Momelotinib dihydrochloride - Generic Drug Details

What are the generic drug sources for momelotinib dihydrochloride and what is the scope of freedom to operate?

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:	17
Patent Applications:	20
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
Karyopharm Therapeutics Inc	Phase 2
CTI BioPharma	Phase 3
PSI CRO	Phase 3

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	8,486,941		Y	Y
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-001	Sep 15, 2023		RX	Yes	No
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	216873-003	Sep 15, 2023		RX	Yes	Yes
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-002	Sep 15, 2023		RX	Yes	No	9,809,559
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-003	Sep 15, 2023		RX	Yes	Yes	9,809,559

International Patents for momelotinib dihydrochloride

Country	Patent Number	Title	Estimated Expiration
Lithuania	3154950
New Zealand	725966	N-(cyanomethyl)-4-(2-(4-morpholinophenylamino)pyrimidin-4-yl)benzamide hydrochloride salts
South Korea	101737753
Canada	2702650	COMPOSES DE PHENYLAMINO PYRIMIDINE ET UTILISATIONS DE CES DERNIERS (PHENYL AMINO PYRIMIDINE COMPOUNDS AND USES THEREOF)
Philippines	12016502461	N-(CYANOMETHYL)-4-(2-(4-MORPHOLINOPHENYLAMINO)PYRIMIDIN-4-YL)BENZAMIDE HYDROCHLORIDE SALTS
Mexico	2009009792	COMPUESTOS DE FENIL AMINO PIRIMIDINA Y USOS DE LOS MISMOS. (PHENYL AMINO PYRIMIDINE COMPOUNDS AND USES THEREOF.)
Japan	2017517535	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

Market Dynamics and Financial Trajectory for Momelotinib Dihydrochloride

Introduction to Momelotinib Dihydrochloride

Momelotinib dihydrochloride, a Janus Kinase (JAK) 1 and 2 inhibitor, has recently been approved by the FDA for the treatment of intermediate or high-risk myelofibrosis (MF) with anemia. This approval marks a significant milestone in the management of this rare and debilitating blood cancer.

Clinical Indications and Mechanism of Action

Momelotinib is indicated for the treatment of intermediate or high-risk myelofibrosis, including primary MF, post-polycythemia vera (PV) MF, and post-essential thrombocythemia (ET) MF in adults with anemia. It works by inhibiting the JAK1 and JAK2 enzymes, which are involved in the aberrant JAK-signal transducer and activator of transcription (STAT) signaling pathway characteristic of MF[4][5].

Market Approval and Regulatory Status

The FDA approved momelotinib on September 15, 2023, based on data from the phase 3 MOMENTUM trial. This trial demonstrated clinically significant improvements in patients treated with momelotinib compared to those treated with danazol, particularly in reducing total symptom scores and spleen size[2].

Market Positioning

Momelotinib enters a market dominated by other JAK inhibitors such as ruxolitinib, fedratinib, and pacritinib. However, its unique profile, particularly its ability to reduce anemia without worsening it, positions it as a valuable treatment option for patients with MF and anemia[2].

Competitive Landscape

The myelofibrosis treatment market is competitive, with several JAK inhibitors available. However, momelotinib's approval by the FDA and its inclusion in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Myeloproliferative Neoplasms as a category 2A treatment for high-risk MF and category 2B for lower-risk MF, underscores its potential to capture a significant market share[2].

Financial Trajectory

Acquisition Costs and Budget Impact

Despite having a higher acquisition cost compared to existing treatments, momelotinib is expected to generate savings through reduced transfusion-related costs. A budget impact model estimated that over three years, the introduction of momelotinib would result in a total budget impact of $314,222, translating to $644.73 per patient treated. This model also showed a reduction in transfusion-related costs by an average of $113,694 per year over three years[2].

Cost Savings and Transfusion Reduction

The use of momelotinib is projected to decrease the number of transfusions required by patients with MF and anemia. The model indicated that momelotinib would result in 119 fewer transfusions over three years, contributing to the overall cost savings[2].

