Details for New Drug Application (NDA): 217388
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NDA 217388 describes WAINUA (AUTOINJECTOR), which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the WAINUA (AUTOINJECTOR) profile page.
The generic ingredient in WAINUA (AUTOINJECTOR) is eplontersen sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the eplontersen sodium profile page.
The generic ingredient in WAINUA (AUTOINJECTOR) is eplontersen sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the eplontersen sodium profile page.
Summary for 217388
| Tradename: | WAINUA (AUTOINJECTOR) |
| Applicant: | Astrazeneca Ab |
| Ingredient: | eplontersen sodium |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217388
Generic Entry Date for 217388*:
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: 217388
| Physiological Effect | Decreased RNA Integrity Increased Protein Breakdown |
Suppliers and Packaging for NDA: 217388
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| WAINUA | eplontersen sodium | SOLUTION;SUBCUTANEOUS | 217388 | NDA | AstraZeneca Pharmaceuticals LP | 0310-9400 | 0310-9400-01 | 1 SYRINGE, GLASS in 1 CARTON (0310-9400-01) / .8 mL in 1 SYRINGE, GLASS |
| WAINUA (AUTOINJECTOR) | eplontersen sodium | SOLUTION;SUBCUTANEOUS | 217388 | NDA | AstraZeneca Pharmaceuticals LP | 0310-9400 | 0310-9400-01 | 1 SYRINGE, GLASS in 1 CARTON (0310-9400-01) / .8 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) | ||||
| Approval Date: | Dec 21, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 21, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Dec 21, 2030 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS | ||||||||
| Patent: | 10,683,499 | Patent Expiration: | Aug 25, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS | ||||||||
Expired US Patents for NDA 217388
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | WAINUA (AUTOINJECTOR) | eplontersen sodium | SOLUTION;SUBCUTANEOUS | 217388-001 | Dec 21, 2023 | 8,101,743 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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