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Last Updated: May 28, 2020

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LAZANDA Drug Profile


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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 are five patents protecting this drug.

This drug has sixty-two patent family members in thirty countries.

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

US ANDA Litigation and Generic Entry Outlook for Lazanda

A generic version of LAZANDA was approved as fentanyl citrate by HOSPIRA on January 12th, 1985.

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Drug patent expirations by year for LAZANDA
Drug Prices for LAZANDA

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Recent Clinical Trials for LAZANDA

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SponsorPhase
University of California, San DiegoPhase 2
DepomedPhase 4
Defense and Veterans Center for Integrative Pain ManagementPhase 4

See all LAZANDA clinical trials

Pharmacology for LAZANDA
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for LAZANDA

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

Supplementary Protection Certificates for LAZANDA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1635783 300653 Netherlands   Start Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0901368 C300523 Netherlands   Start Trial PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0836511 CA 2006 00019 Denmark   Start Trial PRODUCT NAME: FENTANYL HYDROCHLORID
0975367 122011000009 Germany   Start Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1769785 C300521 Netherlands   Start Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1769785 C300522 Netherlands   Start Trial PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
1635783 C300653 Netherlands   Start Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Dow
Baxter
McKinsey
Boehringer Ingelheim
Johnson and Johnson

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