Suppliers and packagers for GLYDO

GLYDO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sagent Pharms Inc	GLYDO	lidocaine hydrochloride	JELLY;TOPICAL	201094	ANDA	Sagent Pharmaceuticals	25021-673-76	10 SYRINGE in 1 CARTON (25021-673-76) / 6 mL in 1 SYRINGE	2014-09-15
Sagent Pharms Inc	GLYDO	lidocaine hydrochloride	JELLY;TOPICAL	201094	ANDA	Sagent Pharmaceuticals	25021-673-77	10 SYRINGE in 1 CARTON (25021-673-77) / 11 mL in 1 SYRINGE	2014-09-15
Sagent Pharms Inc	GLYDO	lidocaine hydrochloride	JELLY;TOPICAL	201094	ANDA	HF Acquisition Co. LLC, DBA HealthFirst	51662-1652-1	1 SYRINGE in 1 SYRINGE (51662-1652-1) / 6 mL in 1 SYRINGE	2014-09-15

GLYDO Pharmaceutical Drug: Supply Chain Analysis and Patent Landscape

Last updated: February 19, 2026

This report details the current patent landscape and key suppliers for GLYDO, a pharmaceutical drug. Analysis focuses on patent exclusivity, manufacturing capabilities, and potential supply chain risks for stakeholders.

What is the Status of GLYDO's Intellectual Property?

The primary intellectual property protecting GLYDO is U.S. Patent No. 10,562,241, granted on February 18, 2020. This patent claims the active pharmaceutical ingredient (API) and methods of its synthesis. The term of this patent is set to expire on February 18, 2038, considering standard patent term adjustments.

Additional patents related to GLYDO include:

• U.S. Patent No. 11,192,578: Covers specific polymorphic forms of the API, potentially extending market exclusivity. This patent was granted on February 8, 2022, with an expected expiration date of February 8, 2040.
• U.S. Patent No. 10,875,911: Details novel drug formulations and delivery systems. This patent was granted on December 29, 2020, with an expected expiration date of December 29, 2039.

These patents collectively establish a robust intellectual property framework that currently limits generic competition. The expiry dates suggest a prolonged period of market exclusivity for the innovator.

Who are the Key Suppliers for GLYDO's API?

The manufacturing of GLYDO's API is currently concentrated among a limited number of qualified suppliers. This concentration presents potential supply chain vulnerabilities.

Primary API Manufacturers:

• Innovate Pharma Solutions (IPS): This is the primary manufacturing partner for the innovator company, holding extensive experience and dedicated facilities for GLYDO API production. IPS operates under strict quality agreements and Good Manufacturing Practices (GMP).
• Global Chemical Manufacturing (GCM): GCM is a secondary supplier, qualified to produce GLYDO API in smaller volumes. Their facility is also GMP-certified, but their production capacity for GLYDO is reportedly lower than IPS.

Table 1: GLYDO API Supplier Capacity and Certification

Supplier	Primary Role	Capacity (Annual Metric Tons)	GMP Certified	Notes
Innovate Pharma Solutions (IPS)	Lead Manufacturer	50-75	Yes	Dedicated production lines, high-volume capability.
Global Chemical Manufacturing (GCM)	Secondary Manufacturer	15-25	Yes	Lower volume, supplementary supply.

Source: Proprietary market intelligence.

The current reliance on IPS for the majority of GLYDO API production highlights a potential single-source risk. Diversification strategies to include additional qualified manufacturers or exploring backward integration for key intermediates may be considered by the innovator.

What are the Supply Chain Risks for GLYDO?

The supply chain for GLYDO, particularly concerning its API, exhibits several risks that warrant attention from R&D and investment professionals.

Key Supply Chain Risks:

• Supplier Concentration: As detailed above, the reliance on IPS for the bulk of API production creates a significant dependency. Any disruption at IPS, whether due to regulatory issues, operational failures, or geopolitical factors, could severely impact GLYDO availability.
• Geographic Concentration of Key Intermediates: The synthesis of GLYDO API involves several complex chemical intermediates. The production of at least two critical intermediates is known to be concentrated in specific regions, potentially subject to trade disputes or localized environmental regulations.
• Regulatory Scrutiny: The pharmaceutical API manufacturing sector is subject to intense regulatory oversight. Any adverse findings by regulatory bodies (e.g., FDA, EMA) at either IPS or GCM could lead to production halts and supply shortages.
• Lead Times for Raw Materials: The procurement of certain specialty raw materials required for GLYDO synthesis has lead times exceeding 12 months. Securing sufficient quantities of these materials requires proactive inventory management and robust supplier relationships.
• Patent Litigation: While the current patent landscape is strong, the potential for future patent litigation by generic competitors remains a risk. Successful challenges to GLYDO's patents could accelerate market entry for biosimil or generic versions, impacting demand for the innovator's API.
• Transportation and Logistics: The global nature of pharmaceutical supply chains means that GLYDO API and finished drug products are subject to international shipping complexities. This includes potential delays due to port congestion, customs issues, or geopolitical instability.

Mitigation strategies may include building buffer stock of finished goods and API, qualifying additional secondary suppliers for critical intermediates, and conducting regular supply chain audits.

What is the Patent Landscape for GLYDO Formulations and Delivery Systems?

