Last updated: May 30, 2026
NULYTELY Suppliers: Who Manufactures and Supplies the Sodium Phosphate Bowel Prep (Orange Book, Contract Manufacturing, and Channel Sources)
Nulytely (generic name: sodium picosulfate, magnesium oxide, and citric acid with polyethylene glycol 3350 as the osmotic component for bowel cleansing, as marketed as a specific 3-drug regimen in a single product) is supplied through a constrained set of primary manufacturers and packagers that win placement on the FDA label and get listed on distributor and wholesale channels. The supplier set is determined by (1) the NDA holder and labeler-of-record, (2) the FDA drug listing for product/strength/packaging, and (3) which firms perform packaging and labeling versus drug substance and bulk formulation under contract.
However, no supplier-identifying data (NDA holder, labeler-of-record, manufacturing sites, or Orange Book/Drugs@FDA manufacturing establishment listings) was provided. With no verifiable FDA or listing identifiers tied to “NULYTELY,” a complete and accurate supplier map cannot be produced.
Which companies supply NULYTELY to wholesalers and pharmacies?
Featured snippet answer: Nulytely’s “supplier” at the operational level is the labeler-of-record on FDA listings, plus any contract manufacturers and packagers working under NDA/ANDA controls. Without the specific FDA listing identifiers for Nulytely, a company-by-company supplier list cannot be compiled.
What role does the labeler-of-record play in Nulytely supply?
- The labeler-of-record is the entity responsible for the drug product label under FDA’s drug listing and distribution controls.
- Contract manufacturing or packaging firms may not be the labeler-of-record; they may appear only in establishment listings.
What distributor models typically apply to bowel-prep products?
- National wholesalers (direct distribution or via distribution centers).
- Chain pharmacy replenishment programs.
- GPO-driven procurement where applicable.
What is the Orange Book status of NULYTELY and how does it affect sourcing?
Featured snippet answer: Orange Book status governs patent and exclusivity, not wholesale sourcing. Sourcing is driven by FDA listing labeler-of-record and manufacturing approvals.
Why Orange Book alone cannot identify NULYTELY suppliers
- Orange Book lists approved patents and applicants for NDA/ANDA products.
- Supplier identification requires cross-checking FDA resources that list manufacturing establishments and drug product labeler information.
What patents protect NULYTELY and who can legally supply it under approval or licensing?
Featured snippet answer: Patent coverage controls generic and “same active ingredient/same dosage form” competition timelines, which can expand or restrict supply. Without the NDA number and Orange Book patent listing for Nulytely, supplier eligibility cannot be mapped.
How supply expands when generics enter
- Generic approvals add manufacturing capacity.
- Packaging and distribution relationships change based on labelers and contract packagers.
What FDA manufacturing sites are used to make NULYTELY?
Featured snippet answer: FDA manufacturing sites are found by matching the drug product to its FDA establishments responsible for manufacture, packing, and labeling. The required FDA establishment mapping is not available in the prompt.
How do generic competitors for NULYTELY change the supplier landscape?
Featured snippet answer: If additional applicants enter with approved products, the supplier landscape widens through multiple labelers and manufacturing sites. The prompt does not provide the presence or absence of generics and does not include ANDA applicants.
Which formulation variants of NULYTELY affect which suppliers?
Featured snippet answer: Differences in strength, dosage form, packaging configuration, and regimen components can move supply to different contract manufacturers and packagers. Nulytely’s exact labeled configuration was not provided, so supplier-to-variant mapping cannot be constructed.
What manufacturing/IP barriers limit alternative suppliers for NULYTELY?
Featured snippet answer: Barriers typically include:
- Patent-protected formulations or methods of use
- NDA/ANDA regulatory controls
- Contract manufacturing capacity constraints
- Labeling/regulatory requirements for bowel-prep regimens
No Nulytely patent estate details were provided, so barrier quantification cannot be performed.
Key Takeaways
- “Suppliers” for Nulytely in commercial practice are the FDA labeler-of-record plus the contract manufacturing/packaging establishments that produce and package the final product.
- A precise list of supplier companies requires the product’s FDA-identifying data (NDA number, labeler-of-record, and manufacturing establishment listings). None is included in the prompt.
- Without those identifiers, providing a company-by-company supplier roster would not be accurate.
FAQs
- What is the labeler-of-record for NULYTELY and who owns the NDA?
- Are there multiple manufacturers for NULYTELY by lot or by packaging size?
- Do NULYTELY generics exist, and which ANDA applicants supply the market?
- Which FDA manufacturing establishments produce and package NULYTELY?
- How do NULYTELY shortages typically trace back to supplier capacity constraints?
References
No sources were provided in the prompt, and no FDA-identifying data for NULYTELY (NDA/ANDA number, Drugs@FDA or Orange Book listing) was included.
