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Suppliers and packagers for XENAZINE
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XENAZINE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bausch | XENAZINE | tetrabenazine | TABLET;ORAL | 021894 | NDA | Lundbeck Pharmaceuticals LLC | 67386-421-01 | 112 TABLET in 1 BOTTLE (67386-421-01) | 2008-11-24 |
| Bausch | XENAZINE | tetrabenazine | TABLET;ORAL | 021894 | NDA | Lundbeck Pharmaceuticals LLC | 67386-422-01 | 112 TABLET in 1 BOTTLE (67386-422-01) | 2008-11-24 |
| Bausch | XENAZINE | tetrabenazine | TABLET;ORAL | 021894 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-421-12 | 112 TABLET in 1 BOTTLE (68682-421-12) | 2015-07-20 |
| Bausch | XENAZINE | tetrabenazine | TABLET;ORAL | 021894 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-422-25 | 112 TABLET in 1 BOTTLE (68682-422-25) | 2015-07-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for XENAZINE
Xenazine suppliers: Who manufactures tetrabenazine and supplies Xenazine (fewer, higher-risk supply points)
Executive summary: “Xenazine” is a branded form of tetrabenazine (active ingredient). Market supply is dominated by the number of firms that can produce tetrabenazine API and the firms that can package and distribute finished dose product into the US (FDA) and other regulated markets. The usable supply-chain answer depends on the specific market and whether the question is about API manufacturers, finished-dose manufacturers (CDMO/OEM), or distributors. No supplier roster can be provided from the prompt alone.
What follows is only the structured supplier view you would typically map in a patent-and-supply diligence workflow, but it cannot be populated with named suppliers without credible, source-backed identification of: (1) Xenazine finished-dose manufacturing sites, (2) tetrabenazine API sources, and (3) US/EMA marketing authorization holder records tied to the active product.
Which companies supply Xenazine (tetrabenazine) in the US and what are the distribution channels?
Featured snippet answer: Xenazine supply in a given country is managed by the marketing authorization holder and finished-dose manufacturer(s) that list manufacturing sites on regulatory filings, with commercial distribution routed through branded drug wholesalers and pharmacy distribution networks.
Supplier mapping you need for diligence (without named entities):
- Regulatory marketing authorization holder (owns product registration and is typically responsible for supply obligations).
- Finished-dose manufacturer (tablets/capsule packaging; may be different from tablet-site).
- API manufacturer (tetrabenazine API; often fewer sites given chemical synthesis complexity and quality requirements).
- Packager/labeler (may add packaging lot controls and distribution-ready presentation).
- Authorized distributors/wholesalers (country-specific).
What finished-dose manufacturers make Xenazine tablets (and how do you verify the site)?
Answer in practice: Finished-dose manufacturers are verified using:
- US FDA labeling and drug product manufacturing descriptions
- FDA application manufacturing site records
- EMA product manufacturing declarations (if marketed in EU)
- Contract manufacturing and packer statements on regulatory documents
Verification artifacts used in supply-chain diligence:
- Label “Manufactured for” or “Distributed by” lines (company-level, not always site-level).
- FDA facility listings tied to the application.
- Inspection history and site registrations.
Which companies make tetrabenazine API used in Xenazine, and what are the supply bottlenecks?
Answer in practice: API sources are verified through:
- DMFs (Drug Master Files) / API listing records
- Quality agreement relationships with the finished-dose application
- Inspection and compliance data for API sites
Common supply bottleneck patterns for specialty small molecules:
- Limited number of qualified API sites due to multi-step synthesis and impurity controls.
- Site changes trigger stability, comparability, and regulatory bridge requirements.
- Shortfalls are often resolved via constrained reallocation from existing qualified sites.
What is the Orange Book status of Xenazine and how does it impact supplier risk?
Featured snippet answer: Patent and exclusivity status does not directly list suppliers, but it affects:
- Number of legal producers (authorized manufacturers in a country)
- Likelihood of generic/authorized-entrant supply expansion
- Manufacturing continuity risk around exclusivity and potential market-entry disruptions
Supplier risk linkages used in diligence:
- If the branded product faces supply constraints, exclusivity reduces near-term generic fallback.
- If patent positions are weak or multiple Paragraph IV events exist, supplier redundancy can increase when generics launch.
How many patents cover Xenazine (tetrabenazine) and what matters for sourcing continuity?
Featured snippet answer: Without the patent estate details for Xenazine in the target jurisdiction, the count and expiration-driven effects cannot be stated from the prompt alone.
How patent estate affects sourcing:
- Longer-lived formulation or method-of-use patents reduce generic competition.
- Manufacturing process patents can limit contract manufacturers even if a legal generic is approved elsewhere.
- Settlement agreements can create “brand-protected” periods for the finished-dose supply base.
When does Xenazine lose exclusivity in the US and how does that change the supplier landscape?
Featured snippet answer: Exclusivity end dates are product- and application-specific (including 505(b)(1) vs 505(b)(2) and patent listings). The prompt does not provide jurisdiction or application identifiers; an exclusivity timeline cannot be stated.
What changes when exclusivity ends:
- More qualified manufacturers become possible.
- Supply resilience usually improves only if generic entrants actively scale manufacturing capacity.
What generic or authorized entrants could create alternate Xenazine sources, and what is the launch risk?
Featured snippet answer: Generic entry timing depends on Orange Book patent challenges and FDA approval. Without the Orange Book listing set and litigation history for Xenazine, the specific entrants and launch risk cannot be determined.
What Xenazine formulation and packaging variants affect who can supply?
Supplier-impacting variants:
- Strength(s) and dosing unit format(s) (tablet strength drives process parameters)
- Release profile and excipient set (impacts formulation-specific manufacturing approvals)
- Label presentation requirements (country-specific packaging)
A supplier can only be “real” for Xenazine sourcing if its finished-dose product is approved for that market presentation.
What FDA regulatory status documents are used to confirm Xenazine suppliers?
Answer in practice: Diligence uses:
- FDA label and prescribing information
- FDA application summaries for the specific product
- FDA facility identifiers and current good manufacturing practice (cGMP) registrations
- Postmarketing change notifications that indicate site transfers
Which company is the marketing authorization holder for Xenazine and who is the current finished-dose manufacturer?
Featured snippet answer: The marketing authorization holder and current finished-dose manufacturer(s) are identified by regulatory records for the specific country and strength. The prompt does not provide that jurisdictional anchor, so named entities cannot be provided.
Key Takeaways
- Xenazine supply depends on who holds regulatory responsibility and who manufactures and packs finished-dose tetrabenazine for each market.
- “Suppliers” must be disaggregated into API suppliers, finished-dose manufacturers, packagers/labelers, and distributors.
- A named supplier list requires market-specific regulatory traceability (FDA/EMA product records and manufacturing site identifiers). The prompt does not contain these anchors.
FAQs
- How do I identify Xenazine API suppliers versus finished-dose manufacturers?
- How do contract manufacturers show up as Xenazine “suppliers” on regulatory labels?
- Does Xenazine supply risk increase around patent expiration or manufacturing site changes?
- What documents confirm Xenazine manufacturing sites for a specific country and strength?
- How do distributors differ from marketing authorization holders for Xenazine in the US?
References
- (No citeable sources were provided in the prompt, and no supplier-identifying regulatory records were supplied.)
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