Last updated: August 21, 2026
Flurazepam hydrochloride is a mature, low-volume generic hypnotic with limited commercial momentum. Its original brand, Dalmane, lost meaningful exclusivity decades ago. Current demand is constrained by long-acting pharmacology, next-day impairment concerns, geriatric safety restrictions, and substitution by newer insomnia therapies. Public companies do not generally report flurazepam revenue separately, so the financial trajectory is best assessed through prescription demand, generic pricing, manufacturing participation, and competitive substitution rather than standalone sales figures.
What is the current FDA status of flurazepam hydrochloride?
Flurazepam hydrochloride is an FDA-approved prescription benzodiazepine indicated for the short-term management of insomnia. It is generally supplied as 15 mg and 30 mg capsules and is classified as a Schedule IV controlled substance in the United States.[1][2]
| Regulatory attribute |
Status |
| Active ingredient |
Flurazepam hydrochloride |
| Drug class |
Benzodiazepine hypnotic |
| Original brand |
Dalmane |
| Dosage form |
Oral capsule |
| Common strengths |
15 mg and 30 mg |
| FDA indication |
Short-term treatment of insomnia |
| Controlled-substance classification |
Schedule IV |
| Regulatory pathway for generics |
ANDA |
| New-drug exclusivity |
Expired |
| Current commercial status |
Mature generic market with limited participation |
Flurazepam was approved in the United States in 1970 under the Dalmane brand.[3] It is an older central nervous system drug and has no remaining new chemical entity exclusivity or modern FDA exclusivity period.
The commercial product landscape is more fragmented than for high-volume generic drugs. Product availability can vary by wholesaler, pharmacy chain, manufacturer, and controlled-substance quota conditions. A product appearing in a drug database does not guarantee continuous national distribution.
When did flurazepam hydrochloride lose exclusivity?
Flurazepam lost effective market exclusivity many years ago after the expiration of its original drug patent and the entry of generic products. Its commercial position is not protected by a current patent or regulatory exclusivity period.
What patents protect flurazepam hydrochloride?
No material U.S. patent barrier is associated with the active ingredient today. The original compound and its principal pharmaceutical use are legacy technologies. Any original composition-of-matter patent protection expired long before the current generic market developed.
The remaining intellectual-property issues are unlikely to involve the core molecule. Potential protection could theoretically relate to a specific formulation, manufacturing process, or delivery system, but flurazepam capsules are conventional immediate-release products. There is no established commercial evidence that a current formulation patent controls the U.S. market.
| IP category |
Commercial relevance |
| Original compound patent |
Expired |
| Original Dalmane exclusivity |
Expired |
| Generic product patents |
No material barrier identified |
| Formulation patents |
Limited relevance for conventional capsules |
| Method-of-use patents |
No meaningful current exclusivity |
| Manufacturing know-how |
Potential operational barrier, not a market exclusivity right |
| Patent litigation |
No major active dispute shaping U.S. entry identified |
The Orange Book framework remains relevant for approved product listings and patents, but flurazepam is not a current patent-led market. FDA Orange Book listings should be distinguished from active market sales because discontinued or sparsely distributed products can remain visible in regulatory records.[4]
How large is the flurazepam hydrochloride market?
The U.S. flurazepam market is small relative to newer insomnia medicines and leading generic benzodiazepines. Public market datasets generally do not provide a reliable, stand-alone revenue series for flurazepam hydrochloride because manufacturers often aggregate the product within broader generic portfolios.
The market is characterized by:
- Low prescription volume compared with zolpidem and newer insomnia products.
- Low average selling prices after generic competition.
- Limited physician adoption.
- Concentrated demand among legacy users and selected prescribers.
- Periodic supply sensitivity because few manufacturers may maintain active production.
- Minimal branded promotional spending.
The product has little economic value as a standalone branded asset. Its value is more likely to arise from portfolio completeness, contract manufacturing, controlled-substance distribution, or niche pharmacy supply than from direct revenue growth.
What is the financial trajectory for flurazepam hydrochloride?
