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Last Updated: January 23, 2020

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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 seventy 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. Twelve suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

US ANDA Litigation and Generic Entry Outlook for Onsolis

A generic version of ONSOLIS was approved as fentanyl citrate by HOSPIRA on January 23rd, 2020.

  Start Trial

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

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

SponsorPhase
BioDelivery Sciences InternationalPhase 3

See all ONSOLIS clinical trials

Recent Litigation for ONSOLIS

Identify potential future generic entrants

District Court Litigation
Case NameDate
BioDelivery Sciences International, Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-16
BioDelivery Sciences International, Inc. v. Teva Pharmaceuticals USA, Inc.2017-02-03
BioDelivery Sciences International, Inc. v. Teva Pharmaceuticals USA Inc.2016-12-22

See all ONSOLIS litigation

PTAB Litigation
PetitionerDate
MONOSOL RX, LLC2014-01-22

See all ONSOLIS litigation

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   Start Trial   Start Trial   Start Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-004 Jul 16, 2009 DISCN No No   Start Trial   Start Trial Y   Start Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-002 Jul 16, 2009 DISCN No No   Start Trial   Start Trial Y   Start Trial
>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
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-003 Jul 16, 2009   Start Trial   Start Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-001 Jul 16, 2009   Start Trial   Start Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-005 Jul 16, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ONSOLIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1769785 C300522 Netherlands   Start Trial PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0836511 SPC/GB06/022 United Kingdom   Start Trial PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1635783 C300653 Netherlands   Start Trial 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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Serving leading biopharmaceutical companies globally:

Medtronic
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