Drugs Containing Excipient (Inactive Ingredient) FD&C RED NO. 40 ALUMINUM LAKE

Branded drugs containing FD&C RED NO. 40 ALUMINUM LAKE excipient, and estimated key patent expiration / generic entry dates

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
BeOne Medicines USA Inc	BEQALZI	sonrotoclax	72579-020	FD&C RED NO. 40 ALUMINUM LAKE	2031-05-13

Generic drugs containing FD&C RED NO. 40 ALUMINUM LAKE excipient

Company	Ingredient	NDC	Excipient
L Perrigo Company	famotidine, calcium carbonate and magnesium hydroxide	0113-0032	FD&C RED NO. 40 ALUMINUM LAKE
Walgreen Company	famotidine, calcium carbonate and magnesium hydroxide	0363-0511	FD&C RED NO. 40 ALUMINUM LAKE
Walgreen Company	ibuprofen	0363-1517	FD&C RED NO. 40 ALUMINUM LAKE

FD&C Red No. 40 Aluminum Lake Market Dynamics, Pricing, Regulation, and Financial Outlook

Last updated: August 27, 2026

FD&C Red No. 40 Aluminum Lake is a certified synthetic color additive used in pharmaceutical tablets, capsules, coatings, oral powders, cosmetics, foods, and supplements. Its market is driven by formulation demand, regulatory compliance, pigment performance, and supply reliability rather than by patent exclusivity. The financial outlook is stable to moderately growing, with pricing power concentrated in certified, pharmaceutical-grade material and in suppliers that provide documentation, custom dispersion, and global regulatory support.

Standalone revenue data for FD&C Red No. 40 Aluminum Lake is not generally disclosed by manufacturers. Public companies report broader color, ingredients, or specialty chemicals segments. Market analysis therefore depends on pharmaceutical production volumes, color additive regulation, supplier economics, and demand across adjacent end markets.

What is FD&C Red No. 40 Aluminum Lake?

FD&C Red No. 40 Aluminum Lake is the aluminum lake form of FD&C Red No. 40, also known as Allura Red AC or E129. The colorant is chemically associated with an aluminum substrate, producing an insoluble pigment rather than a water-soluble dye.

The lake form is used when a formulation requires:

• Color stability in solid dosage forms
• Dispersion in oils, waxes, or coating systems
• Reduced migration compared with water-soluble dyes
• Consistent shade in tablet films and hard-shell capsules
• Compatibility with direct compression, granulation, and coating processes

The material is different from water-soluble FD&C Red No. 40. Pharmaceutical developers select between the dye and lake form based on solubility, processing conditions, dosage-form design, and target color intensity.

Where is FD&C Red No. 40 Aluminum Lake used?

End market	Principal applications	Demand characteristics
Pharmaceuticals	Tablet coating, capsule shells, oral powders, chewables	High documentation and batch-certification requirements
Nutraceuticals	Tablets, gummies, capsules, powders	Sensitive to consumer-labeling trends
Food and beverage	Confectionery, bakery products, dry mixes	Large volume but higher price competition
Cosmetics	Makeup, powders, creams, personal care	Depends on jurisdiction and shade trends
Industrial products	Limited pigment and specialty applications	Smaller share of total demand

Pharmaceutical use is a smaller volume segment than food and beverage but typically generates higher value per kilogram because of tighter quality requirements, traceability, testing, and regulatory documentation.

What is the FDA status of FD&C Red No. 40 Aluminum Lake?

FD&C Red No. 40 is an FDA-certified color additive. The FDA regulates certified color additives through specifications, batch certification, labeling, and permitted uses. The relevant federal framework includes 21 C.F.R. Part 74 for listed color additives subject to certification and 21 C.F.R. Part 82 for color additive specifications and certification-related requirements.[1][2]

For pharmaceutical products, the color must meet the applicable FDA requirements and the finished drug must identify the color additive in its labeling when required. Drug manufacturers generally purchase certified batches from approved color suppliers and retain certification and quality records as part of their supplier qualification systems.

The aluminum lake designation matters because the lake is not simply a different commercial grade of the same dye. It is a distinct physical form with separate specifications for composition, insoluble matter, particle characteristics, and performance.

What FDA requirements affect pharmaceutical use?

The principal compliance requirements are:

1. Use of an FDA-permitted color additive form.
2. Batch certification where required.
3. Compliance with identity and purity specifications.
4. Supplier traceability and change-control documentation.
5. Finished-product labeling and formulation disclosure.
6. Verification that the amount and use are appropriate for the drug product.

Color additives are also subject to broader current good manufacturing practice obligations. A pharmaceutical company may reject a supplier even when the material meets the formal color specification if the supplier cannot provide adequate audit access, impurity data, allergen statements, residual solvent information, or change-notification commitments.

How large is the FD&C Red No. 40 Aluminum Lake market?

There is no widely reported, audited global market total for FD&C Red No. 40 Aluminum Lake as a standalone product. Manufacturers typically combine it with synthetic colors, pigments, food colors, pharmaceutical excipients, or specialty ingredients in their financial reporting.

The commercial market is best understood through four demand pools:

• Pharmaceutical and nutraceutical solid dosage forms
• Processed food and beverage products
• Cosmetics and personal care
• Regional replacement demand created by colorant restrictions

Pharmaceutical demand is linked to prescription and over-the-counter tablet volumes. The strongest applications are film-coated tablets, chewable tablets, capsule shells, and branded products that use color as part of product identification.

Overall volume growth is likely to remain modest because FD&C Red No. 40 Aluminum Lake is a mature commodity colorant. Value growth can exceed volume growth when customers shift toward pharmaceutical-grade material, smaller validated supply chains, low-metal grades, custom particle-size distributions, or premixed coating systems.

What drives pricing for FD&C Red No. 40 Aluminum Lake?

Pricing is determined by raw-material costs, certification requirements, production scale, regional supply, and customer qualification status.

Key cost drivers

• Aromatic chemical intermediates used to manufacture the dye
• Aluminum substrate and precipitation chemistry
• Energy and wastewater-treatment costs
• Batch certification and analytical testing
• Packaging and controlled storage
• Regulatory registration and documentation
• Freight, tariffs, and currency movements
• Capacity utilization at certified production sites

Large food manufacturers generally purchase on a cost-per-kilogram basis and can switch suppliers more readily. Pharmaceutical customers may pay a premium for qualified material because changing color suppliers can require formulation testing, stability work, regulatory assessment, and manufacturing validation.

This creates two separate pricing markets. Bulk food-grade supply is more exposed to commodity competition. Pharmaceutical-grade supply is more dependent on qualification, reliability, and quality systems.

Which companies supply FD&C Red No. 40 Aluminum Lake?

The supplier landscape includes multinational color manufacturers, specialty pigment producers, and regional distributors. Companies active in synthetic colorants or pharmaceutical color systems include Sensient Technologies, DIC/Sun Chemical, Roha, Dynic, and other regional manufacturers and distributors. Colorcon is a major pharmaceutical film-coating supplier and may supply systems incorporating approved colorants, although it is not necessarily the primary manufacturer of every underlying pigment used in those systems.

Supplier selection depends on the specific grade, geography, certification status, and intended use. A company listed as a color supplier may not offer every grade in every market.

Supplier category	Competitive advantage	Commercial risk
Global color manufacturers	Broad regulatory coverage and multinational supply	Higher overhead and less flexibility for small buyers
Specialty pharmaceutical suppliers	Documentation, technical service, and validated grades	Higher unit price
Regional manufacturers	Competitive pricing and local inventory	Variable global regulatory support
Distributors	Availability and smaller order quantities	Less control over manufacturing continuity
Coating-system suppliers	Formulation support and easier customer implementation	Customer dependency on proprietary systems

What formulations are protected by FD&C Red No. 40 Aluminum Lake?

The colorant itself is generally not protected by a commercially important drug patent estate. Protection is more likely to arise from:

• Proprietary tablet-coating compositions
• Controlled-release coating systems
• Color-matching systems
• Pigment dispersion methods
• Low-dust or high-dispersibility grades
• Combination coatings containing polymers, plasticizers, and pigments
• Manufacturing processes that improve shade consistency or particle-size distribution

A pharmaceutical company may protect a finished dosage form that uses FD&C Red No. 40 Aluminum Lake, but that patent would normally cover the drug formulation or manufacturing method rather than the colorant as a standalone molecule.

Is FD&C Red No. 40 Aluminum Lake in the Orange Book?

FD&C Red No. 40 Aluminum Lake is not an active pharmaceutical ingredient and is not independently listed as a drug product in the FDA Orange Book. It does not have standalone Orange Book exclusivity, Paragraph IV litigation, or generic-entry protection.[3]

If a branded tablet uses the colorant, any Orange Book listing would relate to the finished drug’s active ingredient, formulation, method of use, or other qualifying product patent. The color additive would not independently delay generic approval.

