Viewing data from:

OJJAARA

NDA

MOMELOTINIB DIHYDROCHLORIDE | N216873 | GLAXOSMITHKLINE LLC

3 strengths5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

Jun. 11, 2035

Jan. 3, 2035

Jun. 11, 2035

Dec. 2, 2040

Aug. 21, 2039

NCE

Sep. 15, 2028

ODE-441

Sep. 15, 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Ojjaara (2023)

Total Spending

$27.0M

Total Claims

934

Beneficiaries

486

Avg Cost/Unit

$936.45

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Mar 20, 2026	SUPPL -4	View Letter (PDF)
Mar 20, 2026	SUPPL -5	View Letter (PDF)
Apr 28, 2025	SUPPL -2	View Letter (PDF)
Sep 18, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 100MG BASE

RLD

5 patents2 exclusivities▴

TABLET;ORAL | Approved: Sep 15, 2023

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE48285	Jun 11, 2035	—	Yes	Yes		—
8486941	Jan 3, 2035	—	Yes	Yes		—
9809559	Jun 11, 2035	—	—	—		—
11963962	Dec 2, 2040	—	—	—		—
12576089	Aug 21, 2039	—	—	—	U-4441	—

Exclusivities (2)

Code	Date	Status
NCE	Sep 15, 2028	Active
ODE-441	Sep 15, 2030	Active

#002 — EQ 150MG BASE

RLD

5 patents2 exclusivities▾

TABLET;ORAL | Approved: Sep 15, 2023

#003 — EQ 200MG BASE

RLD

5 patents2 exclusivities▾

TABLET;ORAL | Approved: Sep 15, 2023