The financial trajectory is structurally declining or flat at a low base:
| Period |
Market condition |
Financial effect |
| 1970s to 1980s |
Branded Dalmane and limited competition |
Higher price and brand economics |
| 1990s |
Generic entry and broader benzodiazepine competition |
Sharp erosion in price and share |
| 2000s |
Expansion of zolpidem and other insomnia therapies |
Continued volume displacement |
| 2010s |
Safety-focused prescribing and geriatric restrictions |
Further demand contraction |
| 2020s |
Mature generic supply with limited commercial investment |
Low, fragmented revenue |
Revenue is pressured by both price and volume. Generic price erosion reduces gross sales, while substitution reduces the number of prescriptions. A manufacturer can still earn positive contribution margins if it has efficient production, low regulatory overhead, and stable institutional or wholesaler demand. The product is unlikely to generate meaningful incremental operating leverage without a supply disruption affecting competitors.
Which companies manufacture or distribute flurazepam hydrochloride?
Flurazepam has historically been associated with Roche through Dalmane and with multiple generic manufacturers over time. Generic participation can change as companies discontinue low-volume products, transfer approvals, or stop active distribution.
The relevant competitive groups are:
- Generic manufacturers holding or maintaining ANDAs.
- Contract manufacturers producing controlled-substance capsules.
- Wholesalers and specialty distributors serving pharmacies.
- Compounding pharmacies, where legally permitted and commercially relevant.
- Brand or legacy authorization holders with historical FDA records.
A current manufacturer list should be based on active FDA approval and distribution records rather than historical label ownership. The presence of an ANDA holder does not prove that the company is actively selling the product nationwide.
How does flurazepam compare with competing insomnia drugs?
Flurazepam competes against older benzodiazepines, nonbenzodiazepine hypnotics, sedating antidepressants, melatonin-related products, and orexin receptor antagonists.
| Product |
Class |
Main commercial advantage |
Main disadvantage versus flurazepam |
| Flurazepam |
Long-acting benzodiazepine |
Established hypnotic effect and low generic price |
Long half-life and next-day impairment |
| Temazepam |
Intermediate-acting benzodiazepine |
More targeted sleep indication and shorter duration |
Controlled substance and dependence risk |
| Zolpidem |
Nonbenzodiazepine hypnotic |
High physician familiarity and broad generic availability |
Complex sleep behaviors and CNS risks |
| Eszopiclone |
Nonbenzodiazepine hypnotic |
Longer duration than zolpidem |
Bitter taste and generic competition |
| Ramelteon |
Melatonin receptor agonist |
Lower abuse potential |
Lower perceived efficacy for some patients |
| Suvorexant |
Orexin antagonist |
Newer mechanism and differentiated branding |
Higher price and access restrictions |
| Lemborexant |
Orexin antagonist |
Newer branded insomnia option |
Higher cost and payer controls |
| Daridorexant |
Orexin antagonist |
Shorter pharmacologic profile |
Branded pricing and formulary barriers |
Flurazepam's long-acting metabolite is a central competitive weakness. The active metabolite, N-desalkylflurazepam, has a prolonged elimination profile, which can increase residual sedation and psychomotor impairment.[2] The American Geriatrics Society Beers Criteria identify 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 dependence.[5]
What generic entry risks exist for flurazepam hydrochloride?
Patent-based generic entry risk is low because the product is already generic. The more relevant risks are supply interruption, product discontinuation, manufacturing deficiencies, and controlled-substance production constraints.
What could cause a flurazepam shortage?
Potential supply risks include:
- A manufacturer exiting the product because of low profitability.
- Dependence on a single active pharmaceutical ingredient source.
- Controlled-substance quota limitations.
- Capsule or packaging component shortages.
- FDA manufacturing observations or warning actions.
- Wholesaler inventory reductions.
- Low production runs that do not justify continuous manufacturing.
- Pharmacy-level substitution toward more available hypnotics.
A shortage could temporarily improve pricing for remaining suppliers, but the effect would probably be limited by weak underlying demand and therapeutic substitution.
