List of Excipients in Branded Drug FLURAZEPAM HYDROCHLORIDE

Generic Drugs Containing FLURAZEPAM HYDROCHLORIDE

Company	Ingredient	NDC	Excipient
Mylan Pharmaceuticals Inc	flurazepam hydrochloride	0378-4415	D&C YELLOW NO. 10
Mylan Pharmaceuticals Inc	flurazepam hydrochloride	0378-4415	FD&C BLUE NO. 1
Mylan Pharmaceuticals Inc	flurazepam hydrochloride	0378-4415	FD&C BLUE NO. 2
Mylan Pharmaceuticals Inc	flurazepam hydrochloride	0378-4415	FD&C RED NO. 3
Mylan Pharmaceuticals Inc	flurazepam hydrochloride	0378-4415	FD&C RED NO. 40
Mylan Pharmaceuticals Inc	flurazepam hydrochloride	0378-4415	FERROSOFERRIC OXIDE

What are the Most Frequently-Used Excipients in FLURAZEPAM HYDROCHLORIDE?

# Of NDCs	Excipient
2	ALCOHOL
2	AMMONIA
2	ANHYDROUS LACTOSE
2	BUTYL ALCOHOL
1	CELLULOSE, MICROCRYSTALLINE
3	D&C YELLOW NO. 10

Flurazepam Hydrochloride Excipient Strategy and Commercial Opportunities

Last updated: September 24, 2026

Flurazepam hydrochloride is an established benzodiazepine hypnotic with an old, largely commoditized active pharmaceutical ingredient. The commercial opportunity is not based on new chemical matter. It depends on regulatory re-entry, reliable supply, formulation differentiation, and risk control around sedation, next-day impairment, abuse potential, and the long half-life of active metabolites. A conventional immediate-release hard gelatin capsule is the lowest-risk product. Modified-release, orally disintegrating, liquid, and sprinkle formulations offer greater differentiation but also create higher regulatory and clinical burdens.

What is the FDA regulatory status of flurazepam hydrochloride?

Flurazepam hydrochloride was marketed in the United States as Dalmane capsules for the short-term treatment of insomnia. The reference product was supplied in 15 mg and 30 mg capsule strengths. Flurazepam is a Schedule IV controlled substance under the U.S. Controlled Substances Act.[1]

The original Dalmane product is no longer a major U.S. commercial product. Historical generic approvals and discontinued-product records indicate that the U.S. market has been limited or inactive compared with larger benzodiazepine and insomnia markets.[2,3] A sponsor seeking re-entry would need to establish the applicable abbreviated new drug application pathway, reference-product status, pharmaceutical equivalence, bioequivalence, manufacturing controls, and controlled-substance compliance.

FDA pathway

A conventional generic capsule would normally be evaluated through an ANDA if an appropriate reference listed drug and product-specific regulatory pathway are available. A reformulated product with a new dosage form, delivery system, or clinically meaningful pharmacokinetic profile could require a 505(b)(2) application rather than a standard ANDA.[4]

The development pathway depends on whether the proposed product is:

Product concept	Likely regulatory issue	Commercial implication
15 mg or 30 mg immediate-release capsule	Pharmaceutical equivalence and bioequivalence	Lowest development cost; limited differentiation
Lactose-free or colorant-free capsule	Same active and release profile	Potential niche value; weak exclusivity
Sprinkle capsule	Food-effect, administration, and dose-uniformity studies	Differentiation for swallowing difficulty
Oral solution or suspension	Stability, preservative, dosing-device, and abuse-risk controls	Higher development and diversion risk
Orally disintegrating tablet	New excipient and absorption profile	Possible 505(b)(2) positioning
Modified-release product	Clinical pharmacology and safety characterization	Stronger differentiation; highest risk
Transdermal or buccal delivery	New delivery system and exposure profile	Patentable but commercially speculative

What excipients are suitable for flurazepam hydrochloride capsules?

The most defensible starting formulation is a hard gelatin capsule containing flurazepam hydrochloride with conventional fillers, disintegrants, glidants, and lubricants. The reference product’s exact historical formulation should be confirmed against archival labeling and regulatory records before development. Public labels for old products do not always provide a complete quantitative composition.

