ZTLIDO: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962	NDA	Scilex Pharmaceuticals Inc.	69557-111-03	3 POUCH in 1 CARTON (69557-111-03) / 1 PATCH in 1 POUCH	2018-04-26
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962	NDA	Scilex Pharmaceuticals Inc.	69557-111-30	30 POUCH in 1 CARTON (69557-111-30) / 1 PATCH in 1 POUCH (69557-111-01)	2018-04-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Ztlido is a lidocaine topical system (transdermal patch) marketed in the US by Hikma Pharmaceuticals USA. The US supply chain is built around (1) the finished-dose patch and (2) key upstream components such as the backing, release liner, drug reservoir matrix, adhesive system, and lidocaine drug substance handling. This page maps the supplier landscape using publicly accessible regulatory, labeling, and manufacturing disclosures tied to Ztlido’s FDA file and marketing.

Who supplies Ztlido (lidocaine topical system) in the US supply chain?

Answer (practical): The finished product is supplied from contract manufacturing sites used by the brand’s marketing authorization holder (Hikma). Drug delivery and patch assembly typically require specialized processes, so Ztlido supply is concentrated among a small number of suppliers for patch fabrication and adhesive/matrix integration.

Brand holder vs. manufacturer vs. distributor

Marketing authorization holder (US label “Manufactured for” / “Distributed by”): Hikma Pharmaceuticals USA
Contract manufacturing (patch manufacturing sites): Identified through Ztlido’s FDA labeling/manufactured-for statements and the firm(s) named in FDA product records tied to application/CMC data.
Distributor: Often the marketing authorization holder or an affiliated logistics partner, depending on label statements and wholesaler listings.

Upstream suppliers typically needed for a transdermal patch

These are not always named individually on labels, but are core to patch supply:

Drug substance: lidocaine (typically from API suppliers that qualify for pharmaceutical-grade handling)
Drug product matrix: polymeric system that holds lidocaine and controls release rate
Adhesive layer: pressure-sensitive adhesive chemistry suited for skin contact and humidity resistance
Release liner and backing: materials that protect the drug matrix pre-application and support patch integrity
Packaging and sterilization controls: patch-level packaging (sachets or blister-like formats) and desiccation controls where required

What companies manufacture Ztlido patches (finished drug product)?

Answer (practical): The manufacturer of record for Ztlido in the US label and/or FDA listing is the anchor supplier for the finished patch. Contract manufacturing is common for topical systems, so the “maker” is usually a specialized patch manufacturer operating under GMP.

How to identify the finished-dose patch manufacturer

For Ztlido, finished-dose suppliers are determined from:

FDA drug listing and label sections stating “Manufactured for” and “Manufactured by” (or equivalent phrasing)
NDC labeling tied to the approved application
Associated CMC disclosures in regulatory submissions (where public references allow)

Ztlido supply implication

Patch assembly is capital intensive. When a brand is reliant on limited CMO capacity, any of the following can trigger supply pressure:

adhesive or polymer raw material allocation
patch coating line downtime
packaging material lead times
regulatory change control timelines

Which suppliers provide key materials for Ztlido (adhesive, matrix, backing, liner)?

Answer (practical): Ztlido’s supplier set is typically upstream, with material suppliers qualifying through vendor qualification packages and vendor-controlled specifications for patch performance (adhesion, tack hold, moisture barrier, drug release).

Materials categories that constrain patch supply

Pressure-sensitive adhesive (PSA) suppliers
- Determines skin adhesion profile and patient tolerability
Polymer matrix/drug reservoir
- Controls lidocaine loading and release kinetics
Backing film
- Controls mechanical integrity, flexibility, and occlusion
Release liner
- Affects usability, peel strength, and patch surface cleanliness
Packaging components
- Protects from humidity and oxygen exposure, especially during distribution

Where these suppliers show up in practice

These material suppliers usually appear indirectly as:

referenced excipient sources in CMC
supplier qualification statements in regulatory dossiers
vendor master data under GMP change control

What is the Orange Book status of Ztlido and does it affect supplier options?

Answer (practical): Ztlido’s exclusivity and patent estate influence which suppliers can manufacture generic or “AB-rated” alternatives, but do not prevent the brand’s existing CMOs from producing Ztlido. Supplier options expand or contract when generics launch, when patents block entry, or when supply licenses/authorizations change.

Why Orange Book status matters

If Ztlido has active patents or exclusivity covering composition, formulation, or method-of-use, generic entry is constrained.
For supplier planning, the key is whether a manufacturer can legally produce a competing lidocaine patch and still meet FDA requirements for AB-rating.

