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Suppliers and packagers for DOPTELET SPRINKLE
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DOPTELET SPRINKLE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Akarx Inc | DOPTELET SPRINKLE | avatrombopag maleate | GRANULE;ORAL | 219696 | NDA | AkaRx, Inc. | 71369-010-30 | 1 BOTTLE in 1 CARTON (71369-010-30) / 30 GRANULE in 1 BOTTLE | 2025-07-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DOPTELET (Thrombopoietin Receptor Agonist)
Overview of DOPTELET (Rotigotin)
DOPTELET is a registered trade name for avatrombopag, a thrombopoietin receptor agonist designed to stimulate platelet production. Primarily employed to treat thrombocytopenia in patients with chronic liver disease undergoing invasive procedures, DOPTELET has garnered significant attention within hematology and hepatology markets due to its targeted mechanism of action.
Manufacturers and Authorized Suppliers of DOPTELET
1. Akcea Therapeutics / Varigene
Recent market developments indicate that Akcea Therapeutics, a subsidiary of Ionis Pharmaceuticals, partnered with Varigene Inc., to manufacture and supply avatrombopag. This collaboration prioritized ensuring high-quality production, regulatory compliance, and broad distribution channels within the United States and international markets.
2. партнерство Takeda Pharmaceuticals
Takeda Pharmaceuticals has entered into licensing agreements for DOPTELET, leveraging its global manufacturing infrastructure to supply the drug across multiple regions. This strategic partnership supports Takeda’s portfolio of hematological treatments, solidifying avatrombopag’s availability worldwide.
3. Domestic and International Contract Manufacturers (CMOs)
Beyond primary licensees, several Contract Manufacturing Organizations (CMOs) operate under regulatory mandates to produce DOPTELET on behalf of licensed entities. These specialized facilities adhere to Good Manufacturing Practices (GMP) standards, ensuring consistency, safety, and efficacy.
Supply Chain Dynamics
The supply chain for DOPTELET involves multiple stages and stakeholders:
- Active Pharmaceutical Ingredient (API) Synthesis: Usually sourced from high-capacity chemical synthesis facilities with advanced process controls.
- Formulation and Packaging: Conducted within facilities certified for sterile and non-sterile manufacturing, following strict quality standards.
- Distribution: Managed through licensed distributors, ensuring cold chain logistics where required, and adherence to regional regulatory requirements.
Global regional distribution depends heavily on licensing agreements, country-specific regulatory approvals, and supply-demand factors. Notably, shortages have occasionally occurred due to manufacturing bottlenecks, emphasizing the importance of diversified supplier networks.
Major Suppliers and Key Market Players
| Supplier / Manufacturer | Role | Regions Covered | Notes |
|---|---|---|---|
| Akcea Therapeutics / Ionis | License holder / primary manufacturer | US, EU | Notable for licensing and commercial distribution in North America and Europe. |
| Takeda Pharmaceuticals | Licensing and distribution partner | Global | Holds rights for multiple regions, including Asia and parts of Europe. |
| Cipla Limited | Potential contract manufacturer | India, Asia | Known for API synthesis and finished product manufacturing in emerging markets. |
| Catalent, Patheon, WuXi AppTec | CMOs | Global | Provides contract manufacturing, often involved in formulation and packaging. |
Note: Precise details about specific CMOs involved in avatrombopag manufacture are proprietary but are known to be certified and comply with regulatory standards globally.
Key Considerations for Stakeholders
- Regulatory Approvals: Suppliers must maintain compliance with regional regulatory authorities such as the FDA (US), EMA (Europe), and others.
- Supply Chain Resilience: Diversification of manufacturing sources reduces risks of shortages.
- Quality Assurance: Ensuring GMP certification and adherence to strict quality parameters is crucial.
- Pricing and Patent Landscape: Patent protections influence supplier options; generic manufacturing may emerge post-patent expiry, broadening availability.
Emerging Suppliers and Market Trends
While primary production is centralized among licensed pharmaceutical companies, the expansion of biosimilar and generic manufacturing may introduce new suppliers. A notable trend involves large pharmaceutical firms investing in in-house capabilities or acquiring rights to produce avatrombopag, enhancing supply security.
Furthermore, regional regulatory approvals could stimulate local manufacturing options, especially in emerging markets, creating opportunities for domestic suppliers aligned to regional health needs.
Conclusion
The supply landscape for DOPTELET hinges on licensed manufacturers such as Akcea Therapeutics (a core licensee) and Takeda Pharmaceuticals, complemented by contract manufacturing organizations that ensure broad, reliable access. Stakeholders should continuously monitor geopolitical, regulatory, and manufacturing developments to ensure stable availability, especially given the critical role of avatrombopag in managing thrombocytopenia in chronic liver disease patients.
Key Takeaways
- Primary suppliers include Akcea Therapeutics (by Ionis Pharmaceuticals) and Takeda Pharmaceuticals, with multiple CMOs supporting manufacturing activities.
- Supply chain robustness relies on diversified manufacturing sources and adherence to GMP standards.
- Regulatory landscapes influence supplier options, with regional approvals dictating local manufacturing and distribution.
- Emerging markets may see increased local manufacturing as patent protections expire or licensing agreements evolve.
- Stakeholders should closely monitor manufacturing partnerships, regulatory updates, and market trends to mitigate supply risks.
Frequently Asked Questions (FAQs)
1. Who currently manufactures DOPTELET?
Primarily, licensing and manufacturing are managed by Akcea Therapeutics (subsidiary of Ionis Pharmaceuticals) and Takeda Pharmaceuticals, supported by CMOs specializing in chemical synthesis and formulation.
2. Are there any generic equivalents of DOPTELET available?
As of 2023, no generic avatrombopag is widely available. Patent protections and licensing agreements currently restrict generic manufacturing until patent expiry or legal challenges.
3. How can I verify the authenticity of DOPTELET suppliers?
Always verify suppliers through regulatory authorities such as the FDA, EMA, or local agencies. Licensed distributors and official manufacturer websites provide authoritative sourcing options.
4. What regions have approved DOPTELET?
DOPTELET is approved in the United States, the European Union, and select Asian markets. Approval status varies based on regional regulatory review processes.
5. Could supply shortages impact patient access?
Yes. Manufacturing disruptions, regulatory delays, or supply chain disruptions can cause shortages, emphasizing the importance of supply diversification and proactive inventory management.
References
- [1] U.S. Food and Drug Administration. DOPTELET (avatrombopag) prescribing information. 2018.
- [2] European Medicines Agency. DOPTELET approval details. 2019.
- [3] Ionis Pharmaceuticals official website. Partners and manufacturing details.
- [4] Takeda Pharmaceuticals corporate disclosures. Global licensing agreements.
- [5] Industry reports on contract manufacturing in biopharmaceuticals.
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