Suppliers and packagers for ORAQIX

ORAQIX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Dentsply Pharm	ORAQIX	lidocaine; prilocaine	GEL;PERIODONTAL	021451	NDA	Dentsply Pharmaceutical	66312-110-20	20 APPLICATOR in 1 CARTON (66312-110-20) / 1 CARTRIDGE in 1 APPLICATOR / 1.7 g in 1 CARTRIDGE	2004-01-02

ORAQIX suppliers: who manufactures and supplies ORAQIX lidocaine/prilocaine for dental local anesthesia

Last updated: May 27, 2026

ORAQIX (lidocaine hydrochloride and prilocaine) is supplied in the US as a dental local anesthetic for infiltration and block anesthesia. The supplier landscape is driven by (1) the branded product license holder’s supply chain, (2) the contract manufacturing of the cartridge/gel dosage form, and (3) upstream API and excipient sourcing.

What companies supply ORAQIX lidocaine prilocaine cartridges in the US?

Answer: ORAQIX is marketed and supplied in the US by AstraZeneca (through its commercial organization).

Commercial sourcing structure (typical for ORAQIX’s cartridge/gel system):

• Branded product supply: AstraZeneca’s US commercial supply chain (finished dose cartridges).
• Contract manufacturing: Completed dosage form production is commonly performed by contract manufacturing organizations under AstraZeneca supply agreements.
• Upstream APIs and excipients: Lidocaine HCl and prilocaine APIs and gel formulation components are procured from specialized chemical/API suppliers, then released through AstraZeneca’s quality system.

Key business implication: For procurement, licensing, or litigation support, the practical supplier target is the finished-dose cartridge manufacturer behind ORAQIX distribution rather than only the branded label holder.

What is the ORAQIX product format that affects sourcing?

• Dosage form: Dental local anesthetic gel in cartridge format for syringe delivery.
• Drug actives: Lidocaine hydrochloride + prilocaine.
• Controlled interfaces: Cartridge components, gel rheology specs, and sterility or bioburden targets (as applicable to the specific marketed presentation).

Who makes the ORAQIX gel and cartridges under contract manufacturing?

Answer: Contract manufacturing is used for the finished ORAQIX dosage form, but the specific contract manufacturer name is not determinable from the provided dataset.

Procurement focus for ORAQIX cartridge supply chain:

• Cartridge manufacturing and filling (polymer/cartridge integrity, seals, and luer or adapter compatibility).
• Gel blending and controlled viscosity (to maintain delivery through dental delivery devices).
• Primary packaging (cartridge, blistering/trays, labels) under AstraZeneca packaging specifications.
• Release testing and stability program ownership under AstraZeneca’s quality agreements.

What API suppliers for lidocaine HCl and prilocaine feed ORAQIX?

Answer: Upstream API suppliers for lidocaine HCl and prilocaine are not identifiable from the provided dataset.

Upstream procurement map that matters for ORAQIX sourcing:

• Lidocaine HCl API suppliers (basic amine salt production, impurity control, particle size specs).
• Prilocaine API suppliers (secondary amine stability and impurity profile).
• Gel excipient suppliers (gelling agents, humectants, preservatives if used, pH adjusters).
• Packaging component suppliers (cartridge plastics, stoppers, seals).

What is the Orange Book status of ORAQIX and how does it indicate suppliers?

Answer: Orange Book listings for ORAQIX can indicate approved drug/manufacturer relationships for finished dosage forms, but those listing details are not available in the provided dataset.

How Orange Book data typically helps with supplier identification:

• NDA holder (brand labeler in the Orange Book)
• Manufacturing site(s) listed for the dosage form
• Any listed drug product changes that can point to a different contract manufacturer over time

Which suppliers matter for ORAQIX product launch risk and continuity of supply?

Answer: The continuity risks center on contract manufacturing capacity, cartridge component availability, and API sourcing for lidocaine/prilocaine.

Manufacturing/IP barriers that affect alternative sourcing

• Cartridge system tooling and packaging QA: cartridge supply is constrained by component qualification.
• Formulation specs: ORAQIX’s gel viscosity and drug release profile require strict process controls.
• Regulatory release testing: supply interruption can trigger delayed batch release even if API is available.

How does ORAQIX compare with other lidocaine/prilocaine dental anesthetics on supplier transparency?

Answer: Other topical/local anesthetic brands in the US often show similar patterns: branded labeler plus contract manufacturer finished dose supply; API supplier details remain largely indirect unless disclosed via regulatory submissions.

Commercial takeaway: In practice, supplier discovery for ORAQIX usually relies on Orange Book manufacturing sites, NDA manufacturing change histories, and procurement records.

What patent estate or exclusivity affects sourcing of ORAQIX?

Answer: Patent and exclusivity analysis is not determinable from the provided dataset, so supplier entry and generic parallel supply constraints cannot be mapped here.

Business link: Even when generic substitutes exist, supplier relationships may not change immediately due to:

• device compatibility,
• cartridge system qualification,
• and regulatory approval timelines.

Key Takeaways

• ORAQIX is supplied in the US by AstraZeneca under the branded commercial chain.
• The most decision-relevant suppliers for sourcing are the contract manufacturers producing the finished cartridge/gel and the upstream API/excipient providers for lidocaine HCl and prilocaine.
• Orange Book manufacturing-site data is the primary route to identify specific finished-dose manufacturing entities, but those data are not included in the provided dataset.
• Sourcing continuity depends on cartridge component availability, contract manufacturing capacity, and API supply.

FAQs

1. Who is the NDA holder for ORAQIX in the US?
2. Where can ORAQIX manufacturing sites be found if contract suppliers are hidden?
3. What upstream APIs does ORAQIX require and how does that affect sourcing redundancy?
4. How do cartridge delivery systems constrain alternative suppliers of ORAQIX?
5. Do Orange Book manufacturing changes for ORAQIX indicate shifts in contract manufacturing?

References

1. FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations). U.S. FDA. (No ORAQIX listing details provided in the dataset.)