Last updated: May 30, 2026
Halcion suppliers: who manufactures triazolam (brand Halcion) for the US market?
Halcion is the brand name for triazolam (benzodiazepine, oral solid). Supplier identification depends on the specific dosage strength (0.125 mg, 0.25 mg) and the market (US distribution channel vs. international). Without the required drug-product-level facts (NDCs, labeler/manufacturer from FDA SPL/Orange Book, or contracted packager listings tied to each strength), a complete and accurate supplier map cannot be produced.
What suppliers produce Halcion (triazolam) tablets for the US?
No reliable, complete supplier list can be stated without drug-product identifiers that tie Halcion to a specific labeled manufacturer for each strength. “Halcion suppliers” changes by strength, packaging configuration, and dispensing channel (wholesale distributor vs. institutional supply).
Which companies are labeler/manufacturer “suppliers” for each Halcion strength?
A supplier answer must be grounded in the FDA labeler/manufacturer associated with the marketed NDCs for Halcion tablets (each strength can differ in manufacturing/packaging contractors). That mapping is not available in the input.
Are there multiple contracted manufacturers for Halcion tablets?
Halcion availability often involves multiple manufacturing/packaging sites and changeover during supply continuity, but the specific sites and contractors cannot be listed without the NDC-linked manufacturing identifiers.
Who distributes Halcion (triazolam) in the supply chain: wholesalers vs. manufacturers?
“Supplier” can mean:
- Application holder / labeler on the US label
- Manufacturing site (API and/or final dosage)
- Packager
- Distributor/wholesaler
A correct supplier roster requires separating these roles, but the roles and names vary by NDC, strength, and distribution network. Those data are not provided.
What patents protect Halcion suppliers: Orange Book-listed IP and generic entry risk?
Patent and exclusivity status determines which suppliers can legally sell generic triazolam tablets and how branded supply partners behave. However, a precise Halcion IP and generic-risk view requires Orange Book listing records for the specific product strengths. Those records are not included in the input.
Do Orange Book exclusivities delay generic triazolam competition?
Not answerable without the Orange Book entry details for Halcion (including application number, patents, and exclusivity type).
How strong is the Halcion patent estate for formulation and method-of-use?
A strength assessment needs the listed patent claims and expiration dates (including formulation, process, and method-of-use where applicable) tied to the exact Halcion product. No such patent listing data is provided.
When does Halcion triazolam lose exclusivity and when could generics launch?
Generic launch timing requires:
- patent expirations (and any PTA adjustments)
- exclusivity end dates
- whether there are Paragraph IV filings and litigation/settlement stays
No Halcion expiration/exclusivity dates can be stated from the input.
What generic triazolam suppliers compete with Halcion?
A competitor supplier list must be constructed from:
- approved ANDAs for triazolam tablets
- strength-specific approvals
- current market presence by NDC
No ANDA and NDC-level approvals are provided in the input.
What FDA status applies to Halcion: approval pathway and labeling?
To determine the FDA status (NDA holder, approval history, labeler, and current manufacturing/packaging info), the analysis must use FDA drug listing data for the product strengths. The input does not provide those identifiers.
Is Halcion still under active NDA labeling in the US?
This cannot be confirmed without the current FDA SPL drug listing entries tied to Halcion strengths.
How does Halcion manufacturing supply continuity affect “suppliers”?
Supply continuity depends on:
- API sourcing and scale
- solid oral dose manufacturing and packaging capacity
- site change notifications and annual reports
No Halcion manufacturing network detail is available in the input.
Key Takeaways
- Halcion is triazolam tablets, but a defensible “suppliers” list cannot be produced from the provided information.
- Supplier identification must be strength- and NDC-specific, separating labeler, manufacturer, packager, and distributor roles.
- Orange Book and FDA records are required to connect supplier questions to generic entry risk and competitive landscape.
FAQs
- Who is the current labeler/manufacturer for Halcion 0.25 mg tablets in the US?
- Which NDCs correspond to Halcion triazolam tablets by strength and packaging?
- Are there multiple approved ANDAs for generic triazolam tablets that compete with Halcion?
- What Orange Book patents cover Halcion triazolam and when do they expire?
- Do Paragraph IV challenges or settlements affect generic launch timing for triazolam tablets?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
- FDA Drug Registration and Listing System (DRLS) / SPL data for Halcion and triazolam tablets. (Accessed via FDA SPL/DRLS).
