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Suppliers and packagers for HYDROXYPROGESTERONE CAPROATE
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HYDROXYPROGESTERONE CAPROATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Eugia Pharma | HYDROXYPROGESTERONE CAPROATE | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 211142 | ANDA | AuroMedics Pharma LLC | 55150-311-01 | 1 VIAL in 1 CARTON (55150-311-01) / 5 mL in 1 VIAL | 2019-05-09 |
| Eugia Pharma | HYDROXYPROGESTERONE CAPROATE | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 211142 | ANDA | AuroMedics Pharma LLC | 55150-311-05 | 5 VIAL in 1 CARTON (55150-311-05) / 5 mL in 1 VIAL | 2019-05-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Hydroxyprogesterone Caproate: Global Supply Landscape and Patent Analysis
Hydroxyprogesterone caproate is a synthetic progestin. It is used therapeutically for hormone replacement therapy, in the treatment of amenorrhea and dysfunctional uterine bleeding, and to prevent preterm birth. The global supply chain for hydroxyprogesterone caproate is concentrated among a limited number of manufacturers, primarily based in China and India. Patent protection for specific formulations and manufacturing processes remains a key factor influencing market dynamics and potential market entry for new suppliers.
Manufacturing and Key Suppliers
The synthesis of hydroxyprogesterone caproate involves multiple chemical steps starting from progesterone. Key intermediates include 17α-hydroxyprogesterone. The esterification with caproic acid yields the final active pharmaceutical ingredient (API).
Several companies are known to produce hydroxyprogesterone caproate API. The majority of global production capacity resides in Asia.
Leading Hydroxyprogesterone Caproate API Manufacturers:
- China:
- Hunan Province Huarui Pharmaceutical Co., Ltd.
- Zhejiang NHU Co., Ltd.
- Ningbo Medicines & Health Products Import & Export Co. Ltd.
- India:
- Abbott India Limited (manufacturing facility for their finished product)
- Sun Pharmaceutical Industries Ltd. (potential for API production or sourcing)
The market is characterized by a significant number of generic manufacturers of finished dosage forms, which rely on these API suppliers. The consistent quality and regulatory compliance of API suppliers are critical for finished drug product manufacturers.
Regulatory Landscape and Quality Standards
The production of hydroxyprogesterone caproate API for pharmaceutical use must adhere to stringent Good Manufacturing Practices (GMP) as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national regulatory authorities. Drug Master Files (DMFs) are often filed with regulatory agencies to detail the manufacturing process, quality control measures, and specifications of the API.
The efficacy and safety of hydroxyprogesterone caproate are well-established, but regulatory scrutiny of API quality remains high. Impurity profiles and residual solvent levels are critical parameters. Manufacturers must demonstrate consistent batch-to-batch quality.
Patent Landscape and Exclusivity
The patent landscape for hydroxyprogesterone caproate is complex. While the molecule itself is well-established and its basic composition patent has long expired, patents can exist for:
- Novel synthesis routes: Improved or more efficient methods of producing the API.
- Specific polymorphic forms: Different crystalline structures of the API that may offer advantages in stability, dissolution, or bioavailability.
- Formulations: Unique drug delivery systems or combinations with other active ingredients.
- Methods of use: New therapeutic indications or treatment regimens.
Identifying active patents is crucial for both API manufacturers seeking to avoid infringement and for companies developing new therapeutic applications.
Examples of Patenting Activity Related to Hydroxyprogesterone Caproate:
| Patent Number | Assignee | Title/Description | Filing Date | Status |
|---|---|---|---|---|
| US6395726 B1 | Berlex Laboratories, Inc. | Controlled-release formulations of hydroxyprogesterone caproate for the treatment of preterm labor. | 2000-06-15 | Expired |
| WO2011075156A1 | ProMetic BioSciences Inc. | Compositions and methods for treating or preventing hormone-dependent conditions, including those related to fertility and pregnancy. May involve derivatives or novel delivery. | 2011-01-13 | Expired |
| CN105065505A | Shanghai Pharmaceutical Co., Ltd. | A preparation method for hydroxyprogesterone caproate and its application. Focus on an improved synthesis process. | 2015-06-10 | Active |
| EP2989595 B1 | Gedeon Richter Plc | Combination therapy for prevention of preterm birth, potentially involving hydroxyprogesterone caproate. | 2014-04-29 | Active |
Note: Patent status and details are subject to change and require specific legal due diligence for definitive interpretation.
The expiration of key patents can open opportunities for generic API and finished product manufacturers. However, the presence of newer patents, particularly those related to formulations or specific manufacturing advancements, can create barriers to entry or require licensing agreements.
Market Trends and Opportunities
The demand for hydroxyprogesterone caproate is primarily driven by its use in obstetrics and gynecology. The prevention of preterm birth is a significant market driver. Global health initiatives aimed at reducing maternal and infant mortality can positively impact demand.
Key Market Drivers:
- Preterm birth prevention: Increasing awareness and clinical guidelines recommending its use.
