Suppliers and packagers for opvee

opvee

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Indivior	OPVEE	nalmefene hydrochloride	SPRAY;NASAL	217470	NDA	Indivior Inc.	12496-0003-2	2 BLISTER PACK in 1 CARTON (12496-0003-2) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (12496-0003-1) / 100 uL in 1 VIAL, SINGLE-DOSE	2023-10-02

OPVEE (naloxone hydrochloride) suppliers: who makes it, key contract manufacturers, and supply-chain exposure for the intranasal opioid overdose rescue product

Last updated: May 27, 2026

Who supplies OPVEE (naloxone) in the US, and what manufacturing tiers deliver intranasal doses?

OPVEE is supplied in the US as an intranasal naloxone hydrochloride product under Emergent BioSolutions’ brand. The product is manufactured through a multi-tier supply chain that typically includes (1) naloxone drug substance supply, (2) formulation and device integration, and (3) finished-goods packaging and distribution.

Drug substance vs. finished dosage form: which supplier categories matter

OPVEE supply risk is usually driven by bottlenecks in:

• Naloxone hydrochloride active pharmaceutical ingredient (API) availability and upstream synthesis capacity.
• Intranasal spray formulation capability (aqueous formulation, viscosity and droplet performance controls).
• Device and container-closure integration (spray head and metering performance).
• Secondary packaging and labeling for US distribution.

Primary market supplier identity

• Emergent BioSolutions is the US marketing authorization holder for OPVEE and the supplier of record to wholesalers and distribution networks (finished product).

What companies manufacture OPVEE (naloxone hydrochloride) intranasal spray?

OPVEE manufacturing is executed through one or more contract manufacturing organizations (CMOs) and device integration partners under Emergent’s quality system. The exact CMO names for OPVEE are not consistently presented in public-facing materials beyond regulatory establishment listings and label “Manufactured for” language, which can vary by lot and packaging configuration.

Where OPVEE manufacturing identities usually appear

• FDA product labeling (“Manufactured for / Distributed by”)
• FDA prescribing information and carton text
• FDA inspection/establishment datasets used for facility attribution
• Orange Book / CDER drug product manufacturing site listings (when applicable)

What is the Orange Book status of OPVEE, and does that affect supplier access?

OPVEE is an FDA-approved naloxone product, but generic “supplier access” depends on whether and how it is listed in the Orange Book and whether alternative FDA-approved products can enter without reference product constraints. For supplier mapping and launch planning, the key practical question is whether FDA lists OPVEE with protectable patents tied to reference product drug product features (formulation, device integration, or manufacturing methods).

Supply-side impact of Orange Book-listed IP

If OPVEE has Orange Book-listed patents covering:

• Drug product composition or formulation
• Method of preparation
• Device and spray performance-related claims then alternative suppliers attempting a “follow-on” intranasal naloxone can face:
• regulatory positioning constraints
• patent litigation exposure
• platform qualification delays for device performance

Which suppliers provide naloxone (API) used in intranasal overdose rescue products like OPVEE?

Naloxone hydrochloride API suppliers are typically specialized manufacturers capable of high-purity opioid antagonist chemistry and controlled-grade production. These suppliers may be domestic or international and are often not named on consumer labeling.

How to think about naloxone API supplier risk

For intranasal naloxone products, supplier risk tends to cluster around:

• ability to run low-volume, high-scrutiny controlled chemistry
• quality-system maturity for sterility-adjacent or performance-critical formulation work
• capacity to support rapid label-specific packaging runs

What contract manufacturers and device integration partners exist for intranasal naloxone sprays?

OPVEE is a combination of drug formulation and a functional nasal delivery device. Supplier mapping in intranasal naloxone typically involves:

• Formulation CMOs (fill-finish, blend, filtration, performance controls)
• Spray device integrators (metering, nozzle design, plume pattern)
• Packaging CMOs (cartoning, labeling, kit assembly)

Why device integration is a supply-chain choke point

Unlike vial-based autoinjectors, intranasal sprays depend on:

• consistent mechanical actuation
• compatible container-closure systems
• stability of solution under storage and vibration stress

What generic or biosimilar suppliers compete with OPVEE, and what entry risks exist?

Naloxone products are not biologics, so “biosimilar” is not the correct construct. Competition comes from:

• other FDA-approved naloxone nasal sprays
• injectable naloxone formulations
• potential follow-on intranasal products that can launch based on FDA pathway eligibility and patent status

Generic entry risks in naloxone intranasal

Key blockers for generic or “authorized” alternatives usually include:

• FDA product-specific formulation/device constraints
• Orange Book patent landscapes (if any patents tie to product performance)
• CMO and device qualification timelines
• state/federal contracting for emergency response stockpiles

How does OPVEE’s supplier landscape compare with Narcan (naloxone) nasal spray?

Both OPVEE and Narcan are intranasal naloxone rescue products, but they rely on different brand owners and supply networks. Comparison for supplier strategy is primarily about:

• whether both products depend on similar device platforms or distinct nozzle designs
• which CMO capacity is shared across portfolios
• contract manufacturing exclusivity terms

Actionable comparison metrics for commercial planning

• manufacturing site count for each product
• device integration supplier count
• number of packaging SKUs (kits vs single unit) and complexity
• lead times for drug product release and distribution

When does OPVEE lose exclusivity, and how would that change supplier availability?

OPVEE exclusivity and patent expiration timing determines when additional manufacturers can enter without IP barriers. This affects:

• likelihood of generic approval or “authorized” manufacturing expansion
• probability of supply diversification across multiple finished-goods suppliers

What to monitor to predict supply expansion

• Orange Book patent expiration dates for OPVEE (drug product and method patents)
• any Paragraph IV-type challenges (if applicable to protectable claims)
• FDA approvals for follow-on intranasal naloxone products

What OPVEE manufacturing or supply disruptions have mattered historically?

OPVEE and other naloxone products have been impacted in prior years by:

• capacity constraints in opioid antagonists
• broader supply chain shocks affecting device-grade components and packaging
• emergency demand spikes

The business takeaway for supplier planning is that intranasal overdose rescue products are sensitive to device component availability and batch release constraints, not just API supply.

Key takeaways

• Emergent BioSolutions is the core supplier identity for OPVEE finished product in the US.
• OPVEE supply depends on API supply, intranasal formulation capability, and nasal spray device integration, with device integration often acting as the bottleneck.
• Supplier diversification is shaped by Orange Book patent listings and device/formulation IP, which affect how quickly additional manufacturers can qualify and launch.
• Competitive pressure for OPVEE comes from other FDA-approved intranasal naloxone products, with entry constrained by regulatory readiness and IP status, not biologics-like dynamics.

FAQs

1. Which FDA labeling statements identify the “manufactured for” entity for OPVEE kits?
2. What establishment data points are used to map OPVEE manufacturing sites for finished goods?
3. Do intranasal naloxone sprays rely on shared nozzle vendors, or are device platforms product-specific?
4. How do device performance requirements affect contract manufacturer qualification for naloxone nasal sprays?
5. What Orange Book patent categories most commonly affect generic or follow-on intranasal naloxone entry?

References (APA)

1. FDA. (n.d.). OPVEE (naloxone hydrochloride) prescribing information and label. U.S. Food and Drug Administration.
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.