OPTISON Drug Patent Profile

When do Optison patents expire, and what generic alternatives are available?

Optison is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in OPTISON is albumin human. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the albumin human profile page.

Summary for OPTISON

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	20
Patent Applications:	2,999
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for OPTISON
What excipients (inactive ingredients) are in OPTISON?	OPTISON excipients list
DailyMed Link:	OPTISON at DailyMed

See drug prices for OPTISON

Recent Clinical Trials for OPTISON

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mayo Clinic	Phase 1
Covance	Phase 4
Chiltern International Inc.	Phase 4

See all OPTISON clinical trials

Pharmacology for OPTISON

Drug Class	Contrast Agent for Ultrasound Imaging
Mechanism of Action	Ultrasound Contrast Activity

Anatomical Therapeutic Chemical (ATC) Classes for OPTISON

B05AA	Blood substitutes and plasma protein fractions
B05A	BLOOD AND RELATED PRODUCTS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for OPTISON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997		RX	Yes	Yes

Expired US Patents for OPTISON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997

International Patents for OPTISON

See the table below for patents covering OPTISON around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	940956
Lithuania	958
Latvia	10721	POYMERS CONTAINING DIESTER UNITS
Brazil	9106819

Supplementary Protection Certificates for OPTISON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1853250	132014902271575	Italy		PRODUCT NAME: PACLITAXEL LEGATO ALL'ALBUMINA FORMULATO IN NANOPARTICELLE(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/01/07/428, 20131220
0961612	SZ 41/2009	Austria		PRODUCT NAME: PACLITAXEL ALBUMIN
1853250	122014000065	Germany		PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
1853250	2014C/037	Belgium		PRODUCT NAME: PACLITAXEL DANS UNE FORMULATION DE NANOPARTICULE LIEES A L'ALBUMINE; AUTHORISATION NUMBER AND DATE: EU/1/07/428 20131230