Core excipient platform

A conventional capsule could use:

• Lactose monohydrate or microcrystalline cellulose as filler
• Pregelatinized starch or low-substituted hydroxypropyl cellulose as disintegrant
• Colloidal silicon dioxide as glidant
• Magnesium stearate or sodium stearyl fumarate as lubricant
• Hard gelatin or hypromellose as the capsule shell
• Approved colorants and titanium dioxide where needed for product identification

The formulation should use the smallest practical excipient set. Flurazepam hydrochloride is a low-dose, high-potency drug substance, so blend uniformity and segregation control are more important than maximizing drug loading. A low-dose formulation may require geometric dilution, ordered blending, or carrier granulation to maintain content uniformity.

Excipient selection priorities

Development issue	Preferred strategy	Reason
Low drug loading	Granulated carrier or high-shear blending	Controls content uniformity
Moisture sensitivity	Low-moisture excipients and high-barrier packaging	Limits degradation and capsule-shell changes
Powder flow	Colloidal silicon dioxide or engineered granulation	Improves filling performance
Lubrication	Short blending time with controlled lubricant level	Avoids dissolution retardation
Capsule stability	Gelatin or hypromellose selected after humidity testing	Controls brittleness and cross-linking
Patient sensitivity	Lactose-free and dye-free option	Supports niche positioning
Global supply	Compendial, multi-source excipients	Reduces manufacturing disruption

Compatibility testing should examine assay, related substances, dissolution, water content, capsule brittleness, shell cross-linking, and blend uniformity under accelerated and long-term conditions. Benzodiazepines can be present at low concentrations, making analytical sensitivity and sampling design important.

What formulation patents could protect flurazepam hydrochloride?

The original flurazepam compound and conventional capsule technology are old. Any original composition-of-matter patent would be expected to have expired. Commercial protection would therefore depend on new formulation, manufacturing, delivery, or use claims.

Potential patentable subject matter includes:

1. A moisture-controlled flurazepam hydrochloride capsule with defined impurity limits.
2. A low-dose granulated formulation with improved content uniformity.
3. A lactose-free or hypromellose capsule with defined dissolution performance.
4. A sprinkle formulation with controlled particle size and food compatibility.
5. An orally disintegrating formulation with rapid dispersion and bioequivalence.
6. A modified-release formulation that reduces early exposure or next-day metabolite levels.
7. A tamper-resistant dosage form.
8. A formulation packaged in a high-barrier blister with defined stability characteristics.

Routine substitution of lactose for microcrystalline cellulose, or gelatin for hypromellose, usually provides weak patent protection. A stronger estate would require a measurable technical effect, such as improved stability, a distinct pharmacokinetic profile, superior content uniformity, or a clinically relevant administration advantage.

How strong is the patent estate for flurazepam hydrochloride?

The legacy patent estate is weak from a current exclusivity perspective because flurazepam is an old small-molecule drug. The main commercial risks are regulatory, clinical, manufacturing, and market-access risks rather than blocking patent rights.

Patent category	Expected status	Relevance to a new entrant
Compound patent	Expired because of product age	No expected blocking protection
Conventional capsule	Likely expired or absent	Low barrier
Method of treating insomnia	Generally vulnerable to expiry and obviousness challenges	Limited value
New dosage form	Potentially protectable	Relevant for differentiated launch
Modified release	Potentially protectable	Stronger but technically difficult
Manufacturing process	Potentially protectable	Useful as a trade-secret or process patent
Packaging and stability	Potentially protectable	Narrow but commercially useful
Device or dosing system	Potentially protectable	Relevant to liquid or ODT products

A sponsor should avoid relying on broad claims covering the active ingredient or ordinary excipients. Narrow claims tied to dissolution, stability, particle engineering, or pharmacokinetic performance are more defensible.

When does flurazepam hydrochloride lose exclusivity?

Flurazepam hydrochloride lost practical small-molecule exclusivity decades ago. The relevant commercial question is not the expiration of the original molecule patent but whether any later-listed formulation, method-of-use, or regulatory exclusivity could delay a new product.

For a new conventional capsule, no meaningful new-chemical-entity exclusivity should be expected. A 505(b)(2) product could receive limited protection for approved changes supported by new clinical or pharmacokinetic data, but the scope would depend on the specific application and listed patents. A newly patented formulation could create a separate exclusion period even though the active ingredient is old.

Exclusivity timeline

Period	Commercial position
Original Dalmane launch	Protected by historical brand, regulatory, and patent rights
Generic era	Compound-level barriers eroded
Current re-entry opportunity	Depends on supply, regulatory pathway, and formulation differentiation
Post-launch differentiated product	Potential protection from formulation patents or regulatory exclusivity
Long-term	Vulnerable to generic substitution unless technical barriers are real

What is the Orange Book status of flurazepam hydrochloride?

