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. Ten 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.

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Summary for LAZANDA

International Patents:	62
US Patents:	5
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

Drug patent expirations by year for LAZANDA

Recent Clinical Trials for LAZANDA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Joseph Ma	Phase 2
University of California, San Diego	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 five US patents.

Patents protecting LAZANDA

Method of managing or treating pain
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Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER

Intranasal spray device containing pharmaceutical composition
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Patent Expiration: ⤷ Sign Up

Container
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Intranasal spray device containing pharmaceutical composition
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Glossary

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

Expired US Patents for LAZANDA

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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	⤷ Sign Up	⤷ Sign Up
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011	⤷ Sign Up	⤷ Sign Up
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011	⤷ Sign Up	⤷ Sign Up
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011	⤷ Sign Up	⤷ Sign Up
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for LAZANDA

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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2670674	RÉCIPIENT AMÉLIORÉ (IMPROVED CONTAINER)	⤷ Sign Up
San Marino	T201600352	CONTENITORE PERFEZIONATO	⤷ Sign Up
Croatia	P20161168		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2012104607		⤷ Sign Up
Ukraine	85050	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ИНТРАНАЗАЛЬНОГО ВВЕДЕНИЯ ФЕНТАНИЛА;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ ДЛЯ ІНТРАНАЗАЛЬНОГО ВВЕДЕННЯ ФЕНТАНІЛУ (PHARMACEUTICAL COMPOSITIONS COMPRISING FENTANYL FOR INTRANASAL DELIVERY)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LAZANDA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1635783	132014902242643	Italy	⤷ Sign Up	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
0383579	C960030	Netherlands	⤷ Sign Up	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
0836511	CA 2006 00019	Denmark	⤷ Sign Up	PRODUCT NAME: FENTANYL HYDROCHLORID
1635783	122014000024	Germany	⤷ Sign Up	PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1635783	CA 2014 00016	Denmark	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for LAZANDA

Recent Clinical Trials for LAZANDA

Patents protecting LAZANDA

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