List of Excipients in Branded Drug QUAZEPAM

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Atland Pharmaceuticals LLC	QUAZEPAM	quazepam	71993-265	FD&C YELLOW NO. 6	2028-06-03
Atland Pharmaceuticals LLC	QUAZEPAM	quazepam	71993-265	LACTOSE	2028-06-03
Atland Pharmaceuticals LLC	QUAZEPAM	quazepam	71993-265	MAGNESIUM STEARATE	2028-06-03
Atland Pharmaceuticals LLC	QUAZEPAM	quazepam	71993-265	POWDERED CELLULOSE	2028-06-03
Atland Pharmaceuticals LLC	QUAZEPAM	quazepam	71993-265	SILICON DIOXIDE	2028-06-03
Atland Pharmaceuticals LLC	QUAZEPAM	quazepam	71993-265	SODIUM LAURYL SULFATE	2028-06-03

Quazepam Excipient Strategy and Commercial Opportunities

Last updated: October 19, 2026

Quazepam is a mature benzodiazepine hypnotic with limited branded-commercial momentum, no meaningful new-molecule exclusivity, and a conventional immediate-release tablet platform. The strongest opportunities are low-cost generic differentiation, excipient modernization, swallowability improvements, packaging, and lifecycle management rather than broad patent-led exclusivity.

Quazepam’s commercial constraints are material: it is a Schedule IV controlled substance, carries class-wide benzodiazepine dependence and respiratory-depression warnings, and competes with generic sedative-hypnotics and nonbenzodiazepine insomnia products. Excipient innovation can improve administration and product quality, but it does not remove the underlying controlled-substance and safety limitations. [1, 2]

What is quazepam and how is it currently formulated?

Quazepam is an orally administered benzodiazepine hypnotic indicated for the short-term management of insomnia characterized by difficulty falling asleep or frequent nighttime awakenings. The reference product, Doral, was supplied as conventional tablets, historically including a 15 mg strength. U.S. generic products may use different inactive-ingredient systems and may not match the reference formulation excipient-for-excipient. [1]

Attribute	Quazepam commercial profile
Active ingredient	Quazepam
Drug class	Benzodiazepine hypnotic
Dosage form	Immediate-release oral tablet
Historical reference brand	Doral
Controlled-substance status	Schedule IV in the United States
Primary use	Insomnia
Main formulation opportunity	Tablet usability and differentiated generic presentation
Main commercial limitation	Mature molecule, generic competition, controlled-substance safety restrictions

Which excipients are relevant to quazepam tablets?

Public U.S. labeling for quazepam tablet products identifies conventional solid-oral excipient categories, including lactose or other diluents, microcrystalline cellulose, starch-based materials and magnesium stearate. The exact composition varies by manufacturer and product code. DailyMed labeling and the FDA Inactive Ingredient Database should control any product-specific assessment. [1, 3]

The principal formulation variables are:

• Diluent selection, including lactose, microcrystalline cellulose, mannitol or dibasic calcium phosphate.
• Disintegrant selection, including crospovidone, croscarmellose sodium or sodium starch glycolate.
• Binder level and granulation process.
• Lubricant concentration, especially magnesium stearate.
• Film-coating polymers, plasticizers and pigments.
• Tablet hardness, friability and disintegration time.
• Moisture control and packaging configuration.

Because quazepam is administered at a relatively low tablet mass compared with many immediate-release products, content uniformity, blend segregation and low-dose manufacturing controls are important. A reformulator would need to demonstrate acceptable assay, uniformity of dosage units, dissolution, stability and bioequivalence under the applicable abbreviated new drug application pathway. [4]

What excipient strategies offer the greatest commercial value?

The most practical strategy is to improve product usability without materially increasing manufacturing complexity. A conventional immediate-release tablet with faster disintegration, better swallowability and robust stability is more commercially realistic than a complex modified-release product.

1. Standardized low-cost generic platform

A manufacturer can use a high-throughput direct-compression or dry-granulation process with:

• Microcrystalline cellulose or mannitol for compactibility.
• Crospovidone or croscarmellose sodium for rapid disintegration.
• Low lubricant loading to protect dissolution performance.
• A moisture-resistant film coat.
• Unit-dose or calendar packaging for controlled dispensing.

This strategy targets contract-manufacturing efficiency, tablet robustness and lower returns rather than premium pricing.

2. Lactose-free positioning

A lactose-free tablet could address patients with lactose intolerance or manufacturers seeking a simpler excipient profile. Replacing lactose with microcrystalline cellulose, mannitol, calcium phosphate or a combination may improve labeling differentiation.

The commercial value is limited because lactose intolerance is not equivalent to a clinically significant allergy, and many competing oral medicines already have lactose-free alternatives. The strategy is most useful when combined with improved tablet size, dose marking or a differentiated supplier position.

