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Suppliers and packagers for generic pharmaceutical drug: Duvelisib
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Duvelisib
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Duvelisib (Copiktra, idelalisib/duvelisib category) APIs, key intermediates, and contract manufacturing options
Duvelisib drug supply is concentrated in a limited set of commercial-grade API and intermediate sources, with additional capacity supplied through contract manufacturing organizations (CMOs) supporting finished-dose drug product (DP) and packaging. The most relevant supplier universe for due diligence is (1) API and intermediate manufacturers that can support DMF-driven sourcing, (2) DP/packagers supplying the U.S. and ex-U.S. markets under approved NDA/ANDA supply chains, and (3) alternative CMO routes that can qualify for commercial supply and regulatory comparability.
Who supplies the duvelisib API for commercial production?
Duvelisib is supplied as a controlled, technically validated small-molecule API through qualified manufacturing networks tied to the U.S. NDA supply chain and corresponding global registrations.
Duvelisib API supply chain due-diligence lens
- DMF-linked manufacturers: Look for duvelisib API DMFs and Type II drug master files supporting commercial production batches.
- Regulatory qualification: Approved suppliers for manufacturing sites tied to the NDA’s drug product manufacturing and testing sections.
- CMC capability: Ability to make duvelisib at validated scale with impurity controls and robust analytical release testing.
Practical short-list structure used in pharma procurement
- Primary API supplier(s) named in regulatory filings and associated DMFs.
- Secondary qualified API sources with demonstrated comparability and regulatory authorization.
- Interim suppliers for raw material/intermediate steps (for example, halogenated building blocks or advanced intermediates), often the same facilities that supply scale during throughput constraints.
Which companies manufacture duvelisib intermediates and key starting materials?
Intermediates are the bottleneck for small-molecule supply continuity. For duvelisib, supplier risk usually concentrates in a small number of chemical steps that control:
- regioselectivity and impurity profiles,
- halogenated intermediates quality,
- final API crystallization/polymorph control (where applicable),
- compliance with residual solvent and genotoxic impurity controls.
How intermediate suppliers typically map to final API supply
- Primary API manufacturers often outsource specific intermediate steps to specialized plants, then re-integrate them under controlled incoming material specifications.
- CMOs may use API supplied by the NDA/DMF-approved chain or use directly purchased API with validated upstream specs.
Due-diligence checklists used by procurement and CMC teams
- Traceability for intermediates (batch-to-batch CoA).
- Analytical method equivalence between incoming intermediate specs and finished API release tests.
- Capacity stability for bottleneck steps during global demand spikes.
Which CMOs supply duvelisib drug product (tablets/capsules) and packaging?
Finished-dose supply for duvelisib depends on the same constrained set of facilities that can handle:
- small-molecule blending, compression/fill-finish (depending on dosage form),
- dissolution and stability testing,
- GMP packaging and serialization where applicable,
- labeling and distribution chain compliance.
What to verify for DP/packager selection
- GMP readiness and experience with oncology small molecules.
- Ability to meet NDA-specific release testing (assay, impurities, dissolution specs).
- Stability program coverage for duvelisib DP packaging configuration.
- Compliance with U.S. and EU GDP standards for distribution.
What is the Orange Book status for duvelisib that affects supplier sourcing?
Duvelisib’s U.S. exclusivity and patent landscape controls the ability of alternative suppliers to enter the market with authorized generic or interchangeable products. That in turn shapes:
- how suppliers are permitted to produce under regulatory authorization,
- whether alternative supply routes are viable without licensing or patent work.
Impact for supplier selection
- If the market is restricted to the NDA holder’s authorized commercial supply chain, CMOs/API suppliers must stay within qualified and authorized pathways.
- If authorized generics exist, the supplier base can broaden through ANDA supply chains.
When does duvelisib lose exclusivity and how does that change supplier options?
Exclusivity loss drives commercial opportunity for additional manufacturers. Over time, it can shift supplier behavior from:
- reliance on the original NDA holder’s qualified CMC chain, to
- broader ANDA/authorized generic procurement ecosystems with more qualified API and CMO options.
How exclusivity timing affects supply
- Before loss of exclusivity: supplier options are mostly constrained to NDA-authorized supply.
- After loss: supplier options expand through ANDA filings, but only if the manufacturing process and impurity specs support regulatory approval.
Are there any duvelisib Paragraph IV challenges that affect supply and sourcing?
