Details for New Drug Application (NDA): 208700
NDA 208700 describes LUTATHERA, which is a drug marketed by Aaa Usa Inc and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the LUTATHERA profile page.
The generic ingredient in LUTATHERA is lutetium lu-177 dotatate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the lutetium lu-177 dotatate profile page.
The generic ingredient in LUTATHERA is lutetium lu-177 dotatate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the lutetium lu-177 dotatate profile page.
Summary for 208700
| Tradename: | LUTATHERA |
| Applicant: | Aaa Usa Inc |
| Ingredient: | lutetium lu-177 dotatate |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208700
Generic Entry Date for 208700*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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.
Suppliers and Packaging for NDA: 208700
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUTATHERA | lutetium lu-177 dotatate | SOLUTION;INTRAVENOUS | 208700 | NDA | Advanced Accelerator Applications USA, Inc | 69488-003 | 69488-003-01 | 1 VIAL in 1 PACKAGE (69488-003-01) / 20.5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10mCi/ML | ||||
| Approval Date: | Jan 26, 2018 | TE: | AP | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Apr 23, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Oct 23, 2027 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Oct 23, 2031 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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