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	216873-001	Sep 15, 2023		RX	Yes	No
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-001	Sep 15, 2023		RX	Yes	No			Y	Y
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-002	Sep 15, 2023		RX	Yes	No			Y	Y
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-001	Sep 15, 2023		RX	Yes	No			Y	Y
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-003	Sep 15, 2023		RX	Yes	Yes
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

International Patents for momelotinib dihydrochloride

Country	Patent Number	Title	Estimated Expiration
South Korea	20160106786	페닐 아미노 피리미딘 화합물 및 이의 용도 (PHENYL AMINO PYRIMIDINE COMPOUNDS AND USES THEREOF)
Japan	6883560
Eurasian Patent Organization	202190122	СПОСОБЫ ЛЕЧЕНИЯ МИЕЛОФИБРОЗА, НЕ ЗАВИСЯЩИЕ ОТ КОЛИЧЕСТВА ТРОМБОЦИТОВ
Portugal	3154950
Canada	2702650
Japan	5940700
Ecuador	SP16093323	N-(CIANOMETIL)-4-(2-(4-MORFOLINOFENILAMINO)PIRIMIDIN-4-IL)BENZAMIDA

Market Dynamics and Financial Trajectory for Momelotinib Dihydrochloride

Last updated: July 28, 2025

Introduction

Momelotinib dihydrochloride, a selective Janus kinase (JAK) 1 and 2 inhibitor, has emerged as a promising therapeutic candidate primarily targeting myelofibrosis (MF), a rare hematologic malignancy characterized by bone marrow fibrosis, extramedullary hematopoiesis, and symptom burden. Its unique mechanism addresses anemia, splenomegaly, and constitutional symptoms, positioning it within a competitive landscape of JAK inhibitors like ruxolitinib and fedratinib. Understanding market dynamics and financial trajectory necessitates an assessment of clinical development, regulatory milestones, competitive landscape, market potential, and investment risks.

Clinical and Regulatory Landscape

Momelotinib’s development history reflects both promise and setbacks. Initial Phase 3 trials (such as SIMPLIFY-2) demonstrated effectiveness in symptom reduction and splenomegaly but failed to surpass ruxolitinib in certain endpoints, leading to a temporary halt in development[^1^]. Following substantial data review, the developer, Gilead Sciences, returned to pursue regulatory approval, emphasizing its unique benefit in treating anemia associated with MF.

In 2022, Gilead submitted a new drug application (NDA) to the FDA, highlighting its potential to fill unmet needs, particularly anemia management, which remains an area with limited options. As of early 2023, regulatory decisions are pending, with potential for approval contingent upon successful demonstration of efficacy and safety. European regulators may follow with conditional approvals, further affecting market supply and uptake.

Market Dynamics

• Unmet Medical Need and Market Demand:
  Primary indications for momelotinib focus on myelofibrosis, with an estimated patient population of approximately 18,000 globally, concentrated chiefly in North America, Europe, and select Asian regions[^2^]. Despite the availability of ruxolitinib as a first-line treatment, approximately 30-50% of patients experience suboptimal responses or intolerance[^3^], especially regarding anemia. Momelotinib’s potential to mitigate anemia provides a differentiated position in the MF treatment paradigm.

• Competitive Landscape:
  Ruxolitinib (Jakafi), approved since 2011, remains the market leader, with projected 2022 sales exceeding $2.5 billion globally[^4^]. Fedratinib (Inrebic), approved in 2019, offers alternative JAK inhibition but exhibits different side effect profiles. Momelotinib, if approved, could carve a niche as an anemia-targeted therapy, especially in patients refractory or intolerant to existing options. Its success hinges on demonstrated superiority or additive benefits—particularly in anemia management and symptom control.

• Pricing and Reimbursement:
  As a specialty drug targeting a niche population, momelotinib’s pricing strategy will likely mirror or surpass existing JAK inhibitors, which range from $70,000 to $100,000 annually per patient. Demonstrated benefits in anemia could justify premium pricing, provided clinical data support incremental value. Reimbursement access will depend on payer assessments of cost-effectiveness compared to standard therapies.

• Market Adoption Factors:
  Adoption will depend on clinical trial results, safety profile, real-world efficacy, and positioning within treatment algorithms. Physician familiarity, patient preferences, and guidelines updates will also influence uptake. Historically, drug labels emphasizing anemia benefits foster rapid market penetration, as seen with Fedratinib, which gained approval partly due to its unique efficacy profile.

