Last updated: May 28, 2026
ILLUCCIX suppliers: Who manufactures, supplies, and licenses the product?
Executive summary: ILLUCCIX is not an identified, uniquely described FDA-regulated pharmaceutical product in publicly accessible labeling and regulatory databases under that spelling. Without a definitive match to an approved drug product (active ingredient, dosage form, strength, NDA/BLA number, or sponsor) the supplier/manufacturer landscape cannot be produced accurately.
What is ILLUCCIX and which company is the marketing author holder?
Answer: No authoritative mapping to a specific approved drug product can be made from the name alone, so the marketing authorization holder and manufacturing suppliers cannot be stated.
What identifying details determine “suppliers” for an FDA drug product?
Suppliers in the IP and regulatory sense typically map to:
- NDA/BLA holder (labeling “Manufactured for” / “Distributed by” entity)
- Drug substance supplier (API)
- Finished dosage manufacturer (site-specific)
- Contract manufacturing organization (CMO) and fill-finish provider
- Authorized distributor(s)
Why the exact product identity matters
Different spellings, internal brand variants, and salt/drug-delivery formats can change:
- the Orange Book listing
- the labeling “manufactured for” entity
- the CGMP manufacturing sites listed on FDA inspections
- the patent estate and exclusivity owner
Which manufacturers supply ILLUCCIX API and finished dosage form?
Answer: Not determinable without a verified product identity (active ingredient, dosage form, strength, and NDA/BLA).
API suppliers: typical information sources
- NDA/ANDA Chemistry, Manufacturing, and Controls (CMC) disclosures
- FDA drug product facility and inspection data
- Public registries and labeling “manufactured by” language
Finished dosage suppliers: typical information sources
- Labeling sections: “Manufactured for,” “Distributed by,” and “Manufactured by”
- FDA drug registration and listing system (DRLS) and facility registration data
What does the Orange Book list for ILLUCCIX?
Answer: No Orange Book status can be assigned without the exact NDA/BLA identifier and product match.
What you need to confirm in the Orange Book
- Listed drug (active ingredient, dosage form)
- Applicant (Orange Book NDA holder)
- Patents listed (US numbers, patent types)
- Exclusivity end dates (if applicable)
What patents and licensing agreements affect ILLUCCIX suppliers?
Answer: Patent and licensing data cannot be connected to “ILLUCCIX” without a validated product match to specific patent numbers, assignees, and an NDA/BLA.
Supplier impact pathways
For brands, supplier constraints often come from:
- manufacturing-use method patents
- formulation/process patents
- exclusivity periods affecting authorized generic and distribution
When can generic or biosimilar supply challenge ILLUCCIX?
Answer: No generic or biosimilar entry risk timeline can be produced without the exact reference product identity and FDA approval pathway.
What determines entry risk for a branded drug
- NDA/BLA approval date
- patent expiration and exclusivity windows
- whether Paragraph IV filings have occurred
- settlement terms that affect authorized supply timing
Which distributors supply ILLUCCIX to pharmacies and hospitals?
Answer: Not determinable without labeling identification (the “Distributed by” entity is product- and package-specific).
How distribution entities typically appear
- package inserts and cartons
- wholesaler listings
- FDA label “Distributed by” language
Key Takeaways
- “ILLUCCIX” cannot be reliably matched to a specific FDA-approved drug product based on the provided name alone.
- Without a confirmed NDA/BLA and product identity, the supplier set for API, finished dose manufacturing, and distribution cannot be stated accurately.
FAQs
- How do I identify the NDA/BLA holder for a branded drug name?
- Where can contract manufacturing sites for a specific drug be verified?
- How is a drug’s Orange Book listing tied to supplier and patent owners?
- What does FDA labeling say about “manufactured for” vs “distributed by” entities?
- How do Paragraph IV filings affect future supplier and generic availability?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Database).
- U.S. Food and Drug Administration. Drugs@FDA. (Database).
- U.S. Food and Drug Administration. Drug Registration and Listing System (DRLS) and facility information. (Program).
