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Suppliers and packagers for generic pharmaceutical drug: Avapritinib
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Avapritinib
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608 | NDA | Blueprint Medicines Corporation | 72064-110-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-110-30) | 2020-01-09 |
| Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608 | NDA | Blueprint Medicines Corporation | 72064-120-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-120-30) | 2020-01-09 |
| Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608 | NDA | Blueprint Medicines Corporation | 72064-125-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-125-30) | 2021-06-16 |
| Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608 | NDA | Blueprint Medicines Corporation | 72064-130-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-130-30) | 2020-01-09 |
| Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608 | NDA | Blueprint Medicines Corporation | 72064-150-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-150-30) | 2021-06-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: Avapritinib
Avapritinib suppliers: Who manufactures, supplies, and licenses g a v a p r i t i n i b (Ayvakit) active ingredient and finished drug?
Avapritinib (Ayvakit) is commercialized as a branded, FDA-approved oncology product by Blueprint Medicines through its U.S. marketing entity, with manufacturing and API supply handled by contracted third parties. Supplier mapping for avapritinib depends on whether the supply target is (1) active pharmaceutical ingredient, (2) finished drug product tablets, or (3) generic/biosimilar-grade sourcing for research, procurement, or CDMO internalization.
High-level supply-chain reality: the public record used for procurement decisions is split between (a) FDA drug listing and inspections via the Drug Approvals and Recalls and (b) facility-level manufacturing disclosures tied to the approved NDA. Those records typically identify drug product sites and applicant/holder information more reliably than they identify the full multi-tier API vendor list in a way that is complete for all grades and jurisdictions.
What is actionable for supplier selection: the most defensible procurement approach is to anchor to the FDA-approved label manufacturing section and any publicly visible dossier-to-facility links for the approved product, then confirm API sourcing through supplier qualification documents, DMFs, and import records.
Who supplies avapritinib API (active pharmaceutical ingredient) for Ayvakit?
Featured snippet answer: The FDA label and official approval documentation for Ayvakit generally identify manufacturing sites for the finished drug product. It is common that API suppliers are controlled via DMFs and contracted manufacturing, so a full vendor roster is usually not fully exposed in public sources.
Practical sourcing endpoints
- API-grade avapritinib: typically supplied by one or more contract API manufacturers under DMF submissions supporting the NDA.
- Finished tablets (Ayvakit): manufactured by one or more drug product facilities identified on regulatory filings and the approved label.
- Global suppliers: jurisdiction-specific because importation, batch release, and parallel distribution differ by country.
Procurement implication: If the goal is raw procurement, the dominant constraint is DMF-controlled API sourcing. If the goal is licensed manufacture or co-development, the dominant constraint is access to the approved manufacturing chain and regulatory authorization status.
Which companies manufacture avapritinib tablets (Ayvakit drug product) and where?
Featured snippet answer: Identify drug product manufacturing locations from the FDA-approved Ayvakit label “Manufactured for” / “Manufacturing site” information and any site listing tied to the NDA.
What this means for supplier due diligence
- Prefer facilities with a clear regulatory footprint: FDA-inspected sites, cGMP compliance, and consistent lot release records.
- Run supplier onboarding against:
- cGMP inspection history
- batch-to-batch quality agreement reliability
- supply continuity during market expansion or lifecycle changes
How do API suppliers differ from drug-product suppliers for avapritinib?
Featured snippet answer: The API supply chain often sits one tier upstream and is frequently DMF-governed; the drug-product chain is more publicly visible because the NDA ties the finished dosage form to specific manufacturing sites.
Typical chain model for oncology oral small molecules
- API manufacturing: contracted API vendor(s) under DMF
- Drug product manufacturing: contracted tablet production and packaging
- Release testing and batch certification: sometimes at a different site or under a QA release unit
Commercial impact: even if the drug product is “manufactured by” a visible site, API procurement may still rotate among qualified vendors unless the DMF is single-source or tightly controlled.
What is the Orange Book status of avapritinib, and how does that affect supplier options?
Featured snippet answer: Avapritinib is marketed under a branded NDA; any generic entry risk and associated supplier options depend on the regulatory exclusivity, listed patents, and any FDA approvals that follow.
Supplier implications
- If patents and exclusivity remain in force, legitimate generic supply is usually limited.
- If ANDA approvals exist or are launched, they bring additional manufacturing and QA supplier nodes, but those still route through ANDA-specific manufacturing authorizations.
When does avapritinib lose exclusivity, and what supplier churn should be expected?
Featured snippet answer: Exclusivity and patent timelines determine when additional manufacturers can enter without infringement risk. Supplier churn usually accelerates post-exclusivity and after any authorized generic or ANDA settlements.
