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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 12^th, 1985.

Summary for LAZANDA

International Patents:	62
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	26
Clinical Trials:	5
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LAZANDA
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
Depomed	Phase 4
Defense and Veterans Center for Integrative Pain Management	Phase 4

See all LAZANDA clinical trials

Pharmacology for LAZANDA

Drug Class	Opioid Agonist
Mechanism of Action	Full 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
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-003	Dec 21, 2015		DISCN	Yes	No			Y
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011		RX	Yes	No			Y
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011		RX	Yes	Yes			Y
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011		RX	Yes	Yes
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011		RX	Yes	No
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011		RX	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	022569-002	Jun 30, 2011

International Patents for LAZANDA

Country	Patent Number	Estimated Expiration
Spain	2592259
United Kingdom	9924123
European Patent Office	0975367
Slovenia	1635783
Canada	2824385
Australia	741847
European Patent Office	1635783

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