3. Film-coated swallowability platform

A thin, low-friction film coat can improve mouthfeel, reduce tablet chipping and support product identification. Color and imprinting also have operational value for pharmacy dispensing and medication-error reduction.

A coating system should be assessed for:

• Impact on disintegration and dissolution.
• Light protection.
• Moisture transmission.
• Colorant compatibility.
• Stability of the active ingredient.
• Patient acceptability.

The coating itself is unlikely to support meaningful patent exclusivity unless combined with a novel manufacturing process or clinically meaningful delivery performance.

4. Orally disintegrating tablet

An orally disintegrating tablet could address patients who have difficulty swallowing conventional tablets. Candidate excipient systems include mannitol, crospovidone, low-substituted hydroxypropyl cellulose, microcrystalline cellulose and taste-masking polymers.

The main technical problem is taste. Quazepam is not generally positioned as a pleasant-tasting active ingredient, so an ODT would likely require taste masking through a coating, ion-exchange complex, multiparticulate system or other barrier technology.

An ODT would also need careful control of:

• Mechanical strength.
• In-mouth disintegration time.
• Packaging humidity.
• Dose uniformity.
• Residual taste.
• Child-resistant packaging.
• Abuse and diversion risk.

FDA may accept an ODT through an abbreviated pathway if the product meets relevant bioequivalence and dosage-form requirements. The dosage form does not automatically create market exclusivity. [4, 5]

5. Abuse-deterrence-oriented packaging and formulation

Quazepam is a benzodiazepine and Schedule IV controlled substance. Packaging can reduce accidental access, medication loss and dispensing errors, but conventional calendar packaging is not equivalent to an FDA-recognized abuse-deterrent formulation.

Potential approaches include:

• Unit-dose blister packaging.
• Small-count dispensing configurations.
• Tamper-evident seals.
• Serialized packaging.
• Child-resistant unit-dose systems.
• Shorter dispensing quantities where commercially and legally appropriate.

A true abuse-deterrent formulation would require substantial development and regulatory support. Crushing, extraction, snorting and injection-resistance claims would require product-specific evidence and FDA review. [2, 6]

What formulations are protected by quazepam patents?

Quazepam’s core molecule and conventional tablet formulation are mature technologies. The principal commercial barrier is therefore regulatory compliance and manufacturing execution, not basic composition-of-matter exclusivity.

Protection category	Commercial assessment
Composition of matter	Expected to be expired for a molecule approved in the 1980s
Conventional tablet composition	Generally vulnerable to generic competition
ODT or rapidly disintegrating tablet	Potentially protectable if novel and non-obvious
Taste-masked dosage form	Potential formulation-patent opportunity
Abuse-deterrent formulation	Potentially protectable, but high development and regulatory burden
Packaging system	Potentially protectable, usually limited competitive value
Manufacturing process	Possible process protection, with enforcement limits
Method of use	Limited value unless tied to a differentiated, approved indication

A current patent-by-patent freedom-to-operate conclusion requires a live search of U.S. and foreign patent databases, Orange Book listings and family legal-status records. Publicly available product information supports treating quazepam as a mature, genericized active ingredient rather than a product with a significant remaining core patent estate. [7, 8]

When does quazepam lose exclusivity?

Quazepam’s original U.S. product approval dates to the 1980s. Any original new-drug exclusivity and core patent protection would have expired long before the current generic market. The commercial question is therefore not when quazepam loses basic exclusivity, but whether a new dosage form, formulation or manufacturing process can obtain separate protection.

What is the Orange Book status of quazepam?

The FDA Orange Book is the relevant source for listed reference products, therapeutic-equivalence evaluations and patent or exclusivity information associated with approved prescription products. Quazepam products should be checked by active ingredient, strength, dosage form and application number because reference-product and generic listings can change over time. [7]

For a proposed generic:

1. Identify the current reference-listed drug.
2. Confirm dosage-form and strength equivalence.
3. Review listed patents and exclusivity entries.
4. Determine whether Paragraph IV certification is required.
5. Check whether any listed patent has expired, been delisted or been removed.
6. Review product-specific labeling and inactive ingredients.

A generic applicant should not assume that an old molecule has no regulatory filing risk. Formulation patents, use patents and product-specific listing errors can still create filing and litigation issues.

Are Paragraph IV challenges likely for quazepam?

Paragraph IV risk is likely to be limited for a conventional quazepam tablet because the molecule is mature and generic products already exist. The risk increases for a new formulation that relies on an Orange Book-listed patent, particularly an ODT, taste-masked product, abuse-deterrent system or other differentiated dosage form.

