Pharsight

1. Intermezzo 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).
US7682628	PURDUE PHARMA	Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof	Feb, 2025 (9 months from now)
US8252809	PURDUE PHARMA	Compositions for treating insomnia	Feb, 2025 (9 months from now)
US7658945	PURDUE PHARMA	Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof	Apr, 2027 (2 years from now)
US8242131	PURDUE PHARMA	Methods of treating middle-of-the-night insomnia	Aug, 2029 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Nov 23, 2014

Market Authorisation Date: 23 November, 2011

Treatment: Method for treating insomnia; Method of treating middle-of-the-night insomnia

Dosage: TABLET;SUBLINGUAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
1.75 mg and 3.5 mg	10 Apr, 2012	1	03 Jun, 2015	15 Apr, 2027	Eligible

Strength	Dosage	Availability
3.5MG	TABLET;SUBLINGUAL	Discontinued
1.75MG	TABLET;SUBLINGUAL	Discontinued

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).
US6254887	PURDUE PHARMA	Controlled release tramadol	May, 2014 (9 years ago)
US5591452	PURDUE PHARMA	Controlled release formulation	May, 2014 (9 years ago)
US6607748	PURDUE PHARMA	Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture	Jun, 2020 (3 years ago)
US7988998	PURDUE PHARMA	Sustained-release tramadol formulations with 24-hour efficacy	Oct, 2023 (5 months ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Dec 30, 2011

Market Authorisation Date: 30 December, 2008

Treatment: NA

Dosage: TABLET, EXTENDED RELEASE;ORAL

Strength	Dosage	Availability
200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued
300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued
100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued