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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Citi
QuintilesIMS
Federal Trade Commission
US Department of Justice
Farmers Insurance
Boehringer Ingelheim
McKinsey
Mallinckrodt

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,835,460

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Which drugs does patent 8,835,460 protect, and when does it expire?

Patent 8,835,460 protects SUBSYS and is included in one NDA.

This patent has eighteen patent family members in fifteen countries.
Summary for Patent: 8,835,460
Title:Sublingual fentanyl spray and methods of treating pain
Abstract: The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt 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:13/895,124
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Device; Use;

Drugs Protected by US Patent 8,835,460

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 ➤ Try a Free Trial ➤ Try a Free Trial Y TREATMENT OF PAIN ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-002 Jan 4, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y TREATMENT OF PAIN ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-003 Jan 4, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y TREATMENT OF PAIN ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-004 Jan 4, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y TREATMENT OF PAIN ➤ Try a Free Trial
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 8,835,460

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
9,642,797 Sublingual fentanyl spray and methods of use to treat pain ➤ Try a Free Trial
8,486,972 Sublingual fentanyl spray ➤ Try a Free Trial
9,289,387 Method of treating pain by administering sublingual fentanyl spray ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 8,835,460

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
China 101378735 ➤ Try a Free Trial
Cyprus 1117263 ➤ Try a Free Trial
Denmark 1976521 ➤ Try a Free Trial
European Patent Office 1976521 ➤ Try a Free Trial
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School
US Army
Johnson and Johnson
Mallinckrodt
Accenture
Fuji
Baxter
Cipla

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