flurazepam hydrochloride - Profile

What are the generic sources for flurazepam hydrochloride and what is the scope of patent protection?

Flurazepam hydrochloride is the generic ingredient in two branded drugs marketed by Valeant Pharm Intl, Chartwell Rx, Halsey, Hikma Intl Pharms, Novitium Pharma, Purepac Pharm, Rising, Sun Pharm Industries, Superpharm, Usl Pharma, and Warner Chilcott, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for flurazepam hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	22

US Patents and Regulatory Information for flurazepam hydrochloride

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
Chartwell Rx	FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	071205-001	Nov 25, 1986		DISCN	No	No
Chartwell Rx	FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	072368-001	Mar 30, 1989	AB	RX	No	No
Chartwell Rx	FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	071068-001	Nov 25, 1986		DISCN	No	No

Expired US Patents for flurazepam hydrochloride

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
Valeant Pharm Intl	DALMANE	flurazepam hydrochloride	CAPSULE;ORAL	016721-002	Approved Prior to Jan 1, 1982

Last updated: July 9, 2026

Flurazepam Hydrochloride Investment Scenario and Patent/IP Fundamentals: Exclusivity, Generics Risk, and Revenue Exposure

Executive summary: Flurazepam hydrochloride (benzodiazepine for insomnia) is an older, off-patent small molecule in the US with long-standing generic availability. For investment and licensing decisions, the focus is less on near-term market entry barriers and more on (1) whether any residual formulation or use patents still exist in key jurisdictions, (2) whether FDA/Orange Book-listed exclusivities block generic supply in the relevant dosage strengths, and (3) supply-chain and unit-cost dynamics in a mature sedative-hypnotic market. Without evidence of active, enforceable secondary IP in the US for the marketed oral strengths, the default underwriting position is “low IP defensibility, high generic pricing pressure, and limited upside beyond niche channel or cost leadership.”

---

What patents protect flurazepam hydrochloride in the US?

Featured snippet answer: For flurazepam hydrochloride, the base compound patent coverage has long expired; current barriers, if any, typically come from secondary patents (specific formulations, dosage strengths, or method-of-use claims) and from Orange Book-listed patents tied to specific NDA strengths.

How to map the flurazepam IP estate quickly (commercially relevant angles)

Investment-grade IP mapping for a marketed benzodiazepine like flurazepam concentrates on the Orange Book “listed patents” for the exact NDA and dosage form, not on historical chemistry patents alone. For a generic risk model, you need:

• Orange Book listed patents for the active ingredient in the specific strength(s)
• Patent expiration dates and the presence of pediatric exclusivity extensions
• Exclusivity type (regulatory exclusivity vs patent exclusivity)
• Any current Paragraph IV challenges (usually absent for older molecules, but must be checked per NDA/strength)
• Formulation or process patents that could prevent “generic identical” manufacturing (rare for mature benzodiazepines, but possible)

Expected practical outcome for a small-molecule benzodiazepine

Most flurazepam products trade in a generic ecosystem with liquid competition. In those conditions:

• The “patent moat” is usually thin.
• The “investment moat” becomes distribution and manufacturing efficiency rather than IP.

---

When does flurazepam lose exclusivity and when can generics launch?

Featured snippet answer: Flurazepam hydrochloride has been generic for many years in the US; practical exclusivity barriers, if any, would be strength-specific and would typically have expired. Generic entry is therefore usually constrained by business realities (cost and supply) more than by legal exclusivity.

Exclusivity timeline underwriting for an older NDA

A practical investment timeline buckets risk into:

• Patent expiration of base compound (historically long ago)
• Secondary patent expirations (formulation or use)
• Regulatory exclusivity (if any applicable, generally not relevant to legacy drugs this late)
• Pediatric exclusivity (only relevant if tied to a still-active listed patent)
• Regulatory compliance and labeling updates (not exclusivity, but impacts product onboarding)

Generic launch scenario mechanics (US)

For small molecules where generics exist:

• New market entries are usually ANDA supplement or new ANDA supply expansion, not first-ever generic launches blocked by patent terms.
• If a later-issued secondary patent exists, it can trigger:
  • Carve-out labels (if the patent is method-of-use or formulation-specific)
  • Design-around formulations (different excipients, polymorphs, or processes)
  • Litigation/settlement that delays specific launches

For underwriting, the decision driver is whether any Orange Book-listed patents are still in force for the exact strength(s) you plan to commercialize.

---

How many patents cover flurazepam hydrochloride dosage forms and strengths?

Featured snippet answer: In mature generic drugs, the number of active, enforceable Orange Book-listed patents tied to specific NDA strengths tends to be low. The workable IP inventory is the Orange Book for the exact drug/strength combination rather than a broad “compound-only” count.

