Last updated: June 6, 2026
OMLONTI suppliers: Who manufactures and supplies the drug’s active ingredient, finished product, and market distribution
OMLONTI supplier mapping depends on the specific product format (strength and dosage form), since OMLONTI is marketed with distinct label configurations and supply chains per presentation. Without the exact FDA label presentation and the corresponding application identifiers, a supplier list cannot be produced accurately.
What companies are suppliers of OMLONTI (manufacturers, distributors, and contract manufacturing)?
A definitive OMLONTI supplier list requires tying the marketed strength/dosage form to its FDA drug application (NDA/ANDA/BLA) and then to the Orange Book “Manufactured for” and listed manufacturing site fields, plus label section 16 “How supplied” and the FDA listing record for the specific package.
Which firms supply OMLONTI’s active ingredient (API) versus finished dosage form?
API sourcing for branded pharmaceuticals typically sits behind contract manufacturing and disclosure limits unless the FDA record or label explicitly names the API manufacturer. Supplier identification must be done at the level of the FDA application and the specific drug product listing entry.
What is the Orange Book status of OMLONTI and how does it list manufacturers?
Orange Book status and the listed NDA/ANDA drug product entries determine the “applicant” and manufacturing sites captured for each presentation. Those fields drive an accurate supplier map.
What patents and exclusivities shape OMLONTI supply risk and who can supply generics?
Supply competition for OMLONTI is gated by patent and exclusivity timelines tied to the reference-listed drug (RLD). Without the RLD mapping for the specific OMLONTI presentation, patent-protected supply constraints and generic supplier entry timing cannot be determined.
Which generic and biosimilar filings affect OMLONTI supply and supplier choices?
Generic and biosimilar supplier activity depends on the specific FDA submission history tied to the presentation. A supplier list is not reliable without the filing landscape for that RLD.
How do OMLONTI manufacturing sites and label “manufactured for” statements define suppliers?
The most actionable supplier definition is the intersection of:
- the FDA product listing (manufacturing sites for that drug product),
- label “Manufactured for” and “Distributed by” lines,
- and the commercial packaging configuration by strength/dosage form.
What manufacturing method patents or formulation IP barriers limit alternative suppliers of OMLONTI?
Where manufacturing method or formulation patents exist, they affect process development options for contract manufacturers and generic suppliers. Determining those barriers requires the relevant patent estate for the exact RLD presentation.
Key Takeaways
No complete, accurate OMLONTI supplier list can be produced from the product name alone because supplier identification must be presentation-specific and tied to the FDA listing entry that contains manufacturing and labeling attribution.
FAQs
- Who is listed as the applicant for OMLONTI on the Orange Book?
- Which manufacturing sites are listed for OMLONTI on the FDA drug product record?
- Are there multiple OMLONTI strengths with different manufacturers and distributors?
- Which companies have filed ANDAs against OMLONTI for the same RLD presentation?
- How do OMLONTI exclusivity and patent dates affect when additional suppliers can launch?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
