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Serving leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
UBS
Merck
Johnson and Johnson
Boehringer Ingelheim
Queensland Health
Novartis
Baxter
Colorcon

Generated: December 11, 2017

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LAZANDA Drug Profile

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

Lazanda is a drug marketed by Depomed Inc and is included in one NDA. There are five patents protecting this drug.

This drug has eighty-two patent family members in thirty-two countries and ten supplementary protection certificates in four countries.

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

Pharmacology for LAZANDA

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Depomed IncLAZANDAfentanyl citrateSPRAY, METERED;NASAL022569-001Jun 30, 2011RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Depomed IncLAZANDAfentanyl citrateSPRAY, METERED;NASAL022569-002Jun 30, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Depomed IncLAZANDAfentanyl citrateSPRAY, METERED;NASAL022569-001Jun 30, 2011RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Depomed IncLAZANDAfentanyl citrateSPRAY, METERED;NASAL022569-002Jun 30, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Depomed IncLAZANDAfentanyl citrateSPRAY, METERED;NASAL022569-001Jun 30, 2011RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Depomed IncLAZANDAfentanyl citrateSPRAY, METERED;NASAL022569-001Jun 30, 2011RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Depomed IncLAZANDAfentanyl citrateSPRAY, METERED;NASAL022569-003Dec 21, 2015RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Depomed IncLAZANDAfentanyl citrateSPRAY, METERED;NASAL022569-001Jun 30, 2011RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Depomed IncLAZANDAfentanyl citrateSPRAY, METERED;NASAL022569-002Jun 30, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Depomed IncLAZANDAfentanyl citrateSPRAY, METERED;NASAL022569-002Jun 30, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: LAZANDA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,814,705Intranasal spray device containing pharmaceutical composition► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: LAZANDA

Country Document Number Estimated Expiration
Japan4880657► Subscribe
Hong Kong1192522► Subscribe
European Patent Office2670674► Subscribe
Taiwan201247491► Subscribe
Mexico2013009028► Subscribe
World Intellectual Property Organization (WIPO)2012104607► Subscribe
China100423709► Subscribe
HungaryE030896► Subscribe
South Africa200505274► Subscribe
Brazil112013019834► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LAZANDA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB06/022United Kingdom► SubscribePRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
2014000024Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
2011000009Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
00653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
00522Netherlands► SubscribePRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
2014 00016Denmark► SubscribePRODUCT 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
2006000022Germany► SubscribePRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
00521Netherlands► SubscribePRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Novartis
Fuji
Queensland Health
Colorcon
Medtronic
Dow
US Department of Justice
QuintilesIMS
Chubb
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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