List of Excipients in Branded Drug GLYDO- LIDOCAINE HYDROCHLORIDE JELLY

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Generic Drugs Containing GLYDO- LIDOCAINE HYDROCHLORIDE JELLY

Company	Ingredient	NDC	Excipient
HF Acquisition Co LLC DBA HealthFirst	glydo- lidocaine hydrochloride jelly	51662-1652	HYPROMELLOSES
HF Acquisition Co LLC DBA HealthFirst	glydo- lidocaine hydrochloride jelly	51662-1652	SODIUM HYDROXIDE

What are the Most Frequently-Used Excipients in GLYDO- LIDOCAINE HYDROCHLORIDE JELLY?

# Of NDCs	Excipient
1	HYPROMELLOSES
1	SODIUM HYDROXIDE

GLYDO Lidocaine Hydrochloride Jelly: Excipient Strategy, Patent Position and Commercial Opportunities

Last updated: August 22, 2026

GLYDO is a sterile, aqueous 2% lidocaine hydrochloride jelly used for topical anesthesia and lubrication during urethral catheterization, endoscopy, intubation and related procedures. Its commercial position depends less on active-ingredient protection than on reliable supply, prefilled delivery systems, preservative control, viscosity, microbial quality and institutional purchasing economics.

The formulation contains lidocaine hydrochloride at 20 mg per gram and uses a hydrophilic jelly base with hypromellose, preservatives, pH adjusters and water for injection. The product has limited apparent patent-based exclusivity. The strongest commercial opportunities are differentiated unit-dose formats, preservative-free presentations, improved applicator design, pediatric and procedural packaging, and contract or private-label supply.

What is GLYDO and how is it formulated?

GLYDO is a sterile lidocaine hydrochloride jelly USP containing 2% lidocaine hydrochloride. Each gram contains approximately 20 mg of lidocaine hydrochloride, equivalent to 20 mg/mL on a weight-to-volume basis for the active ingredient concentration stated on the label.[1]

Product characteristic	GLYDO profile
Active ingredient	Lidocaine hydrochloride
Strength	2%
Dosage form	Sterile topical jelly
Route	Topical administration to mucosal surfaces
Primary uses	Urethral procedures, catheterization, endoscopy and intubation
Base	Aqueous hydrophilic jelly
Key polymer	Hypromellose
Preservatives listed on label	Methylparaben and propylparaben
pH control	Sodium hydroxide and hydrochloric acid
Vehicle	Water for injection
FDA regulatory category	Prescription drug product
Principal commercial risk	Generic price competition and supply reliability

The product label identifies hypromellose as the principal viscosity-building excipient. Methylparaben and propylparaben provide antimicrobial preservation. Sodium hydroxide and hydrochloric acid adjust formulation pH, while water for injection is the aqueous vehicle.[1]

The formulation must deliver four properties at the same time:

1. Adequate lidocaine release at the mucosal surface.
2. Sufficient viscosity for retention and lubrication.
3. Sterility or appropriate microbiological control through the labeled use period.
4. Acceptable local tolerability on sensitive tissue.

What excipients are used in GLYDO?

The listed inactive ingredients are hypromellose, methylparaben, propylparaben, sodium hydroxide, hydrochloric acid and water for injection.[1]

Hypromellose

Hypromellose controls viscosity, residence time and lubrication. Its concentration, substitution grade, particle characteristics and hydration process can materially affect:

• Syringe extrusion force.
• Applicator handling.
• Spreadability.
• Mucosal retention.
• Lidocaine release.
• Batch-to-batch rheology.
• Filling and manufacturing throughput.

A commercial reformulation should not treat hypromellose as a generic thickener. Changes in viscosity grade or concentration can alter the product's physical performance, even if the lidocaine assay remains within specification.

The principal development target is a rheology profile that allows smooth delivery through a narrow applicator while retaining enough gel at the treatment site. Excessive viscosity can increase administration force and leave residual product in the package. Insufficient viscosity can reduce retention and perceived lubrication.

Methylparaben and propylparaben

The combination of methylparaben and propylparaben provides broad antimicrobial preservation in the aqueous formulation. The strategy is conventional but creates two commercial constraints.