Timing-to-procurement link
- During active protection: procurement of alternative sources is mostly limited to “research-use only” channels or licensed supply agreements.
- After protection windows: expect additional procurement options only when ANDA/generic manufacturing becomes eligible and meets regulatory and commercial supply contracts.
What patents protect avapritinib (method-of-use, formulation, and manufacturing), and who are the practical suppliers?
Featured snippet answer: Patent protection typically covers drug substance, salt forms (if any), formulations, and potentially method-of-use claims. Practical supplier selection is constrained by whether an alternate manufacturer can lawfully source and manufacture without a license.
Supplier-side consequences
- If formulation patents are robust, even an “API-sourced” manufacturer faces barriers to selling finished product.
- If method-of-use patents exist, a supplier may still manufacture under one scope but be blocked in another (labeling and indication restrictions).
What generic entry risks exist for avapritinib that would change the supplier landscape?
Featured snippet answer: Generic entry risk is driven by ANDA Paragraph IV filings, settlement agreements, and the remaining listed patent set. Supplier expansion often follows successful challenges and the ability to sell at launch.
Procurement impact matrix
- Low risk (strong remaining patents/exclusivity): procurement stays concentrated on branded supply and licensed channels
- Higher risk (settlements/early approval paths): more vendors qualify, price competition increases, and procurement options expand
How does avapritinib procurement differ by geography (US, EU, UK, ROW)?
Featured snippet answer: Geography drives differences in approved packaging, labeling, and manufacturing release chains. Even when the API is similar, the finished product supply and batch release responsibilities shift by market.
What to look for
- local marketing authorization holder
- manufacturing and importation partners
- local pharmacovigilance responsibilities
Which licensing deals affect who can supply avapritinib?
Featured snippet answer: Licensing governs both the right to commercialize and the right to manufacture. Supplier options expand when licenses cover manufacturing rights, not just sales rights.
Key procurement questions that licensing determines
- Are third-party manufacturers authorized to produce the finished product for a given territory?
- Is API supply contractually restricted to specific CMOs under NDA/DMF controls?
- Are there exclusivity-based distribution agreements that limit alternative sourcing?
What manufacturing/IP barriers stop third-party suppliers from selling avapritinib?
Featured snippet answer: The principal barriers are DMF-controlled API sourcing, patent-protected dosage/formulation/manufacturing claims, and regulatory labeling protection.
Common barrier patterns
- DMF access constraints (API access restricted to authorized holders)
- Patent barriers (cannot legally market without license)
- Regulatory labeling constraints (indication or population-specific exclusivities)
Do biosimilar-style pathways apply to avapritinib?
Featured snippet answer: No. Avapritinib is a small-molecule drug, so “biosimilar” frameworks do not apply. Competition comes from generic small-molecule pathways (ANDA) and authorized generics, not biologics.
Avapritinib supplier landscape summary table
| Supply tier | What it supplies | Where it is typically visible | Primary constraint | What buyers should verify |
|---|---|---|---|---|
| API | Avapritinib active pharmaceutical ingredient | DMF-linked FDA/approval documentation; import/manufacturing records | DMF control and DMF vendor authorization | DMF reference, API CoA consistency, impurity profile |
| Drug product | Ayvakit tablets (formulated dosage) | FDA label manufacturing statements; NDA-linked site data | Finished product cGMP authorization and site qualification | Tablet batch release traceability, stability data |
| Commercial distributor | Market supply into channel | Marketing authorization holder and distribution contracts | Allocation and distribution rights | Contracted allocation, lead times, continuity plans |
Key Takeaways
- Avapritinib supply is concentrated in the branded NDA manufacturing chain, with API sourcing often DMF-controlled and therefore less transparent than finished drug product manufacturing.
- Supplier due diligence should anchor to FDA-approved label manufacturing disclosures for the finished tablets, then verify API sourcing via DMF reference pathways, quality agreements, and import/release documentation.
- Generic supplier expansion is governed by patent and exclusivity timelines plus any ANDA/Paragraph IV litigation and settlements, which drive when third-party manufacturing can legally market avapritinib.
FAQs
- Which manufacturing sites are listed on the Ayvakit label for drug product?
- How can procurement identify the correct avapritinib API DMF-linked source for qualified supply?
- Are there different avapritinib tablet strengths with different manufacturing/packaging sites?
- What does an ANDA Paragraph IV challenge imply for avapritinib supply availability?
- How should contract manufacturers structure quality agreements to avoid DMF and patent-related sourcing disputes?
References (APA)
- FDA. (n.d.). Drugs@FDA: Ayvakit (avapritinib). U.S. Food and Drug Administration.
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
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