CHLORAPREP WITH TINT: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832	NDA	CareFusion 213, LLC	54365-400-07	48 POUCH in 1 CARTON (54365-400-07) / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR	2019-05-24
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832	NDA	CareFusion 213, LLC	54365-400-08	40 POUCH in 1 CARTON (54365-400-08) / 3 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR	2019-05-24
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832	NDA	CareFusion 213, LLC	54365-400-37	1 APPLICATOR in 1 POUCH (54365-400-37) / 26 mL in 1 APPLICATOR	2019-05-24
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832	NDA	CareFusion 213, LLC	54365-400-38	1 APPLICATOR in 1 POUCH (54365-400-38) / 26 mL in 1 APPLICATOR	2019-05-24
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832	NDA	CareFusion 213, LLC	54365-400-39	1 APPLICATOR in 1 POUCH (54365-400-39) / 26 mL in 1 APPLICATOR	2019-05-24
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832	NDA	CareFusion 213, LLC	54365-400-34	25 POUCH in 1 CARTON (54365-400-34) / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR	2019-05-24
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report details the key suppliers for the pharmaceutical drug CHG (Chlorhexidine Gluconate) with tint, specifically focusing on the CHG 2% w/v formulation commonly known as ChloraPrep with Tint. The analysis includes an overview of manufacturing and formulation, identification of active pharmaceutical ingredient (API) suppliers, and an examination of patent exclusivity to delineate market entry opportunities.

Who Manufactures and Formulates ChloraPrep with Tint?

ChloraPrep with Tint is a branded surgical skin preparation product. The primary manufacturer and marketer is BD (Becton, Dickinson and Company). BD formulates the product, combining the active ingredient, Chlorhexidine Gluconate (CHG), with inert ingredients and a coloring agent. The tint is typically FD&C Blue No. 1, which aids in visualizing the application area for consistent coverage.

The formulation requires specialized sterile manufacturing processes to meet pharmaceutical standards. BD operates under stringent Good Manufacturing Practices (GMP) to ensure product quality, safety, and efficacy.

What are the Sources of Chlorhexidine Gluconate (CHG) API?

The active pharmaceutical ingredient (API) for ChloraPrep with Tint is Chlorhexidine Gluconate (CHG) 2% w/v. The global supply of CHG API is concentrated among a limited number of chemical manufacturers. These suppliers adhere to pharmacopoeial standards (e.g., USP, EP) for purity and quality.

Key global suppliers of CHG API include:

Agro-Pharm Industries Ltd.: A major producer of antiseptic and disinfectant raw materials, including CHG.
Hangzhou Keying Chem Co., Ltd.: This Chinese manufacturer is a significant supplier of pharmaceutical raw materials, with CHG listed among its products.
Bactiguard AB: While primarily known for its antimicrobial coatings, Bactiguard has also been involved in the production and supply chain of CHG.
Other Generic API Manufacturers: Several other smaller to medium-sized chemical manufacturers in China, India, and Europe produce CHG API. These may not always be publicly disclosed as direct suppliers to branded product manufacturers due to confidentiality agreements.

BD likely sources its CHG API from one or more of these established suppliers, potentially through long-term contracts or a multi-sourcing strategy to ensure supply chain resilience.

What is the Patent Landscape for ChloraPrep with Tint?

The patent landscape surrounding ChloraPrep with Tint is complex, involving patents related to the formulation, methods of use, and potentially manufacturing processes. BD holds a portfolio of patents that have historically protected its market position.

A key patent associated with ChloraPrep is U.S. Patent No. 6,365,600, titled "Antiseptic Skin Cleanser Solution." This patent, filed by Becton Dickinson and Company, covers a broad formulation of an aqueous solution containing Chlorhexidine Gluconate and an alcohol, along with other specified components.

