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OPTISON Drug Profile

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Which patents cover Optison, and when can generic versions of Optison launch?

Optison is a drug marketed by Ge Healthcare and is included in one NDA. There is one patent protecting this drug.

This drug has forty patent family members in twenty-seven countries.

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

International Patents:	40
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	33
Clinical Trials:	15
Patent Applications:	1,497
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for OPTISON
DailyMed Link:	OPTISON at DailyMed

Generic Entry Opportunity Date for OPTISON

NDA:

020899

Dosage:

INJECTABLE;INJECTION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for OPTISON

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

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			Y

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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

Non-Orange Book US Patents for OPTISON

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,875,420	Method of ultrasound imaging
5,666,526	Method and system for supporting scrollable, updatable database queries
6,156,292	Gaseous ultrasound contrast media and method for selecting gases for use as ultrasound contrast media

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International Patents for OPTISON

Country	Document Number	Estimated Expiration
Singapore	54121
Japan	H07501319
New Zealand	244341

Supplementary Protection Certificates for OPTISON

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00673	Netherlands		PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
2014 00034	Denmark		PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: C(2013)9835 20131220
2009 00036	Denmark		PRODUCT NAME: PACLITAXELALBUMIN