LAZANDA Drug Patent Profile

Which patents cover Lazanda, and when can generic versions of Lazanda launch?

Lazanda is a drug marketed by Btcp Pharma and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-seven patent family members in twenty-four countries.

The generic ingredient in LAZANDA is fentanyl citrate. There are thirty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lazanda

A generic version of LAZANDA was approved as fentanyl citrate by HIKMA on July 11^th, 1984.

Summary for LAZANDA

International Patents:	27
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	5
Patent Applications:	4,517
Drug Prices:	Drug price information for LAZANDA
What excipients (inactive ingredients) are in LAZANDA?	LAZANDA excipients list
DailyMed Link:	LAZANDA at DailyMed

See drug prices for LAZANDA

Recent Clinical Trials for LAZANDA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of California, San Diego	Phase 2
Joseph Ma	Phase 2
Depomed	Phase 4

See all LAZANDA clinical trials

US Patents and Regulatory Information for LAZANDA

LAZANDA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011		DISCN	Yes	No	9,731,869		Y
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-003	Dec 21, 2015		DISCN	Yes	No	9,731,869		Y
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011		DISCN	Yes	No	9,731,869		Y

Expired US Patents for LAZANDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011	6,432,440
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-003	Dec 21, 2015	9,814,705
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011	8,889,176
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011	8,889,176

International Patents for LAZANDA

See the table below for patents covering LAZANDA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2436375	Compositions pharmaceutiques comprenant du fentanyl pour une administration intranasale (Pharmaceutical compositions comprising fentanyl for intranasal delivery)
European Patent Office	0975367	ADMINISTRATION AMELIOREE DE MEDICAMENTS SUR DES MUQUEUSES (IMPROVED DELIVERY OF DRUGS TO MUCOSAL SURFACES)
South Korea	20140017547	IMPROVED CONTAINER
Eurasian Patent Organization	200501105	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ

Supplementary Protection Certificates for LAZANDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1635783	300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
1635783	C300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0383579	C960030	Netherlands		PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
1635783	CA 2014 00016	Denmark		PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831

Lazanda (fentanyl) Market Dynamics and Financial Trajectory: Sales Trends, Pricing Pressure, and IP-Driven Competition

Last updated: June 8, 2026

Lazanda (fentanyl citrate) intranasal spray is a niche, high-intensity opioid product with revenue driven by controlled-substance demand, payer access, and safety-driven prescribing shifts. Its financial trajectory is dominated by (1) competitive intranasal fentanyl and alternative fentanyl delivery systems, (2) formulary tightening and step therapy for breakthrough cancer pain, and (3) ongoing generic and brand repositioning risk in opioid managed-care channels.

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What is Lazanda and what market does it serve?

Lazanda is an intranasal fentanyl product indicated for breakthrough cancer pain (BCP) in opioid-tolerant patients. Its market is concentrated in oncology infusion centers, oncology clinics, and specialty prescribing via health systems. The product competes for share inside a narrow BCP workflow that is sensitive to:

• opioid-tolerance status documentation
• payer authorization requirements
• prescriber preference for rapid onset and device familiarity
• risk controls and REMS-like operational friction in opioid distribution (process-level constraints even when REMS does not apply in the same way as for other opioid classes)

Therapeutic positioning

• Indication focus: breakthrough cancer pain in opioid-tolerant adults.
• Delivery: intranasal spray (rapid absorption relative to oral options).
• Use setting: oncology-focused prescribing, not general chronic pain.

Who buys it

• Hospital outpatient oncology and specialty pharmacies
• Retail pharmacy chains with oncology penetration via prior authorization workflows
• Integrated delivery networks with centralized formulary committees

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How have Lazanda sales performed and what is the implied financial trajectory?

A complete quarter-by-quarter or year-by-year sales table for Lazanda is not available in the dataset underlying this response. The financial trajectory described here is therefore based on observable market dynamics typical for a small, opioid-specific brand with high payer scrutiny: constrained volume growth, pressure on net price, and gradual share erosion from alternative fentanyl formulations and changing formularies.

Trajectory pattern for niche opioid brands

For intranasal fentanyl brands, the common commercial shape is:

1. early growth driven by novelty and guideline adoption in oncology BCP
2. plateau once preferred alternatives lock into formularies
3. step-down pressure from:
   • formulary exclusions and tier movement
   • gross-to-net expansion as contracting tightens
   • generic entry risk in the fentanyl intranasal space (where feasible by chemistry/format barriers)

Key revenue drivers

• Net price: subject to rebates, discounting, and payer-specific contract rates.
• Script volume: driven by oncology patient identification and BCP regimen consistency.
• Therapy persistence: influenced by efficacy satisfaction, safety outcomes, and switching to other BCP products.

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What market dynamics shape Lazanda demand and payer behavior?

1) Breakthrough cancer pain is a limited, rules-based segment

BCP prescribing is less elastic than chronic pain prescribing. Demand depends on:

• patient selection (opioid tolerant)
• diagnosis and documented cancer status
• clinical protocol adoption by oncology practices

That makes volume harder to scale quickly, even with competitive performance.

2) Net pricing and formulary control are the core battleground

For niche opioid brands, the financial outcome often hinges less on headline WAC and more on:

• preferred status on oncology formularies
• prior authorization criteria
• quantity limits and switching policies
• carve-outs for certain health-system lines

3) Safety scrutiny changes prescribing patterns

Opioid safety actions in the US have tightened operational controls and altered prescriber risk tolerance. For intranasal fentanyl, this often translates into:

• stricter documentation and patient monitoring protocols
• increased switching when prescribers see fewer administrative steps with alternatives

4) Distribution and substitution friction can affect unit share

Intranasal fentanyl products can face:

• substitution restrictions at the pharmacy level
• wholesaler contracting preference
• inventory practices tied to demand volatility

Those frictions can stabilize share for a period, but they do not prevent longer-term tiering changes.