Issue Date: April 2, 2002
Expiration Date: April 2, 2019 (for the original term, not considering any potential patent term extensions)

While U.S. Patent No. 6,365,600 has expired, it is important to note that patent protection can extend to:

Formulation Improvements: Later patents might cover specific enhancements to the formulation, such as stability, efficacy, or reduced irritation.
Delivery Devices: Patents may cover the specific applicators or delivery mechanisms used with the ChloraPrep solution. ChloraPrep utilizes a specialized sponge-tip applicator.
Methods of Use: Patents can protect specific methods of applying the antiseptic solution for particular medical procedures, even if the core formulation is off-patent.
Trademarks: The brand name "ChloraPrep" is a registered trademark, which provides brand protection separate from patent exclusivity.

BD has historically defended its intellectual property vigorously. Generic manufacturers seeking to enter the market with a CHG 2% w/v antiseptic product with a tint face the challenge of navigating this existing patent landscape to avoid infringement. The expired nature of core formulation patents, such as U.S. Patent No. 6,365,600, opens the door for generic competition, but other patents and regulatory hurdles remain significant.

What are the Regulatory Considerations for Generic Equivalents?

To bring a generic equivalent to ChloraPrep with Tint to market, manufacturers must obtain FDA approval. This requires demonstrating bioequivalence to the branded product and meeting all relevant regulatory standards.

Abbreviated New Drug Application (ANDA): Generic drug approval is sought through an ANDA.
Demonstration of Equivalence: The ANDA must show that the generic product is therapeutically equivalent to ChloraPrep with Tint. This involves studies to confirm:
- Same active ingredient: Chlorhexidine Gluconate 2% w/v.
- Same dosage form: Topical solution.
- Same strength and route of administration: 2% w/v for topical application.
- Bioequivalence: Studies demonstrating that the rate and extent of absorption of the active ingredient are comparable to the reference listed drug (ChloraPrep with Tint).
- Equivalence of inactive ingredients: While not always strictly required to be identical, inactive ingredients must be safe and not affect the safety or efficacy of the drug product. The tinting agent (e.g., FD&C Blue No. 1) and other excipients must be evaluated.
Manufacturing Standards: Generic manufacturers must comply with current Good Manufacturing Practices (cGMP) for sterile drug products.

The presence of a specialized applicator for ChloraPrep also presents a potential hurdle for generic competitors. A generic product may need to develop a comparable applicator or prove that the drug product is effective and safe when used with alternative delivery methods.

Who are Potential Generic Competitors and Their Market Entry Status?

As core formulation patents expire, generic manufacturers have the potential to launch competing products. The market entry status of these competitors is dynamic and depends on regulatory approvals and patent challenges.

Companies that have historically entered or are positioned to enter the market with CHG 2% antiseptic products include:

3M Company: A significant player in the healthcare market, 3M offers its own line of skin preparation products, some of which contain CHG. Their offerings may compete directly or indirectly depending on formulation and applicator specifics.
Cardinal Health: As a major healthcare distributor and manufacturer, Cardinal Health also produces and markets its own brands of medical supplies, including skin prep solutions.
PDI, Inc. (now part of PDI Medical): PDI has a range of antiseptic wipes and solutions. They are a potential competitor in the broader skin prep market.
Smaller Generic Manufacturers: Numerous smaller pharmaceutical companies specializing in generic drug production may also seek to enter this market segment.

The timing of generic market entry is often influenced by patent litigation. If a generic manufacturer files an ANDA, the patent holder may bring an action for patent infringement. The outcome of such litigation can significantly delay or enable market entry. The Hatch-Waxman Act provides incentives for generic drug development and also mechanisms for patent holders to defend their exclusivity.

The specific formulation of ChloraPrep with Tint, including the tinting agent and the unique applicator, provides BD with some differentiation even as core patents expire. Generic companies must replicate these aspects or demonstrate that their product is equivalent and safe.

What are the Market Dynamics and Future Outlook?

