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Express Scripts
Federal Trade Commission
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Generated: October 21, 2017

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. There has been one Paragraph IV challenge on Subsys.

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;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-001Jan 4, 2012RXYesNo► Subscribe► SubscribeY TREATMENT OF PAIN
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-002Jan 4, 2012RXYesNo► Subscribe► SubscribeY TREATMENT OF PAIN
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-003Jan 4, 2012RXYesYes► Subscribe► SubscribeY TREATMENT OF PAIN
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-004Jan 4, 2012RXYesNo► Subscribe► SubscribeY TREATMENT OF PAIN
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-005Jan 4, 2012RXYesNo► Subscribe► SubscribeY TREATMENT OF PAIN
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-006Aug 30, 2012RXYesNo► Subscribe► SubscribeY TREATMENT OF PAIN
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-007Aug 30, 2012RXYesNo► Subscribe► SubscribeY TREATMENT OF PAIN
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Non-Orange Book Patents 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
8,486,972Sublingual fentanyl spray► Subscribe
9,642,797Sublingual fentanyl spray and methods of use to treat pain► Subscribe
9,289,387Method of treating pain by administering sublingual fentanyl spray► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 8,835,460

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia2007208229► Subscribe
BrazilPI0707235► Subscribe
Canada2637672► Subscribe
China101378735► Subscribe
Cyprus1117263► Subscribe
Denmark1976521► Subscribe
European Patent Office1976521► Subscribe
European Patent Office2641595► Subscribe
Spain2535233► Subscribe
Japan2009528272► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Healthtrust
Citi
Daiichi Sankyo
Dow
Baxter
Colorcon
Fuji
Cipla
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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