What to count for an investor

Use a “strength-by-strength” inventory:

• Each Orange Book listed patent
• Each patent’s claim scope type:
  • composition/formulation
  • method of use
  • manufacturing/process
• Each patent’s expiration date
• Each patent’s status (listed, expired, challenged, litigated)

Why this matters for valuation

If the active patent count is:

• Zero or expired: valuation rests on manufacturing cost, contracts, and channel positioning.
• Low (1 to 3): valuation hinges on whether those patents are enforceable and whether generic entrants can design around.
• Higher: valuation shifts to legal duration and litigation outcomes.

For flurazepam, the working assumption for investment triage is “low active patent count,” which makes unit economics and supply robustness the main differentiators.

---

What is the Orange Book status of flurazepam hydrochloride?

Featured snippet answer: Orange Book status should be treated as “generic ecosystem present” rather than a single-product exclusivity story. Any investor model should be based on the live Orange Book listing for the relevant NDA and dosage strengths.

What Orange Book inputs determine regulatory timing

For each listed strength:

• Listed patent expiration dates
• Whether any patents are subject to exclusivity extensions
• Whether there is evidence of recent ANDA filings or litigation (Paragraph IV or not)

Investment implication

• If patents are expired: investment case is tied to capacity allocation, pricing floor dynamics, and contract leverage.
• If patents are still listed: the investment case shifts to litigation settlement probability and likely design-around strategies.

---

Which companies are making or selling generic flurazepam hydrochloride?

Featured snippet answer: In a mature benzo market, multiple generic manufacturers typically compete. The key investment question is not “who exists,” but whether any supplier group has credible scale, stable sourcing, and low cost to serve.

What to analyze in the competitor set

• Market share by strength
• Supplier count per channel (wholesale, specialty distributors, contract)
• Evidence of supply interruptions or quality recalls
• Pricing trends by NDC and channel
• Co-pay and formulary positioning (where relevant for patient access)

Why this is more material than patents now

For off-patent benzodiazepines, the largest earnings variability often comes from:

• raw material and conversion costs,
• compliance and batch release efficiency,
• inventory turns,
• and contract pricing volatility.

---

How strong is the patent estate for flurazepam hydrochloride?

Featured snippet answer: Patent strength for mature benzodiazepines is usually limited because primary composition coverage has expired; secondary protections, if they exist, tend to narrow in scope and have largely aged out.

Strength scoring framework used for underwriting

Score each potentially active patent by:

• Claim breadth (composition vs narrow formulation/process)
• Remaining legal life
• Enforceability posture (known challenges)
• Design-around feasibility for generics

Expected investment posture

For flurazepam, absent evidence of still-active secondary IP that blocks generic identical entry, investors should price the asset like a commodity drug:

• lower IP-driven valuation multiple,
• emphasis on cost leadership and supply reliability,
• tighter margin tolerance.

---

What formulations are protected by flurazepam hydrochloride patents?

Featured snippet answer: For older benzodiazepines, formulation protections that remain (if any) usually target specific excipient systems, dissolution profiles, or stability-related properties that generics can often replicate or design around.

Design-around pathways generics use for formulation/process claims

• Alternate excipient sets that do not breach claim boundaries
• Different manufacturing processes that still meet dissolution and bioequivalence
• Label carve-outs if the patent is method-of-use rather than composition

Investment implication

If formulation IP exists and is still active, litigation risk can delay certain ANDAs. If no active formulation IP exists, investment upside collapses into:

• manufacturing cost optimization,
• sourcing leverage,
• and procurement-driven revenue stability.

---

What method-of-use patents cover flurazepam hydrochloride?

Featured snippet answer: Method-of-use patents, when present, are more likely to create label carve-out and litigation leverage than to block generic supply entirely, because generics can often change indications or dosing language to avoid infringing claims.

How this changes the generic risk model

• If method-of-use claims remain: generic launch may require label modifications.
• If claims are expired: generics can enter with broad labeling.

Investment implication

A method-of-use only moat is usually weaker than composition protection because it is:

• easier to design around,
• more likely to settle with a narrow carve-out,
• and less likely to sustain premium pricing over time.

---

What patent litigation affects flurazepam hydrochloride?

Featured snippet answer: For flurazepam, litigation typically occurs early in generic development cycles, not as a recurring barrier in the modern period. If there is active litigation today, it would be tied to still-active Orange Book-listed patents for specific strengths.

Litigation events investors should track

• Court dockets tied to ANDAs
• Settlement dates and terms
• Whether a settlement triggers delayed launches for specific strengths
• Whether any injunctions or carve-out labeling are involved

Investment implication

In a mature generic market, litigation can temporarily protect margins, but it is not usually a long-term valuation pillar unless:

• it affects a major strength,
• it covers a material portion of total volume,
• and it extends over multiple years via settlements or remaining patents.

---

How does flurazepam hydrochloride compare with other insomnia benzodiazepines for investment risk?

Featured snippet answer: Compared with newer non-benzodiazepines (Z-drugs) or newer benzodiazepine-like agents, flurazepam typically has lower patent defensibility and more commoditization risk, but it can offer stable demand if channel contracts support consistent volume.

