Details for New Drug Application (NDA): 210922
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NDA 210922 describes ONPATTRO, 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 ONPATTRO profile page.
The generic ingredient in ONPATTRO is patisiran sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the patisiran sodium profile page.
The generic ingredient in ONPATTRO is patisiran sodium. There is one drug master file entry for this compound. 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: | 13 |
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: | Jan 13, 2026 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 20, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 27, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS | ||||||||
Expired US Patents for NDA 210922
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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