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OPTISON Drug Profile
» See Plans and Pricing
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
Summary for OPTISON
| International Patents: | 40 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 36 |
| Clinical Trials: | 16 |
| Patent Applications: | 2,853 |
| 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 |
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
| Sponsor | Phase |
|---|---|
| Chiltern International Inc. | Phase 4 |
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Early Phase 1 |
| National Cancer Institute (NCI) | Early Phase 1 |
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 | 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 |
International Patents for OPTISON
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Czech Republic | 282532 | Start Trial |
| Bulgaria | 97499 | Start Trial |
| Poland | 173817 | Start Trial |
| Denmark | 0547126 | Start Trial |
| Czech Republic | 286149 | Start Trial |
| Finland | 934227 | Start Trial |
| Brazil | 9106819 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for OPTISON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0961612 | 300417 | Netherlands | Start Trial | PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080114 |
| 1853250 | 122014000065 | Germany | Start Trial | PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220 |
| 0961612 | 2009C/046 | Belgium | Start Trial | PRODUCT NAME: PACLITAXEL ALBUMIN; AUTHORISATION NUMBER AND DATE: EU/1/07/428/001 20080111 |
| 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 |
| 1853250 | 2014C/037 | Belgium | Start Trial | PRODUCT NAME: PACLITAXEL DANS UNE FORMULATION DE NANOPARTICULE LIEES A L'ALBUMINE; AUTHORISATION NUMBER AND DATE: EU/1/07/428 20131230 |
| 1853250 | CA 2014 00034 | Denmark | Start Trial | PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: EU/1/07/428 C(2013)9835 20131230 |
| 1853250 | C300673 | Netherlands | Start Trial | PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