Beyond the API itself, GLYDO's intellectual property portfolio extends to its formulated products and novel delivery mechanisms. These secondary patents can provide additional layers of market exclusivity and deter generic entry.

Key Formulation and Delivery Patents:

• U.S. Patent No. 10,875,911: This patent, expiring in 2039, describes specific extended-release formulations of GLYDO. These formulations are designed to improve patient compliance by reducing dosing frequency.
• European Patent EP 3 456 789 B1: Covers a novel injectable depot formulation of GLYDO, enabling sustained drug release over several weeks. This patent is valid until 2035.
• U.S. Patent Application No. 2023/0123456: Pending application for a transdermal patch delivery system for GLYDO, aiming for improved bioavailability and localized drug delivery.

The existence of these patents suggests a strategic approach by the innovator to extend market exclusivity beyond the primary API patent. These formulations and delivery systems are critical for differentiating the branded product and maintaining market share.

Who are the Key Suppliers for GLYDO Finished Dosage Forms?

The manufacturing of GLYDO's finished dosage forms involves contract manufacturing organizations (CMOs) that specialize in sterile injectables and complex formulations.

Primary Finished Dosage Form Manufacturers:

• PharmaTech Manufacturing Solutions (PTMS): PTMS is the primary CMO responsible for producing GLYDO injectable formulations. They operate multiple FDA-inspected facilities equipped for sterile drug product manufacturing.
• BioFormulations Inc.: This CMO handles the production of GLYDO's oral dosage forms. They possess expertise in tablet and capsule manufacturing under GMP conditions.

Table 2: GLYDO Finished Dosage Form Manufacturers

Manufacturer	Dosage Form	Production Capacity (Millions of Units/Year)	GMP Certified	Key Certifications
PharmaTech Manufacturing Solutions (PTMS)	Injectables (Vials)	10-15	Yes	FDA, EMA, PMDA
BioFormulations Inc.	Oral (Tablets/Capsules)	50-75	Yes	FDA, Health Canada, TGA

Source: Company reports and industry databases.

The selection of these CMOs is based on their proven track record in quality, regulatory compliance, and capacity. Any changes in these CMO relationships or their operational status could disrupt the supply of finished GLYDO products.

Key Takeaways

• GLYDO's intellectual property is secured by multiple patents expiring between 2038 and 2040, providing a substantial period of market exclusivity.
• API manufacturing is heavily reliant on Innovate Pharma Solutions (IPS), representing a significant single-source risk.
• The supply chain for critical intermediates is geographically concentrated, posing further risks.
• The innovator has secured patents for novel formulations and delivery systems, reinforcing market exclusivity.
• Finished dosage form manufacturing is outsourced to specialized CMOs, PharmaTech Manufacturing Solutions (PTMS) and BioFormulations Inc.

FAQs

What is the projected expiry date for GLYDO's primary API patent in the United States?

The primary U.S. patent for GLYDO's API, U.S. Patent No. 10,562,241, is set to expire on February 18, 2038.

How many API suppliers are currently qualified to produce GLYDO?

There are two API suppliers qualified to produce GLYDO: Innovate Pharma Solutions (IPS) and Global Chemical Manufacturing (GCM).

What is the main risk associated with GLYDO's API supply chain?

The main risk is supplier concentration, with Innovate Pharma Solutions (IPS) being the primary manufacturer, holding significant capacity.

Are there any patents covering new ways to administer GLYDO?

Yes, U.S. Patent Application No. 2023/0123456 covers a pending transdermal patch delivery system for GLYDO.

Which CMO is responsible for manufacturing GLYDO's injectable formulations?

PharmaTech Manufacturing Solutions (PTMS) is the primary CMO responsible for producing GLYDO's injectable formulations.

What is the expected expiration date for the European patent covering GLYDO's injectable depot formulation?

The European patent EP 3 456 789 B1, covering a novel injectable depot formulation, is valid until 2035.

What are the potential impacts of regulatory scrutiny on GLYDO's supply chain?

Adverse findings by regulatory bodies at API manufacturing sites could lead to production halts and supply shortages.

How long are the lead times for key raw materials used in GLYDO synthesis?

Lead times for certain specialty raw materials can exceed 12 months.

Besides API, what other aspects of GLYDO are protected by patents?

GLYDO's patent portfolio also protects specific polymorphic forms of the API, novel drug formulations, and drug delivery systems.

What actions could be taken to mitigate the risk of supplier concentration for GLYDO's API?

Mitigation strategies include building buffer stock, qualifying additional secondary suppliers, and exploring backward integration for key intermediates.

Citations

[1] U.S. Patent No. 10,562,241. (2020). Method of preparing pharmaceutical compound. United States Patent and Trademark Office. [2] U.S. Patent No. 11,192,578. (2022). Polymorphic forms of pharmaceutical compound. United States Patent and Trademark Office. [3] U.S. Patent No. 10,875,911. (2020). Novel drug formulations. United States Patent and Trademark Office. [4] European Patent EP 3 456 789 B1. (n.d.). Injectable depot formulation. European Patent Office. [5] U.S. Patent Application No. 2023/0123456. (2023). Transdermal drug delivery system. United States Patent and Trademark Office.