List of Excipients in Branded Drug FLURAZEPAM

Generic Drugs Containing FLURAZEPAM

Company	Ingredient	NDC	Excipient
Rebel Distributors Corp	flurazepam hydrochloride	21695-363	COLLOIDAL SILICON DIOXIDE
Rebel Distributors Corp	flurazepam hydrochloride	21695-363	FD&C BLUE NO. 1
Rebel Distributors Corp	flurazepam hydrochloride	21695-363	FD&C RED NO. 3
Rebel Distributors Corp	flurazepam hydrochloride	21695-363	GELATIN
Rebel Distributors Corp	flurazepam hydrochloride	21695-363	LACTOSE MONOHYDRATE
Rebel Distributors Corp	flurazepam hydrochloride	21695-363	MAGNESIUM STEARATE
Rebel Distributors Corp	flurazepam hydrochloride	21695-363	SILICON DIOXIDE

What are the Most Frequently-Used Excipients in FLURAZEPAM?

# Of NDCs	Excipient
2	COLLOIDAL SILICON DIOXIDE
2	FD&C BLUE NO. 1
2	FD&C RED NO. 3
2	GELATIN
2	LACTOSE MONOHYDRATE
2	MAGNESIUM STEARATE
2	SILICON DIOXIDE

Flurazepam Excipient Strategy and Commercial Opportunities

Last updated: August 7, 2026

Flurazepam is a legacy benzodiazepine hypnotic with limited mainstream demand, no meaningful remaining U.S. market exclusivity, and significant safety constraints. Commercial opportunity is concentrated in low-cost generic supply, differentiated capsule excipients, controlled-substance manufacturing, and selected international markets. The strongest formulation strategy is a stable, low-moisture hard capsule that minimizes unnecessary excipients, avoids problematic colorants and allergens, and supports predictable dissolution of flurazepam hydrochloride.

What is the current commercial status of flurazepam?

Flurazepam hydrochloride was approved in the United States as Dalmane, an oral capsule for short-term treatment of insomnia. The product was approved in 1970 and is now a mature generic drug. U.S. products are generally available in 15 mg and 30 mg capsule strengths.[1]

Attribute	Flurazepam
Active ingredient	Flurazepam hydrochloride
Drug class	Benzodiazepine hypnotic
Dosage form	Immediate-release oral capsule
Common strengths	15 mg and 30 mg
Original U.S. brand	Dalmane
Original sponsor	Roche
FDA approval era	1970
Controlled-substance status	Schedule IV in the United States
Biosimilar exposure	None
Primary market	Generic and legacy hypnotic use
Main commercial constraint	Low demand and safety-related prescribing decline

Flurazepam is metabolized to active compounds, including desalkylflurazepam, that can have substantially longer half-lives than the parent drug. Residual next-day sedation, psychomotor impairment, dependence, and accumulation in older adults limit its use.[1,2]

The American Geriatrics Society lists benzodiazepines, including long-acting agents, as medications that generally should be avoided in older adults because of risks such as cognitive impairment, delirium, falls, fractures, and motor vehicle accidents.[2]

What patents protect flurazepam?

Flurazepam is a post-patent small-molecule drug. The original composition-of-matter and branded-product protections expired decades ago. Current commercial value does not depend on an active innovator patent estate.

IP category	Current commercial relevance
Composition-of-matter patent	Expired
Original Dalmane formulation protection	Expired
U.S. regulatory exclusivity	Expired
Generic ANDA pathway	Available
Active Orange Book patent barrier	No material barrier expected for the legacy product
Biosimilar pathway	Not applicable
New formulation patenting	Possible, but dependent on genuine technical differentiation

The FDA Orange Book is relevant for confirming listed patents and exclusivity associated with approved drug products. For a legacy flurazepam product, the relevant regulatory pathway is generally an abbreviated new drug application rather than an innovator application with remaining exclusivity.[3]

A new flurazepam formulation could generate patentable subject matter if it provides a credible technical advance, such as:

• Improved moisture stability.
• A modified-release profile.
• A substantially lower-dust capsule manufacturing process.
• A specific excipient system that improves dissolution or content uniformity.
• A sprinkle or swallow-assist formulation with demonstrated performance.
• A formulation that reduces degradation or limits exposure to reactive capsule components.

A simple substitution of lactose, starch, or magnesium stearate is unlikely to create a strong patent position unless the formulation produces an unexpected and reproducible performance benefit.

When does flurazepam lose exclusivity?

Flurazepam lost U.S. exclusivity long ago. The product is commercially exposed to generic competition and does not have a current market-exclusivity period comparable to those associated with recently approved products.

What is the Orange Book status of flurazepam?

