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RIVFLOZA Drug Patent Profile

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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-eight 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

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Summary for RIVFLOZA

International Patents:	38
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

Drug patent expirations by year for RIVFLOZA

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

Generic Entry Date for RIVFLOZA^: ⤷ Sign Up* 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RIVFLOZA is ⤷ Sign Up.

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

Therapeutic inhibition of lactate dehydrogenase and agents therefor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Therapeutic inhibition of lactate dehydrogenase and agents therefor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Therapeutic inhibition of lactate dehydrogenase and agents therefor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Methods and compositions for inhibiting expression of LDHA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING PRIMARY HYPEROXALURIA TYPE 1 (PH1)

FDA Regulatory Exclusivity protecting RIVFLOZA

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
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
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	215842-003	Sep 29, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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 RIVFLOZA

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

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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
>Country	>Patent Number	>Title	>Estimated Expiration