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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Questions you can ask:
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Summary for ONSOLIS
International Patents: | 44 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 39 |
Clinical Trials: | 5 |
Patent Applications: | 3,927 |
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 |
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 |