Pharsight

1. Abstral patents expiration

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).
US6761910	SENTYNL THERAPS INC	Pharmaceutical composition for the treatment of acute disorders	Sep, 2019 (4 years ago)
US7910132	SENTYNL THERAPS INC	Pharmaceutical composition for the treatment of acute disorders	Sep, 2019 (4 years ago)
US6759059	SENTYNL THERAPS INC	Fentanyl composition for the treatment of acute pain	Sep, 2019 (4 years ago)

Market Authorisation Date: 07 January, 2011

Treatment: Management of breakthrough pain in patients with cancer

Dosage: TABLET;SUBLINGUAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg	19 Jun, 2014	1	17 Nov, 2017	24 Sep, 2019	Deferred

Strength	Dosage	Availability
EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued
EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued
EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued
EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued
EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued
EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued

ABSTRAL family patents

2. Fentora patents expiration

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).
US8765100	CEPHALON	Transmucosal effervescent	Mar, 2019 (5 years ago)
US6974590	CEPHALON	Sublingual buccal effervescent	Mar, 2019 (5 years ago)
US8753611	CEPHALON	Sublingual buccal effervescent	Mar, 2019 (5 years ago)
US6200604	CEPHALON	Sublingual buccal effervescent	Mar, 2019 (5 years ago)
US8728441	CEPHALON	Sublingual buccal effervescent	Mar, 2019 (5 years ago)
US8092832	CEPHALON	Generally linear effervescent oral fentanyl dosage form and methods of administering	Dec, 2024 (8 months from now)
US8119158	CEPHALON	Effervescent oral fentanyl dosage form and methods of administering fentanyl	Dec, 2024 (8 months from now)
US7862832	CEPHALON	Generally linear effervescent oral fentanyl dosage form and methods of administering	Jun, 2028 (4 years from now)
US7862833	CEPHALON	Effervescent oral opiate dosage forms and methods of administering opiates	Jun, 2028 (4 years from now)

Market Authorisation Date: 25 September, 2006

Treatment: Management of breakthrough pain in patients with cancer; Management of breakthrough pain in patients with cancer by buccal or sublingual administration of fentanyl

Dosage: TABLET;BUCCAL, SUBLINGUAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg	13 Nov, 2007	1	07 Jan, 2011	26 Mar, 2019	Extinguished Deferred

Strength	Dosage	Availability
EQ 0.6MG BASE	TABLET;BUCCAL, SUBLINGUAL	Prescription
EQ 0.4MG BASE	TABLET;BUCCAL, SUBLINGUAL	Prescription
EQ 0.1MG BASE	TABLET;BUCCAL, SUBLINGUAL	Prescription
EQ 0.8MG BASE	TABLET;BUCCAL, SUBLINGUAL	Prescription
EQ 0.2MG BASE	TABLET;BUCCAL, SUBLINGUAL	Prescription
EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;BUCCAL, SUBLINGUAL	Discontinued

FENTORA family patents

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)
US9078814	BTCP PHARMA	Intranasal spray device containing pharmaceutical composition	Jan, 2024 (3 months ago)
US9814705	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

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

LAZANDA family patents

4. Onsolis patents expiration

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).
US6159498	ADALVO	Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces	Oct, 2016 (7 years ago)
US7579019	ADALVO	Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces	Jan, 2020 (4 years ago)
US9579288	ADALVO	Tesofensine and beta blocker combination formulations	Jul, 2027 (3 years from now)
US9597288	ADALVO	Transmucosal delivery devices with enhanced uptake	Jul, 2027 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Jul 16, 2012

Market Authorisation Date: 16 July, 2009

Treatment: Management of breakthrough pain in patients with cancer

Dosage: FILM;BUCCAL

Pharsight

Drugs that contain Fentanyl Citrate

1. Abstral patents expiration

ABSTRAL family patents

2. Fentora patents expiration

FENTORA family patents

3. Lazanda patents expiration

LAZANDA family patents

4. Onsolis patents expiration

ONSOLIS family patents

Related content

Strength	Dosage	Availability
EQ 0.2MG BASE	FILM;BUCCAL	Discontinued
EQ 1.2MG BASE	FILM;BUCCAL	Discontinued
EQ 0.6MG BASE	FILM;BUCCAL	Discontinued
EQ 0.8MG BASE	FILM;BUCCAL	Discontinued
EQ 0.4MG BASE	FILM;BUCCAL	Discontinued