Drugs Containing Excipient (Inactive Ingredient) CI 16035

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Branded drugs containing CI 16035 excipient, and estimated key patent expiration / generic entry dates

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
A-S Medication Solutions	SULFATRIM	sulfamethoxazole and trimethoprim	50090-7836	CI 16035

Generic drugs containing CI 16035 excipient

Company	Ingredient	NDC	Excipient
A-S Medication Solutions	fluconazole	50090-1429	CI 16035
A-S Medication Solutions	amoxicillin	50090-1512	CI 16035
A-S Medication Solutions	amoxicillin	50090-1513	CI 16035
A-S Medication Solutions	amoxicillin	50090-1514	CI 16035

CI 16035 Market Dynamics and Financial Trajectory: Allura Red AC Pharmaceutical Excipient Analysis

Last updated: October 2, 2026

CI 16035, commonly known as Allura Red AC, FD&C Red No. 40, and E129, is a synthetic azo colorant used in pharmaceutical dosage forms, foods, beverages, and cosmetics. Its pharmaceutical market is a small subset of the broader color-additives market and is driven by formulation appearance, patient recognition, regulatory compliance, and supply reliability rather than by patent exclusivity.

No public company reports revenue, volume, or margin specifically for CI 16035. The financial outlook is therefore best assessed through regulatory demand, end-market exposure, raw-material economics, supplier concentration, and substitution risk.

What is CI 16035 and how is it used in pharmaceuticals?

CI 16035 is the disodium salt of a sulfonated azo dye. Its principal identifiers are:

Attribute	Data
Common name	Allura Red AC
U.S. name	FD&C Red No. 40
European Union designation	E129
Colour Index number	CI 16035
CAS number	25956-17-6
Chemical class	Synthetic azo colorant
Primary pharmaceutical role	Tablet, capsule, and oral-liquid colorant
Dosage-form applications	Immediate-release tablets, hard capsules, syrups, suspensions, chewables
Regulatory category	Color additive and pharmaceutical excipient, depending on jurisdiction

In pharmaceuticals, CI 16035 is used at low concentrations to identify strengths, differentiate products, improve visual consistency, and support brand recognition. It does not provide therapeutic activity.

The ingredient is especially relevant to:

• Oral liquid formulations requiring uniform coloration.
• Chewable tablets and pediatric products.
• Multistrength solid-dose products.
• Combination products where color coding reduces medication-selection errors.
• Branded products that use a distinctive tablet or capsule appearance.

U.S. regulatory treatment is controlled through the color-additive framework rather than through a drug-specific monograph. FDA lists FD&C Red No. 40 under 21 C.F.R. § 74.340 and requires certification for applicable batches of color additives used in FDA-regulated products.[1]

What is the global market position of CI 16035?

CI 16035 participates in a broad synthetic food, pharmaceutical, and cosmetic colorants market. Pharmaceutical use is commercially important for qualification and compliance purposes but is not likely the largest demand segment. Food and beverage applications generally account for the largest volume exposure because of wider use across processed foods, beverages, confectionery, and supplements.

The market has four structural characteristics:

1. The molecule is mature and broadly available.
2. Pharmaceutical demand is specification-sensitive but volume-light.
3. Regulatory status differs by jurisdiction.
4. Formulators can often replace it with other synthetic or natural colors.

The commercial value of CI 16035 is therefore based less on molecule-level scarcity and more on:

• Batch certification.
• Heavy-metal and impurity control.
• Microbiological quality.
• Lot-to-lot shade consistency.
• Documentation under GMP or excipient-quality systems.
• Supply-chain continuity.
• Customer qualification and change-control requirements.

Public market research reports often publish revenue estimates for synthetic food colors or the wider food-coloring industry, but these reports generally do not isolate CI 16035 or its pharmaceutical share. Company filings from major color manufacturers also aggregate color revenue across products and industries. A precise standalone market size or revenue CAGR for pharmaceutical-grade CI 16035 is not publicly verifiable.

How does the regulatory status of CI 16035 affect demand?

Regulatory treatment is the main market driver.

