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RIVFLOZA

NDA

NEDOSIRAN SODIUM | N215842 | NOVO NORDISK INC

3 strengths6 unique patents4 unique exclusivities

Patent Timeline

6 unique patents, 4 exclusivities by expiration date

Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Oct. 9, 2035

Oct. 9, 2035

Oct. 29, 2035

Oct. 12, 2038

Oct. 9, 2035

Oct. 12, 2038

NPP

Mar. 27, 2028

NCE

Sep. 29, 2028

ODE-443

Sep. 29, 2030

ODE-531

Mar. 27, 2032

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

3 reexaminations on OB patents from USPTO Patent Center

96/050,128Ex PartePending

Patent: 11661604Filed: 2025-12-22

METHODS AND COMPOSITIONS FOR INHIBITING EXPRESSION OF LDHA

96/050,126Ex PartePending

Patent: 11286488Filed: 2025-12-22

METHODS AND COMPOSITIONS FOR INHIBITING EXPRESSION OF LDHA

96/050,127Ex PartePending

Patent: 11286488Filed: 2025-12-22

METHODS AND COMPOSITIONS FOR INHIBITING EXPRESSION OF LDHA

Recent Events

2026-01-06RXLITSRLitigation Search Conducted

Source: USPTO Patent Center. Ex parte and inter partes reexamination proceedings.

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 28, 2025	SUPPL -2	View Letter (PDF)
Oct 3, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)

RLD

6 patents4 exclusivities▴

SOLUTION;INJECTION | Approved: Sep 29, 2023

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10351854	Oct 9, 2035	—	Yes	Yes	—	—
10738311	Oct 9, 2035	—	Yes	Yes		—
11053502	Oct 29, 2035	—	Yes	Yes	—	—
11286488	Oct 12, 2038	—	Yes	Yes		—
11359203	Oct 9, 2035	—	Yes	Yes		—
11661604	Oct 12, 2038	—	Yes	Yes		—

Exclusivities (4)

Code	Date	Status
NCE	Sep 29, 2028	Active
NPP	Mar 27, 2028	Active
ODE-443	Sep 29, 2030	Active
ODE-531	Mar 27, 2032	Active

#002 — EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)

RLD

6 patents4 exclusivities▾

SOLUTION;INJECTION | Approved: Sep 29, 2023

#003 — EQ 160MG BASE/ML (EQ 160MG BASE/ML)

RLD

6 patents4 exclusivities▾

SOLUTION;INJECTION | Approved: Sep 29, 2023

Change History (3)

Recent changes detected for this application.

ADDED7/1/2026

New: New record

ADDED7/1/2026

Nedosiran sodium (Rivfloza) received orphan drug exclusivity designation, providing seven years of regulatory market protection from FDA approval.

New: New record

ADDED7/1/2026

Novo Nordisk added Orphan Drug Exclusivity (ODE-531) to Rivfloza (nedosiran sodium) for NDA 215842, providing seven years of regulatory exclusivity from approval.

New: New record