Details for New Drug Application (NDA): 214103
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NDA 214103 describes OXLUMO, which is a drug marketed by Alnylam Pharms Inc and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the OXLUMO profile page.
The generic ingredient in OXLUMO is lumasiran sodium. One supplier is listed for this compound. Additional details are available on the lumasiran sodium profile page.
The generic ingredient in OXLUMO is lumasiran sodium. One supplier is listed for this compound. Additional details are available on the lumasiran sodium profile page.
Summary for 214103
| Tradename: | OXLUMO |
| Applicant: | Alnylam Pharms Inc |
| Ingredient: | lumasiran sodium |
| Patents: | 14 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214103
Generic Entry Date for 214103*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS |
*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: 214103
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXLUMO | lumasiran sodium | SOLUTION;SUBCUTANEOUS | 214103 | NDA | Alnylam Pharmaceuticals, Inc. | 71336-1002 | 71336-1002-1 | 1 VIAL, SINGLE-USE in 1 CARTON (71336-1002-1) / .5 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) | ||||
| Approval Date: | Nov 23, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 6, 2025 | ||||||||
| Regulatory Exclusivity Use: | EXPANDED INDICATION TO INCLUDE LOWERING OF PLASMA OXALATE LEVELS IN ADULT AND PEDIATRIC PATIENTS WITH PRIMARY HYPEROXALURIA TYPE 1 (PH1) | ||||||||
| Regulatory Exclusivity Expiration: | Nov 23, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Oct 6, 2029 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1) TO LOWER PLASMA OXALATE LEVELS IN PEDIATRIC AND ADULT PATIENTS | ||||||||
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