Paragraph IV challenges can accelerate generic/authorized generic entry and change the procurement picture for:
- API supplier demand forecasting,
- DP/packager capacity allocation,
- licensing and supply contracts.
If there are active or recently resolved Paragraph IV cases tied to duvelisib, those can also determine:
- which companies become next-wave suppliers for commercial launch,
- whether settlement terms restrict launch timing.
What duvelisib patent estate issues affect CMO and API supplier qualification?
Patent estate questions affect suppliers only indirectly through commercial feasibility and licensing costs. Key areas that can affect process and formulation supply decisions include:
- composition-of-matter patents tied to duvelisib itself,
- formulation patents (if any exist for a specific dosage form or excipient system),
- method-of-use patents tied to therapeutic regimens,
- manufacturing method patents that control synthetic route or purification steps.
CMOs typically avoid process infringement by working from authorized processes and by ensuring their supply is covered by commercial authorizations. API suppliers similarly focus on authorized synthetic routes and impurity profiles.
Which generics or biosimilars compete with duvelisib and what does that imply for suppliers?
Duvelisib is a small-molecule drug, so the competitive universe is generic small molecules, not biosimilars. Supplier implications:
- Generic entrants rely on their own authorized API and DP suppliers, often using different plants than the NDA holder.
- If generic supply expands, API and DP demand becomes less concentrated and procurement leverage improves.
How strong is duvelisib’s supplier leverage: API scarcity vs multiple qualified sources?
Supplier leverage is determined by:
- number of qualified DMF/API sites,
- number of qualified DP/packaging plants,
- intermediate bottlenecks,
- regulatory constraints from approved CMC sections.
In oncology small molecules, supplier leverage usually concentrates in the few facilities able to consistently meet impurity specifications and stability requirements. The supply risk profile is typically more sensitive to intermediate bottlenecks than to finished-dose assembly.
Duvelisib supplier due diligence matrix: what to ask and what to document
API suppliers
- DMF type and status (active and referenced).
- Years of commercial production of duvelisib.
- Impurity control strategy and genotoxic impurity mitigation evidence.
- Batch release testing package alignment with NDA specs.
Intermediate suppliers
- Lot traceability with CoA and full analytical reporting.
- Ability to meet residual solvent and heavy metal specs.
- Confirmed capacity for scale-up and emergency inventory release.
CMOs/DP
- Demonstrated capability for the dosage form and packaging configuration.
- Stability program status and study commitments.
- Equipment qualification and change control history for duvelisib products.
Key supplier categories for duvelisib procurement (actionable view)
- Primary API manufacture: NDA-authorized duvelisib API supplier(s) under DMF support.
- Intermediate manufacture: qualified chemical intermediates suppliers for bottleneck steps.
- DP manufacturing: GMP blending and DP assembly facilities aligned to NDA release specs.
- Packaging/labeling: GMP packaging sites and distribution chain providers.
- Analytical testing labs: in-house or contract labs supporting release, stability, and method validation.
Key Takeaways
- Duvelisib supply is driven by a qualified small set of API and DP/packaging facilities tied to DMFs and NDA-approved CMC sections.
- Supplier risk centers on intermediate bottlenecks and impurity-controlled synthetic steps, not on final formulation assembly alone.
- Patent and exclusivity status shape the breadth of alternative supplier options by limiting or enabling generic and authorized generic entry over time.
FAQs
1) What regulatory documents identify duvelisib API suppliers in U.S. submissions?
Drug Master Files (DMFs) and NDA CMC references to manufacturing and testing sites.
2) How do duvelisib impurity specs affect qualification of new API suppliers?
They require validated impurity profiles, analytical method alignment, and demonstrated batch release capability against NDA specs.
3) What role do duvelisib intermediate suppliers play in supply continuity during shortages?
They control upstream bottleneck steps and often dictate schedule risk and cost due to limited capacity and specific impurity/solvent compliance.
4) Do duvelisib settlements or exclusivity rulings change CMO capacity planning?
Yes, they shift demand forecasts and procurement commitments for DP and packaging ahead of potential generic entry.
5) What should be prioritized when selecting duvelisib DP contract manufacturers?
GMP experience with oncology small molecules, alignment to NDA release/dissolution testing, stability coverage, and validated packaging configuration.
References (APA)
- U.S. Food and Drug Administration. (n.d.). Drugs@FDA: Copiktra (duvelisib). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products and Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/ob/
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