Details for New Drug Application (NDA): 215515
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NDA 215515 describes AMVUTTRA, which is a drug marketed by Alnylam Pharms Inc and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the AMVUTTRA profile page.
The generic ingredient in AMVUTTRA is vutrisiran sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vutrisiran sodium profile page.
The generic ingredient in AMVUTTRA is vutrisiran sodium. There is one drug master file entry for this compound. 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:
TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY, CARDIOVASCULAR HOSPITALIZATIONS AND URGENT HEART FAILURE VISITS 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 | ||||||||
| Regulatory Exclusivity Expiration: | Mar 20, 2032 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY, CARDIOVASCULAR HOSPITALIZATIONS AND URGENT HEART FAILURE VISITS | ||||||||
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