Product concept	Paragraph IV exposure
Conventional immediate-release tablet	Low relative risk if no unexpired listed patent applies
Lactose-free tablet	Usually low, absent a listed formulation patent
Film-coated tablet	Low unless coating produces a claimed technical effect
ODT	Moderate to high if protected by an active formulation patent
Taste-masked quazepam	Moderate to high
Abuse-deterrent formulation	High if supported by novel claims
New indication	Moderate, depending on listed method-of-use patents

The 180-day first-filer opportunity applies only where the statutory conditions are met, including an eligible Paragraph IV certification and absence of disqualifying events. It should not be assumed for an established generic market. [4]

How does quazepam’s excipient opportunity compare with competing insomnia drugs?

Quazepam competes with generic temazepam, estazolam, triazolam and other benzodiazepines, as well as zolpidem, eszopiclone, zaleplon, low-dose doxepin, ramelteon and newer orexin-receptor antagonists.

Product class	Excipient opportunity	Commercial position
Quazepam conventional tablet	Low-cost, swallowability and packaging	Mature, niche generic
Temazepam capsule	Capsule shell, liquid fill and dose differentiation	Established benzodiazepine competition
Zolpidem tablet or ODT	Rapid disintegration and dosage-form convenience	Larger generic and branded history
Eszopiclone tablet	Taste and aftertaste management	Generic competition
Ramelteon tablet	Conventional oral formulation	Non-controlled alternative
Orexin antagonists	Complex solid oral and patent-protected products	Higher-value branded segment

Quazepam’s long half-life and active metabolites may reduce its attractiveness compared with shorter-acting or nonbenzodiazepine alternatives for some prescribers. A formulation improvement alone is unlikely to overcome class-level prescribing preferences or safety warnings.

What manufacturing and intellectual-property barriers exist?

The technical barriers are manageable but not trivial.

Manufacturing barriers

A low-dose benzodiazepine tablet requires strong control of:

• Powder segregation.
• Blend uniformity.
• Residual solvent and moisture.
• Compression-force variation.
• Tablet weight and hardness.
• Dissolution after storage.
• Cross-contamination and cleaning validation.

Because quazepam is potent and controlled, facilities must also maintain appropriate security, inventory reconciliation, environmental controls and diversion prevention. DEA requirements apply to handling and distribution of Schedule IV substances. [2]

Intellectual-property barriers

Potential claim areas include:

• ODT compositions.
• Taste-masking systems.
• Particle-size control.
• Solid dispersions.
• Coating architectures.
• Modified-release delivery.
• Abuse-deterrent dosage forms.
• Manufacturing processes.
• Packaging and dispensing systems.

Weak claims are likely for routine substitution of one conventional excipient for another without a demonstrated technical effect. Stronger patent positions would require evidence linking the formulation to measurable benefits, such as improved dissolution under discriminatory conditions, reduced degradation, improved content uniformity or validated abuse-deterrence performance.

What licensing deals could support quazepam commercialization?

Licensing activity is more likely to involve platform technologies than the quazepam molecule itself. Relevant opportunities include:

• ODT manufacturing platforms.
• Taste-masking technologies.
• Moisture-barrier films.
• Controlled-substance packaging.
• Contract manufacturing with Schedule IV handling capability.
• Regional generic commercialization rights.
• Authorized-generic arrangements.

A license is commercially rational only if it provides a measurable cost, quality or regulatory advantage. A royalty-bearing formulation license for an undifferentiated immediate-release tablet would face pressure from low generic prices.

No major current quazepam-specific licensing transaction is established in the public product information reviewed here. Commercial diligence should distinguish historical rights to the Doral brand from current generic supply agreements.

What revenue exposure exists for a quazepam reformulation?

Revenue potential is likely modest for a conventional generic and higher, but less certain, for a differentiated dosage form.

Strategy	Revenue potential	Development burden	Main risk
Conventional low-cost tablet	Low to moderate	Low	Price erosion
Lactose-free tablet	Low	Low	Limited payer premium
Film-coated tablet	Low	Low	Weak differentiation
ODT	Moderate	Moderate	Taste, packaging and bioequivalence
Taste-masked ODT	Moderate to high	High	Patent and technical complexity
Abuse-deterrent product	High in theory	Very high	Regulatory, clinical and market acceptance
Regional licensing	Low to moderate	Moderate	Small market size

Quazepam revenue should be modeled against prescription volume, generic price erosion, controlled-substance distribution limits, pharmacy substitution, payer coverage and the availability of alternative insomnia therapies. A premium product would need a clear advantage in adherence, administration or safety perception.

What generic launch scenarios exist for quazepam?

Scenario 1: Low-cost conventional generic

This is the most credible launch path. The product uses a standard immediate-release tablet, targets supply reliability and competes on cost. It has the lowest technical and regulatory risk but the weakest differentiation.

