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Suppliers and packagers for generic pharmaceutical drug: ospemifene
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ospemifene
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505 | NDA | Duchesnay USA, Inc. | 55494-580-18 | 1 BLISTER PACK in 1 PACKAGE (55494-580-18) / 15 TABLET, FILM COATED in 1 BLISTER PACK | 2023-04-01 |
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505 | NDA | Duchesnay USA, Inc. | 55494-580-30 | 30 TABLET, FILM COATED in 1 BOTTLE (55494-580-30) | 2023-04-01 |
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505 | NDA | Duchesnay USA, Inc. | 55494-580-55 | 1 BLISTER PACK in 1 PACKAGE (55494-580-55) / 5 TABLET, FILM COATED in 1 BLISTER PACK | 2023-04-01 |
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505 | NDA | Duchesnay USA, Inc. | 55494-580-90 | 90 TABLET, FILM COATED in 1 BOTTLE (55494-580-90) | 2023-04-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ospemifene
Introduction
Ospemifene, marketed under brand names such as Osphena, is an oral selective estrogen receptor modulator (SERM) approved for the treatment of dyspareunia associated with vulvar and vaginal atrophy resulting from menopause. As a relatively specialized pharmaceutical product, its supply chain involves a limited number of manufacturers and suppliers with expertise in hormonal therapies, complex synthesis processes, and regulatory compliance. Understanding the landscape of ospemifene suppliers provides valuable insights for stakeholders, including pharmaceutical companies, healthcare providers, and investors seeking supply stability and competitive intelligence.
Manufacturers of Ospemifene
Manufacturing of ospemifene is predominantly concentrated among a few key players, primarily due to the high barriers to entry related to complex synthesis, regulatory approvals, and patent protections.
1. Pfizer Inc.
Pfizer holds the original patent rights for ospemifene and was the first to bring the compound to market. The company's manufacturing facilities, primarily located in the United States and Europe, produce ospemifene either for Pfizer’s own commercial use or via licensing agreements with other pharmaceutical firms.
- Manufacturing capabilities: Pfizer’s extensive biopharmaceutical manufacturing infrastructure ensures high-quality production and supply reliability.
- Supply focus: Primarily for North American, European, and select international markets under patent protection before generic entry.
2. Teva Pharmaceutical Industries Ltd.
Teva, a leading global generic drug manufacturer, obtained licensing rights or entered into agreements with Pfizer or its successors to produce generic versions of ospemifene.
- Generic manufacturing: Teva specializes in producing cost-effective generic alternatives, increasing accessibility after patent expiration.
- Supply scope: Covers multiple markets including North America, Europe, and other regions where patents have expired or are nearing expiration.
3. Sandoz (Novartis division)
Sandoz, a division of Novartis, also engages in generic drug production, including ospemifene, often through licensing partnerships.
- Market presence: Focused on Europe and emerging markets.
- Manufacturing capacity: Maintains production lines capable of high-volume synthesis compliant with current Good Manufacturing Practices (cGMP).
4. Other Potential Suppliers
While Pfizer and Teva lead the market, additional regional manufacturers may produce ospemifene under licensing agreements or as part of contract manufacturing arrangements. Certain China-based contract manufacturing organizations (CMOs) and Indian pharmaceutical companies have begun exploring hormonal compound synthesis, though specific details on ospemifene production are limited.
Supply Chain and Sourcing Considerations
a. Contract Manufacturing Organizations (CMOs)
Complex chemical synthesis of ospemifene necessitates reliance on CMOs with specialized expertise in hormonal compounds, ensuring process reproducibility and regulatory compliance.
- Role: CMOs are integral in scaling production, particularly for generic manufacturers.
- Regions: Asia-Pacific (India, China) hosts many specialized CMOs capable of producing ospemifene, often at lower costs.
b. Raw Material Suppliers
The synthesis of ospemifene involves multiple chemical intermediates and active pharmaceutical ingredients (APIs). Critical raw materials include:
- Synthetic intermediates: Such as phenolic compounds, benzene derivatives, and chiral catalysts.
