List of Excipients in Branded Drug GLYDO

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Generic Drugs Containing GLYDO

Company	Ingredient	NDC	Excipient
Sagent Pharmaceuticals	lidocaine hydrochloride	25021-673	HYPROMELLOSES
Sagent Pharmaceuticals	lidocaine hydrochloride	25021-673	SODIUM HYDROXIDE
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?

# Of NDCs	Excipient
1	HYPROMELLOSES
1	SODIUM HYDROXIDE

GLYDO Excipient Strategy and Commercial Opportunities in Lidocaine 2% Jelly

Last updated: October 31, 2026

GLYDO is a sterile, water-soluble 2% lidocaine hydrochloride jelly used for mucosal anesthesia and lubrication, particularly in urologic procedures. Its commercial differentiation depends less on active-ingredient exclusivity and more on sterile manufacturing, prefilled delivery systems, excipient performance, packaging, and institutional procurement. The core formulation uses hypromellose, methylparaben, sodium hydroxide, and water for injection. No biologic or biosimilar pathway applies. The principal competitive risk is generic lidocaine hydrochloride jelly supplied in comparable concentrations and presentations.[1]

What is GLYDO and what excipients does it contain?

GLYDO contains lidocaine hydrochloride at a concentration of 2%, equivalent to 20 mg/mL. The product is supplied as a sterile jelly for administration to mucous membranes and as a lubricant during catheterization and related procedures.[1]

Formulation component	Function in GLYDO
Lidocaine hydrochloride	Local anesthetic active ingredient
Hypromellose	Gelling, viscosity control, mucoadhesion and lubrication
Methylparaben	Antimicrobial preservative
Sodium hydroxide	pH adjustment
Water for injection	Sterile aqueous vehicle

The label identifies hypromellose, methylparaben, sodium hydroxide and water for injection as inactive ingredients.[1] The formulation does not rely on a complex delivery technology. Its value is created by maintaining a sterile, homogeneous, lubricating gel that releases lidocaine at the mucosal surface without compromising handling or administration.

Why hypromellose is strategically important

Hypromellose controls the product’s rheology. Its concentration, substitution grade, molecular weight and hydration profile affect:

• Syringe extrusion force
• Retention on mucosal tissue
• Lubrication during catheter insertion
• Lidocaine diffusion and release
• Patient perception of thickness
• Compatibility with sterilization and filling processes

A higher-viscosity hypromellose grade may improve mucosal residence time but can increase administration force and create filling challenges. A lower-viscosity grade may improve syringe usability but reduce retention and lubrication. This creates a formulation optimization window for differentiated products without changing the 2% lidocaine strength.

Why methylparaben matters

Methylparaben supports multidose microbiological protection but can create commercial and regulatory constraints. Preservative sensitivity, patient preference for preservative-free products, and hospital efforts to reduce unnecessary excipients create an opportunity for a preservative-free unit-dose formulation.

A preservative-free design would require a validated sterile manufacturing process, container-closure integrity, aseptic filling controls and microbiological risk assessment. Removing methylparaben without redesigning the packaging or manufacturing process would not provide a sufficient control strategy.

What commercial opportunities exist for GLYDO excipient innovation?

The strongest opportunities are in delivery format, preservative strategy and handling performance rather than in substituting the active ingredient.

1. Preservative-free GLYDO-type formulations

A preservative-free 2% lidocaine jelly could target:

• Urology procedure rooms
• Emergency departments
• Operating rooms
• Pediatric care
• Patients with preservative sensitivity
• Health systems pursuing lower-excipient formulations

The commercial proposition would be strongest in single-use packaging. A sterile unit-dose syringe or foil tube can reduce the need for methylparaben and limit contamination after opening.

The main development burden is aseptic processing and package integrity. A preservative-free formulation may also require tighter control of fill volume, administration instructions and discard-after-use procedures.

2. Prefilled syringe and unit-dose packaging

GLYDO’s sterile, ready-to-use format is more commercially defensible than a conventional multidose tube. Potential packaging improvements include:

• Low-force prefilled syringes
• Tip designs optimized for urethral administration
• Tamper-evident sterile caps
• Color-coded 5 mL, 10 mL and 20 mL presentations
• Procedure-specific kits
• Packaging compatible with automated medication cabinets

Packaging can support device or combination-product intellectual property even when the composition is difficult to protect. Claims may cover syringe geometry, plunger force, seal configuration, sterile barrier packaging or coordinated administration kits.

The key value for hospitals is workflow reduction. A prefilled sterile product can remove preparation steps, reduce vial or tube handling and simplify inventory management.

3. Low-force and high-lubricity formulations

A reformulated hypromellose system could target smoother extrusion and improved catheter passage. Relevant variables include:

• Hypromellose molecular weight
• Polymer concentration
• pH
• Ionic strength
• Water activity
• Lidocaine concentration
• Lubricant compatibility
• Syringe barrel and plunger materials

A lower extrusion force may be commercially valuable for smaller-diameter catheters and pediatric use. A higher-retention gel may support procedures where local anesthetic residence time is important.

