Last updated: April 23, 2026
Who supplies Lybalvi (olanzapine/samidorphan) and what is known from public filings?
Lybalvi is a fixed-dose combination of olanzapine and samidorphan (distributed under the brand by Eli Lilly and Company). The brand-side supply chain is split between (1) the branded manufacturer/distributor and (2) upstream API and intermediate suppliers that are typically disclosed via Drug Master File (DMF) references, procurement contracts, and regulatory submissions. Public, line-item upstream supplier names are not consistently available in a single consolidated source.
Who is the commercial supplier of Lybalvi?
Eli Lilly and Company supplies Lybalvi to the market as the branded product distributor/manufacturer in the US channel.
| Role |
Entity |
Evidence (public) |
Notes |
| Branded product distributor/manufacturer |
Eli Lilly and Company |
FDA label (U.S. prescribing information) |
The US package insert identifies Lilly as the holder/distributor for Lybalvi. |
| Active ingredients |
Olanzapine; Samidorphan |
FDA label |
Confirms combination and drug substances used in the finished product. |
Sources: Lybalvi US prescribing information (FDA label) [1].
What supplier information is publicly available at regulatory level?
Do public FDA labels name API/intermediate suppliers?
No. FDA prescribing information for Lybalvi typically lists the product manufacturer/distributor but does not routinely disclose upstream olanzapine API and samidorphan API suppliers by name.
| Source type |
What it typically contains for Lybalvi |
Can it identify upstream suppliers by name? |
| FDA label (Prescribing Information) |
Product composition, clinical use, pharmacology, and branded distributor/manufacturer |
Usually no for API/intermediates [1] |
| DMF references (if listed in FDA approval package) |
DMF holders and facility information are often used by FDA reviewers |
Not consistently public in a single document |
| Orange Book (drug product and patent listings) |
Drug product (brand) and application/patent data |
Not a supplier roster |
Orange Book does not function as a supplier database for Lybalvi’s upstream API producers. It supports patent and application status rather than procurement naming [2].
Which upstream suppliers are most likely involved (and how they are identified)?
Publicly identifying upstream API and intermediate suppliers for Lybalvi is usually done through one of these mechanisms:
- FDA Chemistry/Manufacturing/Biopharmaceutics (CMC) review documentation tied to the relevant application (often via the NDA/BLA review package).
- DMF holder disclosures within FDA submission history or associated references (DMFs are often held by contract manufacturers, API producers, or intermediate manufacturers).
- Regulatory facility listings in publicly accessible datasets where the finished product or intermediate manufacturing site is disclosed, but not necessarily the corporate supplier brand name.
For Lybalvi, the only consistently available “supplier” identifier in a single public source is the branded distributor/manufacturer (Eli Lilly) from the FDA label [1]. Upstream supplier corporate names require access to the application/DMF reference details not provided in standard public label text.
What can be used to operationally source Lybalvi supply?
How buyers usually identify correct manufacturing sites
Even when corporate API supplier names are not public, buyers can map to manufacturing sites using FDA label and submission-linked facility identifiers.
From the Lybalvi label, the finished product is tied to Eli Lilly’s distribution/manufacturing responsibility as the brand holder [1]. For upstream procurement, procurement teams typically combine:
- DMF holder and site data (where referenced in the submission trail),
- NDC-to-product application mapping (to locate the correct application),
- and facility registration data for corresponding sites used for the drug substance and drug product.
Publicly, the most direct buyer-friendly starting point remains the FDA label for product identification, then application-specific documentation to reach supplier-level details [1][2].
Lybalvi supply chain facts you can verify from public FDA text
| Item |
Lybalvi detail |
Why it matters for sourcing |
| Drug substance identity |
Olanzapine + Samidorphan |
Confirms the exact two actives to target in DMF/application trace searches [1] |
| Brand distributor/manufacturer |
Eli Lilly and Company |
Controls branded supply and product-level manufacturing responsibility [1] |
| Product identification |
US prescription labeling for Lybalvi |
Establishes the correct product and application mapping entry point [1] |
Key Takeaways
- Eli Lilly and Company is the publicly identified branded supplier/distributor for Lybalvi in the US (from the FDA prescribing information).
- Public FDA label text does not provide a complete, named roster of upstream olanzapine and samidorphan API/intermediate suppliers.
- Orange Book supports application/patent status and does not list upstream suppliers as a standard function.
FAQs
-
Is Eli Lilly the supplier of Lybalvi in the US?
Yes, the Lybalvi FDA prescribing information identifies Eli Lilly and Company as the branded product supplier/distributor.
-
Does the Lybalvi FDA label name olanzapine and samidorphan API suppliers?
No. The label identifies the actives but does not typically disclose upstream corporate API/intermediate supplier names.
-
Can the Orange Book be used to find API suppliers for Lybalvi?
No. The Orange Book lists drug product and patent/application data, not upstream API supplier rosters.
-
Where do upstream supplier names come from when they are available?
They usually come from DMF references and application CMC documentation tied to the Lybalvi NDA.
-
What is the practical first step for sourcing upstream inputs for Lybalvi?
Start with the FDA label to confirm the exact product and actives, then map to the corresponding application and DMF reference trail for supplier-level details.
References
[1] U.S. Food and Drug Administration. Lybalvi (olanzapine and samidorphan) prescribing information (FDA label).
[2] U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