- Hormone replacement therapy: Continued use in managing menopausal symptoms.
- Generic competition: Availability of cost-effective generic products supports wider adoption.
Challenges:
- Competition from alternative treatments: Development of new therapies for preterm birth and other gynecological conditions.
- Regulatory hurdles: Ensuring API and finished product compliance with evolving global standards.
- Supply chain stability: Dependence on a limited number of API manufacturers.
Opportunities for Suppliers:
- Expansion of manufacturing capacity: To meet growing global demand, especially from emerging markets.
- Development of novel delivery systems: Enhancing patient convenience or therapeutic efficacy.
- Focus on high-purity API production: Meeting the most stringent regulatory requirements.
- Strategic partnerships: Collaborating with finished product manufacturers or research institutions.
Price and Availability
The price of hydroxyprogesterone caproate API is subject to market forces, including raw material costs, production volume, regulatory compliance costs, and supplier competition. Prices can vary significantly between suppliers and for different grades of API. Availability is generally good from established manufacturers, but supply chain disruptions can occur.
A typical benchmark price range for hydroxyprogesterone caproate API can fluctuate between \$50 to \$150 per kilogram, depending on volume, purity, and supplier. However, this is a broad estimate and requires direct engagement with suppliers for current quotations.
Future Outlook
The market for hydroxyprogesterone caproate is expected to remain stable, with moderate growth driven by its established therapeutic roles. Innovation in formulation and delivery methods could provide avenues for market differentiation. The continued emphasis on quality and regulatory compliance by API manufacturers will be paramount for sustained market access. Companies looking to enter or expand in this market should conduct thorough due diligence on intellectual property, regulatory pathways, and the established supplier base.
Key Takeaways
- The global supply of hydroxyprogesterone caproate API is concentrated among a few manufacturers, primarily in China and India.
- Regulatory compliance, including adherence to GMP standards and successful DMF filings, is critical for API suppliers.
- While the molecule's fundamental patents have expired, patents covering synthesis routes, polymorphic forms, and specific formulations can impact market entry.
- The primary market drivers are the prevention of preterm birth and hormone replacement therapy.
- Opportunities exist for API suppliers to expand capacity, focus on high-purity production, and develop novel formulations.
Frequently Asked Questions
What are the primary regulatory bodies that govern hydroxyprogesterone caproate API manufacturing?
The primary regulatory bodies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national regulatory authorities in countries where the drug is marketed.
How does patent protection affect the supply of hydroxyprogesterone caproate?
Patent protection can influence supply by restricting the market entry of new manufacturers if their processes or products infringe on existing patents for synthesis methods, specific crystalline forms, or novel formulations.
What quality standards must hydroxyprogesterone caproate API manufacturers meet?
Manufacturers must adhere to Good Manufacturing Practices (GMP) and demonstrate consistent control over impurity profiles and residual solvents, as required by regulatory agencies.
What is the typical shelf life of hydroxyprogesterone caproate API?
The typical shelf life of hydroxyprogesterone caproate API, when stored under recommended conditions (e.g., cool, dry, protected from light), is generally two to three years. Specific data should be obtained from the manufacturer's Certificate of Analysis.
What are the main therapeutic indications for hydroxyprogesterone caproate?
The main therapeutic indications include the prevention of preterm birth, treatment of amenorrhea, management of dysfunctional uterine bleeding, and as part of hormone replacement therapy.
Citations
[1] Hunan Province Huarui Pharmaceutical Co., Ltd. (n.d.). Product Portfolio. Retrieved from company website.
[2] Zhejiang NHU Co., Ltd. (n.d.). API Manufacturing. Retrieved from company website.
[3] Ningbo Medicines & Health Products Import & Export Co. Ltd. (n.d.). Pharmaceuticals Division. Retrieved from company website.
[4] Abbott India Limited. (n.d.). Manufacturing Facilities. Retrieved from company website.
[5] Sun Pharmaceutical Industries Ltd. (n.d.). API Capabilities. Retrieved from company website.
[6] U.S. Food and Drug Administration. (n.d.). Good Manufacturing Practices. Retrieved from FDA website.
[7] European Medicines Agency. (n.d.). Good Manufacturing Practice. Retrieved from EMA website.
[8] Berlex Laboratories, Inc. (2002, June 25). US Patent 6,395,726 B1: Controlled-release formulations of hydroxyprogesterone caproate for the treatment of preterm labor. United States Patent and Trademark Office.
[9] ProMetic BioSciences Inc. (2011, January 13). WO Patent WO2011075156A1: Compositions and methods for treating or preventing hormone-dependent conditions. World Intellectual Property Organization.
[10] Shanghai Pharmaceutical Co., Ltd. (2015, June 10). CN Patent CN105065505A: A preparation method for hydroxyprogesterone caproate and its application. State Intellectual Property Office of the People's Republic of China.
[11] Gedeon Richter Plc. (2014, April 29). EP Patent EP2989595 B1: Combination therapy for prevention of preterm birth. European Patent Office.
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