The formulation must preserve lidocaine uniformity and avoid excessive viscosity, which could delay administration or leave residual drug in the syringe.

4. Excipient systems designed for mucosal tolerability

Potential alternatives or complements to hypromellose include other cellulose derivatives, poloxamers, carbomers and polyvinyl alcohol systems. Each carries tradeoffs in mucoadhesion, osmolality, pH, syringeability, microbial control and regulatory precedent.

A commercially attractive system would need to demonstrate:

• Equivalent or improved lubrication
• Consistent lidocaine release
• Acceptable mucosal tolerability
• No clinically meaningful increase in irritation
• Stable viscosity over shelf life
• Compatibility with sterile filling
• A clear regulatory bridge to the reference product

The FDA Inactive Ingredient Database can support excipient selection by showing prior use in approved drug products, but database presence does not eliminate the need for product-specific safety and compatibility work.[2]

What FDA regulatory pathway applies to GLYDO-type products?

GLYDO-type products are small-molecule local anesthetic products, not biologics. A competitive product would generally pursue one of two pathways.

Development route	Likely use
Section 505(j) ANDA	Same active ingredient, dosage form, strength, route and sufficiently comparable formulation
Section 505(b)(2) NDA	Reformulated, repackaged or otherwise differentiated product relying partly on FDA findings for an existing product

An ANDA is commercially efficient when the applicant can match the reference product’s critical quality attributes and satisfy applicable bioequivalence or product-specific requirements. A materially different excipient system, new delivery device, preservative-free design or new clinical claim may push development toward a 505(b)(2) application.[3]

For a locally acting jelly, the regulatory assessment may focus on comparative performance rather than conventional plasma pharmacokinetics. Relevant studies can include drug release, product characterization, viscosity, syringeability, adhesion, microbial quality and, where required, clinical or pharmacodynamic comparisons.

What FDA status does GLYDO have?

GLYDO is an FDA-regulated prescription product labeled as lidocaine hydrochloride jelly USP, 2%.[1] It is not a biologic and therefore does not create a biosimilar opportunity. The relevant competitive pathways are generic ANDA entry and differentiated 505(b)(2) development.

What is the Orange Book and patent status of GLYDO?

The FDA Orange Book identifies approved drug products, therapeutic-equivalence information and, where applicable, listed patents and exclusivity.[4]

For an old small-molecule lidocaine jelly, the principal commercial assumption is that active-ingredient and basic composition exclusivity are weak or expired. The commercial barrier is more likely to arise from:

• Product-specific formulation claims
• Prefilled syringe or applicator claims
• Sterile manufacturing claims
• Packaging patents
• Method-of-use claims
• Regulatory exclusivity attached to a later-approved differentiated product

No active patent protection should be assumed solely from the GLYDO brand name. A current Orange Book and patent-family review is required for a definitive product-specific conclusion, but the formulation components themselves are established pharmaceutical excipients with extensive prior use.

How strong is the patent estate for GLYDO-type products?

The base patent estate is likely weak because lidocaine hydrochloride, hypromellose gels and sterile aqueous delivery are long-established technologies. New protection would need to focus on a narrow technical feature, such as:

• A defined polymer molecular-weight distribution
• A specific viscosity range at a defined shear rate
• A preservative-free sterile composition
• A particular lidocaine release profile
• A low-extrusion-force syringe system
• A package that maintains sterility through a defined shelf life
• A procedure-specific combination of formulation and applicator

Composition claims that merely substitute one conventional gelling agent for another face substantial prior-art and obviousness risks. Device and process claims may offer better protection if they solve a measurable manufacturing or administration problem.

When does GLYDO lose exclusivity?

GLYDO’s principal exclusivity risk is already present because lidocaine hydrochloride is an old active ingredient and generic lidocaine jelly products have long existed. There is no biosimilar exclusivity period. The relevant competitive timetable is therefore driven by approval, manufacturing capacity, procurement contracts and litigation rather than by the expiration of a new chemical entity patent.

Exclusivity or market factor	GLYDO-type product impact
New chemical entity exclusivity	Not applicable to old lidocaine
Biologic exclusivity	Not applicable
Basic lidocaine composition patents	Generally expired or commercially weak
Formulation patents	Potentially relevant if a later product has issued claims
Device patents	Potentially relevant for prefilled delivery systems
ANDA approval	Can enable direct generic competition
Hospital contracting	May determine practical market access

Paragraph IV risk would arise if a generic applicant certifies that a listed patent is invalid, unenforceable or not infringed. For an old lidocaine jelly, Paragraph IV litigation would be product-specific and would depend on any currently listed Orange Book patents. A generic applicant could also use a Paragraph III certification if a listed patent remains valid but has a known expiration date.[5]

What generic entry risks exist for GLYDO?

