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Suppliers and packagers for VISTOGARD
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VISTOGARD
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Btg Intl | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159 | NDA | BTG International Inc | 50633-220-04 | 4 PACKET in 1 CARTON (50633-220-04) / 10 g in 1 PACKET (50633-220-10) | 2024-07-31 |
| Btg Intl | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159 | NDA | BTG International Inc | 50633-220-20 | 20 PACKET in 1 CARTON (50633-220-20) / 10 g in 1 PACKET (50633-220-10) | 2024-07-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for VISTOGARD
Vistogard (Uridine Triacetate) Suppliers: Who Manufactures, Sources API, and Fills Demand
Vistogard (uridine triacetate) supply is tied to the commercial package, the uridine triacetate active pharmaceutical ingredient (API) supply chain, and the contract manufacturing used for sterile or non-sterile drug product depending on the dosage form. The primary commercial supplier is the branded product manufacturer listed by FDA for Vistogard’s NDA product. API and intermediate manufacturing are typically handled by named chemical and formulation suppliers under contract, but the publicly searchable “suppliers” list is constrained to FDA labeling, Orange Book/NDA product records, and disclosed manufacturing sites.
Publicly determinable “who supplies Vistogard” from FDA-facing records is: the NDA commercial holder/manufacturer (for product) and the manufacturing sites listed for drug product. Direct API supplier identities are often not fully disclosed in public FDA summaries.
Who is the manufacturer of Vistogard on FDA records?
Answer (product supplier): Vistogard is marketed in the US under an NDA whose product manufacturing sites are listed in FDA product labeling and submission databases. The “supplier” that can be stated from public FDA-facing records is the company responsible for the NDA product manufacturing and distribution as reflected in labeling and FDA product records.
What company holds and supplies Vistogard in the US
- Vistogard is the branded rescue therapy for fluorouracil (5-FU) and capecitabine overdose.
- The US market supply is tied to the NDA holder and the drug product manufacturing sites associated with that NDA.
Which manufacturing sites supply the drug product
- Drug product manufacturing sites for Vistogard are the most reliable “supplier” identifiers that can be extracted from FDA labeling and product listings.
What is the API manufacturing and source chain for uridine triacetate?
Answer (API supplier): Public sources generally identify the NDA drug product manufacturing sites rather than naming every API contractor. Uridine triacetate API supply is commonly produced via chemical synthesis and intermediate steps, often by contract manufacturers, but contractor names are not always explicitly listed in public-facing FDA labeling.
What parts of synthesis drive supplier risk
- API chemical synthesis for uridine triacetate requires controlled conditions for esterification and purification steps.
- Intermediate availability and patent-licensed routes can create bottlenecks even when final drug product capacity is available.
How to interpret “supplier” in practice
- For supply chain planning, treat “supplier” as:
- drug product manufacturer (site that makes Vistogard dosage form),
- API manufacturer (site that makes uridine triacetate),
- packaging and distribution entity (often the NDA holder logistics).
What packaging configuration does Vistogard use, and how does that affect suppliers?
Answer: Packaging configuration affects which contractors can supply and at what lead times.
Dose form and packaging implications
- Vistogard is administered after 5-FU or capecitabine overdose.
- Lead time is influenced by:
- container closure system
- labeling and kit assembly (often a separate contractor)
- cold-chain requirements if any (label-dependent)
Supplier bottlenecks that matter
- Kit assembly and label configuration are common points of delay, even when the drug product bulk is available.
Which contract manufacturers typically supply Vistogard drug product?
Answer: The most defensible identification is the drug product manufacturer(s) whose sites are listed for Vistogard in FDA product records and labeling.
Drug product vs. kit assembly suppliers
- Drug product manufacturing is distinct from:
- packaging,
- kit configuration,
- distribution labeling for US market requirements.
Where supplier data is usually confirmed
- US labeling section describing manufacturing or “Manufactured for / Distributed by” identifies the party accountable for product in the channel.
- FDA product listings identify additional manufacturing sites used for commercial production.
Which patents protect Vistogard, and does that change who can supply?
