NEDOSIRAN SODIUM - Generic Drug Details
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What are the generic drug sources for nedosiran sodium and what is the scope of patent protection?
Nedosiran sodium
is the generic ingredient in one branded drug marketed by Novo and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Nedosiran sodium has thirty-eight patent family members in seventeen countries.
One supplier is listed for this compound.
Summary for NEDOSIRAN SODIUM
| International Patents: | 38 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | NEDOSIRAN SODIUM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NEDOSIRAN SODIUM
Generic Entry Date for NEDOSIRAN SODIUM*:
Constraining patent/regulatory exclusivity:
TO LOWER URINARY OXALATE LEVELS IN CHILDREN 9 YEARS OF AGE AND OLDER AND ADULTS WITH PRIMARY HYPEROXALURIA TYPE 1 (PH1) AND RELATIVELY PRESERVED KIDNEY FUNCTION, E.G., EGFR GREATER THAN OR EQUAL TO 30 ML/MIN/1.73 M^2 Dosage:
SOLUTION;INJECTION |
*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.
US Patents and Regulatory Information for NEDOSIRAN SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novo | RIVFLOZA | nedosiran sodium | SOLUTION;INJECTION | 215842-003 | Sep 29, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Novo | RIVFLOZA | nedosiran sodium | SOLUTION;INJECTION | 215842-001 | Sep 29, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novo | RIVFLOZA | nedosiran sodium | SOLUTION;INJECTION | 215842-001 | Sep 29, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Novo | RIVFLOZA | nedosiran sodium | SOLUTION;INJECTION | 215842-002 | Sep 29, 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 NEDOSIRAN SODIUM
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 7039539 | ⤷ Sign Up | |
| European Patent Office | 3679141 | MÉTHODES ET COMPOSITIONS POUR INHIBER L'EXPRESSION DE LA LDHA (METHODS AND COMPOSITIONS FOR INHIBITING EXPRESSION OF LDHA) | ⤷ Sign Up |
| Denmark | 3204497 | ⤷ Sign Up | |
| China | 107257858 | 乳酸脱氢酶的治疗性抑制及其试剂 (Therapeutic inhibition of lactate dehydrogenase and agents therefor) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
