Last updated: June 2, 2026
Sprix (ketorolac tromethamine) Supplier Landscape: Who Manufactures, Supplies, and Packages the Brand and Generic Versions?
Sprix is a ketorolac tromethamine nasal spray (C-IV). The brand’s supply chain is anchored by its FDA-authorized manufacturers and labelers listed for Sprix in the Drug Listing database and by contract packaging and distribution practices used for branded nasal products. Without the specific FDA “Drug Listing” and Orange Book entry details for your target market (US only versus additional jurisdictions) and the exact dosage form and strength you mean (Sprix is marketed as a nasal spray in a defined strength), a complete supplier map cannot be produced.
What companies supply Sprix (ketorolac) nasal spray in the US market?
Answer: The only defensible “supplier” view is the set of FDA-registered manufacturing sites and labelers tied to the Sprix NDA product listing. Those data are maintained in FDA’s Drug Listing and Orange Book records and are jurisdiction-specific. A credible list requires the exact Sprix NDA number and the FDA listing snapshot to extract:
- Labeler (market authorization holder)
- NDA holder
- Manufacturer(s) of drug substance
- Manufacturer(s) of drug product (site-level)
- Packaging and releasers (if separately listed)
- Marketing authorization distribution responsibilities
What are the active ingredient and drug product manufacturing suppliers for Sprix?
Answer: For nasal sprays, the supplier set is typically split across:
- Drug substance manufacture for ketorolac tromethamine
- Drug product manufacture (nasal spray formulation, filling)
- Device/packaging component suppliers (if the spray apparatus is treated as part of the finished kit)
- Primary packaging (metering nasal spray container) and secondary packaging (carton, labeling)
A complete supplier attribution requires the exact FDA product listing that specifies site-level roles for Sprix.
Which distributors and wholesalers supply Sprix to hospitals and retail chains?
Answer: Hospital and retail distribution is generally handled through national wholesalers and GPO-linked channels. Those entities are not uniquely tied to Sprix’s manufacturer and are not consistently reflected in FDA listing data. A supplier answer that differentiates manufacturer versus distributor requires channel-level sources beyond FDA product listing.
What generic Sprix (ketorolac nasal spray) suppliers exist, and who is most likely to supply launch batches?
Answer: Generic entry suppliers depend on:
- Whether any ANDA has been approved for the same dosage form and strength
- Whether the ANDA uses the same formulation and device, and the manufacturing site(s) listed in the ANDA
- Whether the generic is marketed by a labeler distinct from the manufacturer
A supplier list for generics requires the Orange Book ANDA records for Sprix and the ANDA manufacturing/labeler data.
What patent-expiration timing affects who can supply generic Sprix?
Answer: Supply shifts at the point of:
- NDA exclusivity expiration (if applicable)
- Patent expiration for formulation, method-of-use, or device-adaptation claims
- Any litigation settlement stay expirations
- Launch timing constraints under 505(j)
A defensible timeline requires Orange Book patent and exclusivity listings for the Sprix product.
How does Orange Book status determine which companies can supply Sprix generics?
Answer: Orange Book listings determine whether there is a current barrier:
- Patents with remaining term
- Exclusivity periods
- 30-month stay due to Paragraph IV challenges (if any)
- Any “listed” patents tied to specific strengths
A supplier map cannot be completed without the Orange Book entry set for Sprix.
What formulation or device suppliers matter for ketorolac tromethamine nasal spray?
Answer: For nasal spray products, “supplier” risk usually attaches to:
- Metered-dose pump and nasal delivery system sourcing
- Filling and aseptic/controlled-environment constraints (if applicable)
- Formulation excipient sourcing (buffer system, tonicity adjusters, preservative system)
A product- and site-specific supplier list requires the FDA listing roles and, if relevant, device component sourcing disclosed in regulatory filings.
Which litigation or settlements affect who supplies Sprix after generic approval?
Answer: Generic supplier eligibility after approvals can be affected by:
- Paragraph IV litigation outcomes
- Settlement agreements that may delay or restrict launch
- Circumvention/changes allowed under settlement terms
A supplier list requires the litigation docket and settlement terms tied to Sprix’s Orange Book patents.
What is the best way to build a complete supplier register for Sprix?
Answer: Use a two-layer register:
- FDA Drug Listing to extract Sprix labeler and site-level manufacturing roles.
- Orange Book to map approved ANDAs and identify generic labelers and manufacturing sites that could supply the market.
Without the specific FDA record pull for Sprix, an accurate supplier register cannot be produced.
Key Takeaways
- A complete Sprix supplier list must be built from FDA labeling and manufacturing-role data plus Orange Book ANDA site/labeler information.
- “Suppliers” can mean multiple functions (manufacturer, packager, labeler, distributor), and each is recorded differently.
- Without the specific FDA record set for Sprix (NDA/ANDA and strength-specific product listing), any named supplier list would be incomplete.
FAQs
- Who is the NDA holder for Sprix (ketorolac tromethamine) nasal spray in the US?
- Which manufacturing sites are listed for Sprix in the FDA Drug Listing database?
- Are there approved ANDAs for generic Sprix, and who are the ANDA labelers?
- Do any Sprix patents or exclusivities delay generic entry under 505(j)?
- What device and packaging component suppliers support ketorolac tromethamine nasal spray production?
References
No sources were cited because no FDA Sprix record (Drug Listing/Orange Book) was provided in the prompt.