United States

FDA permits FD&C Red No. 40 for specified uses under 21 C.F.R. § 74.340. Certified color additives must meet regulatory specifications and undergo FDA batch certification before commercial use in products covered by the certification system.[1]

Pharmaceutical manufacturers generally require:

• Certificate of analysis.
• FDA certification documentation where applicable.
• Identity and assay testing.
• Residual-solvent and heavy-metal data.
• Microbial specifications.
• Allergen and genetically modified organism statements where relevant.
• Change-control commitments.
• Supplier qualification and audit support.

CI 16035 has no FDA drug exclusivity period and is not listed in the Orange Book as an active pharmaceutical ingredient or drug product patent. Orange Book status is therefore not a relevant barrier to competition for the colorant itself.[2]

European Union

The European Union identifies Allura Red AC as E129. Food-additive authorization is governed principally by Regulation (EC) No. 1333/2008 and related specifications.[3] Pharmaceutical use may also depend on national implementation, product-specific authorization, excipient controls, and the marketing authorization dossier.

The European regulatory environment creates commercial friction because the same color may be accepted in one product category and restricted, labeled, or avoided in another. Manufacturers selling across Europe must manage differences between food, cosmetic, and medicinal-product rules.

International markets

JECFA has established an acceptable daily intake for Allura Red AC of 0-7 mg/kg body weight.[4] National rules vary across Asia-Pacific, Latin America, the Middle East, and Africa. Export suppliers must often maintain jurisdiction-specific documentation for identity, purity, permitted use, and labeling.

What is the financial trajectory for CI 16035?

The financial trajectory is likely stable to low-growth in mature pharmaceutical markets, with higher growth potential in emerging-market oral medicines and consumer-health products.

Financial driver	Expected effect
Growth in oral solid-dose medicines	Positive
Growth in pediatric and liquid formulations	Positive
Natural-color substitution	Negative
Consumer avoidance of synthetic dyes	Negative
Regulatory restrictions or reformulation	Negative
Multi-source qualification	Negative for supplier pricing power
Higher GMP and documentation requirements	Positive for qualified suppliers
Raw-material and energy inflation	Volatile input-cost pressure
Expansion of generic medicines	Positive for volume, negative for price
Pharmaceutical outsourcing	Positive for qualified ingredient suppliers

CI 16035 is a low-cost, low-dose excipient. Its contribution to a finished drug’s cost of goods is normally immaterial. A small price increase may have little effect on product economics, but a supply interruption can impose substantial costs through:

• Reformulation.
• Stability testing.
• New supplier qualification.
• Regulatory variation filings.
• Packaging and appearance changes.
• Artwork revision.
• Market-specific approvals.

This creates an asymmetry: the dye has low unit value but can have high operational value once incorporated into an approved product.

Which companies supply CI 16035?

The market is supplied by specialty color manufacturers, synthetic-dye producers, and distributors. Publicly visible industry participants include companies active in food, pharmaceutical, cosmetic, and industrial colors, such as Sensient Technologies, DIC Corporation and its Sun Chemical operations, and other regional color manufacturers.

Supplier economics depend on whether the producer sells:

• Food-grade CI 16035.
• Pharmaceutical-grade material.
• Certified U.S. color.
• Compendial or customer-specific material.
• Blended or lake forms.
• Pre-dispersed systems for liquid or solid dosage forms.

The distinction between food-grade and pharmaceutical-qualified material is commercially important. A pharmaceutical customer may not accept a lower-cost food-grade source without additional qualification, impurity review, and regulatory assessment.

Public company disclosures generally do not break out CI 16035 sales. Revenue exposure is therefore indirect:

Company type	Exposure to CI 16035
Diversified color producer	Low on a company-wide basis
Pharmaceutical excipient distributor	Potentially meaningful at product level
Generic-drug manufacturer	Low direct cost exposure, higher supply-chain exposure
Branded oral-liquid manufacturer	Moderate formulation exposure
Food-color producer	Greater volume exposure than pharmaceutical suppliers
Contract manufacturer	Customer-specific exposure based on approved formulas

How strong is the patent estate for CI 16035?

The core molecule is a mature chemical entity with no meaningful composition-of-matter patent barrier. CI 16035 was developed and commercialized decades ago, and any original molecule-level patents would be expired.

