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RIVFLOZA Drug Patent Profile

When do Rivfloza patents expire, and when can generic versions of Rivfloza launch?

Rivfloza is a drug marketed by Novo and is included in one NDA. There are six patents protecting this drug.

This drug has thirty-seven patent family members in seventeen countries.

The generic ingredient in RIVFLOZA is nedosiran sodium. One supplier is listed for this compound. Additional details are available on the nedosiran sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Rivfloza

Rivfloza will be eligible for patent challenges on September 29, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 29, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RIVFLOZA

International Patents:	37
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in RIVFLOZA?	RIVFLOZA excipients list
DailyMed Link:	RIVFLOZA at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RIVFLOZA

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

NDA:

215842

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 RIVFLOZA

RIVFLOZA is protected by six US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting RIVFLOZA

FDA Regulatory Exclusivity protecting RIVFLOZA

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	215842-001	Sep 29, 2023		RX	Yes	Yes			Y	Y
Novo	RIVFLOZA	nedosiran sodium	SOLUTION;INJECTION	215842-003	Sep 29, 2023		RX	Yes	Yes			Y	Y
Novo	RIVFLOZA	nedosiran sodium	SOLUTION;INJECTION	215842-003	Sep 29, 2023		RX	Yes	Yes
Novo	RIVFLOZA	nedosiran sodium	SOLUTION;INJECTION	215842-001	Sep 29, 2023		RX	Yes	Yes
Novo	RIVFLOZA	nedosiran sodium	SOLUTION;INJECTION	215842-001	Sep 29, 2023		RX	Yes	Yes			Y	Y
Novo	RIVFLOZA	nedosiran sodium	SOLUTION;INJECTION	215842-002	Sep 29, 2023		RX	Yes	Yes			Y	Y

International Patents for RIVFLOZA

See the table below for patents covering RIVFLOZA around the world.

Country	Patent Number	Title	Estimated Expiration
Serbia	64483	POSTUPCI I KOMPOZICIJE ZA INHIBICIJU EKSPRESIJE LDHA (METHODS AND COMPOSITIONS FOR INHIBITING EXPRESSION OF LDHA)
European Patent Office	3204497	INHIBITION THÉRAPEUTIQUE DE LA LACTATE-DÉSHYDROGÉNASE ET AGENTS ASSOCIÉS (THERAPEUTIC INHIBITION OF LACTATE DEHYDROGENASE AND AGENTS THEREFOR)
China	111448319	用于抑制LDHA表达的方法和组合物 (METHODS AND COMPOSITIONS FOR INHIBITING EXPRESSION OF LDHA)
Canada	2964168	INHIBITION THERAPEUTIQUE DE LA LACTATE-DESHYDROGENASE ET AGENTS ASSOCIES (THERAPEUTIC INHIBITION OF LACTATE DEHYDROGENASE AND AGENTS THEREFOR)
World Intellectual Property Organization (WIPO)	2019075419
Croatia	P20231063