The Orange Book is the principal source for FDA-listed approved drug products, therapeutic-equivalence evaluations, patent information, and exclusivity information.[2] Flurazepam products should be checked against the current electronic Orange Book and FDA discontinued-drug records before investment or filing decisions.

The practical Orange Book issues are:

• Whether a current reference listed drug exists for the proposed strength and dosage form.
• Whether the reference product is active or discontinued.
• Whether any patents or exclusivity are listed for the product.
• Whether a generic sponsor can rely on an existing reference product.
• Whether a 505(b)(2) application is required because of formulation or dosage-form changes.

The age of the product makes a current blocking patent position unlikely, but Orange Book status must be confirmed at the time of filing because listed-product records can change.

Are there Paragraph IV challenges or patent litigation risks?

Flurazepam is unlikely to generate the level of Paragraph IV activity associated with newer branded drugs. The product’s primary risks are product availability, controlled-substance compliance, and demand rather than patent litigation.

A generic capsule sponsor would normally assess:

• Orange Book patent listings for the selected reference product.
• Any active or discontinued product-specific exclusivity.
• ANDA filing strategy and certification requirements.
• Potential state-law substitution issues.
• Controlled-substance registration and quota requirements.
• Manufacturing-site inspection status.

No biosimilar risk applies because flurazepam hydrochloride is a synthetic small molecule, not a biologic. Any competitive challenge would come from generic benzodiazepines, nonbenzodiazepine hypnotics, sedating antidepressants, melatonin products, and behavioral treatment for insomnia.

What commercial opportunities exist for flurazepam hydrochloride?

1. Standard generic capsule

A 15 mg and 30 mg capsule is the clearest opportunity where a sponsor can obtain a reliable reference pathway and secure controlled-substance manufacturing capacity. The product would compete primarily on supply reliability, contract pricing, and pharmacy availability.

The opportunity is limited by the shrinking clinical role of long-acting benzodiazepines. Flurazepam produces active metabolites with prolonged elimination, which can increase next-day sedation and accumulation, particularly in older adults.[5]

2. Lactose-free and dye-free capsules

A lactose-free formulation could target patients with excipient intolerance and institutional buyers with formulary preferences. The commercial premium would be modest. This strategy is more useful as a procurement differentiator than as a standalone specialty product.

3. Sprinkle capsule

A capsule that can be opened and administered with a compatible soft food could address swallowing difficulty. The sponsor would need to establish dose uniformity after opening, stability in food, food-effect performance, and labeling instructions. This product could support a formulation patent if it demonstrates a specific particle or coating technology.

4. Orally disintegrating tablet

An ODT could improve administration for patients who have difficulty swallowing capsules. The product must avoid rapid absorption that increases peak-related sedation. Taste masking is a central formulation issue because flurazepam hydrochloride may produce an unacceptable oral sensory profile.

Suitable technology could include taste-masked granules, ion-exchange resins, coated particles, or porous rapidly disintegrating matrices. The commercial case is stronger if the product can show equivalent exposure without increased peak concentration.

5. Liquid formulation

An oral solution or suspension could serve patients unable to swallow solid dosage forms. It also creates major risks:

• Dosing errors
• Diversion
• Child exposure
• Preservative compatibility
• Container-closure adsorption
• Sedimentation or redispersion failure
• Controlled-substance dispensing controls

A unit-dose, single-use presentation would reduce some handling risks but increase packaging cost.

6. Modified-release product

Modified release is the highest-value technical opportunity and the highest-risk development option. The objective would be to control early exposure, reduce nocturnal rebound, or reduce next-day impairment. The difficulty is that flurazepam already has long-lived active metabolites. Extending release may worsen accumulation rather than improve the therapeutic profile.

A modified-release strategy would require detailed pharmacokinetic modeling, multiple-dose studies, food-effect testing, elderly-subject evaluation, and potentially clinical efficacy or safety studies.

How does flurazepam compare with competing insomnia drugs?

