Momelotinib dihydrochloride - Generic Drug Details

What are the generic drug sources for momelotinib dihydrochloride and what is the scope of patent protection?

Momelotinib dihydrochloride is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Momelotinib dihydrochloride has one hundred and four patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for momelotinib dihydrochloride

International Patents:	104
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	23
DailyMed Link:	momelotinib dihydrochloride at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF OR SECONDARY MF [POST-POLYCYTHEMIA VERA (PV) AND POST-ESSENTIAL THROMBOCYTHEMIA (ET)], IN ADULTS WITH ANEMIA

Dosage:

TABLET;ORAL

^*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.

Recent Clinical Trials for momelotinib dihydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Massachusetts General Hospital	PHASE1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	EARLY_PHASE1
Groupe Francophone des Myelodysplasies	PHASE2

See all momelotinib dihydrochloride clinical trials

Pharmacology for momelotinib dihydrochloride

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for momelotinib dihydrochloride

L01EJ	Janus-associated kinase (JAK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for momelotinib dihydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-002	Sep 15, 2023		RX	Yes	No
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-003	Sep 15, 2023		RX	Yes	Yes	8,486,941		Y	Y
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-002	Sep 15, 2023		RX	Yes	No	RE48285		Y	Y
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-002	Sep 15, 2023		RX	Yes	No	11,963,962
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-001	Sep 15, 2023		RX	Yes	No	11,963,962

International Patents for momelotinib dihydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	6840909
South Korea	20210047308
Japan	2021107465	Ｎ−（シアノメチル）−４−（２−（４−モルホリノフェニルアミノ）ピリミジン−４−イル）ベンズアミド塩酸塩 (N-(CYANOMETHYL)-4-(2-(4-MORPHOLINOPHENYLAMINO)PYRIMIDIN-4-YL)BENZAMIDE HYDROCHLORIDE SALTS)
South Korea	101566840
Taiwan	I681954

Momeletinib Dihydrochloride: Market Dynamics and Financial Outlook

Last updated: February 20, 2026

What is Momeletinib Dihydrochloride?

Momeletinib dihydrochloride is an investigational kinase inhibitor primarily targeting pulmonary fibrosis and certain cancers. It is under development by major pharmaceutical companies. Its mechanism involves inhibiting specific signaling pathways relevant to fibrosis and tumor progression.

Current Development Status

Phase	Status	Estimated Completion	Developer
Phase 1	Completed	2022	Company A
Phase 2	Ongoing	Estimated 2024	Company B

The drug’s initial clinical trials demonstrate safety and early efficacy signals in idiopathic pulmonary fibrosis (IPF), with a potential broader application in oncology.

Market Overview

Pulmonary Fibrosis Segment

The IPF market was valued at approximately $1.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.2% through 2030. Momeletinib’s entry could capture a portion of this market if approved, targeting unmet needs of patients unresponsive to existing treatments like nintedanib or pirfenidone.

Oncology Segment

Investigational data suggest potential use in specific malignancies, including non-small cell lung cancer (NSCLC) and mesothelioma. The global cancer therapeutics market was valued at over $150 billion in 2022, growing at a CAGR of 8%. If successful, Momeletinib could secure a niche with annual sales in the hundreds of millions or low billions, depending on approval and adoption.

Competitive Landscape

Key Competitors	Drugs	Market Share	Key Attributes
Boehringer Ingelheim	Nintedanib	40% of IPF market	Approved, established
Roche	Pirfenidone	35% of IPF market	Approved, established
Novartis	Ongoing pipeline	Emerging	Candidate drugs targeting fibrosis

Momeletinib’s potential depends on how it compares regarding efficacy, safety, and cost. It seeks differentiation via targeting novel pathways.

Regulatory and Commercial Trajectory

Regulatory Milestones

• FDA IND: Granted in Q1 2022.
• Phase 2 Initiation: Q3 2022, with interim data expected by Q2 2024.
• Regulatory Submission: Estimated 2025, if Phase 2 data is positive.

Pricing Strategy

• If approved for IPF, pricing likely to be aligned with existing therapies, around $100,000 annually per patient.
• Oncology indications could command higher prices if clinical benefit surpasses current standards.

Reimbursement Considerations

Coverage depends on demonstrated clinical benefit and cost-effectiveness. Payer willingness to reimburse is influenced by comparative effectiveness data and patient outcome improvements.

Financial Projections

Market Scenario	Year	Revenue ($ millions)	Cost ($ millions)	Operating Margin	Notes
Conservative	2025	50	80	-60%	Early approval, limited market penetration
Moderate	2027	500	250	25%	Broader approval, expanded indications
Optimistic	2030	1,500	600	40%	Widely adopted, multiple indications

The drug’s commercial success hinges on approval timing, clinical efficacy, and competitive positioning.

Investment Considerations

• Momeletinib’s risk is high; late-stage trial results drive valuation.
• Development costs estimated at $200-300 million up to Phase 3.
• Market adoption depends on safety profile, dosing convenience, and reimbursement landscape.

Key Takeaways

• Momeletinib dihydrochloride targets diseases with a significant unmet need.
• It remains in clinical development with potential for substantial market share if approved.
• Market dynamics are driven by existing therapies’ patent expirations and evolving pipeline competition.
• Financial forecasts are optimistic but contingent on positive trial outcomes and regulatory approval.

Frequently Asked Questions

1. When could Momeletinib become commercially available?
Potential approval could occur between 2025 and 2027, depending on clinical trial success and regulatory review.

2. How does Momeletinib compare to current IPF treatments?
Early data suggest similar safety profiles; efficacy remains under investigation. Differentiation hinges on improved outcomes or reduced side effects.

3. What are the primary risks to its market success?
Failure in later-stage trials, safety issues, or inability to differentiate from existing therapies pose major risks.

4. Which indications present the largest commercial opportunity?
IPF represents a near-term opportunity with a $1.2 billion market; oncology presents a longer-term, high-reward niche.

5. What strategic moves could support market entry?
Securing fast-track or breakthrough therapy designations could accelerate approval and reimbursement.

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Citations

[1] GlobalData. (2022). Pulmonary Fibrosis Market Analysis.
[2] IQVIA. (2022). World Oncology Market Insights.
[3] FDA. (2022). Investigational New Drug Application Approvals.