory of megestrol acetate.

Market Size and Growth

The global megestrol acetate market is projected to grow at a significant compound annual growth rate (CAGR) from 2024 to 2034. The market size is estimated to reach a substantial value in USD million by 2034, driven by an average growth pattern[1].

Key Drivers

Increasing Incidence of Chronic Illnesses

The rising incidence of chronic illnesses, including cancer and HIV/AIDS, which lead to drastic weight loss, is a primary driver of the global megestrol acetate market. This trend is exacerbated by an aging population, where malnutrition-related illnesses are more common[1].

Growing Use in Oncology

The drug's increasing use in oncology, particularly for the treatment of endometrial and breast cancer, is another significant driver. Ongoing research and new product improvements further enhance its efficacy and market demand[1].

Government Initiatives and Healthcare Access

Growing government initiatives, increased access to healthcare, especially in emerging nations, and rising consumer awareness of healthcare also contribute to the market's growth. These factors make megestrol acetate an essential therapeutic choice[1].

Market Segmentation

By Indication

The megestrol acetate market is segmented by indication into cancer treatment, appetite stimulant, and hormonal therapy. The cancer treatment segment accounts for the largest share, approximately 69% in 2024, due to its widespread use in managing cancer-related weight loss and as a component of palliative care[1].

By Region

• North America: This region has a significant market share due to high cancer incidence rates and advanced healthcare infrastructure.
• Europe: The European market is driven by increasing cancer incidence, advancements in medical technology, and supportive healthcare policies. However, diverse healthcare systems and reimbursement structures present challenges[1].
• Asia Pacific: This region is expected to be the fastest-growing segment during the forecast period, driven by expanding healthcare access, increasing cancer rates, and rising investments in healthcare infrastructure[1].

Market Challenges

Side Effects and Adverse Events

Megestrol acetate is associated with several side effects, including weight gain, fluid retention, mood swings, and an elevated risk of blood clots. Serious adverse events such as deep vein thrombosis, pulmonary embolism, and cardiovascular complications can also occur, particularly in older patients[2][5].

Economic and Healthcare Disparities

Economic disparities and uneven development of healthcare infrastructure in various regions, especially in the Asia Pacific, can affect market uniformity and access to treatments, impacting overall growth[1].

Financial Trajectory

Revenue Projections

The global megestrol acetate market is estimated to reach a significant value in USD million by 2034. The revenue growth is expected to be steady, driven by the increasing demand for the drug across various indications and regions[1].

Key Market Players

The market is dominated by a few large companies, including Par Pharmaceutical, Teva Pharmaceuticals, Hi-tech Pharmacal (Akorn), Nanjing Cuccess Pharmaceutical, and Xianju Pharma. These companies play a crucial role in driving market growth through their product offerings and strategic initiatives[1].

Competitive Landscape

Market Competition

The competitive landscape of the megestrol acetate market is characterized by a few dominant players. These companies compete based on product quality, pricing, and market reach. The report provides extensive competitive intelligence, including business overviews, financial data, product/service segment analysis, and recent developments of key players[4].

Research and Development

Ongoing Research

Ongoing research and new product improvements are critical in enhancing the efficacy and safety profile of megestrol acetate. Studies continue to evaluate its effectiveness in various indications and its potential side effects, such as the risk of venous thromboembolism (VTE) in patients receiving megestrol therapy[2].

Regulatory Environment

Approval and Marketing

Megestrol acetate was approved for the treatment of endometrial cancer in 1971 and wasting syndromes in 1993. It is marketed widely throughout the world, with regulatory approvals playing a crucial role in its market presence[5].

Impact of COVID-19

Market Disruptions

The COVID-19 pandemic has had a mixed impact on the megestrol acetate market. While it has disrupted supply chains and healthcare services, it has also highlighted the importance of effective therapeutic options for chronic illnesses, potentially boosting demand for the drug[4].

Key Takeaways

• The megestrol acetate market is driven by the increasing incidence of chronic illnesses, growing use in oncology, and government initiatives.
• The market is segmented by indication and region, with cancer treatment being the largest segment.
• Side effects and adverse events, along with economic and healthcare disparities, are significant challenges.
• The market is dominated by a few large pharmaceutical companies.
• Ongoing research and regulatory approvals are crucial for market growth.

FAQs

Q: What are the primary indications for megestrol acetate?

A: Megestrol acetate is primarily used for cancer treatment, as an appetite stimulant, and for hormonal therapy in conditions like endometrial and breast cancer[1].

Q: What are the common side effects of megestrol acetate?

A: Common side effects include weight gain, fluid retention, mood swings, and an elevated risk of blood clots. Serious adverse events such as deep vein thrombosis and pulmonary embolism can also occur[2][5].

Q: Which region is expected to be the fastest-growing segment for megestrol acetate?

A: The Asia Pacific region is expected to be the fastest-growing segment during the forecast period due to expanding healthcare access and increasing cancer rates[1].

Q: Who are the key players in the megestrol acetate market?

A: The market is dominated by companies such as Par Pharmaceutical, Teva Pharmaceuticals, Hi-tech Pharmacal (Akorn), Nanjing Cuccess Pharmaceutical, and Xianju Pharma[1].

Q: How has the COVID-19 pandemic impacted the megestrol acetate market?

A: The pandemic has had a mixed impact, disrupting supply chains but also highlighting the need for effective therapeutic options for chronic illnesses, potentially boosting demand[4].

Sources

1. We Market Research: Megestrol Acetate Market Size, Scope, Insights & Forecast 2034.
2. American Academy of Family Physicians: Megestrol for Palliative Care in Patients with Cancer.
3. Market Research Intellect: Novel Oral Anticoagulants Drugs Sales Market Size, Scope And Forecast.
4. Stratagem Market Insights: Megestrol Acetate (Megace) Market Analysis 2022: Industry Size, Share, Growth.
5. Wikipedia: Megestrol acetate.