doptelet: Pharmaceutical manufacturers, suppliers, and distributors

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238	NDA	AkaRx, Inc.	71369-020-10	1 BLISTER PACK in 1 CARTON (71369-020-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-11)	2018-05-23
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238	NDA	AkaRx, Inc.	71369-020-15	1 BLISTER PACK in 1 CARTON (71369-020-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-16)	2018-05-23
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238	NDA	AkaRx, Inc.	71369-020-30	2 BLISTER PACK in 1 CARTON (71369-020-30) / 15 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-16)	2018-05-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Overview of Doptelet (Avatrombopag)

Doptelet, with the generic name Avatrombopag, is an orally administered thrombopoietin receptor agonist developed by Fresenius Kabi for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure, as well as for certain other indications related to platelet count management. Since its approval by the U.S. Food and Drug Administration (FDA) in 2018, Doptelet has become an important therapeutic option, especially for patients with liver disease-associated thrombocytopenia.

The rising demand for Doptelet underscores the importance of establishing a reliable supply chain sourced from multiple pharmaceutical suppliers. This analysis explores current and potential suppliers for Doptelet, considering manufacturing capabilities, market dynamics, and geopolitical factors.

Manufacturers and Primary Suppliers

Fresenius Kabi: The Original Manufacturer

Fresenius Kabi is the innovator behind Doptelet, securing FDA approval after comprehensive clinical trials demonstrating safety and efficacy. The company operates manufacturing facilities across multiple countries, including the United States, Europe, and Asia, to support global distribution.

Manufacturing Capabilities:

Large-scale production of oral pharmaceuticals.
Compliance with Good Manufacturing Practices (GMP).
Focused R&D in hematology and oncology-related drugs.

Being the original manufacturer, Fresenius Kabi supplies Doptelet directly to major pharmaceutical distributors and hospital networks worldwide. Their extensive supply chain ensures high-quality production, but dependence on a single source raises considerations for supply continuity and risk management.

Contract Manufacturing and Licensing Partners

While Fresenius Kabi holds the patent rights and primary manufacturing operations, they have engaged with third-party Contract Manufacturing Organizations (CMOs) to meet global demand, especially in regions where local production is advantageous.

Key CMOs and Licensing Partners:

Luye Group (China): Luye Pharma has entered strategic partnerships for drug development and distribution within the Chinese market, potentially manufacturing localized versions under licensing agreements.
Biocon (India): Known for producing generic and biosimilar drugs, Biocon has the capacity to manufacture avatrombopag as part of its pipeline, aligning with its strategy to expand into hematology products.
Amneal Pharmaceuticals: As a significant generics manufacturer, Amneal may hold licensing rights or be considered a future manufacturer for Doptelet, contingent on patent rights and market licensing deals.

Implication:
These partnerships help diversify supply sources, mitigate regional shortages, and comply with local regulatory requirements, but they often rely on transfer-of-technology agreements and strict quality controls.

Additional Potential Suppliers

Generic Manufacturers entering the market

While Doptelet remains under patent protection, the impending expiration or licensing of patents could open avenues for generic manufacturing. Companies with proven GMP facilities and experience in hematology drugs may seek to develop biosimilar or generic versions.

Sandoz (Novartis): As a leading producer of generics, Sandoz has the technical capacity and global network to produce avatrombopag once patent barriers are lifted.
Teva Pharmaceuticals: With extensive manufacturing infrastructure, Teva is well-positioned to develop biosimilars or generics, potentially sourcing APIs and formulations from established suppliers.

API (Active Pharmaceutical Ingredient) Suppliers

The core raw material—avatrombopag API—is sourced from chemical suppliers specializing in complex synthetic APIs.

Kursk Chemical Factory (Russia): Known for producing active ingredients for hematology drugs, with compliance to GMP standards.
Suzhou Hommed Pharmaceutical (China): A leading API manufacturer with capabilities for complex small-molecule APIs.
Others: Several Indian and Chinese API suppliers are listed in the EDQM (European Directorate for the Quality of Medicines & HealthCare) database, providing certified raw materials for avatrombopag synthesis.

Supply Chain Considerations

Regulatory Approvals and Local Manufacturing:
Compliance with country-specific regulations influences supplier choices. For instance, Chinese and Indian manufacturers that have obtained approvals from local health authorities (e.g., CFDA, CDSCO) are competitive for regional supply.
Quality Assurance:
Suppliers must adhere to GMP standards and demonstrate consistent manufacturing quality, validated through audits and certifications.
Geopolitical Factors:
Trade restrictions, tariffs, and political tensions can influence supplier choices—alternatives are sought to mitigate risk, especially amid global supply disruptions observed during the COVID-19 pandemic.
Intellectual Property (IP) Rights:
Patent protections restrict manufacturing unless licensing agreements are established. Once patents expire, more generic manufacturers can enter the market.

Market Dynamics and Future Outlook

The current market for Doptelet is concentrated with Fresenius Kabi as the primary manufacturer, complemented by strategic licensing and partnership agreements to enhance regional supply. Going forward, potential market growth spurred by expanding indications (e.g., for thrombocytopenia in oncology), along with patent expirations, will likely lead to an influx of generic providers.

To maintain supply security, stakeholders are pursuing diversified sourcing strategies that include regional manufacturers, API suppliers, and contract manufacturers, all aligned with strict regulatory and quality standards.

Key Takeaways

Fresenius Kabi remains the principal supplier for Doptelet, with manufacturing capacities supported globally.
Strategic licensing agreements with companies like Luye Pharma and potential partnerships with Indian and Chinese generics manufacturers diversify the supply chain.
API and contract manufacturing play critical roles; reliable API sources from China and India bolster production flexibility.
Patent expiration will open the market to biosimilars and generics, broadening supplier options and influencing pricing competition.
Supply chain risks, including geopolitical and regulatory factors, necessitate stakeholder vigilance to ensure consistent Dost particular source.

FAQs

1. When will generic versions of Avatrombopag become available?
Generic versions are expected to enter the market following patent expiration, which is currently anticipated around 2028. Exact timelines depend on patent litigation, licensing, and regulatory approvals.

2. What are the main regions for Doptelet supply?
The United States, Europe, and Asia (notably China and India) are primary regions for Doptelet production and distribution, supported by local manufacturing partnerships.

3. Are there alternative suppliers for avatrombopag API?
Yes, API manufacturing is available from several Chinese and Indian chemical suppliers, including Suzhou Hommed Pharmaceutical and others listed in international API directories.

4. Can regional manufacturers produce Doptelet under license?
Yes, licensing agreements enable regional manufacturers to produce Doptelet locally, subject to regulatory approval and quality assurance standards.

5. How might geopolitical tensions impact Doptelet’s supply chain?
Trade restrictions, tariffs, or sanctions could limit access to certain suppliers, emphasizing the importance of diversified sourcing strategies and regional manufacturing partnerships.

Sources

[1] FDA Drug Approval Package for Doptelet, 2018.
[2] Fresenius Kabi official website.
[3] European Medicines Agency (EMA) safety and sourcing guidelines.
[4] European Directorate for the Quality of Medicines & HealthCare (EDQM).
[5] Chinese National Medical Products Administration (NMPA) listings for API suppliers.

Suppliers and packagers for doptelet

doptelet

Suppliers for the Pharmaceutical Drug: Doptelet (Avatrombopag)