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Last Updated: July 12, 2020

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OPTISON Drug Profile


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Which patents cover Optison, and what generic alternatives are available?

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.

US ANDA Litigation and Generic Entry Outlook for Optison

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 20, 2021. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for OPTISON
Drug Prices for OPTISON

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Generic Entry Opportunity Date for OPTISON
Generic Entry Date for OPTISON*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for OPTISON

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

SponsorPhase
Chiltern International Inc.Phase 4
National Cancer Institute (NCI)Early Phase 1
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityEarly Phase 1

See all OPTISON clinical trials

Pharmacology for OPTISON

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

Supplementary Protection Certificates for OPTISON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0961612 09C0050 France   Start Trial PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111
1853250 C300673 Netherlands   Start Trial PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
1853250 132014902271575 Italy   Start Trial PRODUCT NAME: PACLITAXEL LEGATO ALL'ALBUMINA FORMULATO IN NANOPARTICELLE(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/01/07/428, 20131220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Express Scripts
Dow
Medtronic
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.