ENASIDENIB MESYLATE - Generic Drug Details

What are the generic sources for enasidenib mesylate and what is the scope of patent protection?

Enasidenib mesylate is the generic ingredient in one branded drug marketed by Bristol Myers Squibb and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Enasidenib mesylate has one hundred and eleven patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for ENASIDENIB MESYLATE

International Patents:	111
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	6
Patent Applications:	260
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENASIDENIB MESYLATE
What excipients (inactive ingredients) are in ENASIDENIB MESYLATE?	ENASIDENIB MESYLATE excipients list
DailyMed Link:	ENASIDENIB MESYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ENASIDENIB MESYLATE

Constraining patent/regulatory exclusivity:

9,732,062

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 ENASIDENIB MESYLATE

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

Sponsor	Phase
Children's Oncology Group	Phase 2
National Cancer Institute (NCI)	Phase 1
City of Hope Medical Center	Phase 1

See all ENASIDENIB MESYLATE clinical trials

Pharmacology for ENASIDENIB MESYLATE

Drug Class	Isocitrate Dehydrogenase 2 Inhibitor
Mechanism of Action	Isocitrate Dehydrogenase 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ENASIDENIB MESYLATE

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ENASIDENIB MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes	9,732,062			Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes	10,610,125
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes	10,093,654		Y	Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No	9,732,062			Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No	10,294,215		Y

International Patents for ENASIDENIB MESYLATE

Country	Patent Number	Title	Estimated Expiration
New Zealand	716226
Taiwan	201932455	Therapeutically active compounds and their methods of use
Lithuania	2800743
Taiwan	I666208
South Korea	20160037195	치료학적 활성 화합물 및 이의 사용방법 (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Ukraine	121021
Mexico	2020011397

ENASIDENIB MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Enasidenib Mesylate

Introduction to Enasidenib Mesylate

Enasidenib mesylate, marketed as IDHIFA, is a groundbreaking drug approved for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific mutation in the isocitrate dehydrogenase 2 (IDH2) gene. This mutation is present in approximately 12-20% of adult AML patients[4][5].

Approval and Initial Impact

Enasidenib mesylate was first approved by the U.S. Food and Drug Administration (FDA) on August 1, 2017. This approval marked a significant milestone as it was the first-in-class oral targeted inhibitor of mutant IDH2 for treating AML patients with this specific mutation. The drug demonstrated the ability to induce complete remission in some patients and reduce the need for red blood cell and platelet transfusions[1][4].

Market Size and Growth Projections

The global market for enasidenib mesylate has shown promising growth trends. As of 2023, the market was estimated to be worth approximately $78 million. However, it is forecasted to expand to $125.9 million by 2030, with a compound annual growth rate (CAGR) of 7.1% during the period from 2024 to 2030[3].

Key Drivers of Growth

Several factors are driving the growth of the enasidenib mesylate market:

• Expansion of Indications: The potential expansion of indications for already approved therapies is expected to contribute significantly to market growth. This includes exploring the drug's efficacy in other types of cancer beyond AML[1][5].
• Increased R&D Activities: Ongoing research and development activities by leading pharmaceutical companies such as Servier, Bayer, and others are likely to introduce new IDH inhibitors, further boosting the market[1].
• Clinical Trials and Regulatory Pathways: The regulatory pathway, although rigorous and involving extensive clinical trials, is expected to support the approval of new therapies, thereby expanding the market[1].

Competitive Landscape

The competitive landscape for IDH inhibitors, including enasidenib mesylate, is relatively sparse. This presents an opportunity for existing and new players to capture a significant market share. Bristol Myers Squibb, the primary player in the enasidenib mesylate market, continues to dominate, but other companies are also developing novel IDH inhibitors[1][3].

Challenges and Setbacks

Despite the positive growth projections, there have been some challenges and setbacks:

• Market Withdrawal in Canada: IDHIFA was withdrawn from the Canadian market on June 30, 2023, due to its failure to demonstrate improved overall survival (OS) compared to conventional care regimens in a Phase 3 confirmatory study. However, the safety profile of the drug remained unchanged[2].
• Clinical Trial Outcomes: The outcomes of clinical trials, such as the Phase 3 confirmatory study mentioned above, can significantly impact the market trajectory. Negative results can lead to reduced prescriptions and market share[2].

