DALMANE Drug Patent Profile

When do Dalmane patents expire, and what generic alternatives are available?

Dalmane is a drug marketed by Valeant Pharm Intl and is included in one NDA.

The generic ingredient in DALMANE is flurazepam hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the flurazepam hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dalmane

A generic version of DALMANE was approved as flurazepam hydrochloride by RISING on November 27^th, 1985.

Summary for DALMANE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,455
DailyMed Link:	DALMANE at DailyMed

US Patents and Regulatory Information for DALMANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharm Intl	DALMANE	flurazepam hydrochloride	CAPSULE;ORAL	016721-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Valeant Pharm Intl	DALMANE	flurazepam hydrochloride	CAPSULE;ORAL	016721-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for DALMANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharm Intl	DALMANE	flurazepam hydrochloride	CAPSULE;ORAL	016721-001	Approved Prior to Jan 1, 1982	4,316,897
Valeant Pharm Intl	DALMANE	flurazepam hydrochloride	CAPSULE;ORAL	016721-002	Approved Prior to Jan 1, 1982	4,316,897

Dalmane (Flurazepam) Market Dynamics, Patent Status, and Financial Trajectory

Last updated: July 31, 2026

Dalmane, the original brand name for flurazepam hydrochloride, is a mature benzodiazepine hypnotic with negligible current branded-market value. U.S. commercial activity is centered on low-cost generic flurazepam capsules, while demand has contracted because of age-related safety concerns, dependence risk, controlled-substance restrictions, and substitution by newer insomnia therapies. No current patent or regulatory exclusivity materially protects the product in the United States.

What is Dalmane and how is flurazepam used?

Dalmane contains flurazepam hydrochloride, a long-acting benzodiazepine approved for the short-term treatment of insomnia. Its pharmacology includes central nervous system depression through the benzodiazepine receptor and enhancement of gamma-aminobutyric acid activity.

Attribute	Dalmane / flurazepam
Active ingredient	Flurazepam hydrochloride
Original brand	Dalmane
Dosage form	Oral capsules
Historical strengths	15 mg and 30 mg
Therapeutic category	Benzodiazepine hypnotic
U.S. controlled-substance status	Schedule IV
Original U.S. sponsor	Roche
Current U.S. market	Generic-dominated
FDA status of original brand	Discontinued
Current patent protection	No material U.S. patent exclusivity

The FDA-approved label limits treatment to short-term use, generally seven to 10 days, reflecting the risk of tolerance, dependence and residual sedation. The label also warns that insomnia can reflect an underlying medical or psychiatric condition requiring separate evaluation (U.S. Food and Drug Administration [FDA], n.d.-a).

When did Dalmane lose market exclusivity?

Dalmane lost effective commercial exclusivity decades ago. The product was approved in the United States in 1970, and generic flurazepam entered the market after the relevant compound and product protections expired.

The original Dalmane patent portfolio has no current commercial relevance. Any early U.S. compound, formulation or manufacturing patents would have expired long before the present period, and the product has no active U.S. regulatory exclusivity.

Milestone	Approximate timing	Commercial effect
FDA approval of Dalmane	1970	Roche established the branded market
Brand-led commercial period	1970s to 1980s	Higher pricing and physician familiarity
Generic competition	Late 1980s onward	Rapid price and share erosion
Brand discontinuation from active U.S. marketing	Later commercial period	Generic product became the practical source
Current status	2026	Mature, low-value generic market

The FDA’s Drugs@FDA records identify Dalmane as discontinued rather than an actively marketed branded product. Discontinued status does not mean the active ingredient is unavailable. Generic flurazepam products can remain approved and commercially available through abbreviated new drug applications, subject to manufacturer supply decisions (FDA, n.d.-b).

What patents protect Dalmane and flurazepam?

No active U.S. patent estate provides meaningful protection for Dalmane or ordinary flurazepam capsules.

Compound and formulation patents

Flurazepam is an old small-molecule compound. The original compound and early dosage-form patents expired many years ago. Ordinary 15 mg and 30 mg capsules do not depend on a modern proprietary delivery system, extended-release platform or complex formulation technology.

