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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Express Scripts
Daiichi Sankyo
US Army
Farmers Insurance
Cerilliant
Johnson and Johnson
Healthtrust
Federal Trade Commission

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,835,459

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Which drugs does patent 8,835,459 protect, and when does it expire?

Patent 8,835,459 protects SUBSYS and is included in one NDA.

This patent has four patent family members in four countries.
Summary for Patent: 8,835,459
Title:Sublingual fentanyl spray
Abstract: The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable sale thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Inventor(s): Kottayil; S. George (Long Grove, IL), Goskonda; Venkat R. (Phoenix, AZ), Zhu; Zhongyuan (Vernon Hills, IL), Kattookaran; Linet (Mount Prospect, IL), Parikh; Neha (Chicago, IL)
Assignee: Insys Therapeutics, Inc. (Phoenix, AZ)
Application Number:13/895,111
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,835,459
Patent Claim Types:
see list of patent claims
Formulation; Compound;

Drugs Protected by US Patent 8,835,459

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-001 Jan 4, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-003 Jan 4, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-004 Jan 4, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 8,835,459

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,486,973 Sublingual fentanyl spray ➤ Sign Up
9,642,844 Sublingual fentanyl spray ➤ Sign Up
9,241,935 Sublingual fentanyl spray ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Family Members for US Patent 8,835,459

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2008282743 ➤ Sign Up
Canada 2698749 ➤ Sign Up
European Patent Office 2180844 ➤ Sign Up
World Intellectual Property Organization (WIPO) 2009017837 ➤ Sign Up
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Johnson and Johnson
Farmers Insurance
US Army
Cerilliant
Teva
Fuji
Federal Trade Commission
Colorcon

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