Details for New Drug Application (NDA): 203137
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NDA 203137 describes VIZAMYL, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the VIZAMYL profile page.
The generic ingredient in VIZAMYL is flutemetamol f-18. One supplier is listed for this compound. Additional details are available on the flutemetamol f-18 profile page.
The generic ingredient in VIZAMYL is flutemetamol f-18. One supplier is listed for this compound. Additional details are available on the flutemetamol f-18 profile page.
Summary for 203137
| Tradename: | VIZAMYL |
| Applicant: | Ge Healthcare |
| Ingredient: | flutemetamol f-18 |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203137
Generic Entry Date for 203137*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;INTRAVENOUS |
*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: 203137
| Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 203137
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137 | NDA | Medi-Physics, Inc. dba GE Healthcare | 17156-067 | 17156-067-30 | 1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-30) / 30 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 40.5mCi/10ML (4.05mCi/ML) | ||||
| Approval Date: | Oct 25, 2013 | TE: | RLD: | Yes | |||||
| Patent: | 7,270,800 | Patent Expiration: | Sep 3, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | DIAGNOSTIC RADIOIMAGING | ||||||||
| Patent: | 8,236,282 | Patent Expiration: | May 21, 2024 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 8,916,131 | Patent Expiration: | Sep 16, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 203137
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | 7,351,401 | ⤷ Subscribe |
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | 8,236,282 | ⤷ Subscribe |
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | 7,351,401 | ⤷ Subscribe |
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | 8,691,185 | ⤷ Subscribe |
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | 8,236,282 | ⤷ Subscribe |
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | 8,691,185 | ⤷ Subscribe |
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