Financial Performance and Forecast

The financial performance of enasidenib mesylate is closely tied to its market size and growth projections. Here are some key financial metrics:

• Current Market Size: $78 million as of 2023[3].
• Forecasted Market Size: $125.9 million by 2030[3].
• CAGR: 7.1% from 2024 to 2030[3].

Revenue Segmentation

The revenue from enasidenib mesylate is segmented across various regions, including the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. The drug is also segmented by type (50mg and 100mg) and application (hospital and pharmacy settings)[3].

Regulatory and Clinical Considerations

The regulatory pathway for IDH inhibitors is stringent, involving extensive clinical trials to demonstrate safety and efficacy. For instance, enasidenib mesylate was approved under a Notice of Compliance with conditions (NOC/c) in Canada, which highlights the rigorous regulatory scrutiny these drugs undergo[2].

Clinical Trials and Ongoing Research

Enasidenib mesylate is being studied in various clinical trials to explore its efficacy in other types of cancer. These ongoing trials are crucial for expanding the drug's indications and enhancing its market potential[5].

Patient Selection and Treatment

Patients eligible for enasidenib mesylate treatment are selected based on the presence of IDH2 mutations in their blood or bone marrow. This targeted approach ensures that the drug is used effectively in the patient population that can benefit most from it[4][5].

Conclusion

The market dynamics for enasidenib mesylate are characterized by robust growth driven by the expansion of indications, increased R&D activities, and a relatively sparse competitive landscape. Despite some setbacks, such as the market withdrawal in Canada, the overall financial trajectory remains positive, with a forecasted market size of $125.9 million by 2030.

Key Takeaways

• Market Growth: The global market for enasidenib mesylate is projected to grow at a CAGR of 7.1% from 2024 to 2030.
• Current and Forecasted Market Size: The market was worth $78 million in 2023 and is expected to reach $125.9 million by 2030.
• Regulatory Considerations: The drug underwent rigorous clinical trials and regulatory scrutiny before approval.
• Competitive Landscape: The market is relatively sparse, with Bristol Myers Squibb being a key player.
• Challenges: Market withdrawal in Canada due to failure to demonstrate improved overall survival in a Phase 3 trial.

FAQs

What is enasidenib mesylate used for?

Enasidenib mesylate is used to treat adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific mutation in the isocitrate dehydrogenase 2 (IDH2) gene[4][5].

What is the current market size of enasidenib mesylate?

The global market for enasidenib mesylate was estimated to be worth approximately $78 million in 2023[3].

What is the forecasted market size of enasidenib mesylate by 2030?

The market is forecasted to reach $125.9 million by 2030, with a CAGR of 7.1% from 2024 to 2030[3].

Why was IDHIFA withdrawn from the Canadian market?

IDHIFA was withdrawn from the Canadian market due to its failure to demonstrate improved overall survival (OS) compared to conventional care regimens in a Phase 3 confirmatory study[2].

What are the key drivers of growth for the enasidenib mesylate market?

Key drivers include the expansion of indications, increased R&D activities, and a relatively sparse competitive landscape[1][3].

Sources

1. IDH Market Size Will Witness Robust Growth with Emerging Therapies by 2034 | DelveInsight
   • https://www.einpresswire.com/article/767728542/idh-market-size-will-witness-robust-growth-with-emerging-therapies-by-2034-delveinsight
2. Important Safety and Efficacy Information on IDHIFA® (Enasidenib Mesylate) – Market Withdrawal and Continued Access
   • https://www.bms.com/assets/bms/ca/documents/productinformation/IDHIFA_HPRC_EN.pdf
3. Enasidenib Drugs - Market, Report Size, Worth, Revenue, Growth
   • https://reports.valuates.com/market-reports/QYRE-Auto-38A12006/global-enasidenib-drugs-industry
4. Enasidenib: Uses, Interactions, Mechanism of Action - DrugBank
   • https://go.drugbank.com/drugs/DB13874
5. Enasidenib Mesylate - NCI
   • https://www.cancer.gov/about-cancer/treatment/drugs/enasidenibmesylate