Is there a Paragraph IV challenge to flurazepam?
Paragraph IV litigation is not a material current market issue for flurazepam. Paragraph IV certifications are used by generic applicants to challenge listed patents before patent expiration. Because flurazepam's relevant exclusivity period expired decades ago and the product is already a mature generic, a new Paragraph IV campaign would have little commercial rationale unless a newly patented formulation or delivery system emerged.[6]
No major contemporary Paragraph IV dispute is known to determine market access for conventional flurazepam capsules.
What is the Orange Book status of flurazepam hydrochloride?
The Orange Book remains the FDA's principal reference for approved drug products, therapeutic equivalence evaluations, and certain patent or exclusivity information.[4] For flurazepam, the commercial significance of Orange Book data is limited because:
- The original brand exclusivity is expired.
- Conventional generic capsules do not depend on a live patent estate.
- The key commercial question is active distribution, not patent clearance.
- Historical approvals and discontinued products may remain visible in FDA records.
- Therapeutic-equivalence information does not measure current market share.
The absence of a current Orange Book patent barrier does not guarantee that every manufacturer will launch. Low demand, controlled-substance requirements, and manufacturing economics can prevent commercial entry even when legal entry is open.
What patent litigation affects flurazepam hydrochloride?
No major active U.S. patent litigation appears to shape the flurazepam market. The drug's litigation profile differs from newer products, where patent disputes can delay generic entry for years.
| Litigation issue |
Current commercial importance |
| Core compound patent challenge |
None; protection expired |
| Brand-generic infringement case |
No material current dispute identified |
| Formulation patent case |
No established market-defining dispute |
| Method-of-use litigation |
No meaningful current barrier |
| Antitrust or settlement litigation |
No market-defining settlement identified |
| Biosimilar litigation |
Not applicable |
Historical generic settlements, if any, would have little current commercial effect because the market is already post-exclusivity.
Does flurazepam hydrochloride have biosimilar risk?
Biosimilar risk is not applicable. Flurazepam hydrochloride is a chemically synthesized small-molecule drug, not a biologic. Competition proceeds through conventional generic-drug pathways, primarily abbreviated new drug applications and therapeutic-equivalence determinations.
The relevant competitive threat is generic substitution, not biosimilar entry.
What formulations of flurazepam hydrochloride are protected?
The commercially established dosage form is the immediate-release oral capsule. There is no major active formulation patent estate associated with the standard 15 mg and 30 mg products.
A differentiated formulation could theoretically create new intellectual-property value through:
- Modified release.
- Reduced residual sedation.
- Abuse-deterrent delivery.
- Combination therapy.
- Alternative dosage forms.
- Lower-dose geriatric formulations.
Such a product would require clinical, regulatory, and commercial validation. A reformulation would also face competition from established insomnia therapies with stronger prescribing momentum and more modern safety positioning.
How strong is the flurazepam patent estate?
The patent estate is commercially weak. The molecule is old, generic competition is established, and the main product is a conventional capsule.
| Patent-strength factor |
Assessment |
| Remaining compound protection |
None of commercial significance |
| Remaining regulatory exclusivity |
None |
| Formulation differentiation |
Weak |
| Manufacturing complexity |
Low to moderate |
| Switching costs |
Low |
| Generic substitution risk |
High |
| Ability to support premium pricing |
Very low |
| Litigation leverage |
Minimal |
The strongest barriers are operational rather than legal. A supplier with reliable controlled-substance manufacturing and distribution can gain temporary share if competitors leave the market, but that advantage would not create durable exclusivity.
What licensing deals involve flurazepam hydrochloride?
No recent, market-defining licensing transaction for flurazepam hydrochloride is publicly prominent. The product's age, low price, and limited volume reduce the likelihood of a major strategic licensing deal.
Possible commercial arrangements are more likely to involve:
- Transfer of an ANDA.
- Contract manufacturing.
- Regional distribution rights.
- Portfolio acquisitions involving multiple legacy generics.
- Supply agreements with wholesalers or institutional buyers.
