Last updated: July 4, 2026
JAKAFI XR is the extended-release formulation of ruxolitinib. The supplier map for JAKAFI XR is built from (1) the commercial product’s manufacturing network (drug substance and drug product), (2) FDA establishment links for finished-dose manufacture and packaging, and (3) supplier assignments tied to drug substance or critical intermediates.
No complete, source-citable supplier roster (named companies for both drug substance and finished-dose manufacture/packaging) is available in the provided information, so a complete supplier list cannot be produced.
Which companies supply JAKAFI XR (ruxolitinib extended-release) drug product and packaging?
Answer: Not determinable from the information provided.
Drug product manufacturing and packaging linkages
- Finished-dose manufacturing and packaging are identified in FDA systems (typically tied to NDA holder and product-specific labeling manufacturing statements).
- A supplier list requires named FDA-registered establishments and the mapping from establishment name to corporate supplier.
Who supplies JAKAFI XR ruxolitinib active ingredient (drug substance)?
Answer: Not determinable from the information provided.
Drug substance supply chain
- Ruxolitinib API supply is typically identified by:
- FDA drug substance manufacturing/label claims,
- DMF/ASMF holders (if publicly indexed to a named company),
- corporate manufacturing statements in regulatory dossiers.
- Without citable establishment or DMF/ASMF linkages, no accurate supplier list can be compiled.
What raw materials and critical intermediates are most likely constrained for ruxolitinib XR manufacturing?
Answer: Not determinable from the information provided.
Constraint-driven input categories
- JAK inhibitor core scaffold intermediates
- Specific excipients needed for extended-release (matrix or coating components)
- Film-coating or controlled-release technology inputs
- Sterility/bioburden controls (if applicable to manufacturing stage)
What does the FDA CMC documentation imply about JAKAFI XR’s supplier ecosystem?
Answer: Not determinable from the information provided.
CMC documents that normally surface suppliers
- Drug product manufacturing site descriptions (mixing, granulation if used, tableting/encapsulation, coating)
- Scale-up and process validation vendor lists (site-specific)
- Analytical method validation performed at labeled labs or contract testing sites
What is the Orange Book status of JAKAFI XR, and does it affect supplier choices?
Answer: Not determinable from the information provided.
Orange Book inputs needed for the question
- Patent and exclusivity landscape affects:
- contract development and manufacturing willingness for riskier scale-up,
- sourcing decisions due to “design-around” formulation requirements.
- A supplier impact analysis requires Orange Book data for JAKAFI XR’s listed patents and exclusivity periods.
How does patent and formulation protection for ruxolitinib XR influence contract manufacturing availability?
Answer: Not determinable from the information provided.
IP levers that constrain supplier selection
- Formulation patents: extended-release matrix, coating, or dissolution profile
- Process patents: granulation or coating processes
- Analytical method patents (less common to affect suppliers directly, more common to affect QC package readiness)
- Method-of-use patents (can limit indication-specific generics, indirectly shaping manufacturing contracts)
Which generic or biosimilar applicants threaten JAKAFI XR supply chains through Para IV and litigation?
Answer: Not determinable from the information provided.
What is required to answer
- For JAKAFI XR: Paragraph IV filings, litigation captions, settlement agreements.
- Without docket-level data, no mapping to applicants or launch timing is possible.
Commercial and regulatory milestones that typically determine which suppliers win the next batch of JAKAFI XR contracts
Answer: Not determinable from the information provided.
Milestones that drive sourcing
- FDA batch release timing
- Prior approval supplements (manufacturing site changes)
- CMC comparability commitments for tech transfers
- Stability data readouts supporting shelf-life extensions
Key Takeaways
- A complete, named supplier list for JAKAFI XR (drug substance and drug product/packaging) cannot be produced from the provided information.
- A supplier map for JAKAFI XR requires FDA establishment/product-link data and drug substance dossier indexing, plus CMC manufacturing statements.
- Patent and Orange Book status can constrain supplier availability, but the Orange Book and litigation datasets are not provided, so no exclusivity-linked supplier conclusions can be made.
FAQs
1) Which FDA-registered sites manufacture JAKAFI XR tablets and who runs packaging?
Not determinable from the information provided.
2) Who holds the DMF or ASMF for ruxolitinib used in extended-release JAKAFI XR?
Not determinable from the information provided.
3) Are there contract manufacturers that supply extended-release excipients or coatings for JAKAFI XR?
Not determinable from the information provided.
4) Does JAKAFI XR have Para IV challenges that affect supplier procurement or manufacturing capacity planning?
Not determinable from the information provided.
5) How do CMC tech transfers for ruxolitinib XR affect supplier qualification timelines?
Not determinable from the information provided.
References
No sources were provided in the prompt, and no citable supplier or FDA/Orange Book records were included.
