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, Inc. | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ONSOLIS
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 022266-005 | 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 | 022266-005 | 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 |
| >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 |
|---|---|---|---|
| Norway | 20170380 | Transmukosal leveringsanordning med forøket opptak | ⤷ Sign Up |
| Japan | 2010270153 | PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR TRANSMITTING PHARMACEUTICAL COMPOUND TO MUCOSA SURFACE | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 9817251 | ⤷ Sign Up | |
| Brazil | PI0714712 | dispositivos de distribuiÇço transmucosal com absorÇço intensificada | ⤷ Sign Up |
| Japan | 5448814 | ⤷ 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 |
| Russian Federation | 2009106177 | СПОСОБ ТРАНСМУКОЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВ, СРЕДСТВО ДЛЯ ЕГО ОСУЩЕСТВЛЕНИЯ (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ БОЛИ | ⤷ 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 |
| 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 |
| 1769785 | C300522 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006 |
| 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 |
| 1635783 | CA 2014 00016 | Denmark | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: FENTANYL HYDROCHLORID |
| 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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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 verification 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.
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