When does FD&C Red No. 40 Aluminum Lake lose exclusivity?

FD&C Red No. 40 Aluminum Lake has no conventional pharmaceutical exclusivity period. It is a mature color additive subject to regulatory authorization rather than drug-patent exclusivity.

Commercial barriers are based on:

• Supplier qualification
• Manufacturing know-how
• Analytical specifications
• Regulatory files
• Customer switching costs
• Quality history
• Production capacity
• Trade-secret process controls

Any historical patents covering specific manufacturing processes are unlikely to create broad market exclusivity for the colorant. The most durable advantages are operational and regulatory.

What patent litigation affects FD&C Red No. 40 Aluminum Lake?

No major Orange Book patent litigation is associated with FD&C Red No. 40 Aluminum Lake as a standalone excipient. Paragraph IV challenges are not relevant to the color additive itself.

Potential disputes would more likely involve:

• Contractual supply obligations
• Product specifications
• Contamination or off-specification batches
• Trade secrets
• Process patents
• Trademark or labeling claims
• Regulatory responsibility between a manufacturer and distributor

For pharmaceutical companies, the legal risk is usually indirect. A supplier disruption, documentation failure, or specification change can affect a finished drug’s manufacturing validation and regulatory filing even when no patent dispute exists.

How strong is the intellectual-property estate for this colorant?

The IP estate is weak as a product-exclusivity tool and stronger as a manufacturing and service differentiator.

IP category	Strength	Relevance
Standalone composition patent	Low	Mature, widely available colorant
Orange Book listing	None	Not a finished drug product
Process patent	Low to moderate	May protect a particular production route
Trade secret	Moderate	Can cover precipitation, particle control, and purification
Formulation patent	Moderate	Applies to coatings or dosage forms, not the colorant alone
Regulatory know-how	Moderate	Useful in global registration and customer qualification
Trademark and brand rights	Low to moderate	Supports supplier differentiation

The practical moat is supplier approval. Once a pharmaceutical manufacturer validates a color grade, it may avoid switching unless price, supply, or quality performance changes materially.

How do regulatory trends affect demand?

Regulatory and consumer pressure against synthetic food colors creates mixed effects.

In pharmaceuticals, substitution is difficult because color is embedded in approved formulations and product-identification systems. A drug company considering a switch may need to perform compatibility, stability, process, and labeling assessments. That supports continued use in established products.

In food and supplements, demand may face pressure from clean-label positioning, retailer policies, and state-level scrutiny. California’s Food Safety Act, signed in 2023, restricts certain additives in food sold or manufactured in the state, although FD&C Red No. 40 was not included in the initial prohibited list.[4] Broader legislative attention can still accelerate reformulation discussions.

In the European Union, Allura Red AC is designated E129 and is subject to EU food additive rules and labeling requirements. The regulatory status of a lake pigment can differ from that of the soluble dye, so suppliers must assess each jurisdiction and use category separately.[5]

What manufacturing and supply barriers affect the market?

The primary manufacturing barrier is consistent production of a certified lake with controlled shade, strength, particle size, insoluble matter, and impurity profile. Production typically involves dye manufacture followed by precipitation or adsorption onto an aluminum substrate, filtration, washing, drying, milling, and quality testing.

Supply-chain risks include:

• Dependence on a limited number of qualified producers
• Concentration of chemical manufacturing in Asia
• Port and freight disruption
• Changes in environmental controls
• Wastewater-treatment constraints
• Raw-material price volatility
• Batch rejection
• Regulatory changes affecting impurities or heavy metals

Pharmaceutical customers may dual-source, but qualification of a second supplier can take longer than the purchase cycle for ordinary food-grade material. This creates inventory incentives and can support higher margins for suppliers with dependable pharmaceutical documentation.

What is the financial trajectory for FD&C Red No. 40 Aluminum Lake?

The expected financial trajectory is mature and defensive rather than high-growth.