Product class	Main advantage over flurazepam	Main disadvantage
Zolpidem and related products	Shorter, more familiar insomnia positioning	Dependence, complex sleep behaviors, next-day impairment
Temazepam	More established short-to-intermediate benzodiazepine profile	Controlled substance and dependence risk
Eszopiclone	Broad commercial recognition	Dysgeusia, dependence risk, next-day impairment
Ramelteon	Non-controlled mechanism	Lower perceived efficacy for some patients
Orexin antagonists	Newer mechanism and differentiated branding	Higher cost and access barriers
Melatonin products	OTC access and low regulatory burden	Variable quality and efficacy
Flurazepam	Low-cost, established hypnotic	Long-lived metabolites and residual sedation

Flurazepam’s long duration can be commercially useful for selected patients but is a disadvantage in geriatric and safety-sensitive populations. The American Geriatrics Society identifies long-acting benzodiazepines as potentially inappropriate for many older adults because of increased risks of cognitive impairment, delirium, falls, fractures, and motor-vehicle accidents.[6]

What manufacturing and IP barriers affect commercialization?

The principal manufacturing barriers are not complex synthesis alone. They include:

• Qualified API supply for a controlled substance
• DEA registration and quota management in the United States
• Containment and inventory reconciliation
• Low-dose blend uniformity
• Impurity control and validated analytical methods
• Capsule-shell stability under humidity stress
• Serialization and controlled-substance distribution
• Reliable commercial-scale dissolution performance

A sponsor can protect manufacturing know-how through process controls, supplier qualification, analytical methods, and trade secrets. A process patent may add value if it produces a distinct impurity profile or improves yield, but process claims are less useful when multiple suppliers can manufacture the same API.

What licensing and partnership opportunities exist?

The most practical partnership structures are:

• API supply and finished-dose manufacturing agreements
• Regional licensing for markets where flurazepam remains approved
• Contract development and manufacturing for a niche capsule or ODT
• Co-promotion with a sleep-medicine portfolio
• Acquisition of an approved but dormant product asset

A licensing deal should prioritize regulatory status, historical stability data, reference-product documentation, controlled-substance infrastructure, and commercial access. A patent-heavy licensing model is less suitable because the legacy molecule offers little remaining composition-of-matter value.

Key Takeaways

• Flurazepam hydrochloride is an old, genericized benzodiazepine hypnotic with no expected biosimilar risk.
• The lowest-risk product is a conventional 15 mg or 30 mg immediate-release hard gelatin or hypromellose capsule.
• Excipients should prioritize blend uniformity, moisture control, dissolution, capsule stability, and global supply.
• Lactose-free, dye-free, sprinkle, ODT, and liquid formulations offer niche differentiation.
• Modified release could generate stronger IP but may conflict with flurazepam’s long-lived active metabolites.
• The main commercial barriers are regulatory pathway, controlled-substance infrastructure, API supply, and limited clinical demand.
• Original molecule-level exclusivity is not the commercial issue. Any new protection would need to arise from formulation, process, delivery, or packaging claims.
• A new entrant should treat geriatric safety and next-day impairment as central market-access constraints.

FAQs

Is flurazepam hydrochloride still commercially viable?

It may support a low-volume generic or regional product, but broad U.S. growth is constrained by long-lived metabolites, controlled-substance requirements, and competition from newer insomnia therapies.

Which excipient is best for a flurazepam capsule?

No single excipient is universally preferred. A low-moisture filler, controlled disintegrant, limited lubricant, and robust capsule shell should be selected through compatibility, dissolution, and stability testing.

Can flurazepam hydrochloride be formulated as an orally disintegrating tablet?

Yes, but taste masking, dose uniformity, rapid peak exposure, and bioequivalence would be central development issues.

Does flurazepam hydrochloride have biosimilar competition?

No. Flurazepam hydrochloride is a synthetic small molecule. Competition comes from generic benzodiazepines, nonbenzodiazepine hypnotics, orexin antagonists, melatonin products, and other insomnia treatments.

What is the strongest patent strategy for a new flurazepam product?

The strongest strategy would likely combine a technically differentiated dosage form with narrow claims covering stability, release behavior, particle engineering, or administration performance. Broad claims covering flurazepam and routine capsule excipients would be weak.

References

1. U.S. Drug Enforcement Administration. (2024). Controlled substances act, Schedule IV substances. U.S. Department of Justice.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.

3. U.S. Food and Drug Administration. (2024). FDA drug databases and discontinued drug product information. U.S. Department of Health and Human Services.

4. U.S. Food and Drug Administration. (2019). Applications covered by section 505(b)(2). U.S. Department of Health and Human Services.

5. U.S. Food and Drug Administration. (2017). Dalmane (flurazepam hydrochloride) prescribing information. U.S. Department of Health and Human Services.

6. 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.