Details for New Drug Application (NDA): 210922
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The generic ingredient in ONPATTRO is patisiran sodium. One supplier is listed for this compound. Additional details are available on the patisiran sodium profile page.
Summary for 210922
Tradename: | ONPATTRO |
Applicant: | Alnylam Pharms Inc |
Ingredient: | patisiran sodium |
Patents: | 14 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210922
Generic Entry Date for 210922*:
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.
Pharmacology for NDA: 210922
Physiological Effect | Decreased RNA Integrity Increased Protein Breakdown |
Suppliers and Packaging for NDA: 210922
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922 | NDA | Alnylam Pharmaceuticals, Inc. | 71336-1000 | 71336-1000-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71336-1000-1) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 10MG BASE/5ML (EQ 2MG BASE/ML) | ||||
Approval Date: | Aug 10, 2018 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Aug 10, 2025 | ||||||||
Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS | ||||||||
Regulatory Exclusivity Expiration: | Jan 13, 2026 | ||||||||
Regulatory Exclusivity Use: | INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION | ||||||||
Patent: | ⤷ Subscribe | Patent Expiration: | Oct 20, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS |
Expired US Patents for NDA 210922
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