Answer: Patent coverage does not usually limit who can manufacture under contract if they license the patented technology or if the manufacturing is done by the NDA holder. It does, however, affect the pool of qualified second-source API and third-party fill-finish suppliers if the patented process is required.
How patent estate affects supplier availability
- API process patents can constrain:
- contract manufacturers willing to supply,
- API sourcing switches,
- tech-transfer timelines.
- Formulation and method-of-use patents can constrain:
- alternative drug products,
- non-licensed process changes.
Is there a generic or biosimilar equivalent to Vistogard that adds competing suppliers?
Answer: The “supplier landscape” for Vistogard depends on whether FDA has approved an equivalent and whether it has entered the market. If no approved generic exists, supplier options remain tied to the branded NDA supply chain.
What generic entry would change
- An approved generic could add:
- multiple drug product suppliers,
- multiple API suppliers,
- increased competition on procurement.
What to watch for
- Orange Book listings (patents and exclusivities) drive timing for generic entry.
- Approval of a new NDA or ANDA would introduce additional commercial manufacturers.
What is the Orange Book status of Vistogard, and when does it limit additional suppliers?
Answer: Orange Book status governs whether ANDA manufacturers can launch without authorization. As long as relevant patents and exclusivities remain in force, additional suppliers generally cannot lawfully commercialize an equivalent.
Key Orange Book constructs that affect supplier expansion
- Listed patents tied to:
- API,
- formulation,
- method of use.
- Regulatory exclusivities (when applicable).
What Vistogard litigation or settlements could affect supply?
Answer: Patent litigation and settlement agreements can influence timelines for generic entry, which affects whether additional suppliers can emerge.
Where supply impact shows up
- If settlements accelerate entry, multiple generic suppliers can come online earlier.
- If courts uphold or extend patent barriers, supply remains single-source.
How does Vistogard procurement work in hospitals and distributors?
Answer: Hospital procurement typically relies on:
- distributor channels,
- NDA holder allocations during demand spikes,
- limited availability during manufacturing constraints.
Common procurement pathways
- Authorized distributors list on-hand availability based on allocations.
- Emergency ordering depends on inventory position and lead time.
Revenue exposure and demand drivers that stress the supply chain
Answer: Demand for Vistogard is event-driven and tied to oncology prescribing and overdose incidence.
Demand stress scenarios
- increased oncology utilization,
- inventory hoarding and bulk distributor stocking,
- production disruptions at key suppliers.
Key takeaways
- “Supplier” for Vistogard is primarily defined by the NDA product manufacturer(s) and the manufacturing sites listed in FDA-facing records and labeling.
- API supplier identification is less consistently disclosed publicly; supply chain planning should treat API procurement as contract-dependent and site-specific.
- Patent and Orange Book status determine whether new commercial suppliers can enter through approved equivalents, which is the main structural path to a broadened supplier base.
- For practical procurement and risk planning, the critical constraints are drug product manufacturing site capacity and kit packaging/assembly contractors.
FAQs
-
Who manufactures Vistogard in the US?
The manufacturer is the NDA-associated drug product manufacturer whose site and role are stated in FDA product records and labeling. -
Does Vistogard have generic competition in the US?
Generic or equivalent supplier entry depends on Orange Book patent and exclusivity status and FDA approvals. -
What companies supply uridine triacetate API for Vistogard?
API suppliers are often disclosed only in limited form; the most reliable public identifiers are the drug product manufacturing sites and NDA-associated supply entities. -
How do patent listings affect future Vistogard supplier options?
Listed patents and exclusivities restrict lawful commercialization by ANDA/ANDA-type competitors, limiting new supplier emergence until expiration. -
Can kit assembly or packaging contractors become a supply bottleneck?
Yes. Even when bulk drug product is available, labeling and kit assembly constraints can limit commercial shipment.
References (APA)
- U.S. Food and Drug Administration. Vistogard (uridine triacetate) product labeling and FDA product record sources.
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Vistogard listings and patent status).
- U.S. Food and Drug Administration. Drug Approval Reports and application records for Vistogard-related NDA submissions.
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