Details for New Drug Application (NDA): 212194
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The generic ingredient in GIVLAARI is givosiran sodium. One supplier is listed for this compound. Additional details are available on the givosiran sodium profile page.
Summary for 212194
Tradename: | GIVLAARI |
Applicant: | Alnylam Pharms Inc |
Ingredient: | givosiran sodium |
Patents: | 12 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212194
Generic Entry Date for 212194*:
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: 212194
Physiological Effect | Decreased RNA Integrity |
Suppliers and Packaging for NDA: 212194
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194 | NDA | Alnylam Pharmaceuticals, Inc. | 71336-1001 | 71336-1001-1 | 1 VIAL, SINGLE-USE in 1 CARTON (71336-1001-1) / 1 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 189MG BASE/ML (EQ 189MG BASE/ML) | ||||
Approval Date: | Nov 20, 2019 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Nov 20, 2026 | ||||||||
Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ADULTS WITH ACUTE HEPATIC PORPHYRIA (AHP) | ||||||||
Regulatory Exclusivity Expiration: | Nov 20, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 3, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | TREATMENT OF ACUTE HEPATIC PORPHYRIA |
Expired US Patents for NDA 212194
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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