Details for New Drug Application (NDA): 202207
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NDA 202207 describes LYMPHOSEEK KIT, which is a drug marketed by Cardinal Health 414 and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the LYMPHOSEEK KIT profile page.
The generic ingredient in LYMPHOSEEK KIT is technetium tc-99m tilmanocept. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m tilmanocept profile page.
The generic ingredient in LYMPHOSEEK KIT is technetium tc-99m tilmanocept. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m tilmanocept profile page.
Summary for 202207
| Tradename: | LYMPHOSEEK KIT |
| Applicant: | Cardinal Health 414 |
| Ingredient: | technetium tc-99m tilmanocept |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202207
Generic Entry Date for 202207*:
Constraining patent/regulatory exclusivity:
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.
Suppliers and Packaging for NDA: 202207
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LYMPHOSEEK KIT | technetium tc-99m tilmanocept | INJECTABLE;INJECTION | 202207 | NDA | Cardinal Health 414, LLC | 65857-425 | 65857-425-05 | 1 KIT in 1 CARTON (65857-425-05) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01) |
| LYMPHOSEEK KIT | technetium tc-99m tilmanocept | INJECTABLE;INJECTION | 202207 | NDA | Cardinal Health 414, LLC | 65857-450 | 65857-450-05 | 1 KIT in 1 CARTON (65857-450-05) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01) * 1 INJECTION, SOLUTION in 1 VIAL (65857-401-45) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | N/A | ||||
| Approval Date: | Mar 13, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 19, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | 6,409,990 | Patent Expiration: | May 12, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | 9,439,985 | Patent Expiration: | Jan 30, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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