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 11^th, 1984.

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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
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ONSOLIS
DailyMed Link:	ONSOLIS at DailyMed

Drug patent expirations by year for ONSOLIS

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

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

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Glossary

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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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-003	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	022266-002	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.

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Country	Patent Number	Title	Estimated Expiration
Slovenia	3265126		⤷ Sign Up
Cyprus	1117450		⤷ Sign Up
Israel	196529	בופרנורפין לשימוש בהכנת תכשיר רוקחי להגרת הספיגה מחדש של בופרנורפין וכהתקן לשחרור תרופה מתכלה מוקואדהסיבי (Buprenorphine for use in the preparation of a pharmaceutical composition for providing enhanced uptake of buprenorphine and mucoadhesive bioerodable drug delivery device based thereon)	⤷ Sign Up
Saudi Arabia	517382209	تيسوفنسين، صياغة تركيبة مثبط بيتا (Tesofensine, beta blocker combination formulation)	⤷ Sign Up
Australia	2016228002	Tesofensine, beta blocker combination formulation	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ONSOLIS

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1769785	C300521	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0836511	SPC/GB06/022	United Kingdom	⤷ Sign Up	PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1635783	300653	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0901368	C300523	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for ONSOLIS

Recent Clinical Trials for ONSOLIS

Patents protecting ONSOLIS

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