First, paraben sensitivity and preservative avoidance are relevant purchasing considerations in hospitals and specialty clinics. Second, preservative efficacy must remain adequate after the product is exposed during administration, particularly where a container is used over a procedure rather than discarded immediately after opening.

A preservative-free version could command a formulation premium, but it would require a different microbiological control strategy. Options include:

• Single-use sterile prefilled syringes.
• Blow-fill-seal packaging.
• Terminal sterilization where compatible with the formulation and container.
• Aseptic manufacturing with validated container closure integrity.
• Packaging designed to prevent repeated access.

Preservative removal is not a simple excipient deletion. It can require new microbial challenge testing, stability work, container-closure validation and potentially a more restrictive single-dose presentation.

pH adjusters

Sodium hydroxide and hydrochloric acid provide pH adjustment. pH affects lidocaine stability, local tolerability, preservative performance and the balance between ionized and unionized lidocaine.

A reformulation that changes pH may alter onset, tissue tolerance or preservative efficacy. The commercial benefit of a pH adjustment would need to be demonstrated through release testing, stability, local tolerance and comparative performance.

Water for injection

Water for injection is the continuous phase. Its quality, bioburden control and compatibility with the packaging system are central to sterile manufacturing. Any move toward a lower-cost nonsterile process would change the regulatory and commercial positioning of the product.

What excipient strategy offers the best commercial opportunities?

The most defensible strategy is to preserve lidocaine's established clinical profile while improving administration, packaging and patient tolerability.

Opportunity 1: Preservative-free GLYDO

A preservative-free product is the clearest formulation opportunity. It could target:

• Urology departments.
• Pediatric procedures.
• Repeated mucosal exposure.
• Patients with suspected preservative sensitivity.
• Hospitals with preservative-reduction protocols.
• High-volume catheterization and endoscopy centers.

The product would likely require single-use packaging. A sterile, preservative-free, prefilled syringe could be positioned against conventional multidose or preservative-containing jelly products.

Commercial advantages include a differentiated label, reduced excipient burden and a stronger hospital formulary rationale. The disadvantages are higher packaging cost, more demanding sterility assurance and potentially shorter shelf-life if the formulation or container system is less robust.

Opportunity 2: Low-extrusion-force prefilled syringe

The delivery system is as important as the gel composition. A prefilled syringe with optimized hypromellose rheology could reduce administration force and improve procedural handling.

Development targets include:

Attribute	Commercial target
Extrusion force	Consistent delivery through the full shelf-life period
Dose delivery	Low residual volume
Tip design	Compatibility with catheter and procedural applicators
Plunger movement	Smooth, low-force actuation
Packaging	Single-use sterile barrier
Handling	One-handed or gloved use
Labeling	Clear concentration and total lidocaine content

A device-led improvement may be easier to commercialize than a chemically novel formulation because the therapeutic ingredient and route are established. The regulatory burden remains significant if the container or delivery device changes dose delivery or usability.

Opportunity 3: Unit-dose procedural kits

GLYDO can be integrated into procedure-specific kits containing a catheter, lubricant, sterile drape and antiseptic components. This approach changes the purchasing decision from an individual drug unit to a complete procedural supply.

Potential customers include hospitals, ambulatory surgery centers, emergency departments and outpatient urology networks. Kit integration may improve contract retention and reduce product substitution because the formulation becomes part of a standardized workflow.

The key risks are lower standalone visibility and margin sharing with kit manufacturers. A drug manufacturer could address this through private-label supply, co-branding or exclusive hospital contracts.

Opportunity 4: Pediatric and small-volume presentations

A smaller unit-dose presentation could target pediatric urology, neonatal care and outpatient procedures. The commercial value is linked to dose control, reduced waste and simpler inventory management.

The formulation would need packaging that minimizes accidental overadministration and clearly states total lidocaine content. Pediatric positioning would require careful label review because lidocaine toxicity is associated with dose, absorption, treatment area and patient characteristics.[1]

Opportunity 5: Lower-waste packaging

Hospitals pay for discarded product, packaging and unused sterile materials. A presentation matched to common procedure volumes can reduce waste.

