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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Moodys
Healthtrust
Chubb
US Department of Justice
UBS
Fuji
Chinese Patent Office
Argus Health

Generated: June 18, 2018

DrugPatentWatch Database Preview

ONSOLIS Drug Profile

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Which patents cover Onsolis, and when can generic versions of Onsolis launch?

Onsolis is a drug marketed by Bdsi and is included in one NDA. There are two patents protecting this drug.

This drug has sixty-nine patent family members in twenty-seven countries.

The generic ingredient in ONSOLIS is fentanyl citrate. There are thirty-one drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

US Patents and Regulatory Information for ONSOLIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-001 Jul 16, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-004 Jul 16, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-002 Jul 16, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-004 Jul 16, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ONSOLIS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-004 Jul 16, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-001 Jul 16, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-003 Jul 16, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-002 Jul 16, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for ONSOLIS

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
9,655,843 Transmucosal delivery devices with enhanced uptake ➤ Try a Free Trial
5,800,832 Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces ➤ Try a Free Trial
8,147,866 Transmucosal delivery devices with enhanced uptake ➤ Try a Free Trial
6,159,498 Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ONSOLIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00016 Denmark ➤ Try a Free Trial PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
00523 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
2006 00019 Denmark ➤ Try a Free Trial PRODUCT NAME: FENTANYL HYDROCHLORID
00653 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Cerilliant
Teva
Boehringer Ingelheim
McKesson
Citi
Mallinckrodt
Julphar
Farmers Insurance

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.