Base-case outlook

• Volume growth: low single digits, tied to solid dosage and processed-food production
• Pricing: stable in normal supply conditions, with periodic increases from chemicals, energy, freight, or compliance costs
• Margin profile: higher for pharmaceutical grades and coating systems than for bulk food-grade product
• Capital intensity: moderate, driven by chemical processing, environmental controls, and quality systems
• Consolidation risk: persistent, because scale improves batch economics and regulatory coverage

Upside factors

• Growth in generic tablets and capsules
• Expansion of contract manufacturing
• Increased use of colored film coatings
• Demand for global regulatory documentation
• Supplier consolidation
• Premium grades with better dispersion and lower dust

Downside factors

• Reformulation away from synthetic colors
• Retailer and consumer pressure
• Environmental compliance costs
• Low-cost regional competition
• Customer concentration
• Substitution by other approved red colorants

Revenue exposure is likely to be more meaningful for diversified color suppliers as part of broad colorant portfolios than for pharmaceutical manufacturers. A drug company’s direct financial exposure is usually limited to procurement cost, inventory, validation expenses, and potential production interruption. A supply failure can have a larger economic impact than the colorant’s purchase price because it may delay batch release or require regulatory work.

How does FD&C Red No. 40 Aluminum Lake compare with competing red colorants?

Colorant	Form	Primary advantage	Principal limitation
FD&C Red No. 40	Water-soluble dye	Strong, economical red shade	Migration and water sensitivity
FD&C Red No. 40 Aluminum Lake	Insoluble lake pigment	Better solid-dose and coating performance	Requires dispersion; regulatory form differs
D&C Red No. 7 Calcium Lake	Lake pigment	Use in selected drug and cosmetic applications	Different permitted-use profile
D&C Red No. 33 Aluminum Lake	Lake pigment	Pharmaceutical and cosmetic color options	Narrower application and shade profile
Iron oxides	Inorganic pigments	Strong stability and opacity	Earthier shades and heavier pigment loading
Carmine or cochineal	Natural color	Natural-origin positioning	Allergen, labeling, and shade limitations

The most direct substitutes are other approved red lakes, not every red dye. Selection depends on jurisdiction, dosage form, target shade, opacity, light stability, and customer marketing requirements.

What generic launch risks exist for products using this colorant?

The colorant creates little direct generic-entry risk. A generic manufacturer can generally select an approved equivalent colorant if the finished product meets regulatory, bioequivalence, quality, and labeling requirements.

The main operational risks are:

• Inability to match the reference product’s appearance
• Dissolution or coating changes after pigment substitution
• Stability differences
• Delayed supplier qualification
• Labeling discrepancies
• Color mismatch that affects product identification

These are formulation and manufacturing risks, not exclusivity barriers. Generic launch timing is primarily determined by active-ingredient patents, regulatory exclusivity, litigation settlements, and FDA approval status.

Key Takeaways

• FD&C Red No. 40 Aluminum Lake is a mature synthetic colorant used heavily in solid pharmaceutical dosage forms and across food, supplement, and cosmetics markets.
• The lake form is insoluble and is selected for tablet coatings, capsules, powders, and other systems where a water-soluble dye is unsuitable.
• FDA compliance depends on permitted use, certification, specifications, supplier records, and finished-product labeling.
• The product has no standalone Orange Book listing, drug exclusivity period, or Paragraph IV litigation pathway.
• Patent protection is limited; manufacturing know-how, documentation, quality history, and supplier qualification create the main commercial barriers.
• Financial growth should track low-single-digit volume expansion, with better pricing and margins in pharmaceutical-grade material and integrated coating systems.
• Regulatory pressure on synthetic colors is a larger long-term demand risk in food and supplements than in approved pharmaceutical products.
• Generic products using the colorant face formulation and supply-chain risks, not direct colorant-based patent barriers.

FAQs About FD&C Red No. 40 Aluminum Lake

Is FD&C Red No. 40 Aluminum Lake the same as Allura Red AC?

No. Both are based on the same colorant family, but the aluminum lake is an insoluble pigment form. Allura Red AC generally refers to the soluble dye form, while the lake form is deposited on an aluminum substrate.

Is FD&C Red No. 40 Aluminum Lake an active pharmaceutical ingredient?

No. It is an inactive color additive used to identify, coat, or improve the appearance of a pharmaceutical product.

Can FD&C Red No. 40 Aluminum Lake be used in capsules?

Yes, where the specific color form is permitted and the capsule formulation meets applicable regulatory and quality requirements. It is used in capsule shells, coatings, and related solid dosage applications.

Does a pharmaceutical company need a separate regulatory filing to change suppliers?

A supplier change can require quality, stability, formulation, and regulatory assessment. The filing impact depends on the drug product, the approved specification, the change in material characteristics, and the relevant jurisdiction.

What is the main investment risk for suppliers of this colorant?

The main risks are synthetic-color reformulation, environmental compliance costs, raw-material volatility, customer concentration, and loss of qualified pharmaceutical business to lower-cost competitors.