Suppliers and packagers for ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703	NDA	WG Critical Care, LLC	44567-811-10	10 BAG in 1 CARTON (44567-811-10) / 250 mL in 1 BAG	2017-12-04
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703	NDA	WG Critical Care, LLC	44567-812-10	10 BAG in 1 CARTON (44567-812-10) / 100 mL in 1 BAG	2017-12-04

Suppliers for Esmolol Hydrochloride in Plastic Container: Who Manufactures, Supplies, and Distributes US-Governed Products

Last updated: June 3, 2026

Esmolol hydrochloride in plastic container is supplied through a combination of contract manufacturers, finished-dose manufacturers, and authorized distributors tied to specific FDA-labeled product presentations. The supplier set is presentation-dependent (container type, strength, and label holder), so the practical “supplier list” for procurement and sourcing is the set of firms that (1) hold the FDA-listed finished drug account for the specific plastic-container presentation and (2) supply through approved distribution channels.

What companies supply esmolol hydrochloride infusion in plastic containers?

Answer (procurement reality): The supply chain is anchored by the FDA label holder for the exact presentation, plus the contract manufacturers that actually make the sterile infusion product and the distributors that fulfill customer orders.

Common US supply-chain components for sterile esmolol injections

• FDA label holder (marketing authorization holder in the Orange Book sense): the firm listed as the manufacturer/holder tied to the NDA and the specific strength and dosage form.
• Contract manufacturing sites: companies that produce the sterile drug product, typically identified via cGMP site listings associated with the label/NDA in FDA records and industry submissions.
• Authorized wholesalers and specialty distributors: the commercial suppliers used in hospital procurement, group purchasing, and channel distribution.

Which label holders manufacture esmolol hydrochloride injection in plastic containers?

Answer (what to request in RFPs): In practice, procurement teams qualify suppliers by matching the exact NDC and container presentation. The label holder linked to that NDC is the first “supplier” to confirm.

How plastic-container presentations change supplier identification

Esmolol hydrochloride injection is offered in multiple presentations (commonly infusion-ready formats). “Plastic container” can map to different marketed containers by manufacturer, including:

• prefilled infusion containers
• bottles or IV containers made from plastic materials
• pharmacy bulk or single-unit systems depending on the label

Because suppliers differ by NDC, “plastic container” should be treated as an attribute tied to an NDC, not a universal category.

How many manufacturers make esmolol hydrochloride in plastic containers in the US?

Answer: Multiple firms can appear across NDCs, even within the same drug and strength, because FDA product numbering and container configuration can vary by marketing holder and manufacturing site.

What “number of suppliers” means operationally

• Finished-dose manufacturers count: firms holding the NDA/label listing for specific NDCs.
• Contract manufacturers count: manufacturing sites that may not be the same as the label holder.
• Distributor count: wholesalers change frequently, especially during shortages.

What patents protect esmolol hydrochloride in plastic containers?

No patent estate is specific to “plastic container” alone in a way that uniformly maps to all presentations. Protection typically attaches to:

• drug substance and formulation
• sterile manufacturing process
• delivery system design (container, infusion mechanics) where supported by formulation/process claims
• method-of-use (dose/titration schemes, indications)

Where “container patents” usually show up

When container-related IP exists, it usually relates to one of the following:

• compatibility and leachables/minimized adsorption approaches for the specific container-material and fill system
• stabilization and pH control in the specific sterile container configuration
• manufacturing and filling process parameters that are claimed

When do patents or exclusivity for esmolol hydrochloride injections expire?

Esmolol hydrochloride is a long-established cardiovascular agent. For most practical purposes, the market operates under:

• no meaningful remaining new-drug exclusivity comparable to modern small-molecule NCEs
• ongoing IP mainly from formulation/process or specific line extensions rather than broad composition-of-matter exclusivity

What generic entry risks exist for esmolol hydrochloride plastic-container presentations?

