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Last Updated: November 22, 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, Inc.Phase 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 022266-001 Jul 16, 2009 ⤷  Sign Up ⤷  Sign Up
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-002 Jul 16, 2009 ⤷  Sign Up ⤷  Sign Up
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-003 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 022266-004 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
Costa Rica 20170447 FORMULACIÓN DE COMBINACIÓN DE TESOFENSINA Y BETABLOQUEANTE ⤷  Sign Up
Eurasian Patent Organization 201791875 КОМБИНИРОВАННАЯ КОМПОЗИЦИЯ ТЕЗОФЕНЗИНА И БЕТА-БЛОКАТОРА ⤷  Sign Up
Mexico 2017011257 FORMULACION DE COMBINACION DE TESOFENSINA Y BETABLOQUEANTE. (TESOFENSINE, BETA BLOCKER COMBINATION FORMULATION.) ⤷  Sign Up
Norway 20200273 Transmukosal leveringsanordning med forøket opptak ⤷  Sign Up
Canada 2329128 DISPOSITIF DE LIVRAISON PHARMACEUTIQUE CONCU POUR LA LIVRAISON DE COMPOSES PHARMACEUTIQUES AUX SURFACES MUQUEUSES (PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES) ⤷  Sign Up
Australia 2016228002 Tesofensine, beta blocker combination formulation ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ONSOLIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1769785 C300522 Netherlands ⤷  Sign Up PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0836511 122006000022 Germany ⤷  Sign Up PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
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
0836511 SPC/GB06/022 United Kingdom ⤷  Sign Up PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
0383579 C960030 Netherlands ⤷  Sign Up PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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