Details for New Drug Application (NDA): 212194
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NDA 212194 describes GIVLAARI, which is a drug marketed by Alnylam Pharms Inc and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the GIVLAARI profile page.
The generic ingredient in GIVLAARI is givosiran sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the givosiran sodium profile page.
The generic ingredient in GIVLAARI is givosiran sodium. There is one drug master file entry for this compound. 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: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212194
Generic Entry Date for 212194*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF ADULTS WITH ACUTE HEPATIC PORPHYRIA (AHP) 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) | ||||||||
| Patent: | 10,119,143 | Patent Expiration: | Oct 3, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF ACUTE HEPATIC PORPHYRIA | ||||||||
| Patent: | 10,125,364 | Patent Expiration: | Mar 15, 2033 | 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 | 10,273,477 | ⤷ Start Trial |
| Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | 9,150,605 | ⤷ Start Trial |
| Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | 8,546,143 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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