• Strategic Collaborations and Investments:
  Potential licensing deals, partnerships, or acquisitions may accelerate market penetration or expand indications. Gilead’s previous strategy involves collaborations for MF treatments, which could influence momelotinib’s commercial trajectory if licensed out or co-marketed with local distributors.

Financial Trajectory and Investment Outlook

• Development Costs and Capital Investment:
  Gilead’s investment in clinical trials, regulatory processes, and manufacturing infrastructure underscores substantial costs—potentially exceeding hundreds of millions USD. Regulatory delays or negative trial outcomes could result in sunk costs, impacting overall valuation.

• Revenue Streams and Sales Forecasts:
  Should momelotinib gain approvals, initial sales are expected to be modest, contingent on market share capture. Industry analysts project peak sales in the range of $400–600 million annually within 5–7 years post-launch, based on similar niche hematology products[^5^].

• Market Penetration Timeline:
  Adoption rates depend on clinical acceptance, payer coverage, and competitive dynamics. Early adopters are likely to be hematologists specializing in MF, with subsequent expansion into broader oncology and rare disease markets.

• Risks and Uncertainties:
  Clinical efficacy hurdles, safety concerns, regulatory rejections, or unfavorable market responses could impede financial progress. Conversely, successful approval and favorable positioning could translate into lucrative revenue streams, especially given the unmet needs in anemia management among MF patients.

• Potential for Off-Label and Line Extension Uses:
  Though primarily developed for MF, second indications may include other myeloproliferative neoplasms or hematologic disorders involving JAK pathway dysregulation, diversifying revenue streams.

Regulatory and Market Risks

The ongoing regulatory review exposes momelotinib to the inherent risks associated with drug approval processes—delays, requirement for additional data, or outright rejection could significantly compromise its financial trajectory. Additionally, market risks involve rapid development of competing therapies, reimbursement hurdles, and physician inertia delaying adoption.

Conclusion

Momelotinib dihydrochloride’s market dynamics are shaped by its unique therapeutic profile addressing anemia in myelofibrosis—a substantial unmet need. While clinical data, regulatory decisions, and strategic positioning will dictate its commercial success, the drug embodies promising upside for stakeholders willing to navigate the inherent developmental uncertainties. Its financial trajectory hinges on obtaining timely regulatory approval, favorable reimbursement, and gaining clinician acceptance amid a competitive landscape.

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Key Takeaways

• Unlocking Unmet Need: Momelotinib’s potential in anemia management gives it a competitive edge in MF treatment, addressing a critical unmet medical need.

• Regulatory Milestones Critical: Approval from FDA and EMA in 2023-2024 will significantly influence market launch strategies and financial prospects.

• Market Penetration Potential: Estimated peak sales suggest a niche but profitable market opportunity, contingent on clinical and payer acceptance.

• Investment Risks & Opportunities: Regulatory uncertainties, clinical trial outcomes, and competitive dynamics pose risks; successful approval and positioning could yield substantial financial returns.

• Strategic Positioning Needed: Collaborations, clear differentiation, and rapid clinician education are essential to maximize market share post-approval.

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FAQs

1. What distinguishes momelotinib from existing JAK inhibitors?
Momelotinib uniquely addresses anemia in myelofibrosis by activating hepcidin suppression pathways, which existing JAK inhibitors like ruxolitinib do not effectively target.

2. What are the primary regulatory milestones for momelotinib?
Gilead submitted its NDA to the FDA in 2022, with decisions anticipated in 2023. European and other regional regulator decisions may follow based on the submission and review process.

3. How large is the potential market for momelotinib?
The global MF patient population suitable for momelotinib is approximately 18,000, with higher prevalence in North America and Europe. The drug’s niche positioning supports peak sales estimates of $400–600 million annually.

4. What are key factors influencing momelotinib’s commercial success?
Regulatory approval, demonstrated efficacy in anemia management, safety profile, physician acceptance, and reimbursement coverage are paramount.

5. What are major risks associated with momelotinib’s market entry?
Clinical trial failure, regulatory rejection, intense competition, and payer resistance pose significant risks that could delay or limit its market potential.

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Sources:

[1] Gilead Sciences. (2022). Submission of NDA for Momelotinib.
[2] International MPN Foundation. (2021). Myelofibrosis epidemiology.
[3] Tefferi, A., & Vainchenker, W. (2011). Myelofibrosis pathogenesis and management. Blood.
[4] EvaluatePharma. (2022). Hematology drug sales data.
[5] Market Research Future. (2022). Hematologic Malignancies Market Analysis.