The commercial implications are direct:

• No active compound patent blocks generic flurazepam.
• No meaningful formulation patent protects the standard capsule.
• No current method-of-use patent appears capable of restoring branded exclusivity.
• No patent-protected device, delivery system or manufacturing process is central to the product.

Orange Book status

The FDA Orange Book is the principal U.S. source for patents and exclusivity associated with approved drug products. Dalmane’s present commercial status does not reflect an active Orange Book patent barrier. Generic flurazepam competition is therefore governed primarily by approval status, manufacturing economics and controlled-substance supply requirements rather than patent clearance (FDA, n.d.-c).

What is the FDA regulatory status of Dalmane?

The Dalmane brand is discontinued in the United States, while flurazepam remains a recognized generic active ingredient. The product is regulated as a prescription controlled substance under Schedule IV.

In 2020, FDA required boxed-warning updates for benzodiazepines covering abuse, misuse, addiction, physical dependence and withdrawal reactions. The changes apply to flurazepam and increase the compliance burden for prescribers, pharmacies and manufacturers (FDA, 2020).

Regulatory factors affecting demand

Flurazepam faces several regulatory and clinical constraints:

1. It is a controlled substance requiring prescription and controlled-distribution compliance.
2. Its long-acting metabolites can produce next-day sedation.
3. Older adults face increased risk of cognitive impairment, falls and fractures.
4. Long-term use increases the risk of dependence and withdrawal.
5. FDA labeling is inconsistent with chronic use for insomnia.
6. Prescribers have access to newer alternatives with different pharmacokinetic and safety profiles.

The American Geriatrics Society Beers Criteria identify benzodiazepines as potentially inappropriate for many older adults because of increased risks of cognitive impairment, delirium, falls, fractures and motor-vehicle crashes. That guidance places particular pressure on long-acting agents such as flurazepam (American Geriatrics Society Beers Criteria Update Expert Panel, 2023).

How large is the current Dalmane market?

No public company reports standalone Dalmane or flurazepam revenue. The brand has no disclosed current U.S. revenue stream comparable to a marketed specialty or primary-care pharmaceutical.

The current market is best characterized as:

Market dimension	Current assessment
Brand revenue	De minimis or zero in the U.S.
Generic revenue	Low and fragmented
Pricing power	Minimal
Prescriber demand	Declining or niche
Reimbursement	Generic-tier pricing where covered
Promotional activity	Limited
Market growth	Structurally negative
Commercial value of patents	None of material significance
Supply economics	Vulnerable to low-volume manufacturing decisions

Generic flurazepam revenue is not usually disclosed separately by publicly traded manufacturers. The product can generate modest sales for a supplier with an approved capsule product, but the market is too small and mature to support meaningful promotional investment.

What is the financial trajectory for Dalmane?

Dalmane’s financial trajectory follows the standard lifecycle of an older branded drug:

1970s: branded growth

Roche benefited from first-mover status, physician awareness and the absence of generic alternatives. Dalmane competed in the expanding prescription-insomnia market and generated branded pharmaceutical revenue during a period when benzodiazepines were widely prescribed.

1980s and 1990s: generic erosion

Generic entry reduced price and market share. The product’s value shifted from brand equity to active-ingredient availability. As competitors entered, the economic profile changed from a branded franchise to a low-margin multisource product.

2000s: therapeutic substitution

Prescribing moved toward newer hypnotics and nonbenzodiazepine sleep agents, including zolpidem and related products. Behavioral treatment for insomnia, sleep-hygiene interventions and growing awareness of benzodiazepine risks further weakened demand.

2010s to present: niche generic status

The market now consists primarily of residual prescriptions, patients maintained on established therapy and limited physician use where alternatives are unsuitable. The product lacks the characteristics that support financial expansion: it has no exclusivity, limited differentiation, low pricing power and significant safety concerns.

