Last updated: May 31, 2026
ORILISSA (elagolix) is supplied through a limited set of branded manufacturing and commercial sourcing channels anchored to the product’s original developer and branded supply chain. However, a complete, supply-chain-level supplier map (site-by-site manufacturers, contract manufacturing organizations, and downstream packaging partners) cannot be produced from the information provided.
Who supplies ORILISSA (elagolix) in the US market?
Direct answer: Branded ORILISSA supply is controlled through the NDA holder’s branded drug supply chain and its drug substance and drug product manufacturing partners. A site-level supplier list cannot be generated without verifiable manufacturing and labeling records.
What entities typically appear as ORILISSA suppliers on labeling or regulatory filings?
US-branded oncology and women’s health drug supply chains commonly show multiple parties across the value chain:
- Drug substance manufacturer(s)
- Drug product manufacturer(s) (tablet/capsule fill-and-finish equivalent)
- Packaging and labeling operations
- Distribution channels supplying wholesalers, specialty pharmacies, and GPOs
What are the ORILISSA drug substance and drug product manufacturing partners?
Direct answer: The drug substance (elagolix API) and the drug product manufacturing are handled by identified manufacturers in regulatory documentation and product labeling. Those specific names are not available in the information supplied.
Do DMF-holder and CMC documents determine ORILISSA supplier identity?
Yes. For small-molecule brands, API supplier identity often traces to DMF holders, while final dosage form manufacturing is shown in CMC sections and in FDA labeling under “Manufactured for / Distributed by.” Without the cited documents or the specific labeling copy being provided, a precise supplier list cannot be produced.
Which companies supply ORILISSA to wholesalers and specialty pharmacies?
Direct answer: ORILISSA is distributed through branded commercial channels tied to the marketing authorization holder. A complete supplier roster for US distribution cannot be produced without ORILISSA’s specific FDA label distribution line and the associated commercial entity identifiers.
Where do “distributed by” and “manufactured for” lines usually point?
- “Manufactured for” lines identify the marketing authorization holder and sometimes the packaging/labeling party
- “Distributed by” lines identify the US commercialization distributor
- “Manufactured by” or “Manufacturing site” statements identify final dosage form manufacturers
What dosage forms and strengths does ORILISSA supply, and who makes each?
Direct answer: ORILISSA is supplied as oral tablets at multiple strengths. A supplier-by-strength manufacturing attribution requires strength-specific label/manufacturing statements and site-level CMC records.
How do ORILISSA supplier changes affect availability and recalls?
Direct answer: Availability risk increases when manufacturing is concentrated in one or few sites or when packaging/labeling depends on a single partner. A supply-risk assessment requires the actual manufacturing and packaging party identities, plus change history and inspection findings, which are not present.
What triggers ORILISSA supply interruptions?
Typical high-impact triggers include:
- API batch shortages
- Quality system deviations at manufacturing sites
- Packaging line downtime
- Distribution constraints to specialty channels
What is the ORILISSA supply chain for generic or future biosimilar-like pathways?
Direct answer: For small molecules like elagolix, generic entry is driven by ANDA applicants and approved manufacturing. A supplier landscape for generics requires the ANDA’s manufacturer and ANDA label manufacturing statement. No ANDA manufacturing information is provided.
Which ORILISSA suppliers are involved in patent licensing or formulation supply?
Direct answer: Supply partners are not the same as patent licensees. Patent licensing affects who can legally manufacture and sell, while suppliers determine who can operationally produce. Supplier identities tied to licensing require named parties from the agreements, filings, or litigation records, none of which are included.
Key Takeaways
- ORILISSA supply is managed through a branded drug supply chain anchored to the marketing authorization holder and its manufacturing partners.
- A supplier list at the level of API manufacturer, final dosage form manufacturer, packaging, and distribution cannot be produced from the information provided.
- Supply risk, manufacturing change control, and downstream generic sourcing all depend on the specific “manufactured for/distributed by” and manufacturing site records, which are not included.
FAQs
- Who is the US distributor of ORILISSA (elagolix) on the label?
- Which company manufactures the ORILISSA tablets and at what manufacturing site?
- Who supplies the ORILISSA API (elagolix) under DMF filings?
- Are there contract manufacturers (CMOs) involved in ORILISSA packaging and labeling?
- How can I identify ORILISSA suppliers using FDA labeling and manufacturing statement lines?
References
- FDA Orange Book. ORILISSA (elagolix). U.S. Food and Drug Administration.
- FDA Label (prescribing information) for ORILISSA (elagolix). U.S. Food and Drug Administration.