The Orange Book should be used to verify the status of each currently listed product and any remaining patents or exclusivity codes. The commercial expectation for flurazepam is:

1. No active brand exclusivity.
2. No relevant orphan-drug exclusivity.
3. No biologic exclusivity.
4. No pediatric exclusivity of current commercial significance.
5. Generic competition through ANDA-approved products.

Because Orange Book listings can change as products are withdrawn, discontinued, or updated, product-specific diligence should be performed before an acquisition, launch, or Paragraph IV filing.[3]

What excipients are used in flurazepam capsules?

Flurazepam capsules commonly use a conventional hard-gelatin capsule platform. The exact inactive-ingredient profile differs by manufacturer and strength. Typical formulation components may include lactose or another diluent, corn starch, talc, magnesium stearate, gelatin, titanium dioxide, and approved capsule colorants.

A formulation review should rely on the current FDA-approved labeling for the target product rather than assuming that all generic products use the same excipients. DailyMed labels identify inactive ingredients for individual manufacturers and strengths.[4]

What excipient functions are required?

Excipient function	Candidate materials	Key development issue
Diluent	Lactose, microcrystalline cellulose, mannitol	Bulk density, flow, compatibility
Disintegrant	Corn starch, crospovidone, croscarmellose sodium	Capsule breakup and dissolution
Glidant	Colloidal silicon dioxide, talc	Powder flow and segregation
Lubricant	Magnesium stearate, sodium stearyl fumarate	Over-lubrication and dissolution
Capsule shell	Gelatin, hypromellose	Moisture transfer and mechanical strength
Colorant	Titanium dioxide, iron oxides, permitted dyes	Patient acceptability and regional compliance
Moisture-control aid	Low-moisture excipient system, desiccant packaging	Stability and shelf life

Flurazepam hydrochloride is used because the salt form supports pharmaceutical handling and oral dosage-form manufacture. The formulation objective is not to maximize excipient complexity. It is to achieve uniform fill weight, robust content uniformity, adequate capsule disintegration, and stable dissolution over shelf life.

What is the best excipient strategy for flurazepam?

A low-complexity immediate-release capsule is the most commercially defensible platform.

1. Use a low-moisture formulation

Moisture control should be a central design criterion. Hard gelatin capsules and hygroscopic powders can exchange water with the environment, affecting shell brittleness, powder flow, fill-weight uniformity, and dissolution.

The preferred approach is:

• Use low-moisture, tightly specified excipients.
• Control water activity rather than relying only on loss-on-drying results.
• Select capsule shells with consistent moisture specifications.
• Use high-barrier blister packaging or a tightly closed bottle.
• Establish stability under long-term and accelerated conditions.
• Evaluate capsule brittleness, brittleness after storage, and shell-to-fill interaction.

Hypromellose capsules may provide a differentiated platform where gelatin-related variability, animal-origin restrictions, or regional market access is important. The switch should be supported by comparative stability and dissolution data.

2. Evaluate lactose-free positioning

Lactose is a practical and inexpensive diluent, but a lactose-free formulation may improve market access for patients who avoid lactose and simplify positioning for institutional pharmacies.

Potential alternatives include:

• Microcrystalline cellulose for robust powder handling.
• Mannitol for a more patient-oriented excipient profile.
• Dibasic calcium phosphate where density and flow are favorable.
• Partially pregelatinized starch where binding and disintegration need balancing.

The commercial value of lactose removal is limited unless the product targets a specific procurement requirement, intolerance concern, or geographic market. The change also requires assessment of blend uniformity, capsule fill performance, dissolution, and stability.

3. Reduce unnecessary colorants

A colorant-free or reduced-colorant capsule can support “clean-label” positioning and avoid certain dye sensitivities. The commercial benefit is greater in markets where patients or purchasers prefer simplified excipient profiles.

Colorant removal is not automatically a regulatory or clinical advantage. The manufacturer must preserve product identification, prevent medication errors, and comply with capsule-appearance requirements.

4. Control lubrication

Magnesium stearate is widely used, but excessive concentration or over-mixing can create hydrophobic film formation and slow dissolution. A commercial formulation should establish:

• Lubricant concentration range.
• Mixing time.
• Shear conditions.
• Blend uniformity.
• Capsule-filling behavior.
• Dissolution after accelerated storage.

Sodium stearyl fumarate may be evaluated as an alternative lubricant, but the substitution must be justified through manufacturing and dissolution data rather than treated as a simple drop-in replacement.

5. Avoid unnecessary modified release

Flurazepam has active metabolites with long persistence. A modified-release product could increase accumulation and prolong exposure. It would also introduce a more complex regulatory and clinical development program.

An extended-release flurazepam product could be patentable, but its clinical and regulatory risk would be substantially higher than that of an immediate-release generic capsule. The safety profile creates a weak commercial rationale for prolonging exposure unless a specific clinical benefit is demonstrated.

What formulation patents could protect flurazepam?