IP category	Current relevance
Composition-of-matter patents	No meaningful active barrier expected
Manufacturing-process patents	Possible at supplier level, usually narrow
Purification patents	Possible, but unlikely to block market entry
Pharmaceutical formulation patents	Possible for a specific finished product
Color-blend patents	Possible but product-specific
Trade secrets	Relevant to yield, shade control, and impurity management
Regulatory exclusivity	None for the colorant
Orange Book listing	None expected
Paragraph IV litigation	Not applicable to the excipient itself

The principal defensible assets are process know-how, customer qualification, regulatory files, analytical methods, and supply reliability. These assets can protect a supplier commercially without creating legal exclusivity over the molecule.

What formulations are protected by CI 16035?

CI 16035 may appear in finished-product patents covering:

• Tablet coatings.
• Capsule shells.
• Oral suspensions.
• Syrups.
• Chewable tablets.
• Multiparticulate dosage forms.
• Color-coded combination products.
• Taste-masked pediatric formulations.

Such patents would generally protect a formulation, dosage form, coating composition, or therapeutic product. They would not normally prevent another manufacturer from selling CI 16035 as an excipient or using a different color system.

A generic applicant using CI 16035 could face product-specific formulation patents, but that risk would arise from the drug product rather than from CI 16035 itself.

Are there Paragraph IV challenges or patent litigation involving CI 16035?

There is no conventional Paragraph IV risk for CI 16035 as an excipient. Paragraph IV certifications address listed patents for approved drug products under the Abbreviated New Drug Application pathway. The colorant itself is not an Orange Book-listed drug and does not have an independent generic-drug litigation pathway.[2]

Potential disputes are more likely to involve:

• Supplier quality failures.
• Contract breaches.
• Adulteration or contamination.
• Regulatory noncompliance.
• Trademark or trade-dress claims involving product appearance.
• Finished-drug formulation patents that happen to use CI 16035.

No broad, molecule-level patent litigation is expected to affect ordinary CI 16035 supply.

What is the biosimilar and generic-entry risk?

Biosimilar risk is not applicable because CI 16035 is a small-molecule colorant, not a biologic.

Generic-drug entry has mixed effects:

• It increases unit demand for excipients used in oral medicines.
• It compresses prices for finished products.
• It encourages formulation simplification.
• It can reduce the willingness of manufacturers to pay premiums for customized color systems.
• It increases demand for reliable, qualified, multi-source suppliers.

The largest commercial threat is not generic substitution of CI 16035. It is substitution by another colorant, color blend, lake, or natural pigment during product development or reformulation.

How does CI 16035 compare with competing pharmaceutical colorants?

Colorant	Main advantages	Main risks
CI 16035 / FD&C Red No. 40	Strong red shade, low cost, broad familiarity	Synthetic-dye restrictions and consumer avoidance
FD&C Red No. 3	Bright pink-red shade, established use	Significant regulatory and reformulation scrutiny
Carmine	Strong natural red color	Allergen, animal-origin, labeling, and religious concerns
Betanin	Natural red source	Lower heat and pH stability
Iron oxides	Strong opacity and stability	Limited color range and heavier appearance
Anthocyanins	Natural positioning	pH and stability limitations
Ponceau 4R	Comparable synthetic red option in some markets	Jurisdictional restrictions and customer preference
Titanium dioxide blends	Opacity and whiteness	Regulatory restrictions in certain markets

CI 16035 remains competitive where cost, shade intensity, and stability matter more than natural-label positioning. It is less competitive in products marketed around clean labels, dye-free formulations, or pediatric ingredient avoidance.

What manufacturing and supply barriers affect CI 16035?

Manufacturing is based on synthetic aromatic chemistry, sulfonation, diazotization, coupling, purification, drying, and milling or standardization. Commercial barriers include:

• Control of aromatic intermediates.
• Batch-to-batch hue consistency.
• Removal of unreacted intermediates.
• Heavy-metal control.
• Residual impurity management.
• Wastewater treatment.
• Environmental permits.
• Transport and storage compliance.
• FDA certification capability.
• Qualified alternative production sites.

The most important barrier is not technological complexity. It is the ability to produce consistent, regulatorily acceptable material at scale while maintaining a complete documentation package.

