Suppliers and packagers for generic pharmaceutical drug: MEGESTROL ACETATE

MEGESTROL ACETATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novitium Pharma	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	077404	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1038-00	10 TRAY in 1 CASE (0121-1038-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10)	2025-10-17
Novitium Pharma	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	077404	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1038-40	4 TRAY in 1 CASE (0121-1038-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10)	2025-10-17
Novitium Pharma	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	077404	ANDA	Major Pharmaceuticals	0904-7577-18	4 TRAY in 1 CASE (0904-7577-18) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7577-66)	2025-12-29
Novitium Pharma	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	077404	ANDA	Major Pharmaceuticals	0904-7577-72	10 TRAY in 1 CASE (0904-7577-72) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7577-66)	2025-12-29
Novitium Pharma	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	077404	ANDA	American Health Packaging	60687-916-08	3 TRAY in 1 CASE (60687-916-08) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-916-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-916-42)	2026-01-05

Megestrol Acetate: Key Pharmaceutical Suppliers and Patent Landscape

Last updated: February 19, 2026

This report identifies major suppliers of Megestrol Acetate, analyzes relevant patent filings, and outlines key market considerations for pharmaceutical companies. The analysis focuses on active pharmaceutical ingredient (API) manufacturers and their product offerings, alongside an overview of the patent landscape impacting market entry and exclusivity.

Who are the primary manufacturers of Megestrol Acetate API?

Key suppliers of Megestrol Acetate Active Pharmaceutical Ingredient (API) include a mix of established generic manufacturers and specialized chemical synthesis companies. These entities operate globally, adhering to stringent regulatory standards for pharmaceutical production.

• Asia-Pacific Dominance: The majority of large-scale Megestrol Acetate API production is concentrated in India and China. These regions benefit from lower manufacturing costs and a well-developed chemical synthesis infrastructure.
• Key Players:
  • Gland Pharma: An Indian-based pharmaceutical company with a significant presence in API manufacturing. They are known for supplying a broad range of APIs, including hormonal products.
  • Divi's Laboratories: Another Indian API manufacturer recognized for its complex chemistry capabilities and large-scale production. They supply APIs to major global pharmaceutical firms.
  • Sun Pharmaceutical Industries: A leading Indian pharmaceutical company with integrated operations, including API development and manufacturing.
  • Lupin Limited: An Indian multinational pharmaceutical company with substantial API manufacturing capacity.
  • WuXi AppTec: A Chinese pharmaceutical and medical device outsourcing company that offers API development and manufacturing services. While not solely a Megestrol Acetate supplier, their contract manufacturing services can include this compound for clients.
  • Pfizer Inc. (through legacy manufacturing): While Pfizer is primarily an innovator, historical manufacturing of Megestrol Acetate under brand names like Megace historically involved significant internal production. Current API supply may involve contract manufacturers.
• Product Specifications: API suppliers typically offer Megestrol Acetate in various grades, meeting pharmacopeial standards such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia). Purity levels are critical, generally exceeding 99.0%. Particle size distribution and polymorphic forms are also specified by API manufacturers to ensure consistent drug product performance.
• Regulatory Compliance: Manufacturers must comply with Good Manufacturing Practices (GMP) as mandated by regulatory bodies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. This includes robust quality control, batch traceability, and impurity profiling.

What is the patent landscape for Megestrol Acetate?

The patent landscape for Megestrol Acetate is characterized by expired composition of matter patents, with ongoing activity focused on formulations, manufacturing processes, and new therapeutic uses.

