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LAZANDA Drug Patent 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. Nine 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 HOSPIRA on January 12^th, 1985.

Summary for LAZANDA

International Patents:	62
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	5
Formulation / Manufacturing:	see details
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
Depomed	Phase 4

See all LAZANDA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LAZANDA

N01AH	Opioid anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

N02AB	Phenylpiperidine derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for LAZANDA

LAZANDA is protected by five US patents.

Patents protecting 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

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
Portugal	1635783
Germany	69822805
United Kingdom	9924123
Brazil	112013019834
Israel	169480
Denmark	0975367

Supplementary Protection Certificates for LAZANDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0836511	122006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
0901368	C300523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
1635783	122014000024	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
0836511	SPC/GB06/022	United Kingdom		PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124