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OPTISON Drug Profile

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

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

The generic ingredient in OPTISON is albumin human. There are six 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 Tradename: OPTISON

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: OPTISON

Clinical Trials for: OPTISON

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare
OPTISON
albumin human
INJECTABLE;INJECTION020899-001Dec 31, 1997RXYes6,723,303<disabled>Y <disabled>
Ge Healthcare
OPTISON
albumin human
INJECTABLE;INJECTION020899-001Dec 31, 1997RXYes<disabled><disabled>
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Expired Patents for Tradename: OPTISON

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ge Healthcare
OPTISON
albumin human
INJECTABLE;INJECTION020899-001Dec 31, 19975,529,766<disabled>
Ge Healthcare
OPTISON
albumin human
INJECTABLE;INJECTION020899-001Dec 31, 19975,573,751<disabled>
Ge Healthcare
OPTISON
albumin human
INJECTABLE;INJECTION020899-001Dec 31, 19975,558,094<disabled>
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Non-Orange Book Patents for Tradename: 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
5,573,751 Persistent gaseous bubbles as ultrasound contrast media<disabled in preview>
6,875,420 Method of ultrasound imaging<disabled in preview>
5,393,524 Methods for selecting and using gases as ultrasound contrast media<disabled in preview>
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International Patent Family for Tradename: OPTISON

Country Document Number Estimated Expiration
Czech Republic286149<disabled in preview>
Czech Republic9400612<disabled in preview>
Australia679428<disabled in preview>
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Supplementary Protection Certificates for Tradename: OPTISON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0050France<disabled>PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/428/001 DU 20080111; REGISTRATION NO/DATE AT EEC: EU/1/07/428/001 DU 20080111
2014 00034Denmark<disabled>PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: C(2013)9835 20131220
00673Netherlands<disabled>PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
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