These arrangements generally do not create material innovation value or extend market exclusivity.
What generic launch scenarios are possible?
Three scenarios define the current market:
Base case: low-volume continuity
One or more generic suppliers continue limited production. Prices remain low, prescriptions continue to decline slowly, and the product remains available through selected pharmacies.
Downside case: supplier exit
A manufacturer discontinues production because of low margins or compliance costs. Availability contracts, but physicians and patients shift to temazepam, zolpidem, or other alternatives rather than sustaining a large price increase.
Temporary upside case: supply disruption
A shortage at competing manufacturers allows the remaining supplier to increase volume or improve net pricing. The opportunity is likely temporary because the product's clinical disadvantages limit demand expansion.
What geographic markets offer commercial opportunity?
The United States has the clearest regulatory history but limited growth potential. International markets may have continuing use of flurazepam under local brand or generic names, although approval status, controlled-substance rules, prescribing practices, and reimbursement vary.
| Region |
Commercial outlook |
| United States |
Mature, low-volume generic market |
| Europe |
Fragmented national markets and tighter benzodiazepine stewardship |
| Japan |
Potential legacy use, but strict regulatory and prescribing controls |
| Latin America |
Variable generic availability and lower pricing |
| Asia-Pacific |
Country-specific registration and controlled-substance requirements |
| Emerging markets |
Possible low-cost demand, but limited margin and inconsistent distribution |
Geographic expansion would require local registrations and compliant controlled-substance distribution. The age of the molecule provides little pricing power.
Key Takeaways
- Flurazepam hydrochloride is a legacy benzodiazepine hypnotic with no meaningful remaining U.S. exclusivity.
- Dalmane's brand economics ended after generic entry and patent expiration.
- The product's financial trajectory is low-volume, low-price, and generally declining.
- Long-acting pharmacology and geriatric safety concerns reduce demand.
- Zolpidem, temazepam, newer insomnia drugs, and orexin antagonists are the principal competitive alternatives.
- Patent litigation, Paragraph IV challenges, biosimilar competition, and settlement agreements are not material current risks.
- Supply reliability, controlled-substance manufacturing, and product discontinuation are more important than patent rights.
- A supplier could gain temporary share during a shortage, but durable revenue growth is unlikely without a differentiated formulation.
- Public financial reporting generally does not isolate flurazepam revenue, preventing a reliable standalone sales forecast.
- The product has limited licensing value except as part of a broader generic portfolio or supply transaction.
FAQs About Flurazepam Hydrochloride Market Economics
Is flurazepam hydrochloride still commercially available?
It may remain available through selected generic suppliers and pharmacies, but distribution is more limited and variable than for high-volume insomnia medicines.
Why did flurazepam lose market share?
Its long half-life, residual sedation, dependence risk, and unfavorable geriatric safety profile reduced prescribing as shorter-acting and newer insomnia treatments became available.[2][5]
Can a company obtain premium pricing for flurazepam hydrochloride?
Sustained premium pricing is unlikely. Temporary price increases could occur during a supply disruption, but low demand and therapeutic substitution constrain pricing power.
Is flurazepam hydrochloride a controlled substance?
Yes. In the United States, flurazepam is classified as a Schedule IV controlled substance.[1]
Would a new flurazepam formulation have commercial value?
A reformulation could create value only if it materially improved residual sedation, dosing flexibility, abuse risk, or tolerability and secured regulatory and intellectual-property protection. A conventional reformulation would face substantial competition from existing insomnia products.
References
-
U.S. Drug Enforcement Administration. (2024). Controlled substances by schedule: Schedule IV. https://www.dea.gov
-
U.S. National Library of Medicine. (2024). Flurazepam hydrochloride capsule prescribing information. DailyMed. https://dailymed.nlm.nih.gov
-
U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs database. https://www.accessdata.fda.gov/scripts/cder/daf/
-
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book
-
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.
-
U.S. Food and Drug Administration. (2024). Guidance for industry: ANDAs for certain highly purified synthetic peptides. https://www.fda.gov/regulatory-information/search-fda-guidance-documents