Generic or AB-rated products can enter once:

• Orange Book listed patents are not asserted or expire, and/or
• Paragraph IV pathways resolve via settlement or litigation
• the applicant demonstrates bioequivalence for the specific presentation

What most affects entry for plastic-container products

• sterile manufacturing capability and fill-finish yields
• container-material compatibility and stability data
• risk of delays tied to sterile regulatory submissions

How does esmolol hydrochloride in plastic containers compare with vial or glass container versions?

Answer: Clinical performance should match within label equivalence for the active ingredient, but procurement differences often come from:

• packaging format and nursing workflow
• storage and handling
• stability windows and use instructions
• procurement availability during shortages

What FDA status applies to esmolol hydrochloride injection products in plastic containers?

Answer: FDA status is presentation-specific. The controlling items for regulatory sourcing are:

• NDC-to-label match
• Orange Book listing presence (if any)
• approval pathway classification (NDA, ANDA, listed drug status)

Which companies are challenging esmolol hydrochloride products via Paragraph IV?

No specific Paragraph IV challenge mapping can be stated here without a presentation-specific Orange Book and litigation dataset for the exact plastic-container NDC(s). In sourcing terms, these are the entities that typically appear, but a factual supplier-vs-challenger list requires exact product identification.

What patent litigation affects esmolol hydrochloride injection?

Similar limitation applies. Litigation is factored by:

• the specific NDA/ANDA and listed patents
• the asserted claims (formulation, process, container compatibility, or method-of-use)
• settlement terms that can govern launch timing

What formulations are protected by esmolol hydrochloride container-related patents?

When present, formulation protection tends to cover:

• pH range and buffering system
• stabilizer system
• excipient selection that mitigates degradation in the sterile container
• adsorption-minimizing strategies for the infusion solution

How strong is the patent estate for esmolol hydrochloride injection?

For most legacy drugs like esmolol hydrochloride, the strength that matters commercially is usually:

• whether any formulation/process patents remain for a given NDC
• whether those patents are enforceable against ANDA fill-finish and formulation approaches
• whether those patents are narrow enough to allow design-around

Which suppliers can procurement teams qualify quickly for “esmolol hydrochloride in plastic container”?

Answer (fast qualification approach): qualify by NDC-locked label identity:

1. the finished-dose label holder tied to the exact plastic-container presentation
2. the approved manufacturing site(s) supplying that NDC
3. the authorized distributor listing for hospital procurement channels

Key Takeaways

• “Plastic container” is a presentation attribute that maps to specific NDCs, and supplier identity is NDC-specific.
• The supplier set in practice is the label holder for the exact plastic-container presentation plus the contract manufacturing sites and authorized distributors fulfilling that NDC.
• Container-focused IP, when it exists, usually targets stability/compatibility and adsorption/leachables for specific fill-finish systems rather than the active ingredient alone.
• Patent and exclusivity timing for esmolol hydrochloride is generally driven by legacy expiration status, with remaining enforceable value typically in narrow formulation/process patents tied to specific presentations.

FAQs

1. How do I identify the correct esmolol hydrochloride plastic-container product for purchasing? Use the NDC and confirm the labeled container type on the package insert for the exact strength and presentation.
2. Do plastic-container versions of esmolol hydrochloride have different stability or administration instructions? Label-specific stability and handling instructions can differ by presentation even when the active ingredient is the same.
3. Can an ANDA applicant launch esmolol hydrochloride in a new plastic container format? Only if formulation/process compatibility and any listed patent landscape tied to the specific presentation are resolved.
4. Who typically manufactures sterile infusion products for legacy injectables like esmolol? Sterile fill-finish is often performed by contract manufacturing sites under NDA/ANDA supply agreements, with the label holder responsible for release and regulatory obligations.
5. What documentation matters most for hospitals sourcing esmolol hydrochloride plastic containers? NDC confirmation, lot release documentation, stability/use-by statements, and handling guidance in the package insert for that exact presentation.

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA Label and Drug Listing information (NDC Directory and Drug Labels). U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-labels