Details for New Drug Application (NDA): 020899
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NDA 020899 describes OPTISON, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from one supplier. Additional details are available on the OPTISON profile page.
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.
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 020899
| Tradename: | OPTISON |
| Applicant: | Ge Healthcare |
| Ingredient: | albumin human |
| Patents: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 020899
Generic Entry Date for 020899*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION 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 NDA: 020899
| Mechanism of Action | Ultrasound Contrast Activity |
Suppliers and Packaging for NDA: 020899
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OPTISON | albumin human | INJECTABLE;INJECTION | 020899 | NDA | GE Healthcare Inc. | 0407-2707 | 0407-2707-03 | 5 VIAL, SINGLE-USE in 1 CARTON (0407-2707-03) / 3 mL in 1 VIAL, SINGLE-USE |
| OPTISON | albumin human | INJECTABLE;INJECTION | 020899 | NDA | GE Healthcare Inc. | 0407-2707 | 0407-2707-18 | 18 VIAL, SINGLE-USE in 1 CARTON (0407-2707-18) / 3 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Dec 31, 1997 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 9, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Expired US Patents for NDA 020899
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ge Healthcare | OPTISON | albumin human | INJECTABLE;INJECTION | 020899-001 | Dec 31, 1997 | 5,529,766 | ⤷ Get Started Free |
| Ge Healthcare | OPTISON | albumin human | INJECTABLE;INJECTION | 020899-001 | Dec 31, 1997 | 6,723,303 | ⤷ Get Started Free |
| Ge Healthcare | OPTISON | albumin human | INJECTABLE;INJECTION | 020899-001 | Dec 31, 1997 | 5,573,751 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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