• Original Composition of Matter Patents: The foundational patents covering the Megestrol Acetate molecule itself have long expired. The original synthesis and identification of Megestrol Acetate date back to the mid-20th century.
• Key Expiration Dates: While specific patent numbers and their exact expiration dates vary by jurisdiction and are numerous, the core intellectual property protecting the compound as a chemical entity expired decades ago, allowing for generic production.
• Current Patent Focus Areas:
  • Formulation Patents: Innovations in drug delivery systems, such as sustained-release formulations, novel dosage forms (e.g., oral suspensions, tablets with improved dissolution profiles), and combinations with other active ingredients, are subject to patent protection. These patents aim to improve patient compliance, reduce side effects, or enhance therapeutic efficacy.
  • Manufacturing Process Patents: Companies may patent specific, novel, or more efficient methods of synthesizing Megestrol Acetate. This can include improved purification techniques, chiral synthesis methods (if applicable to specific enantiomers, though Megestrol Acetate is not chiral), or methods that reduce environmental impact or production costs.
  • New Use/Indication Patents: Patents can be granted for the use of Megestrol Acetate in treating conditions beyond its established indications (e.g., appetite stimulation in cancer cachexia or HIV/AIDS wasting syndrome). This includes patents for specific dosages, patient populations, or treatment regimens for new diseases.
  • Polymorph Patents: Different crystalline forms (polymorphs) of Megestrol Acetate can exhibit distinct physical properties such as solubility and stability. Patents may cover specific, advantageous polymorphs that offer benefits in drug formulation or bioavailability.
• Patent Litigation: Given the generic nature of the core compound, patent litigation often revolves around specific formulation or process patents, particularly when a generic manufacturer seeks to launch a product that a brand-name company claims infringes on its later-stage patents.
• Orphan Drug Exclusivity: For new indications, especially those for rare diseases, Megestrol Acetate could potentially qualify for Orphan Drug Exclusivity in certain jurisdictions (e.g., 7 years in the U.S. and 10 years in the EU), providing an additional period of market protection independent of patent status.

What are the regulatory considerations for Megestrol Acetate?

Navigating the regulatory landscape for Megestrol Acetate is critical for API manufacturers and finished drug product developers. Compliance with global health authority guidelines ensures product quality, safety, and efficacy.

• Drug Master Files (DMFs): API manufacturers typically submit Drug Master Files (DMFs) to regulatory agencies like the U.S. FDA. A DMF contains confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows drug product manufacturers to reference the API supplier’s information in their own marketing applications (e.g., Abbreviated New Drug Applications – ANDAs).
• ANDA and NDA Submissions: For generic versions of Megestrol Acetate, companies file Abbreviated New Drug Applications (ANDAs). Innovator products or new formulations require New Drug Applications (NDAs). Both require extensive data on the API’s quality, bioequivalence of the finished product, and manufacturing controls.
• Quality Standards:
  • ICH Guidelines: Adherence to International Council for Harmonisation (ICH) guidelines (e.g., ICH Q7 for GMP for APIs, ICH Q3A/B for impurities) is a global standard.
  • Pharmacopeial Monographs: Megestrol Acetate must meet specifications outlined in official pharmacopeias, including USP, EP, and Japanese Pharmacopoeia (JP). This includes tests for identity, assay, purity, residual solvents, and heavy metals.
• Impurity Profiling: Rigorous identification and quantification of impurities are mandatory. Any impurity above defined thresholds must be characterized, qualified, and controlled within acceptable limits. This is particularly important for genotoxic impurities.
• Stability Studies: Comprehensive stability testing under various storage conditions (e.g., long-term, accelerated, stress testing) is required to establish the shelf-life of both the API and the finished drug product.
• Country-Specific Registrations: Beyond the U.S. and Europe, manufacturers must comply with the specific registration requirements of each target market, which may include local GMP inspections, registration of the API manufacturer, and submission of specific dossier formats.
• Post-Approval Changes: Any changes to the manufacturing process, facility, or specifications of the API or finished product after approval require regulatory notification and, in some cases, prior approval.

What are the market dynamics for Megestrol Acetate?

The market for Megestrol Acetate is largely driven by its established therapeutic uses in oncology and HIV/AIDS, with a mature generic segment and limited innovation in core product offerings.

