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Suppliers and packagers for copiktra
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copiktra
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155 | NDA | Secura Bio, Inc | 73116-215-28 | 28 CAPSULE in 1 PACKAGE (73116-215-28) | 2018-09-25 |
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155 | NDA | Secura Bio, Inc | 73116-215-56 | 56 CAPSULE in 1 PACKAGE (73116-215-56) | 2018-09-25 |
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155 | NDA | Secura Bio, Inc | 73116-225-28 | 28 CAPSULE in 1 PACKAGE (73116-225-28) | 2018-09-25 |
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155 | NDA | Secura Bio, Inc | 73116-225-56 | 56 CAPSULE in 1 PACKAGE (73116-225-56) | 2018-09-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and Distribution Network for Copiktra (Duvelisib)
Copiktra (duvelisib), an oral dual phosphoinositide 3-kinase (PI3K) inhibitor, is a critical therapy for relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma (FL). Its supply chain involves a network of pharmaceutical manufacturers, specialty pharmacies, and international partners. This report examines the key suppliers, manufacturing collaborations, distribution channels, and global commercialization strategies supporting Copiktra’s availability.
Manufacturing and Development Partnerships
Catalent Pharma Solutions: Primary Manufacturing Partner
Catalent Pharma Solutions, a global leader in advanced drug delivery technologies, has been integral to Copiktra’s production since its FDA approval in 2018[4]. The Kansas City, Missouri, facility provided clinical development and commercial manufacturing services for Verastem Oncology, including formulation support and analytical testing[4]. Catalent’s role extended beyond production to include packaging and logistics, ensuring compliance with regulatory standards for oral dose forms[4]. This partnership highlights the reliance on specialized contract development and manufacturing organizations (CDMOs) to bring complex oncology therapies to market.
Secura Bio: Global Rights Holder
In 2020, Secura Bio acquired global commercialization and development rights for Copiktra from Verastem Oncology in a deal worth up to $381 million[12]. This acquisition included responsibility for ongoing clinical trials, regulatory submissions, and manufacturing oversight[8]. Secura Bio’s portfolio integration of Copiktra with Farydak® (panobinostat) positioned the company to explore combination therapies for T-cell lymphomas, leveraging synergies between PI3K and HDAC inhibitors[8]. The transition underscored the strategic importance of licensing agreements in expanding a drug’s lifecycle beyond its initial developer.
Distribution Channels and Specialty Pharmacy Networks
Biologics by McKesson: Limited Distribution Partner
Biologics, McKesson’s oncology-focused specialty pharmacy, was selected as a limited distribution partner for Copiktra in 2018[1][9]. This partnership ensured patient access through a high-touch care model, combining clinical expertise with financial assistance programs[1]. Biologics’ multidisciplinary teams—including pharmacists, nurses, and financial counselors—streamlined coordination between prescribers and patients, addressing challenges such as prior authorization and reimbursement[1]. The limited distribution model restricted Copiktra’s availability to select pharmacies, optimizing adherence and safety monitoring.
Pricing and Insurance Considerations
As of 2025, Copiktra remains a brand-only medication with no generic equivalents, resulting in a monthly list price of approximately $11,800[6][10]. Secura Bio’s patient support programs, such as the Copay Assistance Program, reduce out-of-pocket costs to $5 per month for eligible commercially insured patients[10]. Insurance providers like Cigna enforce quantity limits (e.g., 56 capsules per prescription) to align with dosing protocols and mitigate risks of overutilization[11]. These measures reflect the balance between ensuring patient access and managing healthcare costs for high-priced specialty drugs.
International Suppliers and Regional Licensing
CSPC Pharmaceutical Group: Exclusive Rights in China
CSPC Pharmaceutical Group secured exclusive rights to develop and commercialize Copiktra in China through a 2018 licensing agreement with Verastem Oncology[7][13]. The deal included a $15 million upfront payment and potential royalties based on net sales, enabling CSPC to leverage its established oncology distribution network[7]. CSPC’s portfolio, which includes DUOMEISU (doxorubicin liposome) and KEAILI (nab-paclitaxel), provided infrastructure to navigate China’s regulatory landscape and address unmet needs in hematologic malignancies[7]. This collaboration exemplifies the role of regional licensors in expanding a drug’s global footprint.
European Market Access
Secura Bio submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2019, seeking approval for CLL/SLL and FL indications[8]. While the application’s status remains pending as of 2025, Secura Bio’s acquisition of global rights included obligations to honor existing partnerships, such as Sanofi’s European commercialization efforts[12]. The European strategy focuses on differentiating Copiktra from competitors like Zydelig (idelalisib) through its dual PI3K-delta/gamma inhibition and oral administration[6].
Strategic Collaborations and Future Directions
Clinical Development for Peripheral T-Cell Lymphoma
Secura Bio is advancing Copiktra’s development for peripheral T-cell lymphoma (PTCL), utilizing Fast Track and Orphan Drug designations to accelerate regulatory pathways[8]. The PRIMO trial, investigating Copiktra as a monotherapy, aims to support label expansion and address the lack of effective PTCL treatments[8]. Additionally, combination studies with Farydak explore synergistic mechanisms to improve response rates in aggressive lymphoma subtypes[8].
Supply Chain Resilience and Challenges
The absence of generic alternatives[3] and reliance on limited distribution networks[1][9] pose risks to Copiktra’s supply chain. Catalent’s manufacturing infrastructure[4] and Secura Bio’s commercialization expertise[12] mitigate these risks, but geopolitical factors—such as U.S.-China trade tensions—could impact CSPC’s ability to distribute the drug in Asia[7]. Furthermore, the voluntary withdrawal of Copiktra’s accelerated FL indication in 2021[5] underscores the importance of post-marketing studies in maintaining market access.
Conclusion
Copiktra’s supplier ecosystem revolves around strategic partnerships between manufacturers (Catalent), distributors (Biologics), and licensors (Secura Bio, CSPC). These collaborations ensure global availability while addressing region-specific regulatory and market challenges. Future success hinges on clinical expansions into PTCL, combination therapies, and maintaining cost-effectiveness in competitive oncology markets.
References
- https://www.mckesson.com/about-mckesson/newsroom/press-releases/2018/copiktra-available-for-order-at-biologics/
- https://everyone.org/copiktra-duvelisib
- https://www.drugs.com/availability/generic-copiktra.html
- https://www.catalent.com/catalent-news/catalent-and-verastem-oncology-partner-on-newly-launched-fda-approved-copiktra-duvelisib-capsules/
- https://www.drugs.com/history/copiktra.html
- https://www.pharmaceutical-technology.com/comment/fda-approvals-copiktras-commercial-prospects/
- https://www.biospace.com/cspc-pharmaceutical-group-limited-and-verastem-oncology-sign-exclusive-license-agreement-for-the-development-and-commercialization-of-copiktra-duvelisib-in-china
- https://www.biospace.com/secura-bio-completes-acquisition-of-global-rights-to-oncology-drug-copiktra
- https://biologics.mckesson.com/copiktra-duvelisib-available-order-biologics-by-mckesson/
- https://www.drugs.com/price-guide/copiktra
- https://static.cigna.com/assets/chcp/pdf/coveragePolicies/cnf/cnf_882_coveragepositioncriteria_oncology_copiktra_dqm_per_rx.pdf
- https://www.pharmaceutical-technology.com/news/verastem-copiktra-secura-bio/
- https://pharmashots.com/150/cspc-pharmaceutical-signs-exclusive-license-agreement-with-verastem-oncology-to-develop-and-commercialize-copiktra-in-china
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