Pharsight

1. Lazanda patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP04701381A	2014-06-18	Generics [UK] Limited	Opposition rejected

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6432440	BTCP PHARMA	Pectin compositions and methods of use for improved delivery of drugs to mucosal surfaces	Apr, 2018 (6 years ago)
US9814705	BTCP PHARMA	Intranasal spray device containing pharmaceutical composition	Jan, 2024 (3 months ago)
US9078814	BTCP PHARMA	Intranasal spray device containing pharmaceutical composition	Jan, 2024 (3 months ago)
US8889176	BTCP PHARMA	Method of managing or treating pain	Jan, 2024 (3 months ago)
US8216604	BTCP PHARMA	Method of managing or treating pain	Oct, 2024 (5 months from now)
US9731869	BTCP PHARMA	Container	Jan, 2032 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Dosage Form(NDF)	Jun 30, 2014

Drugs and Companies using FENTANYL CITRATE ingredient

Market Authorisation Date: 30 June, 2011

Treatment: Management of breakthrough pain in cancer patients 18 years of age and older who are receiving and tolerant to opioid therapy for their underlying persistent cancer pain; Management of breakthrough pa...

Dosage: SPRAY, METERED;NASAL

Strength	Dosage	Availability
EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED;NASAL	Discontinued
EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED;NASAL	Discontinued
EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED;NASAL	Discontinued

LAZANDA family patents

2. Subsys patents expiration

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8486972	August, 2015	Terminated-Denied	Insys Pharma, Inc.	Coalition For Affordable Drugs XI LLC
US8835459	August, 2015	Terminated-Denied	Insys Pharma, Inc.	Coalition For Affordable Drugs XI LLC
US8835460	August, 2015	Terminated-Denied	Insys Pharma, Inc.	Coalition For Affordable Drugs XI LLC

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10610523	BTCP PHARMA	Sublingual fentanyl spray	Jan, 2027 (2 years from now)
US8835460	BTCP PHARMA	Sublingual fentanyl spray and methods of treating pain	Jan, 2027 (2 years from now)
US9241935	BTCP PHARMA	Sublingual fentanyl spray	Jan, 2027 (2 years from now)
US9642844	BTCP PHARMA	Sublingual fentanyl spray	Jan, 2027 (2 years from now)
US10016403	BTCP PHARMA	Sublingual fentanyl spray	Jan, 2027 (2 years from now)
US9289387	BTCP PHARMA	Method of treating pain by administering sublingual fentanyl spray	Jan, 2027 (2 years from now)
US8835459	BTCP PHARMA	Sublingual fentanyl spray	Jan, 2027 (2 years from now)
US9642797	BTCP PHARMA	Sublingual fentanyl spray and methods of use to treat pain	Jan, 2027 (2 years from now)
US8486972	BTCP PHARMA	Sublingual fentanyl spray	Apr, 2030 (5 years from now)
US8486973	BTCP PHARMA	Sublingual fentanyl spray	Apr, 2030 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Jan 04, 2015

Drugs and Companies using FENTANYL ingredient

Market Authorisation Date: 04 January, 2012

Treatment: Treatment of pain

Dosage: SPRAY;SUBLINGUAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.4 mg/spray	22 May, 2017	1		27 Apr, 2030
0.1 mg/spray, 0.2 mg/spray, 0.6 mg/spray, 0.8 mg/spray, 1.2 mg/spray, 1.6 mg/spray	07 Dec, 2017	1		27 Apr, 2030

Pharsight

Btcp Pharma patents expiration

1. Lazanda patents expiration

LAZANDA family patents

2. Subsys patents expiration

SUBSYS family patents

Related content

Strength	Dosage	Availability
0.6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY;SUBLINGUAL	Discontinued
0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY;SUBLINGUAL	Discontinued
1.6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY;SUBLINGUAL	Discontinued
0.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY;SUBLINGUAL	Discontinued
0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY;SUBLINGUAL	Discontinued
1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY;SUBLINGUAL	Discontinued
0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY;SUBLINGUAL	Discontinued