Last updated: June 10, 2026
VYKAT XR Suppliers: Which Companies Manufacture, Distribute, and Supply the Drug in the U.S.?
Executive summary: VYKAT XR is supplied in the U.S. under an FDA-labeled product listing tied to specific manufacturer and distributor roles. The supply chain hinges on the labeled applicant/holder and the listed manufacturers for the finished dosage form and, in many cases, the underlying extended-release technology platform. Without the product’s FDA label listing details (e.g., Orange Book/Drug Label “Manufactured for” and “Distributed by” parties), a definitive supplier map cannot be produced.
Who supplies VYKAT XR to pharmacies and wholesalers?
Featured snippet answer: The supply parties for VYKAT XR are the FDA-labeled manufacturer(s) and distributor/labeler shown on the product label and FDA product listing. These entities can differ from the company owning the brand.
What roles typically appear in the VYKAT XR supply chain
- Labeler/applicant (brand owner or marketing authorization holder in the U.S.)
- Finished dosage form manufacturer (site(s) producing the XR tablets)
- Contract manufacturer (if production is outsourced)
- National distributor/wholesaler (who ships to pharmacies, often via standard drug distribution channels)
What to check to identify the true suppliers
- FDA product labeling section “Manufactured for” and “Distributed by”
- Orange Book “Applicant” and “Manufacturer” fields (when listed for the product)
- NDC directory and labeler code mapping
- NDA/BLA holder and supplement ownership (for controlled-release products)
Which manufacturers make VYKAT XR extended-release tablets?
Featured snippet answer: The manufacturers are the specific finished dose manufacturers named on the FDA label and FDA product listing. Extended-release products often involve at least one site dedicated to coating, blending, and tablet compression.
Manufacturing-related supplier nodes
- XR core tablet blending and compression
- Coating and controlled-release layer application
- Packaging and labeling
- Quality systems for dissolution and release specification compliance
What is the Orange Book status of VYKAT XR and how does that impact supplier access?
Featured snippet answer: If VYKAT XR is listed in the Orange Book, the listing identifies the applicant and any patents tied to the product. Those listings also correlate with which parties control manufacturing and regulatory control of the product.
What Orange Book listings typically reveal for supply
- Brand applicant identity (who controls the approved product submission)
- Patent-protected formulation or method-of-use coverage
- Potential generic entry risk and timing that can shift supplier economics
When do VYKAT XR exclusivity or patent terms end and how does that change suppliers?
Featured snippet answer: Exclusivity and patent expiry timelines determine when generic and/or AB-rated alternatives can enter under FDA approval routes. When expiry approaches, the market can attract additional manufacturers, increasing supply redundancy.
Key timeline drivers
- Patent expiration (composition, method, formulation, process)
- Statutory exclusivity end dates (e.g., new chemical entity, pediatric, orphan if applicable)
- Orange Book patent listing removals or expirations that unblock generic filing
What generic entry risks exist for VYKAT XR that could change the supplier set?
Featured snippet answer: Generic entry risk rises when Orange Book protections lapse or when companies file Paragraph IV challenges. Those events can introduce new labeled suppliers for the same NDC strength/form.
Paragraph IV and supply-chain knock-on effects
- Settlement agreements often freeze launch dates but may expand allowable manufacturer pathways later
- Launch of AB-rated products can dilute brand volume, shifting which contract manufacturers remain active
Which companies supply active ingredient or excipients for VYKAT XR’s extended-release formulation?
Featured snippet answer: The active ingredient and excipients are sourced from suppliers approved through the brand’s quality system, but the specific vendor list is usually not publicly disclosed unless named in regulatory correspondence, inspection records, or contractual disclosures. Publicly available supply certainty is typically limited to finished-dose manufacturers.
Common supplier categories that affect XR supply
- API supplier(s) for the active pharmaceutical ingredient
- Controlled-release excipient suppliers (depending on the XR technology)
- Coating and processing materials vendors
How does VYKAT XR compare with other extended-release drugs in supplier structure?
Featured snippet answer: XR products often rely on a smaller number of validated manufacturing sites for critical steps (coating and dissolution control). Brand-specific XR technology can narrow the supplier base versus immediate-release products.
Competitive landscape impact
- If multiple XR competitors exist, generic and branded manufacturing tends to diversify.
- If the XR platform is constrained by formulation/process know-how, supplier count stays limited.
Key Takeaways
- The definitive VYKAT XR “suppliers” are the FDA-labeled manufacturer(s) and distributor/labeler listed for the product.
- Extended-release manufacturing typically concentrates in fewer validated XR production sites, making the labeled manufacturer identity central to supply-chain mapping.
- Orange Book status and patent/exclusivity timing determine when additional suppliers (generics/authorized manufacturers) can enter and change market supply.
FAQs
- How can I identify the manufacturer of a specific VYKAT XR NDC?
- Does the Orange Book listing for VYKAT XR list the same party as the labeler?
- What manufacturing step for extended-release tablets most affects supplier availability?
- Do Paragraph IV challenges for similar XR products typically change the number of suppliers at launch?
- Can a distributor name on the label be different from the finished-dose manufacturer?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-06-10).
- FDA. Drugs@FDA Product Information and Labeling. (Accessed 2026-06-10).
