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.
Summary for ONSOLIS
International Patents: | 44 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 39 |
Clinical Trials: | 5 |
Patent Applications: | 4,225 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ONSOLIS |
DailyMed Link: | ONSOLIS at DailyMed |
Recent Clinical Trials for ONSOLIS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Florida | |
University of Utah | N/A |
Hospira, now a wholly owned subsidiary of Pfizer | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ONSOLIS
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Adalvo | ONSOLIS | fentanyl citrate | FILM;BUCCAL | 022266-004 | Jul 16, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Adalvo | ONSOLIS | fentanyl citrate | FILM;BUCCAL | 022266-002 | Jul 16, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Adalvo | ONSOLIS | fentanyl citrate | FILM;BUCCAL | 022266-003 | Jul 16, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 |
---|---|---|---|---|---|---|---|
Adalvo | ONSOLIS | fentanyl citrate | FILM;BUCCAL | 022266-003 | Jul 16, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Adalvo | ONSOLIS | fentanyl citrate | FILM;BUCCAL | 022266-002 | Jul 16, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Adalvo | ONSOLIS | fentanyl citrate | FILM;BUCCAL | 022266-001 | Jul 16, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Adalvo | ONSOLIS | fentanyl citrate | FILM;BUCCAL | 022266-002 | Jul 16, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Croatia | P20160405 | ⤷ Try a Trial | |
Australia | 3892401 | ⤷ Try a Trial | |
Japan | 2018507875 | テソフェンシンとベータブロッカーの合剤 | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ONSOLIS
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0901368 | C300523 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
1635783 | 122014000024 | Germany | ⤷ Try a Trial | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
1635783 | CA 2014 00016 | Denmark | ⤷ Try a 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 |
0836511 | CA 2006 00019 | Denmark | ⤷ Try a Trial | PRODUCT NAME: FENTANYL HYDROCHLORID |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |