Eplontersen sodium - Generic Drug Details
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What are the generic drug sources for eplontersen sodium and what is the scope of freedom to operate?
Eplontersen sodium
is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Eplontersen sodium has two hundred and thirty-four patent family members in thirty-five countries.
One supplier is listed for this compound.
Summary for eplontersen sodium
| International Patents: | 234 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | eplontersen sodium at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for eplontersen sodium
Generic Entry Date for eplontersen sodium*:
Constraining patent/regulatory exclusivity:
TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS 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.
Anatomical Therapeutic Chemical (ATC) Classes for eplontersen sodium
US Patents and Regulatory Information for eplontersen sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | WAINUA (AUTOINJECTOR) | eplontersen sodium | SOLUTION;SUBCUTANEOUS | 217388-001 | Dec 21, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | WAINUA (AUTOINJECTOR) | eplontersen sodium | SOLUTION;SUBCUTANEOUS | 217388-001 | Dec 21, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca Ab | WAINUA (AUTOINJECTOR) | eplontersen sodium | SOLUTION;SUBCUTANEOUS | 217388-001 | Dec 21, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca Ab | WAINUA (AUTOINJECTOR) | eplontersen sodium | SOLUTION;SUBCUTANEOUS | 217388-001 | Dec 21, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | WAINUA (AUTOINJECTOR) | eplontersen sodium | SOLUTION;SUBCUTANEOUS | 217388-001 | Dec 21, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for eplontersen sodium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| New Zealand | 631537 | Compositions and methods for modulating apolipoprotein c-iii expression | ⤷ Sign Up |
| Japan | 2021107408 | ⤷ Sign Up | |
| South Korea | 20230113835 | ⤷ Sign Up | |
| Costa Rica | 20150612 | COMPOSICIONES Y MÉTODOS PARA MODULAR LA EXPRESIÓN DE TTR Y VHB | ⤷ Sign Up |
| Israel | 284593 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