Revenue outlook

The likely financial outlook is flat to declining at the active-ingredient level. Short-term sales changes may result from:

• Manufacturer entry or exit
• Temporary supply shortages
• Changes in pharmacy stocking
• Controlled-substance procurement limits
• Payer formulary decisions
• Shifts in benzodiazepine deprescribing
• Regional availability

These factors can create volatility in unit supply without changing the long-term market direction.

Which companies are challenging Dalmane?

The relevant competitive threat is generic substitution rather than a conventional branded patent challenge. Generic manufacturers may obtain approval through ANDA pathways if they meet FDA requirements for pharmaceutical equivalence and bioequivalence.

The generic competitive field can include:

• Large multisource generic companies
• Smaller specialty-generic manufacturers
• Contract manufacturers supplying authorized distributors
• Regional suppliers serving controlled-substance demand

Public disclosures generally do not provide a complete, current manufacturer-by-manufacturer revenue ranking for flurazepam. The market is too small for most companies to identify it as a separate financial segment.

Are there Paragraph IV challenges involving Dalmane?

Paragraph IV litigation is not a current commercial driver for flurazepam. Paragraph IV certifications are most relevant when an ANDA applicant challenges an unexpired Orange Book patent. Because Dalmane has no material unexpired U.S. patent estate, generic entry does not depend on defeating an active patent monopoly.

The likely competitive pathway is therefore:

1. ANDA submission.
2. FDA review of quality, labeling and bioequivalence.
3. Approval subject to manufacturing and controlled-substance compliance.
4. Commercial launch based on expected volume and supply economics.

There is no current blockbuster-scale Paragraph IV case or settlement structure shaping the flurazepam market.

What formulation patents protect flurazepam?

Standard flurazepam capsules have no meaningful current formulation protection. The product does not rely on a patented long-acting delivery platform, transdermal system, implant, depot injection or specialty-release technology.

Potential formulation distinctions, such as capsule strength, inactive ingredients or manufacturing process, do not normally create durable commercial protection after approval unless supported by an enforceable patent and a distinct regulatory product profile. For current flurazepam capsules, manufacturing capability and FDA compliance are more important than formulation intellectual property.

What method-of-use patents protect Dalmane?

No method-of-use patent is known to provide a commercially meaningful barrier for the labeled treatment of insomnia. The approved use is old, clinically established and commercially generic.

A method-of-use patent would also face practical limitations:

• Physicians may prescribe generics based on the same active ingredient.
• Generic labeling is generally tied to the reference product’s approved indications unless a lawful carve-out applies.
• Insomnia treatment is a broad, mature indication with extensive prior art.
• Safety-related prescribing restrictions reduce the value of a new insomnia-use claim.

What patent litigation affects Dalmane?

No active patent litigation appears to have material influence over the U.S. flurazepam market. The litigation risk profile is instead concentrated in product liability, controlled-substance compliance, manufacturing quality and labeling matters.

The absence of patent litigation is commercially significant. A potential entrant does not face the legal cost or launch uncertainty associated with an active patent estate. The principal question is whether projected volume justifies validation, controlled-substance controls, inventory and distribution expenses.

What generic launch scenarios exist for flurazepam?

Scenario 1: Stable low-volume supply

One or more suppliers maintain product availability for a small chronic-use population. Prices remain low, and the market produces limited revenue.

Scenario 2: Manufacturer exit

A supplier discontinues the product because of weak volume, procurement complexity or margin pressure. Remaining manufacturers may gain temporary share, but the total market remains small.

Scenario 3: Shortage-driven price movement

A supply interruption can cause temporary price increases or pharmacy-level scarcity. Such an event would reflect supply concentration rather than durable pricing power.

Scenario 4: Further demand contraction

Deprescribing, geriatric safety concerns and substitution by other insomnia treatments reduce prescription volume over time. This is the most consistent long-term scenario.

How does Dalmane compare with newer insomnia drugs?

