OPTISON Drug Patent 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.
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.
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Summary for OPTISON
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 53 |
| Clinical Trials: | 20 |
| Drug Prices: | Drug price information for OPTISON |
| What excipients (inactive ingredients) are in OPTISON? | OPTISON excipients list |
| DailyMed Link: | OPTISON at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OPTISON
Generic Entry Date for OPTISON*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION 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
| Sponsor | Phase |
|---|---|
| Mayo Clinic | Phase 1 |
| Covance | Phase 4 |
| Chiltern International Inc. | Phase 4 |
Pharmacology for OPTISON
| Drug Class | Contrast Agent for Ultrasound Imaging |
| Mechanism of Action | Ultrasound Contrast Activity |
US Patents and Regulatory Information for OPTISON
OPTISON is protected by zero US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of OPTISON is ⤷ Start Trial.
This potential generic entry date is based on NEW PATIENT POPULATION.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| 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 | ⤷ 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 |
| 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 |
International Patents for OPTISON
See the table below for patents covering OPTISON around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 133158 | ⤷ Start Trial | |
| Austria | 134668 | ⤷ Start Trial | |
| Austria | 157547 | ⤷ Start Trial | |
| Australia | 1428392 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OPTISON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0961612 | CA 2009 00036 | Denmark | ⤷ Start Trial | PRODUCT NAME: PACLITAXELALBUMIN |
| 0961612 | 09C0050 | France | ⤷ Start Trial | PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111 |
| 0961612 | C00961612/01 | Switzerland | ⤷ Start Trial | PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014 |
| 0961612 | SZ 41/2009 | Austria | ⤷ Start Trial | PRODUCT NAME: PACLITAXEL ALBUMIN |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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