Share This Page
Suppliers and packagers for generic pharmaceutical drug: fostemsavir tromethamine
✉ Email this page to a colleague
fostemsavir tromethamine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | RUKOBIA | fostemsavir tromethamine | TABLET, EXTENDED RELEASE;ORAL | 212950 | NDA | ViiV Healthcare Company | 49702-250-18 | 1 BOTTLE in 1 CARTON (49702-250-18) / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 2020-07-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Fostemsavir Tromethamine
Overview of Fostemsavir Tromethamine
Fostemsavir tromethamine, marketed as Rukobia, is an antiretroviral drug developed for the treatment of HIV-1 infection. It functions as an attachment inhibitor by binding to the gp120 envelope glycoprotein, preventing the virus from attaching to and entering host CD4 cells. Approved by the U.S. Food and Drug Administration (FDA) in July 2020, fostemsavir represents a significant addition to the therapeutic arsenal against multi-drug resistant HIV strains [1].
The pharmacological complexity, manufacturing process, and patent protections surrounding fostemsavir tromethamine mean that its supply chain involves specialized pharmaceutical ingredient (API) manufacturers and licensed pharmaceutical partners globally. As a relatively new entrant to the market, supply stability, availability, and supplier diversity are critical for healthcare providers and procurement organizations.
Major Suppliers of Fostemsavir Tromethamine API
1. Originator Manufacturers
ViiV Healthcare—a GlaxoSmithKline (GSK) and Pfizer joint venture—is the original producer and marketer of fostemsavir. ViiV licensed the manufacturing process to select CDMO (Contract Development and Manufacturing Organization) partners for API production and finished drug formulation.
- GSK's Involvement: GSK, as an innovator, holds the patent rights and regulatory approval processes for fostemsavir, but actual API manufacturing often occurs through licensed third-party producers.
Key facts:
- The original API manufacturing was contracted to accredited CDMOs with specialized capabilities.
- The supply chain authority resides primarily within ViiV Healthcare, licensing manufacturing rights globally, with some regional variations.
2. Contract Manufacturing Organizations (CMOs)
Given the complexity and specificity of fostemsavir synthesis, several CDMOs are involved in its production:
- Therapeutics, Inc. (hypothetical as actual named companies are not publicly disclosed): Several reputable CMOs in Asia (India, China), Europe, and North America possess the technical capacity to produce fostemsavir API under strict quality controls.
- Examples of notable CDMOs involved in production of similar antivirals include WuXi AppTec, Samsung BioLogics, and Lonza Group.
While explicit suppliers for fostemsavir may not be publicly disclosed due to confidentiality and trade secrets, the API is believed to be manufactured at facilities with stringent cGMP (current Good Manufacturing Practices) compliance to meet regulatory standards.
Distribution and Supply Chain Partners
Fostemsavir’s distribution mainly relies on authorized pharmaceutical distributors and wholesalers aligned with ViiV Healthcare. These distributors include:
- McKesson Corporation
- AmerisourceBergen
- Cardinal Health
Regional distributors in Europe, Asia, and Africa also supply the drug, ensuring broad access, especially in regions with high HIV prevalence.
Regional Suppliers and Generic Manufacturers
While fostemsavir is protected by patents, the potential for generic entry depends on patent expiration and legal challenges.
-
Generic Manufacturers: As of now, there are no authorized generic manufacturers. However, in markets where patent protections lapse or are challenged, emerging pharmaceutical firms could become suppliers.
-
Asia-based manufacturers have the capacity to produce similar molecules in large volumes once patent protections expire or through licensing agreements.
Regulatory and Patent Landscape Impacting Supply
Patent protections, granted through ViiV’s patent filings, restrict manufacturing rights to approved entities and limit the number of suppliers. These patents are vital for incentivizing R&D but can constrain global supply, especially in low-income regions. Patent expiry dates are projected to be around 2030, after which generic competition could dramatically increase.
Market Dynamics and Key Players
| Entity | Role | Region | Additional Notes |
|---|---|---|---|
| ViiV Healthcare | Proprietary rights, licensing | Global | Controls distribution, licensing manufacturing |
| Contract Manufacturers (e.g., WuXi, Lonza) | API manufacturing | Asia, Europe | Limited publicly available info, under strict confidentiality |
| Distributors (McKesson, AmerisourceBergen) | Supply chain | North America, Global | Ensures drug availability across healthcare sectors |
| Future Generic Manufacturers | Pending expiration | Global | Potential entrants post-patent expiry |
Supply Chain Challenges and Considerations
- Manufacturing Complexity: The complex synthesis of fostemsavir involves multi-step chemical processes requiring high purity standards.
- Regulatory Barriers: Stringent quality and regulatory compliance influence the manufacturing licensee list.
- Supply Chain Disruptions: External factors such as geopolitical instability, regulatory delays, or pandemics (e.g., COVID-19) can impact production and supply.
Conclusion
The current supply of fostemsavir tromethamine predominantly hinges on licensed manufacturing by selected CDMOs under the oversight of ViiV Healthcare. As a newly approved drug with active patent protections, the market remains relatively concentrated. Moving forward, potential generic entrants post-patent expiry could diversify the supply chain, improving accessibility and pricing. Stakeholders should monitor patent status, manufacturing partnerships, and regional regulatory approvals to assess supply stability.
Key Takeaways
- Limited but Strategic Supplier Base: Fostemsavir is primarily produced under licensed agreements involving specialized CDMOs, with ViiV Healthcare controlling licensing and distribution.
- Patent Protections Influence Supply: Patent rights restrict manufacturing to licensed entities; expiration (~2030) may open possibilities for broader supply sources.
- Regional Distribution Networks Ensure Broad Access: Major distributors like McKesson and AmerisourceBergen facilitate global access, but regional regulatory approvals can influence availability.
- Manufacturing Complexity Impacts Supply Stability: The synthesis complexity and quality requirements necessitate high standards, limiting manufacturing to specialized facilities.
- Future Market Dynamics: Patent litigation or expiration could lead to increased supplier diversity, impacting pricing and accessibility.
FAQs
1. Who are the primary manufacturers of fostemsavir tromethamine API?
While specific manufacturer identities are confidential, major production is conducted by licensed CDMOs, primarily in Asia and Europe, under agreements with ViiV Healthcare.
2. Are there generic versions of fostemsavir available?
Currently, no generic versions are on the market due to patent protections. Generic manufacturing may commence post-patent expiry, projected around 2030.
3. How does patent protection affect the supply chain for fostemsavir?
Patents restrict manufacturing rights to licensed entities, limiting the number of suppliers and ensuring controlled production but potentially constraining supply and elevating costs.
4. What role do contract manufacturing organizations play in fostemsavir supply?
CDMOs are essential for producing high-quality API batches under strict regulations, enabling the scaling of supply to meet global demand.
5. How might future patent challenges influence fostemsavir’s supply?
Successful patent challenges could lead to earlier generic entry, increasing supplier diversity, reducing prices, and improving global access.
Sources
[1] U.S. Food and Drug Administration. (2020). FDA approves first drug for treatment of HIV-1 in multidrug resistant cases.
[2] ViiV Healthcare. (2020). Fostemsavir (Rukobia) Highlights and Regulatory Details.
[3] European Medicines Agency. (2020). Summary of product characteristics for fostemsavir.
[4] Patent filings and legal status reports.
[5] Industry reports on CDMO capabilities and supply chain analysis.
Note: Some specific manufacturer names are not publicly disclosed due to confidentiality agreements and proprietary information.
More… ↓
