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RHAPSIDO

NDA

REMIBRUTINIB | N218436 | NOVARTIS PHARMACEUTICALS CORP

1 strength3 unique patents1 unique exclusivity

Patent Timeline

3 unique patents, 1 exclusivity by expiration date

Active (3)TodayExclusivity

2026

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Today

9512084

Nov. 13, 2034

10457647

Nov. 13, 2034

12419889

Jan. 19, 2043

NCE

Sep. 30, 2030

PTAB Proceedings

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

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

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

5 trials from ClinicalTrials.gov — 5 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS NCT07665437	Phase 3	Not Yet Recruiting	Novartis Pharmaceuticals	710	2026-07-09 → 2031-10-27
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)NCT07681271	Phase 2	Not Yet Recruiting	Novartis Pharmaceuticals	80	2026-07-29 → 2027-12-07
Remibrutinib Open Label Roll-over Post-trial Access Protocol NCT07456891	Phase 3	Recruiting	Novartis Pharmaceuticals	648	2026-04-16 → 2033-01-30
A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis NCT07225504	Phase 3	Recruiting	Novartis Pharmaceuticals	1,275	2025-11-11 → 2034-01-02
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.NCT06846281	Phase 3	Recruiting	Novartis Pharmaceuticals	360	2025-06-23 → 2031-06-24

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 17, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25MG

RLD

3 patents1 exclusivity▴

TABLET;ORAL | Approved: Sep 30, 2025

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9512084	Nov 13, 2034	—	Yes	Yes	—	—
10457647	Nov 13, 2034	—	—	—		—
12419889	Jan 19, 2043	—	—	—		—

Exclusivities (1)

Code	Date	Status
NCE	Sep 30, 2030	Active