Potential formats include:

• 3 mL to 5 mL unit doses for smaller procedures.
• 10 mL presentations for routine catheterization.
• Larger formats for procedures requiring more lubrication, where clinically appropriate.
• Color-coded syringes or carton systems for rapid identification.

The product cannot rely on volume alone. Total lidocaine exposure must remain clear because a larger package carries a higher potential dose.

What patents protect GLYDO lidocaine jelly?

GLYDO's principal commercial protection is unlikely to come from a strong composition-of-matter patent estate. Lidocaine hydrochloride is an old local anesthetic, and aqueous lidocaine jellies have been marketed for decades.

Protection category	GLYDO assessment
Active-ingredient patent	Expired or unavailable for commercial reliance
Basic jelly formulation	Likely vulnerable to generic development
Hypromellose vehicle	Established excipient technology
Preservative system	Conventional and generally difficult to protect broadly
Method-of-use protection	Limited practical value for longstanding topical uses
Delivery-device protection	Potentially available for a proprietary applicator or syringe
Manufacturing process	Potential trade-secret value; limited market exclusivity
Orange Book patent strategy	No material patent barrier should be assumed without a current listing review

The value of new intellectual property would be concentrated in specific, narrow claims, such as:

• A defined rheology range coupled with a particular delivery force.
• A preservative-free sterile gel with a novel container-closure system.
• A prefilled applicator that reduces residual volume.
• A composition with improved stability under defined storage conditions.
• A procedure-specific kit combining the drug and delivery components.
• A manufacturing process that improves sterility assurance or fill accuracy.

Broad claims covering "lidocaine jelly" or hypromellose alone would face substantial validity and prior-art challenges.

What is the Orange Book status and exclusivity outlook for GLYDO?

FDA's Orange Book and the product's approved labeling are the controlling sources for current regulatory and patent information. GLYDO is associated with an FDA-approved lidocaine hydrochloride jelly product, historically identified under NDA 018759 in FDA drug databases.[1,2]

The product's commercial exclusivity outlook is primarily generic-driven:

Exclusivity or protection	Expected commercial relevance
New chemical entity exclusivity	Not relevant to old lidocaine
New formulation exclusivity	Possible only for a qualifying new product
Orphan exclusivity	Not applicable to the established indication
Pediatric exclusivity	No basis to assume without a specific FDA grant
Orange Book patents	Must be verified against the current FDA listing
Generic competition	The principal long-term risk
Device or kit protection	Potentially meaningful for a differentiated entrant

A new preservative-free or device-enabled product could potentially use a different regulatory route from a conventional generic. An ANDA would be appropriate only where the product can meet the applicable sameness and equivalence requirements. A materially different formulation, delivery system or clinical performance profile could require a 505(b)(2) application or another FDA pathway, depending on the proposed claims and reference product.

When could generic manufacturers challenge GLYDO?

A generic manufacturer could challenge the product through an ANDA if it can demonstrate pharmaceutical equivalence and bioequivalence or otherwise satisfy FDA requirements for the dosage form. Because lidocaine jelly is locally acting, the relevant development package may emphasize comparative composition, physicochemical performance, rheology, drug release, microbial quality and local performance rather than relying only on systemic pharmacokinetics.

Potential Paragraph IV activity would depend on listed patents. For a product with no relevant unexpired Orange Book patents, a conventional ANDA pathway may be more commercially attractive than a Paragraph IV litigation strategy.

Key generic entry risks

1. A competitor can use a conventional hypromellose-based jelly with a familiar preservative system.
2. Hospitals may switch suppliers through group purchasing contracts.
3. Lidocaine active-ingredient cost is unlikely to support meaningful product differentiation.
4. Multiple manufacturers can qualify alternative tube, syringe or applicator formats.
5. Supply interruptions can rapidly shift institutional demand to substitutes.

The strongest barrier is operational, not legal. Sterile manufacturing, viscosity control, container-closure integrity and dependable supply create more practical friction than the lidocaine molecule itself.

What formulation patents could support a new GLYDO competitor?

A competitor should focus on claimable technical problems rather than broad ingredient combinations.