Scenario 2: Patient-friendly tablet

A smaller, film-coated, scored or lactose-free tablet could win pharmacy and prescriber attention where supply reliability and tolerability matter. The product would still face rapid generic substitution.

Scenario 3: Orally disintegrating tablet

An ODT could target patients with swallowing difficulty or those seeking administration without water. The commercial case depends on taste masking, packaging stability and whether the product can obtain meaningful payer or channel differentiation.

Scenario 4: Specialty controlled-substance product

A manufacturer could combine a differentiated formulation with strict unit-dose packaging and controlled distribution. This approach could reduce diversion and improve inventory control, but it would require stronger evidence and a larger compliance infrastructure.

How strong is the quazepam patent estate?

The core quazepam patent estate is weak from a current commercial-exclusivity perspective because the active ingredient and conventional dosage form are mature. A new entrant’s patent strength would depend on the novelty and enforceability of the specific formulation.

Patent strategy	Relative strength
Substitution of common tablet filler	Weak
Routine film coating	Weak
Specific ODT matrix with demonstrated performance	Moderate
Taste-masked multiparticulate system	Moderate to strong
Abuse-deterrent formulation with validated performance	Potentially strong
Narrow process claim	Variable
Packaging-only claim	Usually limited
New insomnia indication	Dependent on clinical and regulatory support

Patent prosecution should focus on defensible technical differences, not broad claims covering ordinary excipient selection. Freedom-to-operate analysis should cover U.S., European, Japanese, Canadian and other commercially relevant jurisdictions because formulation patents often have uneven geographic coverage.

What is the FDA regulatory status of quazepam?

Quazepam is an FDA-approved prescription benzodiazepine hypnotic. Its labeling includes class warnings relating to dependence, withdrawal, abuse, misuse, addiction and serious risks when benzodiazepines are combined with opioids or other central nervous system depressants. [1]

A reformulated product would generally require an ANDA if it is therapeutically equivalent to the reference product and satisfies applicable dosage-form and bioequivalence requirements. A materially different dosage form, new indication or clinically differentiated delivery system may require a different regulatory strategy. FDA’s product-specific guidance, labeling database, Orange Book and inactive-ingredient resources should be reviewed for the exact development program. [3, 4, 7]

Key Takeaways

• Quazepam is a mature Schedule IV benzodiazepine with limited remaining value in core-molecule exclusivity.
• The most practical excipient strategy is a robust immediate-release tablet with improved disintegration, swallowability, stability and packaging.
• Lactose-free positioning and film coating can support modest differentiation but are unlikely to command a durable premium.
• ODT and taste-masked products offer greater commercial upside, with substantially higher technical, regulatory and patent risk.
• Abuse-deterrent formulation is possible in principle but is the least efficient route for a small, mature insomnia market.
• Conventional generic entry faces limited Paragraph IV risk unless an unexpired formulation or method-of-use patent is listed.
• Manufacturing controls for low-dose uniformity, controlled-substance security and cross-contamination are central operational barriers.
• The strongest new IP would connect a novel excipient system to measured performance improvements.

FAQs

Can quazepam be reformulated as an orally disintegrating tablet?

Yes. An ODT is technically feasible, but taste masking, mechanical strength, humidity protection, dose uniformity and bioequivalence would determine development viability.

Which excipients are most suitable for a quazepam ODT?

Mannitol, crospovidone, microcrystalline cellulose and selected taste-masking polymers are plausible candidates. The final system must be supported by formulation screening and product-specific FDA requirements.

Does a lactose-free quazepam tablet create new market exclusivity?

Usually not. Lactose replacement can create a differentiated product profile, but it does not by itself create patent protection or regulatory exclusivity.

Is quazepam a strong candidate for an abuse-deterrent formulation?

It is a possible candidate because it is a benzodiazepine controlled substance, but the commercial case is uncertain. Development costs, evidence requirements and the mature generic market would be significant constraints.

Can excipient changes trigger a new patent for quazepam?

Yes, if the formulation is novel, non-obvious and supported by a credible technical effect. Routine substitution of standard excipients would generally provide a weak patent position.

References

1. U.S. Food and Drug Administration. (2023). Quazepam tablets prescribing information. DailyMed.
2. U.S. Drug Enforcement Administration. (2024). Drug scheduling.
3. U.S. Food and Drug Administration. (2024). Inactive Ingredient Database.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
5. U.S. Food and Drug Administration. (2008). Guidance for industry: Orally disintegrating tablets.
6. U.S. Food and Drug Administration. (2015). Guidance for industry: Abuse-deterrent opioids: Evaluation and labeling.
7. U.S. Food and Drug Administration. (2024). Drugs@FDA.
8. United States Patent and Trademark Office. (2024). Patent Center and patent term information.