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. Eight 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:	34
Clinical Trials:	5
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
Defense and Veterans Center for Integrative Pain Management	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			Y
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011		DISCN	Yes	No			Y
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-003	Dec 21, 2015		DISCN	Yes	No			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
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011

International Patents for LAZANDA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2014511307
New Zealand	337289	Composition comprising therapeutic agent, pectin and aqueous carrier for delivery of drugs to mucosal surfaces
Spain	2221706
United Kingdom	9707934

Supplementary Protection Certificates for LAZANDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
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

Market Dynamics and Financial Trajectory for Lazanda

Introduction

Lazanda, a fentanyl nasal spray, is a prescription medication designed to manage breakthrough pain in cancer patients who are already receiving opioid therapy. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Need and Target Population

Lazanda addresses a critical need in the management of breakthrough pain in cancer patients. Breakthrough pain is a common and distressing condition that affects many patients with cancer, leading to increased distress, poorer function, and higher healthcare costs[1].

Product Acquisition and Ownership

In 2013, Depomed, Inc. acquired the United States and Canadian rights to Lazanda from Archimedes Pharma Limited. This acquisition included a cash payment of $4 million, royalties on net sales, potential milestone payments, and the assumption of certain liabilities[1].

Product Characteristics

Lazanda uses the patented PecSys® drug delivery system, which delivers fentanyl in a rapid but controlled manner. The spray forms a gel when it contacts the nasal mucosa, allowing for rapid absorption into the bloodstream. This formulation is particularly beneficial for cancer patients who may have difficulty with oral administration due to their condition[1].

Regulatory Approval and Safety Measures

Lazanda was approved by the FDA in June 2011 as a transmucosal immediate-release fentanyl (TIRF) product, with a Medication Guide (MG) and a Risk Evaluation and Mitigation Strategy (REMS) in place to ensure safe use. The REMS program is part of the FDA's efforts to mitigate the risks associated with opioid use, including abuse and overdose[4].

Financial Performance

• Initial Sales: At the time of Depomed's acquisition, Lazanda's sales in the U.S. for the 12 months ended June 30, 2013, were $3.3 million[1].
• Post-Acquisition: Depomed intended to leverage its commercial infrastructure to support the marketing of Lazanda, aiming for significant returns for shareholders. However, detailed financial performance post-acquisition is not extensively documented in the public domain.
• Later Developments: By 2020, Lazanda was no longer a commercially active product for Assertio Holdings, Inc. (the successor company after various mergers and acquisitions involving Depomed). Assertio reported that product sales for Lazanda, along with other divested products like Gralise and NUCYNTA, were no longer part of their commercial activities[2][5].

Market Dynamics

• Competition: The market for TIRF products is relatively niche but competitive. Other products like Abstral and Actiq also compete in this space. The FDA's regulatory measures, including REMS programs, have been crucial in managing the risks associated with these potent opioids[4].
• Pricing and Innovation: The economics of drug development, particularly for precision medicines and niche products like Lazanda, often involve high prices due to the small patient population and significant R&D investments. This can lead to higher prices and limited generic competition[3].

Challenges and Opportunities

• Abuse Potential: One of the significant challenges for Lazanda and similar opioids is their abuse potential. The FDA and manufacturers have implemented various measures, including REMS programs, to mitigate this risk[1][4].
• Regulatory Environment: The regulatory landscape for opioids is stringent and evolving. Manufacturers must comply with FDA guidelines and safety measures, which can impact the product's market trajectory[4].

Key Takeaways

• Market Need: Lazanda fills a critical need in managing breakthrough pain in cancer patients.
• Acquisition and Ownership: The drug was acquired by Depomed from Archimedes Pharma Limited in 2013.
• Regulatory Approval: Approved by the FDA with a REMS program to ensure safe use.
• Financial Performance: Initial sales were modest, and the product is no longer commercially active for Assertio Holdings, Inc.
• Market Dynamics: The market is niche but competitive, with high prices due to R&D investments and limited generic competition.

FAQs

Q: What is Lazanda used for? A: Lazanda is used to manage breakthrough pain in cancer patients who are already receiving opioid therapy.

Q: Who acquired the rights to Lazanda in 2013? A: Depomed, Inc. acquired the United States and Canadian rights to Lazanda from Archimedes Pharma Limited in 2013.

Q: What is the PecSys® drug delivery system? A: The PecSys® system delivers fentanyl in a rapid but controlled manner, forming a gel when it contacts the nasal mucosa for rapid absorption.

Q: What regulatory measures are in place for Lazanda? A: Lazanda was approved with a Medication Guide (MG) and a Risk Evaluation and Mitigation Strategy (REMS) to ensure safe use.

Q: Is Lazanda still commercially active? A: No, Lazanda is no longer commercially active for Assertio Holdings, Inc., the successor company after various mergers and acquisitions involving Depomed.

Sources

1. Depomed, Inc. Announces Acquisition of Lazanda® (fentanyl) Nasal Spray from Archimedes Pharma Limited. Biospace.
2. Assertio Reports Fourth Quarter and Full Year 2020 Financial Results. Assertio Holdings, Inc.
3. The Economics of Drug Development: Pricing and Innovation in a Changing Market. National Bureau of Economic Research.
4. Overdose Prevention Activities Timeline. FDA.
5. Assertio Reports Fourth Quarter and Full Year 2020 Financial Results. GlobeNewswire.