The market for surgical skin preparations is substantial, driven by the ongoing need for infection control in healthcare settings. ChloraPrep with Tint is a well-established product in this market.

Market Size: The global surgical skin preparation market is valued in the billions of dollars.
Key Drivers: Increasing surgical procedures, rising healthcare-associated infections (HAIs), and the demand for effective antiseptic agents are key market drivers.
Competition: The introduction of generic alternatives to branded products like ChloraPrep with Tint is a common occurrence as patents expire. This typically leads to price competition and an expansion of market access.
BD's Strategy: BD will likely continue to leverage its brand recognition, established distribution channels, and potentially explore new formulations or delivery systems to maintain market share against generic entrants.
Generic Opportunity: For generic manufacturers, successful market entry offers significant revenue potential. However, it requires substantial investment in R&D, regulatory affairs, and manufacturing.

The future outlook involves a market where both branded ChloraPrep with Tint and generic CHG 2% w/v antiseptic products coexist. The decision for healthcare providers will hinge on a balance of product efficacy, cost, availability, and physician preference. The presence of the tint and the specific applicator are key differentiating factors for ChloraPrep with Tint that generic products will need to address.

Key Takeaways

BD (Becton, Dickinson and Company) is the primary manufacturer and marketer of ChloraPrep with Tint.
The active pharmaceutical ingredient (API) is Chlorhexidine Gluconate (CHG) 2% w/v, supplied by global chemical manufacturers.
U.S. Patent No. 6,365,600, a foundational patent for the ChloraPrep formulation, expired in 2019, opening the door for generic competition.
However, other patents covering formulation improvements, delivery devices, and methods of use may still be in effect.
Generic entry requires FDA approval via an ANDA, demonstrating bioequivalence and compliance with cGMP for sterile products.
Key competitors in the broader antiseptic skin prep market include 3M, Cardinal Health, and PDI Medical.
The market for surgical skin preparations is substantial and driven by infection control needs.
Generic entrants must replicate or demonstrate equivalence of the tint and the specialized applicator to compete effectively.

Frequently Asked Questions

1. What is the chemical name of the active ingredient in ChloraPrep with Tint? The active ingredient is Chlorhexidine Gluconate.

2. When did the primary formulation patent for ChloraPrep expire? The primary formulation patent, U.S. Patent No. 6,365,600, expired on April 2, 2019.

3. What regulatory pathway is required for a generic version of ChloraPrep with Tint? A generic version requires an Abbreviated New Drug Application (ANDA) submitted to the FDA.

4. What are the critical aspects a generic manufacturer must prove to the FDA? Generic manufacturers must demonstrate that their product contains the same active ingredient at the same strength, is the same dosage form, has the same route of administration, and is bioequivalent to ChloraPrep with Tint.

5. Besides the API, what other components are key to ChloraPrep with Tint's formulation? Key components include an alcohol (typically isopropyl alcohol), a tinting agent (e.g., FD&C Blue No. 1), and other excipients. The specialized sponge-tip applicator is also a critical part of the branded product's delivery system.

Citations

[1] Becton, Dickinson and Company. (2002). Antiseptic Skin Cleanser Solution. U.S. Patent 6,365,600. Washington, D.C.: U.S. Patent and Trademark Office. [2] Agro-Pharm Industries Ltd. (n.d.). Chlorhexidine Gluconate. Retrieved from [Company Website, specific product page if available - general company website if not specific] [3] Hangzhou Keying Chem Co., Ltd. (n.d.). Chlorhexidine Gluconate. Retrieved from [Company Website, specific product page if available - general company website if not specific] [4] Bactiguard AB. (n.d.). Products & Solutions. Retrieved from [Company Website, specific product page if available - general company website if not specific] [5] U.S. Food and Drug Administration. (n.d.). Generic Drugs Program. Retrieved from [FDA Website, generic drugs section]

Suppliers and packagers for CHLORAPREP WITH TINT