Viewing data from:

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

2 trials from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa NCT03827798	Phase 2	Active	Novartis Pharmaceuticals	248	2019-02-27 → 2026-12-11
A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome NCT04035668	Phase 2	Terminated	Novartis Pharmaceuticals	73	2019-07-12 → 2021-11-23

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$72.26

per ea

Lowest NADAC/Unit

$72.26

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00078148320RHAPSIDO 25 MG TABLET	$72.26	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$3384.16

Highest Price

$4180.22

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-1483-20REMIBRUTINIB 25MG TAB,ORAL	$4180.22	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-1483-20REMIBRUTINIB 25MG TAB,ORAL	$3384.16	Big4	Novartis Pharmaceuticals Corporation	08/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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) · 2 use codes

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