Details for New Drug Application (NDA): 215515
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The generic ingredient in AMVUTTRA is vutrisiran sodium. One supplier is listed for this compound. Additional details are available on the vutrisiran sodium profile page.
Summary for 215515
Tradename: | AMVUTTRA |
Applicant: | Alnylam Pharms Inc |
Ingredient: | vutrisiran sodium |
Patents: | 13 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215515
Generic Entry Date for 215515*:
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.
Pharmacology for NDA: 215515
Physiological Effect | Decreased RNA Integrity Increased Protein Breakdown |
Suppliers and Packaging for NDA: 215515
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMVUTTRA | vutrisiran sodium | SOLUTION;SUBCUTANEOUS | 215515 | NDA | Alnylam Pharmaceuticals, Inc. | 71336-1003 | 71336-1003-1 | 1 SYRINGE, GLASS in 1 CARTON (71336-1003-1) / .5 mL in 1 SYRINGE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) | ||||
Approval Date: | Jun 13, 2022 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jun 13, 2029 | ||||||||
Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS | ||||||||
Regulatory Exclusivity Expiration: | Jun 13, 2027 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Subscribe | Patent Expiration: | Aug 24, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS |
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