- Chemical reagents: High-purity reagents required for multi-step synthesis.
Suppliers of these raw materials are diverse, with many based in Europe, North America, and Asia. Ensuring high-quality, consistent raw material supply is essential to maintaining compliance and avoiding production disruptions.
c. Regulatory and Quality Assurance
Due to the hormonal activity and complex synthesis, suppliers must comply with stringent regulatory standards such as cGMP, ICH guidelines, and local regulatory authorities’ requirements (FDA, EMA, PMDA).
Market Dynamics and Supplier Trends
As patents for ospemifene expire or approach expiration, a surge in generic manufacturers is projected to increase global supply and reduce prices. Strategic licensing and contractual agreements are common, allowing larger pharmaceutical firms to expand their manufacturing footprint and market reach.
Regional manufacturers in India and China are positioning themselves as cost-efficient alternatives, notably in emerging markets. Such players may serve as stable suppliers for regional distribution but must demonstrate compliance with international standards for global markets.
Supply Risks and Challenges
- Manufacturing complexity: The synthesis involves multi-step chemical processes, increasing vulnerability to technical failures or quality issues.
- Regulatory hurdles: Approval of manufacturing facilities and raw materials requires significant compliance investments.
- Intellectual property: Patent disputes or licensing restrictions can limit supply options, especially prior to patent expiry.
- Market competition: Entry of generics intensifies competition, possibly impacting supply stability and pricing.
Conclusion
The supply landscape of ospemifene is characterized by a limited number of established manufacturers, primarily Pfizer (patent holders) and generic producers like Teva and Sandoz. Contract manufacturing organizations (CMOs), especially those based in Asia, play a crucial role in supporting manufacturing capacity, raw material supply, and cost efficiencies. As patent protections lapse, competition will increase, expanding supplier options but also accentuating the importance of quality, regulatory compliance, and supply chain resilience.
Key Takeaways
- Dominant manufacturers: Pfizer leads with original production, while Teva and Sandoz offer robust generic manufacturing capabilities.
- Global sourcing: Asia-based CMOs and raw material suppliers are increasingly involved, offering scalable and cost-effective options.
- Regulatory compliance: Strict adherence to cGMP and international standards is critical for all suppliers.
- Market trends: Patent expirations will facilitate increased generic competition, expanding the supplier landscape.
- Supply risks: Complex synthesis, regulatory hurdles, and intellectual property issues must be carefully managed to ensure uninterrupted supply.
Frequently Asked Questions
1. Who are the main global manufacturers of ospemifene?
Pfizer is the original patent holder and primary manufacturer. Generic producers like Teva and Sandoz also supply ospemifene, with increasing participation from regional CMOs, especially in Asia.
2. How does patent expiration impact ospemifene suppliers?
Patent expiration opens the market to more generic manufacturers, increasing supply options and reducing prices. This also encourages licensing agreements and contract manufacturing alliances.
3. What are the primary raw materials used in ospemifene synthesis?
Key intermediates include phenolic compounds, benzene derivatives, and specific chiral catalysts. These materials are sourced globally from specialized chemical suppliers.
4. Are there quality challenges associated with ospemifene manufacturing?
Yes, owing to its complex multi-step synthesis and hormonal activity, maintaining strict quality controls, regulatory compliance, and batch consistency is essential to ensure safety and efficacy.
5. How can stakeholders ensure a stable supply of ospemifene?
Diversifying supplier relationships, establishing long-term licensing agreements, and partnering with qualified CMOs are effective strategies to mitigate supply risks and ensure regulatory compliance.
Sources
[1] U.S. Food and Drug Administration (FDA). Osphena (ospemifene) PDE. [Online] Available at: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/osphena-ospemifene
[2] Pfizer Inc. Annual Reports. [Online] Available at: https://www.pfizer.com/investors
[3] Teva Pharmaceuticals. Product Portfolio. [Online] Available at: https://www.tevapharm.com/products/
[4] Sandoz. Generic Drug Portfolio. [Online] Available at: https://www.sandoz.com/portfolio
[5] Market research reports on hormonal drug manufacturing and market dynamics, 2022.
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