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).
US7910132	SENTYNL THERAPS INC	Pharmaceutical composition for the treatment of acute disorders	Sep, 2019 (4 years ago)
US6761910	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EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued
EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued
EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued
EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued
EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued
EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7504095	SENTYNL THERAPS INC	Method for obtaining precursor Z and use thereof for the production of a means for therapy of human molybdenum cofactor deficiency	Jan, 2025 (9 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-342)	Feb 26, 2028
New Chemical Entity Exclusivity(NCE)	Feb 26, 2026
M(M-286)	Oct 27, 2025

NCE-1 date: 26 February, 2025

Market Authorisation Date: 26 February, 2021

Treatment: Method of treating molybdenum cofactor deficiency type a

Dosage: POWDER;INTRAVENOUS