Last Updated: September 28, 2026

Details for New Drug Application (NDA): 022266

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NDA 022266 describes ONSOLIS, which is a drug marketed by Adalvo and is included in one NDA. There is one patent protecting this drug. Additional details are available on the ONSOLIS profile page.

The generic ingredient in ONSOLIS is fentanyl citrate. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

Summary for 022266

Tradename:	ONSOLIS
Applicant:	Adalvo
Ingredient:	fentanyl citrate
Patents:	1

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM;BUCCAL			Strength	EQ 0.2MG BASE
Approval Date:	Jul 16, 2009	TE:		RLD:	No
Patent:	9,597,288	Patent Expiration:	Jul 23, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM;BUCCAL			Strength	EQ 0.4MG BASE
Approval Date:	Jul 16, 2009	TE:		RLD:	No
Patent:	9,597,288	Patent Expiration:	Jul 23, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM;BUCCAL			Strength	EQ 0.6MG BASE
Approval Date:	Jul 16, 2009	TE:		RLD:	No
Patent:	9,597,288	Patent Expiration:	Jul 23, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER

Expired US Patents for NDA 022266

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-005	Jul 16, 2009	6,159,498	⤷ Start Trial
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-003	Jul 16, 2009	6,159,498	⤷ Start Trial
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-001	Jul 16, 2009	6,159,498	⤷ Start Trial
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-005	Jul 16, 2009	7,579,019	⤷ Start Trial
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-002	Jul 16, 2009	7,579,019	⤷ Start Trial
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-002	Jul 16, 2009	6,159,498	⤷ Start Trial
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-001	Jul 16, 2009	7,579,019	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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