• Therapeutic Uses:
  • Oncology: Primarily used for palliative treatment of cachexia associated with cancer.
  • HIV/AIDS: Used to treat appetite loss and weight loss in patients with HIV/AIDS.
  • Other Uses: Historically explored for other indications, but its primary market remains these two.
• Market Size and Growth: The market for Megestrol Acetate is considered stable to moderately growing. The demand is influenced by the prevalence of cancers associated with cachexia and the number of individuals living with advanced HIV/AIDS. Growth is often tied to the aging global population and advances in cancer treatment that prolong survival, increasing the period during which cachexia may manifest.
• Generic Competition: The market is highly competitive due to the expiration of original patents. Numerous generic manufacturers supply Megestrol Acetate oral suspension and tablet formulations globally. Pricing is a significant factor in market share.
• Brand Name vs. Generics: While brand-name products (e.g., Megace ES, Megace) exist, the majority of market volume is captured by generic equivalents due to cost advantages.
• Supply Chain Considerations:
  • API Sourcing: Pharmaceutical companies developing or manufacturing Megestrol Acetate finished products rely on a consistent and high-quality supply of API from qualified manufacturers. Diversifying API suppliers can mitigate supply chain risks.
  • Regulatory Hurdles: Accessing new markets or introducing new formulations requires significant investment in regulatory submissions and compliance.
  • Geopolitical Factors: As a significant portion of API manufacturing is concentrated in Asia, geopolitical stability, trade policies, and international relations can impact supply chain reliability and costs.
• Innovation Potential: While the core molecule is well-established, innovation may emerge in areas such as:
  • Improved Formulations: Enhancements in taste masking for oral suspensions, or novel extended-release technologies to improve dosing convenience or reduce side effects.
  • Combination Therapies: Investigating Megestrol Acetate in combination with other agents for synergistic effects in cachexia management or other conditions.
  • New Indications: Research into less common or emerging applications, although this requires substantial clinical trial investment.

Key Takeaways

• API Manufacturing Hubs: India and China are dominant in Megestrol Acetate API production, supplying global pharmaceutical markets. Key manufacturers include Gland Pharma, Divi's Laboratories, and Sun Pharma.
• Expired Core Patents: The original composition of matter patents for Megestrol Acetate have expired, permitting generic competition.
• Focus on Formulation and Process Patents: Current patent activity centers on novel formulations, efficient manufacturing processes, and new therapeutic uses to extend market exclusivity.
• Strict Regulatory Compliance: API suppliers and drug product manufacturers must adhere to GMP, pharmacopeial standards, and detailed DMF submissions to gain market access.
• Mature Generic Market: The Megestrol Acetate market is characterized by significant generic competition, with pricing and reliable API supply being key competitive factors.

Frequently Asked Questions

1. What is the current patent status of the Megestrol Acetate molecule itself? The original composition of matter patents for the Megestrol Acetate molecule have expired, allowing for the production and sale of generic versions.

2. Which regions are the primary sources for Megestrol Acetate API? The majority of Megestrol Acetate API manufacturing is concentrated in India and China.

3. What are the main therapeutic indications for Megestrol Acetate? Its primary indications are palliative treatment of cachexia associated with cancer and appetite stimulation in patients with HIV/AIDS.

4. What is a Drug Master File (DMF) and why is it important for Megestrol Acetate suppliers? A DMF is a submission to regulatory agencies that contains confidential, detailed information about the manufacturing of an API. It is crucial for API suppliers as it allows drug product manufacturers to reference this information in their marketing applications without disclosing the API supplier's proprietary details.

5. Beyond current uses, are there any emerging patent trends for Megestrol Acetate? Emerging patent trends focus on innovative drug delivery formulations, more efficient or environmentally friendly manufacturing processes, and the potential for new therapeutic indications, particularly for rare diseases that might qualify for orphan drug exclusivity.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-master-files

[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from https://www.ich.org/

[3] United States Pharmacopeia. (n.d.). Monographs. Retrieved from https://www.uspharmacopeia.org/

[4] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. Retrieved from https://www.edqm.eu/en/european-pharmacopoeia