Geographic supply risk depends on concentration in China, India, Europe, and other synthetic-dye manufacturing regions. Disruptions involving environmental inspections, energy costs, freight, export controls, or plant shutdowns can affect lead times even when nominal global capacity is adequate.

What generic launch scenarios could affect CI 16035 demand?

Base case

Demand remains stable, supported by oral generics, consumer health, and food applications. Pricing tracks raw-material, energy, and compliance costs. Pharmaceutical customers maintain dual sourcing but avoid unnecessary reformulation.

Upside case

Demand increases through growth in generic oral medicines, pediatric products, emerging-market manufacturing, and contract development and manufacturing organizations. Qualified suppliers gain share because customers prioritize continuity over marginal price differences.

Downside case

Demand declines in selected markets because of clean-label policies, consumer pressure, dye-free product launches, or restrictions on synthetic colors. Pharmaceutical customers replace CI 16035 during routine reformulation cycles.

The most probable scenario is volume stability with modest pricing pressure and periodic regional substitution.

What is the investment and commercial outlook for CI 16035?

CI 16035 is not an attractive standalone growth asset based on molecule economics. It is more relevant as part of a broader color-excipient portfolio.

Commercial attractiveness is strongest for suppliers that have:

• FDA-certified production.
• Pharmaceutical customer approvals.
• Multi-region manufacturing.
• Strong impurity analytics.
• Short lead times.
• Broad color portfolios.
• Regulatory support for reformulation.
• Natural and synthetic alternatives under one supply relationship.

Revenue concentration in CI 16035 alone is unlikely to be material for diversified manufacturers. The relevant financial exposure is at the product-family level, where CI 16035 can contribute to recurring sales but usually does not determine corporate earnings.

Key Takeaways

• CI 16035 is Allura Red AC, FD&C Red No. 40, and E129.
• It is used mainly as a colorant in tablets, capsules, oral liquids, and chewables.
• The molecule has no meaningful active composition patent or regulatory exclusivity.
• Orange Book listings, Paragraph IV challenges, biosimilar disputes, and molecule-level patent litigation are not relevant to the excipient.
• Pharmaceutical-grade demand is stable but represents only part of the broader colorant market.
• No public company discloses standalone CI 16035 revenue or profit.
• Supplier qualification, FDA certification, impurity control, and continuity of supply are the main commercial barriers.
• The principal long-term threat is substitution by natural colors, dye-free formulations, or alternative synthetic red colorants.
• The strongest suppliers are diversified color companies with pharmaceutical documentation and multi-jurisdictional regulatory capability.

FAQs

Is CI 16035 approved for use in medicines?

CI 16035 is permitted as FD&C Red No. 40 for applicable uses under U.S. color-additive regulations. Its use in a specific medicine also depends on the product’s approved formulation and regulatory dossier.

Is CI 16035 the same as Red 40?

Yes. CI 16035 is the Colour Index designation for Allura Red AC, which is commonly called FD&C Red No. 40 in the United States and E129 in the European Union.

Does CI 16035 increase pharmaceutical product cost materially?

Usually not. The dye is used at low concentrations and generally has a small direct cost contribution. Its indirect cost is higher because a supplier change or color change can require formulation, stability, regulatory, and packaging work.

Can a generic drug manufacturer use CI 16035 without a license?

There is no molecule-level patent license requirement for CI 16035. A generic manufacturer must still comply with applicable color-additive rules and avoid infringing patents covering the finished drug formulation or product design.

Will natural-color regulation eliminate CI 16035 from pharmaceuticals?

A broad elimination is unlikely. Substitution will vary by market, product category, patient population, and brand positioning. CI 16035 remains commercially useful where stability, cost, and color intensity are priorities.

References

1. U.S. Food and Drug Administration. (2024). 21 C.F.R. § 74.340: FD&C Red No. 40. Electronic Code of Federal Regulations.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.

3. European Parliament and Council. (2008). Regulation (EC) No. 1333/2008 on food additives. Official Journal of the European Union.

4. Joint FAO/WHO Expert Committee on Food Additives. (2017). Evaluation of certain food additives: Eighty-second report of JECFA. World Health Organization.