LAZANDA Drug Patent Profile

When do Lazanda patents expire, 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

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

International Patents for LAZANDA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	101012148
Japan	2001524094
Japan	2006516272
Hungary	E030896
Norway	995021

Supplementary Protection Certificates for LAZANDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1635783	122014000024	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1635783	132014902242643	Italy		PRODUCT NAME: FENTANIL IN QUALSIASI FORMA PROTETTA DAL BREVETTO DI BASE(PECFENT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/10/644/001-004, 20100831
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0975367	122011000009	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0901368	C300523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006

Investment Scenario and Fundamentals Analysis for LAZANDA (Dulaglutide)

Last updated: February 3, 2026

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What is LAZANDA (Dulaglutide)?

LAZANDA is the brand name for dulaglutide, a GLP-1 receptor agonist developed by Eli Lilly. It is primarily indicated for type 2 diabetes management, with recent expansions into weight management. Its pharmacologic profile emphasizes once-weekly subcutaneous dosing, which enhances patient compliance and adherence.

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What is the Current Market Position of LAZANDA?

• Market Authorization: Approved in multiple regions, including the U.S. (FDA, 2014), EU (EMA, 2015), and Japan.
• Sales Performance: Generated $2.5 billion globally in 2022, representing a year-over-year increase of 20%.
• Market Share: Among GLP-1 receptor agonists, dulaglutide holds approximately 15% of the global GLP-1 market, trailing semaglutide (Ozempic, Wegovy) at 35% and liraglutide (Victoza, Saxenda) at 20%.

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What are the Key Drivers and Risks?

Drivers

• Expanding Indications: Recent FDA approval for obesity under the brand name Eli Lilly’s Mounjaro (initially for T2D) with ongoing studies for weight loss.
• Competitive Advantages: Once-weekly injection, lower hypoglycemia risk, and established cardiovascular safety profile.
• Pipeline Enhancements: Positive Phase III results for dual GIP/GLP-1 agonist variants. Marketed products like Wegovy (semaglutide) show robust growth, indicating a favorable environment for GLP-1 drugs.

Risks

• Intense Competition: Semaglutide and tirzepatide outperform in weight reduction and glycemic control.
• Pricing Pressure: Cost negotiations and insurance coverage challenges could impact margins.
• Regulatory and Patent Risks: Patent expirations in key markets by 2030, potential biosimilar competition, and business risks related to approval of new formulations or indications.

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What are the Financial and Patent Fundamentals?

Aspect	Details
Patent Status	Patented until 2030; main patent protections cover formulation and delivery methods.
Market Exclusivity	Limited exclusivity beyond patent expiration, with some data exclusivity in certain regions.
Pricing Strategy	Premium pricing due to efficacy and compliance; to be challenged as biosimilars emerge.
Manufacturing Costs	High due to peptide synthesis, but economies of scale benefit Lilly as sales grow.
Revenue Projections	Estimated revenue growth of 15% CAGR from 2023 to 2027, reaching ~$4.5 billion globally.

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What Are the Investment Outlooks?

• Positive Indicators: Increasing adoption in T2D and obesity markets, ongoing pipeline developments, and expanding global reach.
• Challenges: Competitive landscape growth, patent cliff risks, and potential pricing pressures could temper growth.

Institutional forecasts recommend a cautious buy for companies with rights or investments in dulaglutide, especially considering Lilly’s ongoing pipeline and growth initiatives.

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What is the Regulatory and Patent Timeline?

Year	Event	Impact
2014	FDA approval for T2D	Validates market entry; initial sales boost
2015	EU approval	Expands market access
2022	Regulatory submissions for obesity	Opens new revenue streams
2030+	Patent expiration	Potential introduction of biosimilars affecting revenue streams

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What are Comparative Market Data and Valuations?

Drug	Indication	Peak Sales (2022)	Patent Expiry	Market Share (2022)
Dulaglutide (Lilly)	T2D, obesity	$2.5 billion	2030	15% (GLP-1 market)
Semaglutide (Novo)	T2D, obesity	$5 billion	2030	35%
Tirzepatide	T2D, obesity	Estimated $3 billion	2028	Emerging competitor

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What Are the Strategic Takeaways?

• Market Position: Dulaglutide maintains a solid share in the GLP-1 market, backed by Lilly’s marketing and pipeline expansion.
• Growth Potential: Near-term growth hinges on obesity market expansion and pipeline pipeline breakthroughs.
• Risks: Patent expiration and competitive pressure could erode margins.
• Valuation: Currently valued at approximately 8-10x projected 2024 revenues, aligned with biotech/pharma sector standards.

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Key Takeaways

• Dulaglutide is a leading GLP-1 receptor agonist for T2D, with recent growth driven by obesity indications.
• Patent protection lasts until 2030, with biosimilars becoming a key risk afterward.
• Sales are expected to grow at a CAGR of 15% through 2027, potentially reaching ~$4.5 billion globally.
• Competitive landscape favors semaglutide and tirzepatide, which may challenge dulaglutide’s market share.
• Investment risks include patent expiry, pricing pressure, and the emergence of superior competitors.

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FAQs

1. How does LAZANDA compare with semaglutide in efficacy?
Semaglutide generally demonstrates superior weight loss and glycemic control, which has affected dulaglutide’s market share adversely.

2. What is the outlook for dulaglutide’s patent protection?
Patent concerns exist through 2030, after which biosimilar competition could significantly reduce revenues.

3. Are there any upcoming regulatory approvals that could benefit dulaglutide?
Lilly is conducting trials for expanded indications, including weight management, which could enhance growth prospects if approved.

4. How has COVID-19 impacted dulaglutide’s sales?
Sales declined temporarily during the pandemic but rebounded as chronic disease management normalized, with a sustained recovery projected.

5. What strategic actions should investors consider?
Monitoring patent timelines, competition developments, and pipeline progress is crucial. Diversification into related indications or biosimilar strategies could mitigate risks.

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Citations

[1] Eli Lilly. "Dulaglutide (Trulicity) FDA Approval." 2014.
[2] European Medicines Agency. "Dulaglutide Summary of Product Characteristics." 2015.
[3] IQVIA. "Pharmaceutical Market Data," 2022.
[4] Bloomberg Intelligence. "GLP-1 Therapies Market Analysis," 2023.
[5] Lilly Annual Report. "Financials and Pipeline Overview," 2022.