VORASIDENIB - Generic Drug Details

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

Vorasidenib is the generic ingredient in one branded drug marketed by Servier and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vorasidenib has ninety-eight patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for VORASIDENIB

International Patents:	98
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	13
Patent Applications:	1,220
What excipients (inactive ingredients) are in VORASIDENIB?	VORASIDENIB excipients list
DailyMed Link:	VORASIDENIB at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH GRADE 2 ASTROCYTOMA OR OLIGODENDROGLIOMA WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) OR ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION FOLLOWING SURGERY INCLUDING BIOPSY, SUB-TOTAL RESECTION, OR GROSS TOTAL RESECTION

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 VORASIDENIB

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

Sponsor	Phase
Canadian Cancer Trials Group	PHASE3
European Organisation for Research and Treatment of Cancer - EORTC	PHASE3
Cooperative Trials Group for Neuro-Oncology (COGNO)	PHASE3

See all VORASIDENIB clinical trials

Pharmacology for VORASIDENIB

Drug Class	Isocitrate Dehydrogenase 1 Inhibitor Isocitrate Dehydrogenase 2 Inhibitor
Mechanism of Action	Cytochrome P450 3A Inducers Isocitrate Dehydrogenase 1 Inhibitors Isocitrate Dehydrogenase 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for VORASIDENIB

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

US Patents and Regulatory Information for VORASIDENIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Servier	VORANIGO	vorasidenib	TABLET;ORAL	218784-002	Aug 6, 2024		RX	Yes	Yes
Servier	VORANIGO	vorasidenib	TABLET;ORAL	218784-002	Aug 6, 2024		RX	Yes	Yes			Y	Y
Servier	VORANIGO	vorasidenib	TABLET;ORAL	218784-001	Aug 6, 2024		RX	Yes	No
Servier	VORANIGO	vorasidenib	TABLET;ORAL	218784-001	Aug 6, 2024		RX	Yes	No

International Patents for VORASIDENIB

Country	Patent Number	Title	Estimated Expiration
Chile	2017000554
Israel	243494	תרכובות מדכאי איזוציטראט דיהידרוגנאז מוטאנטיות, תכשירים המכילים אותן ושימושים בהן (Mutant isocitrate dehydrogenase inhibitor compounds, compositions comprising same and uses thereof)
South Korea	20160030403	치료학적 활성 화합물 및 이들의 사용 방법 (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Japan	2024057088

Supplementary Protection Certificates for VORASIDENIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3019483	C03019483/01	Switzerland		PRODUCT NAME: VORASIDENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69364 15.11.2024

Market Dynamics and Financial Trajectory for Vorasidenib

Last updated: July 29, 2025

Introduction

Vorasidenib, an investigational oral small-molecule inhibitor targeting mutant IDH1 and IDH2 enzymes, has garnered significant attention within the oncology therapeutic landscape. As a potent agent designed to treat IDH-mutant gliomas, its development reflects growing emphasis on precision medicine for brain cancers. This analysis explores the current and projected market dynamics, investment considerations, competitive landscape, and financial trajectory of vorasidenib, with emphasis on factors influencing its commercial potential.

Pharmacological Profile and Therapeutic Context

Vorasidenib (AG-881) functions by selectively inhibiting mutant isocitrate dehydrogenase enzymes, disrupting oncogenic metabolic pathways. Autochthonous to gliomas with IDH1/2 mutations—particularly low-grade gliomas and some high-grade gliomas—its mechanism offers a targeted approach that could overhaul treatment paradigms for this niche. The evolving understanding of glioma molecular classification enhances the potential for vorasidenib’s clinical success, as ongoing trials aim to establish its efficacy and safety profile (clinicaltrials.gov).

Market Size and Segmentation

Prevalence and Incidence

Gliomas account for approximately 30% of all brain and central nervous system tumors, with IDH mutations present in up to 70-80% of low-grade gliomas [1]. Globally, the annual incidence of gliomas is approximately 6 per 100,000, translating into thousands of newly diagnosed cases annually. The subset with IDH mutations presents a smaller but significant patient pool, predominantly comprising adults aged 30-50.

Unmet Medical Need

Current treatments involve surgical resection, radiotherapy, and temozolomide-based chemotherapies. Despite these modalities, gliomas have limited durable responses, and recurrence is common. The targeted action of vorasidenib holds promise for improved progression-free survival (PFS) and overall survival (OS), filling a critical therapeutic gap.

Market Segmentation

The primary market includes adults diagnosed with IDH-mutant gliomas, encompassing:

• Low-grade gliomas (WHO grade II)
• Certain high-grade gliomas (e.g., glioblastoma with IDH mutation)
• Relapsed or refractory disease settings

Secondary markets may emerge if further indications are identified or if the agent demonstrates efficacy in other IDH-mutant tumors.

Regulatory Landscape and Developmental Milestones

Vorasidenib has demonstrated promising results in Phase I/II trials, with ongoing Phase III studies such as INDIGO aiming to confirm clinical benefits [2]. The regulatory pathway is influenced by the orphan status of low-grade gliomas and unmet Medical Need, potentially accelerating market entry through mechanisms like accelerated approval or breakthrough therapy designation, depending on trial outcomes.

