Suppliers and packagers for WAKIX

WAKIX

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150	NDA	Harmony Biosciences, LLC	72028-045-03	1 BOTTLE, PLASTIC in 1 CARTON (72028-045-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2019-08-14
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150	NDA	Harmony Biosciences, LLC	72028-178-03	1 BOTTLE, PLASTIC in 1 CARTON (72028-178-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2019-08-14

WAKIX (pitolisant) Suppliers and Upstream Manufacturing: Who Makes It, Who Ships It, and What to Map for IP and Formulation Risk

Last updated: May 23, 2026

WAKIX is the branded pitolisant product (H3 receptor antagonist/inverse agonist) used for narcolepsy with cataplexy and for excessive daytime sleepiness in adults with narcolepsy. Supplier mapping for WAKIX should be built around (1) the commercial drug product manufacturer and packager/labeler on the FDA label, (2) API and key intermediate suppliers used by the approved drug substance process, and (3) distributor and logistics entities tied to NDC distribution.

What is the WAKIX supply chain (drug product vs. drug substance)?

• Drug product supply chain: the manufacturer(s) and packager(s) listed on the WAKIX FDA label and associated FDA filings.
• Drug substance (pitolisant) supply chain: API manufacturing sites referenced in FDA submissions (DMF/CTD) and the supply chain history in quality/regulatory documents.
• Commercial distribution: the distributor(s) on the label and the typical WAKIX channel.

Which companies supply WAKIX in the US (labeler, manufacturer, packager)?

Featured snippet answer: WAKIX’s “supplier” for compliance purposes is the labeler and listed manufacturers/packagers on the FDA prescribing information (US labeling controls how supply risk is assessed for recalls, GMP compliance, and change notifications).

How to identify the WAKIX drug product supplier(s)

1. Use the WAKIX prescribing information (section “Manufactured for” / “Distributed by”) to extract:
   • Labeler (commercial owner/distributor)
   • Drug product manufacturer(s)
   • Packager and/or secondary manufacturer(s) if listed
2. Match those entities to:
   • Product listing in the FDA NDC directory
   • Label “Revised” dates and lot/packaging details if present
3. Cross-check against:
   • FDA Drug Establishment Inspection records for identified sites
   • Any announced “recall by” entities tied to WAKIX lots

Supply mapping deliverable (what to build in your internal tracker)

• Entity name (as written on label)
• Role (labeler, manufacturer, packager)
• Site address (if available in label or establishment records)
• NDC-level linkage (NDCs covered by the site)
• GMP status indicators (inspection outcomes and dates, when available from FDA)

Who supplies pitolisant API for WAKIX (drug substance manufacturers)?

Featured snippet answer: The “API supplier” for WAKIX is the pitolisant drug substance manufacturing site(s) listed in FDA drug substance filings (commonly via DMF references) tied to the NDA.

Where API suppliers appear in practice

• In the FDA review history and submission components:
  • Drug substance manufacturing and testing sites
  • Process descriptions and key intermediates
  • DMF holders and cross-reference identifiers
• In quality disclosures:
  • Site transfer notifications
  • Supplemental NDA manufacturing change approvals

How to map upstream supplier risk

• Identify:
  • Original and current pitolisant API manufacturer(s)
  • Any alternate API sites added via CBE-30/sNDA changes
  • Any intermediate suppliers if disclosed (often less publicly visible than drug substance sites)
• Flag:
  • Single-site dependence (supply resilience risk)
  • Any ongoing process transfer that affects comparability or stability
  • Any FDA observations tied to drug substance sites

What ingredient suppliers matter most for WAKIX formulation (excipients, coating, dosage build)?

Featured snippet answer: Excipients rarely drive patent exclusivity for WAKIX, but they drive procurement continuity and can create availability risk during shortages or GMP holds.

Formulation supply chain nodes to track

• Oral dosage unit manufacturing:
  • Tablet manufacturing step suppliers (granulation, compression, coating, packaging)
• Excipients:
  • Critical functional excipients (binders, disintegrants, lubricants, coatings)
  • Colorants or film-formers if used for tablet identity
• Primary and secondary packaging:
  • Bottles/blisters
  • Desiccant/caps and packaging line qualification

What “supplier” means in litigation and regulatory audits

• In IP disputes, the key is not “who sells excipients,” it is:
  • Who manufactures the drug product under the approved process
  • Whether alternative processes implicate method and formulation patents
• In FDA inspections, “supplier” risk is tied to:
  • GMP sites for drug product and drug substance, not commodity excipients

How do you map WAKIX supplier changes over time (site transfers, alternate suppliers)?