Operational impact

During active protection, suppliers usually remain tied to the brand and to materials that do not create patent infringement through the final dosage design.
After expiration, supplier competition can increase for patch manufacturing lines and packaging.

What patent constraints shape where Ztlido can be made or reformulated?

Answer (practical): Patent constraints are typically relevant to:

generic “same active, same dosage form” products that must show they do not infringe formulation or process claims
reformulations (different matrix/adhesive/backing compositions)
manufacturing process changes that create equivalence issues

Typical patent targets in transdermal systems

Even without naming each Ztlido patent (which would require a specific Ztlido patent list), transdermal patches commonly have IP around:

drug-in-adhesive or drug-in-matrix structure
lidocaine concentration and release-rate profile
adhesive composition and layering
manufacturing processes controlling uniformity and release
methods for treating postherpetic neuralgia (if use claims exist)

Who are the likely CMO categories supplying Ztlido versus generic lidocaine patch entrants?

Answer (practical): Two distinct ecosystems exist:

Brand CMOs that build and qualify a specific patch architecture to brand specs and FDA-approved CMC
Generic patch CMOs that can handle bioequivalence/clinical bridge requirements and manage design-around IP

Design-around and line specialization

Generic patch makers often:

use different polymer/adhesive systems that achieve comparable release
rely on different coating and lamination workflows
need regulatory documentation for equivalence

What generic entry risks exist for Ztlido and how do they affect supplier leverage?

Answer (practical): Supplier leverage weakens when generics enter because manufacturing lines can switch to multiple customers. Supplier leverage strengthens when exclusivity blocks entry or if patch performance is difficult to replicate.

Generic entry mechanism

Paragraph IV challenges can trigger earlier entry for certain generic formulations if litigation ends favorably.
Even when patents expire, formulation/process differences can delay ANDA approval.

Supplier planning impact

If a generic enters, patch manufacturing capacity can be bid across brands.
If protection holds, capacity stays concentrated with fewer purchasers.

Which FDA regulatory identifiers should buyers use to map Ztlido suppliers precisely?

Answer (practical): Use the identifiers tied to the specific NDC strength and dosage form.

Identifiers that anchor manufacturer mapping

NDC for each marketed configuration
Label “Manufactured for” company name on the package insert or carton label
FDA Structured Product Labeling (SPL) version associated with the label package
Orange Book listings for the active patent/exclusivity framework relevant to Ztlido

Key Takeaways

Ztlido’s supplier chain is anchored by the finished-dose patch manufacturer(s) disclosed as “manufactured for/by” on label and FDA product records for the relevant NDCs.
Upstream suppliers for lidocaine handling and patch materials (adhesive, matrix polymers, backing, liner, packaging) typically operate through qualified vendor programs rather than being named on the consumer label.
Orange Book and patent status influence competitive manufacturing availability, not the brand’s ability to produce Ztlido through its existing CMOs.
Supplier and capacity risk in transdermal systems most often arises from patch coating/lamination lines and specialty excipient/adhesive allocation, not from the drug substance alone.

FAQs

1) Where can I find the Ztlido manufacturer name on US packaging?

Check the box and package insert sections labeled “Manufactured for” or “Manufactured by,” matched to the NDC listed on the carton.

2) Does Hikma manufacture Ztlido itself or through contract manufacturing?

Ztlido is supplied through labeled manufacturing arrangements that commonly involve CMOs under GMP, with Hikma serving as the marketing authorization holder shown on labeling.

3) Are there multiple Ztlido NDCs with different manufacturing sites?

Different strengths and pack configurations can map to different label and NDC records, which can reflect different manufacturing sites depending on the approved CMC and label history.

4) Do material suppliers for transdermal patches change over time?

Yes. Adhesives, polymers, and backing films can change via approved CMC supplements, with vendor qualification required to maintain product performance.

5) How do patents and exclusivity affect generic supply of lidocaine patches like Ztlido?

They affect whether generic patch manufacturers can produce an “AB-rated” alternative without infringement risk and on what timeline, impacting CMO customer allocation and pricing power.

References (APA)

FDA. (n.d.). Drugs@FDA: Ztlido (lidocaine) topical system. U.S. Food and Drug Administration.
FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Ztlido/lidocaine topical system). U.S. Food and Drug Administration.
DailyMed. (n.d.). Ztlido (lidocaine) topical system label information. National Library of Medicine.

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