Competitive Landscape

Major competitors include other IDH inhibitors such as Ivosidenib (AG-120) and Enasidenib (AG-221), approved for AML but investigated for gliomas. The primary differentiation of vorasidenib lies in its dual inhibition profile and potential clinical efficacy. Additional competition may arise from emerging agents targeting glioma-specific pathways or combination regimens involving immunotherapy.

Key companies:

• Agios Pharmaceuticals, developer of vorasidenib
• Novartis and Bayer exploring IDH inhibitor indications
• Emerging biotech firms focusing on glioma-specific targeted therapies

Market Dynamics Factors

Clinical Efficacy and Safety

Phase I/II trials suggest manageable safety profiles and preliminary efficacy signals, critical for clinician adoption and payer reimbursement. Demonstrating significant PFS and OS benefits will be essential for market penetration.

Regulatory Approvals and Reimbursement

Approval by agencies such as the FDA and EMA will catalyze commercialization. Reimbursement strategies hinge on demonstrating substantial clinical benefits and cost-effectiveness. Value-based pricing models can influence access and revenue streams.

Physician Adoption and Prescription Dynamics

Neurologists and neuro-oncologists' familiarity, clinical guidelines incorporation, and patient advocacy influence prescribing patterns. Early engagement through scientific publications and conferences will be pivotal.

Manufacturing and Supply Chain

Reliable, scalable manufacturing processes ensure consistent supply, minimize costs, and support global distribution. The complexity of formulation and stability considerations impact market readiness.

Market Entry Challenges

Potential hurdles include:

• Delays in trial completion
• Regulatory uncertainties
• Competition from other therapies
• Limited awareness among clinicians initially

Financial Trajectory and Investment Outlook

Revenue Projections

Based on comparable targeted oncology agents, initial annual revenues could range from $50 million to $200 million upon market approval, influenced by:

• Indication breadth
• Competition intensity
• Pricing strategies
• Reimbursement frameworks

Long-term revenues may reach $500 million or more if vorasidenib secures broader indications and demonstrates durable benefits.

Profitability and Investment Risks

High R&D costs are typical at advanced stages; however, successful approval could generate substantial ROI, particularly if label extension or combination therapies enhance its utility. Risks include clinical trial failures, regulatory delays, or insufficient market uptake.

Market Penetration and Growth Drivers

• Most significant growth emerges if vorasidenib becomes a standard of care in front-line or recurrent settings.
• Expansion into other IDH-mutant cancers (e.g., cholangiocarcinoma, AML) could diversify revenue.
• Strategic alliances or licensing agreements may accelerate global expansion.

Future Market Outlook

The global oncology therapeutics market is projected to grow at a CAGR of over 7% in the next decade, driven by precision medicine and targeted therapies (Fortune Business Insights). Vorasidenib’s niche positioning positions it as a potentially lucrative asset within this growth trajectory, contingent on positive trial outcomes and regulatory success.

Key Factors Influencing Financial Success

• Speed and success of clinical trials
• Regulatory pathway efficiency
• Effective commercial strategy
• Competitive pressures
• Reimbursement and pricing negotiations

Conclusion

Vorasidenib’s potential hinges on its clinical trial outcomes, regulatory pathway, and ability to capture and sustain market share in a highly specialized but underserved segment. Strategic positioning, stakeholder engagement, and ongoing trials will shape its financial trajectory, with promising prospects if early data translates into durable clinical benefits.

Key Takeaways

• Vorasidenib targets a significant unmet need in IDH-mutant gliomas, promising a niche market with growth potential.
• Developmental progress and clinical trial success are critical for regulatory approval, shaping early market entry and revenue prospects.
• Competitive differentiation depends on demonstrating superior efficacy, safety, and biomarker-driven patient selection.
• Market dynamics are influenced by evolving treatment guidelines, clinician adoption, and reimbursement policies.
• Long-term financial success hinges on trial outcomes, regulatory approval, and expanding indications.

FAQs

1. What is the current clinical development stage of vorasidenib?
   Vorasidenib is in Phase III clinical trials, specifically the INDIGO study, designed to evaluate its efficacy in treating IDH-mutant gliomas.

2. What are the main challenges for vorasidenib’s market entry?
   Challenges include demonstrating significant clinical benefits, navigating regulatory requirements, clinician adoption, and competing targeted therapies.

3. How significant is the market for IDH-mutant gliomas?
   Though relatively niche, the market is sizable within neuro-oncology, with thousands of annual cases globally, and an urgent need for effective targeted treatments.

4. Could vorasidenib be used for other cancers?
   Potential exists for expansion into other IDH-mutant malignancies such as cholangiocarcinoma and AML, pending clinical data.

5. What strategies can enhance vorasidenib’s commercial success?
   Successful trial outcomes, strategic partnerships, early clinician engagement, patient advocacy, and favorable reimbursement negotiations are crucial.

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References

[1] Louis, D. N., Perry, A., Reifenberger, G., et al. (2016). The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathologica, 131(6), 803-820.

[2] ClinicalTrials.gov. (2023). Study of Vorasidenib (AG-881) for the Treatment of Glioma. Retrieved from https://clinicaltrials.gov/ct2/show/NCT04164901