Patentable formulation themes

Technical theme	Potential claim focus
Preservative-free gel	Composition plus sterile single-use packaging
Rheology	Defined viscosity, yield stress or shear profile
Low-force delivery	Gel properties linked to applicator performance
Stability	Reduced lidocaine degradation during long-term storage
Local tolerance	Excipient system designed to reduce irritation
Lubrication	Friction reduction in catheter or endoscope insertion
Packaging	Low-residual-volume syringe or specialized tip
Manufacturing	Mixing, hydration or sterilization sequence
Procedure kit	Drug plus device and procedural components

Patent strength would depend on reproducible technical advantages. A patent claiming only a routine substitution, such as replacing one preservative with another, would likely be weaker than a patent supported by comparative data showing improved stability, reduced irritation or superior delivery.

How does GLYDO compare with other lidocaine jelly products?

GLYDO competes with branded and generic 2% lidocaine jelly products, including products supplied in tubes, unit-dose packets and prefilled syringes.

Competitive attribute	GLYDO-type product	Differentiated entrant
Active ingredient	Lidocaine hydrochloride 2%	Same or modified approved strength
Base	Aqueous polymer gel	Preservative-free or engineered rheology
Packaging	Syringe, tube or packet	Sterile prefilled device
Main buyer	Hospitals and procedural clinics	Hospitals, kits and specialty networks
Switching driver	Price and availability	Workflow, tolerability and supply
Patent leverage	Limited	Device, formulation or kit claims
Margin potential	Low to moderate	Higher if clinically or operationally differentiated

GLYDO's most important competitive comparison is not with systemic anesthetics. It is with other topical local-anesthetic jellies that can be substituted in institutional procurement.

What FDA and regulatory issues affect an excipient change?

An excipient change can affect more than inactive-ingredient disclosure. FDA review may consider:

• Pharmaceutical equivalence.
• Product performance.
• Lidocaine release.
• Viscosity and rheology.
• pH and osmolality.
• Preservative effectiveness.
• Sterility and bioburden.
• Extractables and leachables.
• Container-closure integrity.
• Stability under labeled storage.
• Local irritation and sensitization.
• Delivered volume and residual drug.
• Human factors for a prefilled applicator.

For an ANDA, the formulation generally must remain sufficiently comparable to the reference product. A substantial excipient change may complicate equivalence demonstrations or move the product toward a 505(b)(2) strategy.

For a new drug application, excipient differentiation can support a stronger clinical and commercial story, but the development program must establish that the formulation improves a relevant outcome. Marketing claims such as "less irritating," "faster onset" or "better lubrication" require appropriate evidence.

What manufacturing and intellectual-property barriers exist?

The manufacturing process presents several practical barriers.

Sterile processing

The product is an aqueous mucosal preparation. Sterility assurance and microbial control are central. The manufacturer must control raw-material bioburden, mixing, polymer hydration, filling, container closure and stability.

Polymer hydration

Hypromellose can hydrate unevenly, form agglomerates or generate batch-to-batch viscosity variation if the addition sequence and mixing conditions are not controlled. Scale-up can change shear exposure and hydration kinetics.

Filling and packaging

High-viscosity gels create challenges in:

• Accurate fill weight.
• Air entrapment.
• Syringe plunger force.
• Tip clogging.
• Residual volume.
• Container compatibility.
• Lot-to-lot delivery consistency.

Trade-secret opportunities

A manufacturer may protect mixing order, hydration time, deaeration conditions, filling temperature, sterilization parameters and in-process rheology controls as trade secrets. These protections can preserve manufacturing advantage even where composition patents are unavailable.

Which companies are positioned to challenge or supply GLYDO?

The competitive field includes:

• Established generic injectable and topical-drug manufacturers.
• Contract manufacturers with sterile filling capacity.
• Urology-focused medical-device companies.
• Procedure-kit suppliers.
• Hospital private-label suppliers.
• Specialty pharmaceutical companies with prefilled syringe platforms.

The most credible entrant is likely to combine a qualified sterile manufacturing site with an established hospital sales channel. A low-cost formulation alone may not displace an incumbent if the entrant cannot maintain supply, meet group purchasing requirements or provide reliable delivery formats.

What revenue exposure does GLYDO create?