Featured snippet answer: Supplier changes are usually documented as manufacturing site additions or process changes in FDA supplements. Track these changes by label revision history and FDA submission dates.

Practical supplier-change tracking framework

• Label revision date timeline:
  • “Manufactured for/Distributed by” changes often accompany:
    • Packager/labeler changes
    • Repackaging responsibilities
• NDA manufacturing supplement tracking:
  • Identify when alternate drug substance sites were approved
  • Identify when oral dosage manufacturing sites were replaced or added
• Recalls and wholesaler holds:
  • “Distribution by” and “manufactured by” entities show the operational chain on affected lots

Which NDCs and dosage forms define WAKIX supplier scope?

Featured snippet answer: Supplier scope is NDC-driven; WAKIX supply risks should be mapped per NDC strength and dosage form.

Supplier mapping table template (fill from FDA label and NDC directory) | NDC | Strength | Dosage form | Labeler | Drug product manufacturer | Packager | Primary packaging | |---|---|---|---|---|---|---| | (from FDA NDC directory) | (e.g., mg strength) | Tablet | (labeler) | (site) | (site) | (bottle/blister) |

What generic entry risks exist for WAKIX suppliers (Paragraph IV and manufacturing readiness)?

Featured snippet answer: Generic entry risk for WAKIX depends on Orange Book patent coverage and any Paragraph IV certifications that target the approved reference product’s patents. Supplier mapping matters because challenger ANDA/505(b)(2) manufacturing plans can require proving bioequivalence with different manufacturing processes.

How supplier mapping intersects patent risk

• If a generic challenger targets formulations or method-of-use patents:
  • Manufacturing process and controls become central
• If it targets the drug substance route:
  • API synthesis and polymorph control become central
• If it targets method-of-use:
  • Labeling strategy drives risk, not just supply

What to verify in the Orange Book

• Patent numbers and expiration dates tied to WAKIX:
  • Drug substance patents
  • Drug product/formulation patents
  • Method-of-use patents
• Whether there are active ANDAs with Paragraph IV certifications:
  • If yes, map which generic manufacturers are challenging
  • Tie challenger ANDA manufacturing sites to quality execution risk

How does WAKIX supplier landscape compare with other narcolepsy drugs (Xywav, Wakix class)?

Featured snippet answer: Different narcolepsy medicines have different “supplier risk shapes.”

• Sodium oxybate class (e.g., Xywav) tends to have more complex manufacturing supply chains and depot-like distribution complexities.
• Pitolisant (WAKIX) is a conventional oral small-molecule tablet, so supply chain risk is typically dominated by tablet manufacturing and API stability/process capability.

Comparable risk dimensions to benchmark

• Number of approved drug product manufacturing sites
• API source concentration (single vs multi-site)
• Dose strength complexity (simpler tablet strengths generally have fewer scaling bottlenecks)

Key Takeaways

• For WAKIX, “supplier” should be defined by the entities listed on the FDA WAKIX label for drug product, plus the pitolisant drug substance manufacturing sites referenced in FDA filings.
• Build a supplier tracker by NDC, strength, and packaging configuration, then map to drug product and drug substance sites.
• Supplier change risk is audit-relevant and should be tracked via label revisions, FDA manufacturing supplements, and lot-level distribution records from FDA recalls and holds.
• Patent and generic entry risk should be layered onto supplier mapping because challenger manufacturing plans can hinge on process controls that interact with formulation and method patents.

FAQs

1. Where on the WAKIX label are the manufacturer and distributor suppliers listed?
   In the “Manufactured for” and “Distributed by” sections of the US prescribing information.

2. How do I find the pitolisant API manufacturing sites for WAKIX?
   From the drug substance references in FDA submission components tied to the WAKIX NDA.

3. Do WAKIX excipient suppliers affect FDA approval status?
   Typically the formulation excipient suppliers are not individually approved, but they affect GMP execution, specification compliance, and consistency.

4. How do I map WAKIX supplier scope by NDC?
   Use FDA NDC directory for NDC strength/form and match to labeler and manufacturer/packager listed for that NDC.

5. Does WAKIX supplier concentration increase recall or shortage risk?
   Yes, when a small number of GMP sites supply the product, a single site issue can constrain national supply.

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References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. Food and Drug Administration. NDC Directory.
3. U.S. Food and Drug Administration. Drug Product Labeling (WAKIX prescribing information).