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What patents protect Lazanda and how do they affect competition?

Lazanda’s competitive landscape is shaped by the patent estate covering:

• fentanyl intranasal composition and formulations
• delivery system/device components
• manufacturing methods and stability/particle-related attributes
• potential method-of-use coverage around breakthrough cancer pain regimens

Where exclusivity typically sits for intranasal opioids

Patent protection in this category is commonly partitioned into:

• product formulation patents (composition, excipients, spray properties)
• device and dosing mechanism patents
• manufacturing/process patents
• use patents (limited role if generic/biosimilar pathway is product-driven)

Commercial effect

Even if the underlying API is off-patent, brand economics can persist as long as:

• formulation and device patents block “generic equivalent” approval
• exclusivity protections delay ANDA submissions or market entry
• brand remains a preferred formulary choice pending generics

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When does Lazanda lose exclusivity and how long is the run-rate protected?

A precise exclusivity calendar cannot be stated in this response because no source-backed Orange Book exclusivity and patent expiration dataset is provided here. The practical approach for this category is:

• Generic entry risk accelerates when the last formulation or device patent covering the approved product reaches expiration.
• Payer contract cycles and formulary revisions determine whether brands keep share after legal barriers clear.

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What generic entry risks exist for Lazanda (ANDAs, Paragraph IV)?

A complete Paragraph IV and ANDA litigation map is not included in the dataset supporting this response. For fentanyl intranasal products, generic entry risk is usually concentrated in:

• filing strategies that rely on formulation/process equivalence
• device/delivery-specific constraints that may trigger additional patent challenges
• litigations that can delay launch even when the active ingredient is widely available

What governs whether generics can launch quickly

• whether the generic can avoid or design around device/formulation claims
• whether any method-of-use claims are asserted
• whether courts grant injunctions or stay relief pending appeal

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What patent litigation affects Lazanda and who has challenged it?

No litigation docket or party-specific assertions are available in the dataset used for this response. For business decisions, Lazanda’s litigation impact would be assessed through:

• timing of ANDA filings and FDA acceptance
• lawsuit filing dates and injunction outcomes
• settlement terms that can include delayed launch, market-share carve-outs, or patent licensing

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What is the Orange Book status of Lazanda?

A product-level Orange Book list with patent numbers, expiration dates, and exclusivity codes is not present in the dataset available for this response, so an itemized status table cannot be produced.

For intranasal fentanyl brands, Orange Book status is typically the definitive source for:

• the set of patents that could be asserted against an ANDA
• exclusivity milestones that prevent generic approval even after patent expiration

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How does Lazanda compare with other breakthrough cancer pain fentanyl options?

Lazanda sits in the “rapid-onset breakthrough cancer pain” workflow where prescribers also consider other intranasal fentanyl or alternative fentanyl delivery technologies and schedules.

Competitive substitution dynamics

• If an alternative is on-preferred formulary, Lazanda’s share usually declines through incremental switching, not sudden collapse.
• If an alternative has a lower payer burden (fewer prior auth denials), it tends to capture scripts from Lazanda over time.

Implication for revenue

• Expect margin compression first, then volume loss if formulary status changes.
• Device familiarity and patient handling can temporarily defend share despite price pressure.

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What manufacturing and IP barriers matter for intranasal fentanyl competition?

Even when chemical equivalence is plausible, intranasal fentanyl competition can face barriers in:

• spray/droplet size distribution
• device dosing consistency
• stability across temperature and shelf-life constraints
• bioavailability comparability under intranasal administration variability

These barriers can increase generic development time and litigation risk, extending brand protection beyond chemical API maturity.

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Revenue exposure: what could change Lazanda’s financial trajectory next?

High-impact levers

• Formulary tier changes at large payers and health-system formularies
• Net price resets via contracting and rebate adjustments
• Patent expirations or settlements that shorten the timeline to launch for challengers
• Continued opioid policy effects that reshape oncology BCP prescribing norms

What to watch commercially

• script mix (BCP patient population identification and retention)
• pharmacy channel penetration (specialty vs retail)
• utilization management tightening (authorization criteria and quantity limits)

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Key takeaways

• Lazanda is a niche BCP intranasal fentanyl brand with revenue driven by oncology-specific prescribing and payer formulary access.
• Its financial trajectory is typically characterized by a volume plateau followed by net-price compression and gradual share erosion as competing fentanyl delivery options gain preferred status.
• Competitive risk is governed by formulation/device patentability, intranasal performance comparability, and any litigation or settlement outcomes that delay generic ANDA launches.
• Business outcomes for Lazanda are most sensitive to contracting and formulary movement rather than broad market demand expansion.

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FAQs

1) What is Lazanda used for and who qualifies?
It is used for breakthrough cancer pain in opioid-tolerant adults.

2) Does Lazanda face payer barriers like prior authorization?
BCP opioids commonly face authorization, quantity limits, and documentation requirements tied to opioid tolerance and cancer status.

3) What competitive products most threaten Lazanda share?
Other fentanyl breakthrough options and intranasal or rapid-onset fentanyl delivery products that gain preferred formulary status.

4) How do intranasal formulation differences affect generic substitution?
Spray characteristics, dosing consistency, and bioavailability performance can constrain generic equivalence and extend litigation or delay launch.

5) What is the main driver of Lazanda profitability?
Net price after rebates and contracting, amplified by payer access and formulary tier placement.

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed via FDA Orange Book).
2. FDA. Drug Approval Package and labeling for Lazanda (fentanyl) intranasal spray. U.S. Food and Drug Administration.
3. FDA. Generic Drug Development and ANDA regulatory guidance. U.S. Food and Drug Administration.