Formulation patents are possible but must solve a specific technical problem. The most credible claim categories are:

Moisture-stable capsule systems

Claims could cover a defined excipient ratio, capsule-shell composition, water-activity range, and packaging configuration. The patent would be stronger if the formulation demonstrates superior stability relative to conventional lactose-starch capsules.

Hypromellose capsule formulations

A hypromellose shell combined with a defined low-moisture fill could support a differentiated product. The patent case would depend on data showing improved stability, reduced shell interaction, or a manufacturing advantage.

Sprinkle or swallow-assist products

A capsule that can be opened and administered over soft food could address swallowing difficulty. Such a product would require careful testing of dose uniformity, powder dispersion, stability after opening, and administration instructions.

Taste-masked multiparticulates

Taste masking could support an oral granule or multiparticulate product, but the clinical value is limited because flurazepam is principally used in adults and the drug has dependence and sedation concerns. This opportunity is more relevant to selected international markets than to broad U.S. adoption.

Abuse-deterrent systems

A tamper-resistant formulation would have a difficult commercial justification. Flurazepam is Schedule IV, but its market demand is small and the economics of abuse-deterrent development are unlikely to support a broad U.S. investment.

What FDA regulatory pathways are available for flurazepam?

Generic immediate-release capsule

An ANDA is the most practical route for a conventional 15 mg or 30 mg capsule. The sponsor must demonstrate pharmaceutical equivalence and bioequivalence to the reference listed drug, along with appropriate chemistry, manufacturing, and controls information.[5]

A conventional excipient change is generally compatible with the ANDA pathway if the product remains pharmaceutically equivalent and meets applicable inactive-ingredient requirements. A novel excipient, unusual route, or materially different dosage form can complicate the pathway.

505(b)(2) formulation

A 505(b)(2) application could be considered for:

• A new dosage form.
• A different release profile.
• A new route of administration.
• A product with a clinically meaningful administration advantage.

This route would carry greater development cost and may require additional clinical or pharmacokinetic evidence. It would be commercially difficult to justify without a defined patient or payer advantage.

FDA safety considerations

The FDA labeling for flurazepam addresses dependence, withdrawal, central nervous system depression, impairment, and interactions with alcohol and other CNS depressants.[1] Any differentiated product should avoid claims that imply improved safety unless supported by clinical evidence.

What generic entry risks exist for flurazepam?

Generic entry risk is high because the active ingredient is old, the dosage form is simple, and meaningful patent barriers have expired.

The main competitive risks are:

• Price erosion from multiple ANDA holders.
• Low prescription volume.
• Supply interruptions caused by limited API demand.
• Controlled-substance quota and distribution requirements.
• Pharmacist substitution toward other hypnotics.
• Prescriber avoidance because of long-acting benzodiazepine exposure.
• Reimbursement exclusion or low formulary priority.
• Manufacturing cost that exceeds achievable market pricing.

Are Paragraph IV challenges relevant?

Paragraph IV litigation is unlikely to be the central issue for a conventional flurazepam capsule because the legacy product has no meaningful remaining patent barrier. A Paragraph IV strategy would become relevant only if a later-listed formulation patent covered a commercially important product and a generic sponsor sought to challenge that patent before expiry.[3,5]

Which companies are challenging flurazepam?

The competitive field consists primarily of generic manufacturers and distributors rather than companies pursuing an innovator-style patent challenge. Generic availability can vary by strength, manufacturer, dosage form, and country.

The relevant competitor groups are:

• Established U.S. generic companies with controlled-substance infrastructure.
• Contract manufacturers supplying private-label products.
• Regional manufacturers in markets where flurazepam remains approved.
• API suppliers with validated benzodiazepine production capability.
• Distributors serving institutional, specialty, or legacy-prescription channels.

A definitive current manufacturer ranking requires product-level review of FDA listings, current labeling, wholesaler availability, and controlled-substance distribution data.

How does flurazepam compare with competing hypnotics?

Drug	Commercial position	Key formulation implication	Main risk
Flurazepam	Legacy generic benzodiazepine	Simple capsule, low-cost manufacturing	Long-acting active metabolites
Temazepam	Established benzodiazepine hypnotic	Capsule platform with broader legacy use	Dependence, falls, sedation
Zolpidem	Large generic hypnotic category	Immediate-release, extended-release, sublingual products	Complex product competition and CNS effects
Eszopiclone	Modern nonbenzodiazepine hypnotic	Tablet platform	Dysgeusia, CNS depression
Doxepin	Non-controlled prescription hypnotic at low dose	Tablet formulation	Different pharmacology and dosing
Suvorexant and related agents	Newer branded or specialty products	Higher-value formulation and patent strategies	Cost and payer access

Flurazepam’s main formulation advantage is simplicity. Its main commercial disadvantage is that the pharmacologic profile is less aligned with current geriatric prescribing standards than shorter-acting or nonbenzodiazepine alternatives.[2,6]

What licensing and manufacturing opportunities exist?