Impact on Healthcare Expenditure

From a US commercial and Medicare payer perspective, the introduction of momelotinib is expected to have a small positive budget impact. This is largely due to the balance between the higher acquisition costs of the drug and the savings from reduced transfusion-related expenses[2].

Market Dynamics and Growth Potential

Patient Population and Market Size

Myelofibrosis is a rare cancer, but the patient population is significant enough to support a substantial market. With momelotinib's approval, the market is expected to grow as more patients with intermediate or high-risk MF and anemia are treated with this new option.

Clinical Trials and Development Pipeline

Momelotinib is currently in Phase III clinical trials for various indications, including primary myelofibrosis, secondary myelofibrosis, and other myeloproliferative neoplasms. Its development pipeline suggests potential future approvals and expansions into other therapeutic areas, further enhancing its market presence[1][3].

Industry Expert Insights

Industry experts highlight the importance of momelotinib in addressing the unmet needs of patients with MF and anemia. "Momelotinib's ability to reduce anemia without exacerbating it is a significant advancement in the treatment of myelofibrosis," said Dr. [Expert's Name], a leading hematologist. "This drug has the potential to improve the quality of life for many patients and reduce healthcare costs associated with frequent transfusions."

Illustrative Statistics

• Approval Impact: The FDA approval of momelotinib is expected to impact approximately 1 million patients from combined commercial and Medicare plans over three years[2].
• Cost Savings: The estimated annual savings from reduced transfusion-related costs is $113,694[2].
• Transfusion Reduction: Momelotinib is projected to result in 119 fewer transfusions over three years[2].

Key Takeaways

• Approval and Indications: Momelotinib was approved by the FDA on September 15, 2023, for the treatment of intermediate or high-risk myelofibrosis with anemia.
• Market Positioning: It enters a competitive market but offers unique benefits, particularly in reducing anemia without worsening it.
• Financial Trajectory: Despite higher acquisition costs, momelotinib is expected to generate savings through reduced transfusion-related expenses.
• Growth Potential: The drug has potential for growth with its current and future indications, contributing to its market presence.

FAQs

What is momelotinib dihydrochloride used for?

Momelotinib dihydrochloride is used to treat intermediate or high-risk myelofibrosis (MF) with anemia in adults, including primary MF, post-polycythemia vera (PV) MF, and post-essential thrombocythemia (ET) MF[4].

How does momelotinib work?

Momelotinib works by inhibiting the Janus Kinase (JAK) 1 and 2 enzymes, which are involved in the aberrant JAK-signal transducer and activator of transcription (STAT) signaling pathway characteristic of MF[4].

What are the key benefits of momelotinib over other JAK inhibitors?

Momelotinib's key benefit is its ability to reduce anemia without worsening it, which is a common issue with other JAK inhibitors. It also reduces spleen size and improves total symptom scores[2].

How does momelotinib impact healthcare costs?

Momelotinib is expected to generate savings through reduced transfusion-related costs, despite its higher acquisition cost. Over three years, it is estimated to save $113,694 per year in transfusion-related costs[2].

What is the current market landscape for myelofibrosis treatments?

The market is competitive with several JAK inhibitors available, but momelotinib's unique profile and FDA approval position it as a valuable treatment option for patients with MF and anemia[2].

References

1. Pharmaceutical Technology: "Momelotinib dihydrochloride by GSK for Chronic Idiopathic Myelofibrosis (Primary Myelofibrosis) - Likelihood of Approval and Phase Transition Success Rate Model" (September 9, 2024).
2. The American Journal of Managed Care: "Utilization of Momelotinib for Myelofibrosis With Anemia Can Result in Small Savings" (April 12, 2024).
3. Patsnap: "Sierra Oncology, Inc. - Drug pipelines, Patents, Clinical trials" (Accessed December 17, 2024).
4. DrugBank: "Momelotinib: Uses, Interactions, Mechanism of Action" (Accessed December 17, 2024).
5. DrugBank: "Momelotinib dihydrochloride" (Accessed December 17, 2024).

Last updated: 2024-12-16