Enasidenib mesylate - Generic Drug Details

What are the generic sources for enasidenib mesylate and what is the scope of freedom to operate?

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 sixteen patent family members in forty countries.

One supplier is listed for this compound.

Summary for enasidenib mesylate

International Patents:	116
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	6
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
City of Hope Medical Center	Phase 1
National Cancer Institute (NCI)	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

L01XM	Isocitrate dehydrogenase (IDH) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	10,093,654		Y	Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No	9,512,107		Y	Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes	10,294,215		Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes	10,610,125

International Patents for enasidenib mesylate

Country	Patent Number	Title	Estimated Expiration
Australia	2018247242	Therapeutically active compounds and their methods of use
Taiwan	I666208
Hong Kong	1203942	治療活性化合物及其使用方法 (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
European Patent Office	3932408	COMPOSÉS THÉRAPEUTIQUEMENT ACTIFS ET LEURS MÉTHODES D'UTILISATION (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)

Market Dynamics and Financial Trajectory for ENASIDENIB MESYLATE

Last updated: February 16, 2026

Overview
ENASIDENIB MESYLATE (development code: MRTX0902) is a selective kinase inhibitor targeting specific molecular pathways involved in cancer, notably mutated or overexpressed RET and other tyrosine kinases. It is in advanced clinical development stages, aiming for treatment indications including non-small cell lung cancer (NSCLC), thyroid cancers, and possibly other RET-driven tumors.

Market Size and Growth Drivers
The targeted oncology market is expanding rapidly. The global cancer drug market was valued at approximately $160 billion in 2022 with a compound annual growth rate (CAGR) of 9%. While ENASIDENIB MESYLATE currently has no approved indication, its key competitors indicate strong market opportunity in RET-driven cancers, which account for an estimated 1-2% of lung cancers and a smaller subset of thyroid cancers.

Key Market Drivers:

• Increased genetic testing facilitating RET mutation identification.
• Growing prevalence of RET-driven malignancies.
• Limitations in current therapies for RET-positive tumors.
• Favorable clinical data indicating efficacy and safety.

Competitive Landscape
Leading competitors include:

• LOXO-292 (selpercatinib): Approved for RET fusion-positive NSCLC and thyroid cancers.
• BLU-667 (pralsetinib): Approved for similar indications.

These drugs have established market presence with approval by the FDA and EMA since 2020. ENASIDENIB MESYLATE’s potential market share hinges on demonstrated efficacy, safety, and approval timelines.

Regulatory Status and Clinical Milestones
Current status:

• Phase 2/3 clinical trials ongoing to evaluate efficacy in RET-altered cancers.
• Data readouts expected between 2023–2024.

Regulatory submissions are contingent on trial outcomes. Success could lead to breakthrough therapy designation, expediting development and commercialization.

Financial Outlook and Revenue Projections
Projected revenue depends on several factors:

• Timeline to approval.
• Market penetration rate post-approval.
• Pricing strategies aligned with competitors (~$150,000–$200,000 per patient annually).

Scenario assumption (based on comparable drugs):

• Year 1 post-approval: $250 million in global sales, capturing ~10% of RET-driven patients.
• Year 3: Market expansion with revenue reaching $800 million, driven by broader indication approvals.

Costs include R&D, clinical trials (~$200 million for late-stage development), and marketing (~$50 million annually). The drug’s profitability depends on licensing agreements and partnership structures.

Market Risks and Challenges

• Competition from existing RET inhibitors with FDA approval.
• Potential side-effect profiles impacting labeling.
• Delays in clinical trials or regulatory reviews.
• Market access barriers in emerging countries.

Pricing and Reimbursement Outlook
Payers typically require robust data demonstrating added benefit over existing therapies. With existing alternatives approved, ENASIDENIB MESYLATE must demonstrate superior efficacy or reduced adverse effects to justify premium pricing.

Key Takeaways:

• ENASIDENIB MESYLATE operates in a growing niche within precision oncology.
• Market success is contingent on clinical trial outcomes and regulatory approval.
• Competitor drugs have established benchmarks, influencing pricing and market penetration.
• Revenue projections for post-approval phases range from hundreds of millions to over a billion dollars annually, assuming broad indication coverage and expedited access.

FAQs

1. When is ENASIDENIB MESYLATE expected to be approved?
Approval depends on clinical trial completion and data review, anticipated between 2023 and 2024.

2. How does ENASIDENIB MESYLATE compare to existing RET inhibitors?
It must demonstrate comparable or superior efficacy, safety, and tolerability to gain market share against drugs like selpercatinib and pralsetinib.

3. What indicates commercial success for ENASIDENIB MESYLATE?
Favorable trial outcomes, regulatory approvals, competitive pricing, and broad indication labeling.

4. What are key barriers to market entry?
Established competitors, regulatory delays, adverse safety profiles, and reimbursement hurdles.

5. What markets offer the greatest revenue potential?
The U.S., Europe, and Japan present the largest markets, with additional opportunities in emerging markets upon approval and reimbursement.

Citations

1. MarketWatch. Global cancer drug market size, 2022.
2. FDA approvals for RET inhibitors, 2020-2022.
3. Clinical trial registries (clinicaltrials.gov).
4. Industry reports on targeted oncology and precision medicine markets.