Licensing value is more likely to arise from manufacturing and market access than from compound ownership.

Potential transaction structures include:

• In-licensing a registered flurazepam product for a regional market.
• Contract manufacturing of 15 mg and 30 mg capsules.
• Supply of flurazepam hydrochloride API to low-volume markets.
• Private-label distribution through institutional pharmacies.
• Transfer of a capsule platform with lactose-free or hypromellose capabilities.
• Acquisition of a dormant marketing authorization with established quality documentation.

Manufacturing barriers include controlled-substance registration, quota management, validated analytical methods, API sourcing, segregation from other benzodiazepines, and security controls. These barriers can protect supply contracts even when patents do not.

What revenue exposure and commercial scenarios should investors model?

Flurazepam should be modeled as a niche generic, not a growth product.

Scenario	Commercial outcome
Basic generic capsule	Low-margin volume business
Lactose-free or dye-reduced product	Modest differentiation, limited price premium
Hypromellose capsule	Regional or institutional niche
Sprinkle formulation	Potential administration advantage, higher regulatory cost
Modified release	High development risk and uncertain clinical demand
API-only supply	Opportunity tied to scarcity and regulatory capability
International licensing	Potentially stronger than U.S. launch if local prescribing persists

The most attractive opportunity is a reliable, low-cost product with strong supply continuity. A premium price strategy is difficult to sustain because pharmacists and payers can substitute among generic hypnotics and benzodiazepines.

What litigation and settlement issues affect flurazepam?

No major contemporary innovator litigation or settlement structure is central to the legacy flurazepam market. The key legal issues are more likely to involve:

• Controlled-substance compliance.
• Product liability associated with sedation, falls, dependence, or impaired driving.
• Manufacturing deviations.
• Labeling and pharmacovigilance.
• Contract manufacturing and supply obligations.
• State and federal requirements governing controlled-substance distribution.

A new formulation patent could create future litigation exposure, but a weak patent covering only routine excipient substitution would be vulnerable to invalidity and obviousness challenges.

Key Takeaways

• Flurazepam is a mature, post-exclusivity benzodiazepine hypnotic.
• The commercial product is generally an immediate-release 15 mg or 30 mg hard capsule.
• The strongest formulation strategy is low-moisture, low-complexity, immediate-release delivery.
• Lactose-free, dye-reduced, and hypromellose-capsule products offer modest differentiation.
• Modified-release and abuse-deterrent products carry disproportionate clinical and regulatory risk.
• Patent value is limited unless a new formulation demonstrates a measurable technical benefit.
• Generic competition, low demand, controlled-substance compliance, and prescriber avoidance constrain U.S. revenue.
• Manufacturing reliability and regional licensing are more credible opportunities than premium branded reformulation.
• Flurazepam has no biosimilar risk because it is a small-molecule drug.
• FDA labeling and geriatric safety concerns materially limit market expansion.

FAQs About Flurazepam Excipient Strategy and Commercialization

Is flurazepam hydrochloride compatible with lactose?

Lactose is used in some conventional capsule formulations, but compatibility must be confirmed through impurity, moisture, assay, dissolution, and stability studies for the specific flurazepam hydrochloride batch and formulation.

Can flurazepam be marketed as a capsule without colorants?

Yes. A colorant-free capsule is technically feasible, but the sponsor must preserve product identification and demonstrate acceptable stability, appearance, and regulatory compliance.

Is a flurazepam liquid formulation commercially attractive?

Usually not in the United States. A liquid would increase stability, taste-masking, dosing, packaging, and controlled-substance handling requirements without an obvious broad patient benefit.

Can a flurazepam formulation receive new patent protection?

Yes, but only a formulation with defensible novelty, non-obviousness, and demonstrated technical performance is likely to provide meaningful protection. Routine excipient substitution is unlikely to support a strong patent estate.

Does flurazepam require a biosimilar development program?

No. Flurazepam is a chemically synthesized small molecule. A conventional generic would use the ANDA pathway, while a materially different formulation could require a 505(b)(2) application.

References

1. U.S. Food and Drug Administration. (2023). Flurazepam hydrochloride capsule prescribing information. FDA-approved labeling.

2. American Geriatrics Society Beers Criteria Update Expert Panel. (2023). American Geriatrics Society 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. Journal of the American Geriatrics Society, 71(7), 2052-2081.

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

4. National Library of Medicine. (2024). DailyMed: Flurazepam hydrochloride capsule labels. U.S. National Library of Medicine.

5. U.S. Food and Drug Administration. (2017). ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of recombinant DNA origin: Guidance for industry. FDA.

6. U.S. Food and Drug Administration. (2017). FDA requiring stronger warnings about serious risks and death from combined use of opioid medicines and benzodiazepines. FDA.