Key comparison dimensions

• Remaining IP (newer products often retain longer active exclusivity)
• Generic penetration and number of suppliers
• Pricing volatility and margin profile
• Formulary and payer dynamics
• Regulatory and safety scrutiny for chronic sedation use

Investment implication

Flurazepam’s main value proposition is usually supply and cost. If a portfolio requires “low volatility revenue contribution” rather than “high upside,” flurazepam can fit, but only at the right procurement basis.

---

What biosimilar risk exists for flurazepam hydrochloride?

Featured snippet answer: Biosimilar risk does not apply. Flurazepam hydrochloride is a small molecule chemical drug, not a biologic.

Investment implication

• No biosimilar pathway.
• All competition is via small-molecule generic ANDAs and potential authorized generics.

---

What generic entry risks exist for flurazepam hydrochloride in 2026 and beyond?

Featured snippet answer: Generic entry risk is primarily ongoing supply competition risk rather than a discrete legal trigger. If flurazepam is already widely generic, incremental launches may be driven by capacity and demand, not patent sunsets.

Risk drivers that still matter post-patent

• Price suppression from additional suppliers
• Disruption risk if API or intermediates concentrate in fewer plants
• Regulatory enforcement affecting batch release timelines
• Contract renewal cycles with wholesalers or pharmacy benefit managers

Investment implication

Underwriting should incorporate:

• scenario pricing (downside contract resets),
• inventory carrying and batch turnover,
• and plant-level compliance risk.

---

How do FDA regulatory status and ANDA pathway affect flurazepam hydrochloride competitiveness?

Featured snippet answer: For off-patent small molecules, the ANDA pathway supports rapid competition once bioequivalence and chemistry controls are satisfied. Competitiveness depends on manufacturing and regulatory execution more than on exclusivity.

Competitiveness levers in FDA execution

• Stability and dissolution control
• Analytical method transfer robustness
• Batch release timelines and documentation quality
• Ability to maintain consistent NDC supply

Investment implication

For commodity drugs, the cost of regulatory delays can outweigh any theoretical IP advantage. Buyers reward dependable supply.

---

Is flurazepam hydrochloride a good licensing target for a branded company?

Featured snippet answer: For licensing, the business case usually depends on whether you can secure distribution economics (authorized generic, channel exclusivity deals, or supply agreements) rather than expecting premium pricing backed by IP.

Licensing structures that work in mature generics

• Authorized generic arrangements
• Long-term supply and distribution agreements
• Co-marketing tied to specific wholesaler or hospital formularies
• Manufacturing transfers with quality system commitments

Investment implication

If there is no active IP, licensing terms must reflect a commodity risk profile:

• lower royalty expectations,
• tight performance and supply clauses,
• shorter term commitments with renegotiation triggers.

---

What commercialization and revenue exposure assumptions should investors use?

Featured snippet answer: Revenue exposure is driven by generic price erosion, contract pricing, and supply continuity. IP-driven revenue lift is unlikely unless a still-active secondary patent materially constrains supply for a specific strength.

Underwriting checklist (practical)

• Map net revenue by strength and channel
• Track pricing vs generic basket moves
• Build volume sensitivity to formulary changes and contract resets
• Stress test supply shocks (batch failures, recalls, API shortages)
• Model margin after compliance and manufacturing overhead

Investment implication

If the cost-to-serve is competitive, flurazepam can be a stable manufacturing asset. If costs are higher than market leaders, it becomes a margin risk.

---

Key Takeaways

• Flurazepam hydrochloride is positioned as an older, off-patent benzodiazepine in a mature generic market; the default investment framing is commodity-like competition.
• Exclusivity and patent value, if any, is strength-specific and would hinge on currently active Orange Book-listed patents tied to the relevant NDA and dosage form.
• In mature benzos, the main economic drivers are supply reliability, manufacturing cost, and contract pricing rather than litigation upside.
• No biosimilar pathway applies because flurazepam is a small molecule.
• The highest-return opportunities typically come from distribution and manufacturing leverage, not from patent-driven premium pricing.

---

FAQs

1. What NDA is flurazepam hydrochloride listed under in the FDA Orange Book, and which patents are tied to each strength?
2. Do any still-active method-of-use or formulation patents for flurazepam hydrochloride restrict generic label claims or dosing indications?
3. Have there been any recent Paragraph IV filings for flurazepam hydrochloride that could delay ANDA approvals?
4. Which generic manufacturers have the strongest supply track record for flurazepam hydrochloride and how does that affect contract pricing?
5. What manufacturing or analytical risks most commonly impact batch release for older benzodiazepine tablet/capsule products like flurazepam?

---

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-07-09)
2. FDA. Abbreviated New Drug Applications (ANDA). https://www.fda.gov/drugs/abbreviated-new-drug-application-anda (accessed 2026-07-09)