Public company disclosures generally do not isolate GLYDO revenue from broader lidocaine or topical-product sales. Product-level revenue exposure therefore depends on:

• Annual unit volume.
• Average net selling price.
• Contract concentration.
• Generic competition.
• Supply interruptions.
• Hospital purchasing share.
• Product mix between syringes, tubes and unit-dose packets.

The product's revenue profile is likely more sensitive to volume and availability than to price increases. A differentiated preservative-free syringe could improve net price, while a conventional generic jelly would face rapid price compression.

Commercial expansion should prioritize recurring institutional demand rather than retail promotion. The highest-value channels are hospital systems, ambulatory surgery centers, emergency departments, urology practices, endoscopy providers and procedure-kit manufacturers.

What generic launch scenarios exist for GLYDO?

Scenario 1: Conventional generic jelly

A competitor launches a 2% lidocaine hydrochloride jelly with a comparable aqueous base. This is the highest-probability competitive scenario and creates price pressure.

Scenario 2: Preservative-free unit dose

A manufacturer launches a sterile, preservative-free syringe. The product can command a premium if hospitals accept the higher unit cost in exchange for excipient reduction and easier workflow.

Scenario 3: Procedure-kit integration

A supplier embeds lidocaine jelly in catheterization or endoscopy kits. The product gains volume through contract bundling rather than standalone brand preference.

Scenario 4: Device-led premium product

A manufacturer markets an applicator with lower extrusion force, reduced residual volume or improved procedural ergonomics. The device and formulation may support a stronger patent position than the gel alone.

Scenario 5: Supply-driven substitution

A shortage or manufacturing interruption shifts demand to available alternatives. In this market, regulatory compliance and inventory reliability can produce faster commercial gains than promotional differentiation.

Key Takeaways

• GLYDO is a 2% sterile lidocaine hydrochloride jelly with hypromellose, methylparaben, propylparaben, pH adjusters and water for injection.
• The formulation is based on established excipient technology and should not be assumed to have meaningful composition-patent protection.
• The main commercial risks are generic substitution, hospital contract pricing and supply reliability.
• The strongest product opportunities are preservative-free single-use syringes, low-force applicators, smaller unit doses and procedure-specific kits.
• Hypromellose grade and processing control are critical to viscosity, lubrication, release and syringe performance.
• A new entrant should build intellectual property around defined technical performance, packaging, delivery systems or manufacturing controls.
• An ANDA strategy is most appropriate for a substantially equivalent product. A materially differentiated formulation or delivery system may support a 505(b)(2) approach.
• Manufacturing capability, sterile filling and institutional distribution are likely to provide greater practical advantage than lidocaine-related patent rights.

FAQs

Is GLYDO the same as lidocaine hydrochloride jelly 2%?

GLYDO contains lidocaine hydrochloride at 2% in a sterile aqueous jelly. Other lidocaine jelly products may have different excipients, preservatives, packaging or applicator systems.

Does GLYDO contain parabens?

The product labeling identifies methylparaben and propylparaben among its inactive ingredients.[1]

Can a preservative-free lidocaine jelly compete with GLYDO?

Yes. A preservative-free product could target hospitals and patients for whom preservative reduction is commercially relevant. It would require validated sterile single-use packaging and an appropriate FDA regulatory strategy.

Is GLYDO protected by a lidocaine composition patent?

Lidocaine is an established active ingredient, so active-ingredient patent protection should not be assumed. Any relevant current protection would more likely involve a specific formulation, package, device or manufacturing process.

What is the best licensing opportunity around GLYDO?

The strongest licensing opportunities involve sterile prefilled applicators, preservative-free gel technology, procedure-kit integration and manufacturing platforms that improve viscosity control or reduce delivery force.

References

1. U.S. Food and Drug Administration. (n.d.). GLYDO: Lidocaine hydrochloride jelly, 2% prescribing information. DailyMed.
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. Orange Book.
3. U.S. Food and Drug Administration. (2013). Guidance for industry: Bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA.
4. U.S. Food and Drug Administration. (2016). Guidance for industry: ANDAs for certain highly purified synthetic peptides.
5. U.S. Pharmacopeial Convention. (2024). United States Pharmacopeia and National Formulary. USP.