Suppliers and packagers for XOPENEX HFA

XOPENEX HFA Suppliers: Who Manufactures and Supplies Albuterol Sulfate HFA CFC-Free Inhaler in the U.S.?

XOPENEX HFA is a brand of albuterol sulfate metered-dose inhaler (MDI). The supplier landscape is structured around (1) the branded-label holder that sells the product to distributors and (2) the contract manufacturing organizations (CMOs) and packaging/labeling sites that produce and release finished drug product (FDP) for the U.S. market.

Who are the manufacturers and suppliers behind XOPENEX HFA (albuterol sulfate) in the U.S.?

Direct supply chain for U.S.-market XOPENEX HFA generally splits into:

1. Marketing authorization holder / labeler (the entity on the U.S. product label and typically the Drug Establishment Registration and listing pathway).
2. Finished dose manufacturer (FDP) for the inhaler canister and metered-dose unit.
3. Packaging and labeling operations (including cartonization and NDC-specific labeling).
4. Primary container and fill-finish supplier ecosystem (pressurized canister fill, valve/canister component supply, and coating/materials stream).
5. Propellant and component supply (HFA propellant stream and elastomer/valve component sourcing).

How do you identify the “supplier” entity that matters commercially?

For R&D, licensing, or litigation work, the “supplier” that matters is usually the FDP manufacturer and site(s) named on:

• FDA drug establishment listings (site-level manufacturer/packer),
• Orange Book entry (brand + reference product linking where applicable),
• FDA labeling and product information in the SPL/label package.

Is XOPENEX HFA made by the same company that holds the brand label?

In most inhaler portfolios, the brand labeler and the site releasing the final product are often different entities. The practical read is:

• The labeler controls product stewardship, pharmacovigilance, and regulatory submissions.
• The CMO/packager produces bulk drug product (as applicable) and fills/assembles the inhaler units and/or packs cartons under NDA/ANDA controls.

For XOPENEX HFA, the specific labeler and site-level manufacturer should be pulled from current FDA establishment listing records tied to the NDC(s) for XOPENEX HFA.

What patents or exclusivity influence who supplies XOPENEX HFA albuterol inhaler?

For an approved albuterol MDI brand like XOPENEX HFA, supply is driven less by active exclusivity and more by:

• regulatory listing status (NDA/ANDA and FDA inspections),
• component availability (HFA propellant, valves, canisters),
• quality-system capability to assemble pressurized MDIs,
• IP barriers (typically formulation/pressurized assembly or device-related improvements, though older albuterol inhaler patents often expired).

If the goal is to identify who can legally enter with a competing inhaler, the key is whether any device/formulation/manufacturing method patents still burden “generic-equivalent” MDIs and whether there are any Orange Book listings that can trigger Paragraph IV strategies.

What is the Orange Book status of XOPENEX HFA (and does it constrain suppliers)?

XOPENEX HFA is expected to map to albuterol sulfate inhaler listings. Whether it has active Orange Book patents depends on the specific NDA/BLA record and the current patent-by-patent listing. The supplier constraint mechanisms are:

• still-active Orange Book patents tied to the NDA (which can deter certain entrants),
• device-related or method-of-use claims that can affect design-around feasibility,
• existing authorized generics or distribution agreements.

Supplier mapping for entrants should be tied to the current Orange Book list for the exact XOPENEX HFA NDA/NDC set.

Which companies supply albuterol sulfate HFA inhalers in the U.S. competitive landscape?

The inhaler supply chain for albuterol HFA typically includes a mix of:

• brand manufacturers and their CMOs,
• authorized generic partners,
• generic inhaler manufacturers using their own contract fill/assembly sites.

A supplier comparison for XOPENEX HFA requires a NDC-specific look at:

• FDA Drug Establishment Registrations (site release and packer),
• FDA listing of finished product manufacturing and packaging sites,
• distribution partners listed on labeling or in FDA-regulated submission data.

How do FDA inspection and CMO release sites affect XOPENEX HFA sourcing?

For pressurized MDIs, supplier risk is largely operational:

• sterile and non-sterile quality controls relevant to valve/canister fill,
• leachables/extractables from container closure and materials,
• propellant and aerosol performance testing (dose uniformity, spray pattern, plume geometry),
• stability and shipping vibration performance.

Supplier selection for XOPENEX HFA tends to be constrained to CMO capabilities that can document and pass these checks under current GMP expectations.

Key Takeaways

• XOPENEX HFA is an albuterol sulfate HFA metered-dose inhaler, so the meaningful “supplier” entities are the FDA-registered labeler and the site-level finished drug product and packaging/labeling manufacturers tied to the product’s NDC(s).
• Commercial supplier mapping is NDC-driven and depends on FDA establishment listing records, not generic assumptions about which company “owns” the brand.
• Patent constraints on new suppliers depend on the current Orange Book status tied to the exact NDA record for XOPENEX HFA, not the general albuterol category.

FAQs

1. How do I find the finished drug product manufacturer for an HFA inhaler like XOPENEX HFA by NDC?
   Use FDA drug establishment listings and the establishment registration linked to the NDC’s finished product and packer/labeler sites.

2. Do inhaler suppliers for albuterol HFA include valve and canister component manufacturers?
   Yes, component supply is part of the effective supply chain, but “supplier” designations for compliance and audits focus on the FDA-registered fill/assemble/release sites.

3. What typically determines whether a CMO can supply albuterol HFA under GMP?
   Experience with pressurized MDI fill-finish/assembly, validated aerosol performance controls, and stability and packaging qualification for HFA products.

4. Can competitors supply an albuterol HFA inhaler if Orange Book patents remain listed for the XOPENEX HFA NDA?
   They can supply only if they navigate or design around active Orange Book patents, and their regulatory pathway aligns with those patent listings.

5. What’s the practical difference between “labeler” and “manufacturer” for XOPENEX HFA?
   The labeler controls regulatory ownership and stewardship; the manufacturer is the FDA-registered site that manufactures, fills/assembles, releases, or packs the product.

References

1. U.S. Food and Drug Administration. Drug Establishment Registration and Drug Listing (industry submissions and establishment data). FDA.
2. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (albuterol sulfate inhaler NDA/patent listings). FDA.