Details for New Drug Application (NDA): 202207
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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
Expired US Patents for NDA 202207
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cardinal Health 414 | LYMPHOSEEK KIT | technetium tc-99m tilmanocept | INJECTABLE;INJECTION | 202207-001 | Mar 13, 2013 | 6,409,990 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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