Generic entry risk is high for the basic product because the active ingredient is established, the formulation is relatively simple and the clinical use is well understood.

The principal generic advantages are:

• Low active pharmaceutical ingredient cost
• Familiar excipients
• Established sterile manufacturing methods
• Limited need for new clinical development
• Ability to compete through hospital purchasing contracts
• Multiple potential suppliers of lidocaine jelly

GLYDO can retain commercial value through supply reliability, prefilled packaging, procedure kits, consistent syringe performance and customer service. Brand retention is less likely to depend on exclusivity than on formulary status and procurement performance.

Which companies are competing in lidocaine jelly?

The competitive landscape includes:

1. Branded or legacy lidocaine jelly products.
2. Generic lidocaine hydrochloride jelly products.
3. Hospital-compounded or institutionally prepared alternatives.
4. Topical anesthetic gels with different active ingredients.
5. Lubricating gels used without local anesthetic.
6. Procedure kits containing anesthetic jelly and catheterization supplies.

Competition is shaped by FDA approval status, sterile supply, packaging, National Drug Code availability, wholesaler access and contract pricing. A company entering this market would need reliable sterile production and a distribution strategy directed at hospitals, ambulatory surgery centers, urology clinics and emergency departments.

What licensing opportunities exist around GLYDO excipients and delivery systems?

Licensing value is more likely to reside in enabling technologies than in GLYDO’s base composition. Relevant assets include:

• Low-force sterile prefilled syringes
• Preservative-free aqueous gel platforms
• Mucoadhesive polymer systems
• Sterile fill-finish capacity
• Procedure-specific catheterization kits
• Container-closure systems for viscous products
• Manufacturing processes that reduce gel deaeration or fill variability

A licensee could combine an established lidocaine formulation with a protected delivery device or a differentiated sterile manufacturing platform. The most practical deal structure would likely involve an upfront payment, development milestones, supply commitments and royalties tied to product sales.

What revenue exposure does GLYDO create?

Public revenue disclosure for GLYDO as a standalone product is limited. The commercial exposure is best assessed through market structure rather than reported brand sales.

Revenue sensitivity is linked to:

• Number of catheterization procedures
• Hospital conversion from tubes to prefilled syringes
• Contract wins and losses
• Generic price erosion
• Sterile manufacturing interruptions
• Shortages of competing products
• Adoption of preservative-free formats
• Use in outpatient and ambulatory settings

A differentiated sterile presentation can support higher pricing than a standard generic tube, but the price premium must be justified by lower preparation burden, reduced contamination risk or improved procedural performance.

Key Takeaways

• GLYDO is a sterile 2% lidocaine hydrochloride jelly using hypromellose, methylparaben, sodium hydroxide and water for injection.
• The strongest commercial opportunities are preservative-free unit-dose packaging, prefilled syringes, low-force delivery and procedure-specific kits.
• The base composition has limited patent strength because the active ingredient and excipient technology are established.
• Generic competition is structurally high and is likely to be driven by price, supply reliability and hospital contracts.
• A differentiated product could pursue an ANDA if it remains sufficiently comparable or a 505(b)(2) pathway if it introduces meaningful formulation or device differences.
• Biosimilar risk does not apply.
• New intellectual property is more defensible around delivery devices, sterile packaging, defined rheology and manufacturing controls than around conventional excipient substitution.
• No exclusivity strategy should rely on the GLYDO brand alone.

FAQs

Can GLYDO be reformulated without methylparaben?

Yes, but a preservative-free version would require a suitable sterile manufacturing and packaging strategy. Removing methylparaben without controlling contamination risk would not be sufficient.

Is hypromellose essential to GLYDO?

Hypromellose is central to the labeled formulation’s gel structure, viscosity and lubrication, but alternative polymers may be evaluated. Substitution would require comparative quality, performance and tolerability data.

Can a GLYDO competitor use a different gelling agent?

Potentially. A different gelling agent may support an ANDA only if the product meets applicable sameness and performance requirements. A materially different formulation may require a 505(b)(2) strategy.

Is lidocaine jelly eligible for biosimilar development?

No. Lidocaine is a small-molecule active ingredient. Competitive products would use generic-drug or new-drug pathways, not the biosimilar pathway.

What is the most valuable patent strategy for a new GLYDO-type product?

The strongest opportunities are likely to involve prefilled syringe architecture, sterile package integrity, defined viscosity and extrusion-force profiles, preservative-free compositions, and manufacturing processes that provide measurable performance advantages.

References

1. U.S. Food and Drug Administration. (n.d.). GLYDO: Lidocaine hydrochloride jelly USP, 2% prescribing information. DailyMed.

2. U.S. Food and Drug Administration. (n.d.). Inactive Ingredient Database. FDA.

3. U.S. Food and Drug Administration. (2023). Applications covered by section 505(b)(2). FDA.

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

5. U.S. Food and Drug Administration. (2024). Approved drug products and patent certifications under the Hatch-Waxman Amendments. FDA.