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Last Updated: November 2, 2024

ONSOLIS Drug Patent Profile


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

Onsolis is a drug marketed by Adalvo and is included in one NDA. There is one patent protecting this drug.

This drug has forty-four patent family members in twenty-four countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Onsolis

A generic version of ONSOLIS was approved as fentanyl citrate by HIKMA on July 11th, 1984.

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Drug patent expirations by year for ONSOLIS
Recent Clinical Trials for ONSOLIS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Florida
University of UtahN/A
Hospira, now a wholly owned subsidiary of PfizerPhase 4

See all ONSOLIS clinical trials

US Patents and Regulatory Information for ONSOLIS

ONSOLIS is protected by one US patents.

Patents protecting ONSOLIS

Transmucosal delivery devices with enhanced uptake
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-001 Jul 16, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-004 Jul 16, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-002 Jul 16, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-003 Jul 16, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-005 Jul 16, 2009 DISCN No 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. >Exclusivity Expiration

Expired US Patents for ONSOLIS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-002 Jul 16, 2009 ⤷  Sign Up ⤷  Sign Up
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-001 Jul 16, 2009 ⤷  Sign Up ⤷  Sign Up
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-004 Jul 16, 2009 ⤷  Sign Up ⤷  Sign Up
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-005 Jul 16, 2009 ⤷  Sign Up ⤷  Sign Up
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-005 Jul 16, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ONSOLIS

See the table below for patents covering ONSOLIS around the world.

Country Patent Number Title Estimated Expiration
Brazil 112017018871 formulação para combinação de tesofensina e betabloqueador ⤷  Sign Up
Israel 220722 שימוש בפנטניל להכנת תכשיר רוקחי להקלה מהירה לכאב מתפרץ והתקן מתכלה ביולוגית למתן דרך הרירית המתאים למתן ישיר דרך הרירית של פנטיל (Use of fentanyl in the preparation of a pharmaceutical composition for providing rapid onset of relief from breakthrough pain and a mucoadhesive bioerodable drug delivery device suitable for direct transmucosal administration of fentanyl) ⤷  Sign Up
China 103550136 Transmucosal delivery devices with enhanced uptake ⤷  Sign Up
Portugal 1079813 ⤷  Sign Up
European Patent Office 3566692 DISPOSITIFS D'ADMINISTRATION TRANSMUQUEUSE AVEC ABSORPTION ACCRUE (TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ONSOLIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0836511 122006000022 Germany ⤷  Sign Up PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
1635783 122014000024 Germany ⤷  Sign Up PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0975367 122011000009 Germany ⤷  Sign Up PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0836511 SPC/GB06/022 United Kingdom ⤷  Sign Up PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1635783 C300653 Netherlands ⤷  Sign Up PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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