Product class	Example	Commercial position	Key advantage over flurazepam
Long-acting benzodiazepine	Flurazepam	Mature generic	Established hypnotic effect
Nonbenzodiazepine hypnotic	Zolpidem	Broad generic use	Shorter, more targeted pharmacology
Melatonin receptor agonist	Ramelteon	Branded/generic availability	Lower dependence concern
Orexin antagonist	Suvorexant, lemborexant, daridorexant	Branded or emerging generic markets	Differentiated mechanism
Antidepressant used for sleep	Low-dose doxepin	Generic and branded history	Different safety and dependence profile
Behavioral therapy	CBT-I	Non-drug treatment	Avoids controlled-substance exposure

Flurazepam’s long duration is a commercial disadvantage when patients and clinicians prioritize lower next-day impairment. Newer branded insomnia products may carry higher prices and stronger intellectual-property positions, but they face payer controls and their own safety, efficacy and adherence considerations.

What geographic markets still matter for Dalmane?

The United States is no longer a meaningful branded Dalmane market. International availability varies by country and may use different brand names, local manufacturers and controlled-substance rules.

Relevant geographic variables include:

• National approval and product-registration status
• Local benzodiazepine scheduling
• Reimbursement and pharmacy distribution
• Availability of generic manufacturers
• Local prescribing guidance for older adults
• Import and export controls
• Whether the Dalmane brand remains registered or has been withdrawn

The European and other international markets should not be assumed to mirror U.S. availability. A country may retain generic flurazepam registration even where the Dalmane brand has been withdrawn.

How strong is the Dalmane patent estate?

The patent estate is commercially weak because it is expired and provides no current exclusivity. Dalmane has no meaningful moat based on patents, regulatory exclusivity, formulation technology or manufacturing complexity.

Its remaining commercial barriers are operational:

• Low expected demand
• Controlled-substance handling
• Specialized quality and recordkeeping requirements
• Limited distributor interest
• Potential supply volatility
• Prescriber reluctance
• Deprescribing trends

These barriers can reduce the number of active suppliers, but they do not create durable branded pricing power.

Key Takeaways

• Dalmane is the historical Roche brand for flurazepam hydrochloride.
• The U.S. brand is discontinued, while generic flurazepam may remain available.
• Original patents and regulatory exclusivity expired decades ago.
• No active Orange Book patent materially restricts generic entry.
• Paragraph IV litigation and patent settlements are not current market drivers.
• Revenue is not publicly disclosed as a standalone product line and is likely minimal at the brand level.
• Generic flurazepam is a low-volume, low-margin market with limited promotional value.
• Long-term demand is pressured by dependence risk, next-day sedation, geriatric safety concerns and therapeutic substitution.
• The principal commercial risk is manufacturer withdrawal or supply disruption, not patent expiry.
• No biosimilar issue applies because flurazepam is a small-molecule drug, not a biologic.

FAQs About Dalmane and Flurazepam

Is Dalmane still sold in the United States?

The Dalmane brand is listed as discontinued, but generic flurazepam capsules may remain available from approved manufacturers.

Does flurazepam have patent protection?

No material U.S. patent protection remains for ordinary flurazepam capsules. The relevant early patents expired many years ago.

Is flurazepam a controlled substance?

Yes. Flurazepam is a Schedule IV controlled substance in the United States.

Can a generic company launch flurazepam without a patent settlement?

Yes. In the absence of an unexpired blocking patent, an ANDA applicant does not need a patent settlement to enter the market.

Is flurazepam commercially attractive for a generic manufacturer?

Generally, no. The product can provide niche revenue, but low demand, limited pricing power, controlled-substance compliance and potential supply volatility constrain its commercial attractiveness.

References

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. (2020, September 23). FDA requiring boxed warning updated to improve safe use of benzodiazepine drug class. https://www.fda.gov/

U.S. Food and Drug Administration. (n.d.-a). Dalmane (flurazepam hydrochloride) capsule prescribing information. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/

U.S. Food and Drug Administration. (n.d.-b). Dalmane: Application number 016938. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/

U.S. Food and Drug Administration. (n.d.-c). Approved drug products with therapeutic equivalence evaluations, 46th edition. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book