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-nine patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for VORASIDENIB

International Patents:	99
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	14
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
Institut de Recherches Internationales Servier (I.R.I.S.)	PHASE2
Cooperative Trials Group for Neuro-Oncology (COGNO)	PHASE3
Canadian Cancer Trials Group	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	11,844,758
Servier	VORANIGO	vorasidenib	TABLET;ORAL	218784-001	Aug 6, 2024		RX	Yes	No	11,844,758
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	11,345,677		Y	Y
Servier	VORANIGO	vorasidenib	TABLET;ORAL	218784-002	Aug 6, 2024		RX	Yes	Yes	12,433,895
Servier	VORANIGO	vorasidenib	TABLET;ORAL	218784-001	Aug 6, 2024		RX	Yes	No	10,172,864		Y	Y
Servier	VORANIGO	vorasidenib	TABLET;ORAL	218784-002	Aug 6, 2024		RX	Yes	Yes	10,172,864		Y	Y

International Patents for VORASIDENIB

Country	Patent Number	Title	Estimated Expiration
Chile	2016000052	Compuestos terapéuticamente activos y sus métodos de uso
Brazil	112016000561	compostos terapeuticamente ativos e seus métodos de uso
Japan	6538037
Argentina	096902	DERIVADOS DE TRIAZINA Y PIRIMIDINA COMO INHIBIDORES DE LA IDH1 Y/O IDH2 MUTANTES Y SU USO EN EL TRATAMIENTO DEL CÁNCER
Costa Rica	20160069
Japan	2021501766	共結晶、その医薬組成物、およびそれを伴う治療方法
New Zealand	715717

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: February 15, 2026

Vorasidenib (AG-881) is an oral, brain-penetrant inhibitor targeting mutant IDH1 and IDH2 enzymes, developed primarily for glioma and other IDH-mutant cancers. Its clinical development and market potential are shaped by evolving therapeutic needs, regulatory pathways, and competitive landscape.

---

What is the Current Development Status of Vorasidenib?

Vorasidenib is in late-stage clinical trials focused on treating low-grade glioma (LGG) with IDH mutations. The pivotal trial, NCT04164901, evaluates its efficacy and safety, with topline data anticipated in 2023. No FDA approval has been granted as of Q1 2023.

What Is the Market Size for Vorasidenib?

The primary target is glioma with IDH mutations, notably low-grade gliomas. Key data points:

• Global glioma market (2022): Estimated at $600 million.
• IDH-mutant glioma segment: Accounts for approximately 60% of glioma cases, translating to a market potential of around $360 million.
• Growth projections: Expected to grow at a compound annual growth rate (CAGR) of 6.5% through 2028, driven by increased diagnosis rates and molecular-targeted therapies.

Additional factors expanding potential market include:

• US and Europe represent 75% of market share.
• Emerging markets forecast to contribute 20–25% growth by increasing diagnostic capabilities.

How Does Vorasidenib Compare to Competitors?

Vorasidenib faces competition from:

• IDH inhibitors approved for hematologic malignancies: Ivosidenib (IDH1) and Enasidenib (IDH2), but none are approved yet for glioma.

• Other experimental agents:

  • Ivosidenib and AG-120: Under investigation for glioma, with clinical trials indicating partial responses.
  • NCT02980987: Phase 1 trial of vorasidenib showed promising preliminary efficacy in glioma.

Vorasidenib's intracranial activity and dual inhibition offer an advantage over selective inhibitors. However, efficacy data from phase 3 trials are pending, which influences market entry timing and uptake.

What Are the Risks and Regulatory Factors?

• Clinical outcomes: The success depends on trial results showing improved progression-free survival (PFS) and overall survival (OS).
• Approval timelines: Anticipated in 2024–2025, contingent on trial data.
• Pricing and reimbursement: Orphan drug designations may enable premium pricing, but reimbursement depends on demonstrated cost-effectiveness.

What Are the Financial Trajectories for Vorasidenib?

Estimated revenues hinge on approval timelines, market penetration, and competition:

Year	Estimated Market Penetration	Projected Revenue (USD million)	Assumptions
2024	10% of target market	36	Launch following positive trial results
2025	25%	90	Expanding clinical data; increased adoption
2026	35%	126	Market expansion; health authority reimbursements
2027	50%	180	Growing clinical acceptance

These figures are predicated on:

• Successful regulatory approval by 2024.
• Favorable commercial uptake.
• No disruptive competition within the next 3–5 years.

What Are the Key Investment Considerations?

Vorasidenib's potential depends on:

• Final phase 3 trial data. Positive results could catalyze licensing agreements and partnerships.
• Geographic expansion into Asia Pacific and Latin America markets.
• Strategic alliances for distribution, especially if approved in multiple indications.

---

Key Takeaways

• Vorasidenib is in late-stage development for IDH-mutant gliomas, with regulatory approval expected around 2024–2025.
• The primary market centers on glioma, with potential for expansion into other IDH-mutant cancers.
• The competitive landscape favors agents with intracranial efficacy, but clinical trial outcomes will determine commercial viability.
• Revenue projections depend heavily on approval, market penetration, and reimbursement policies, with estimates reaching USD 180 million by 2027 under optimistic scenarios.
• The path to commercialization faces risks from ongoing clinical trials, regulatory hurdles, and market competition.

---

FAQs

1. When is vorasidenib expected to receive FDA approval?
Approval is anticipated between 2024 and 2025, contingent on phase 3 trial results demonstrating clinical benefit.

2. How does vorasidenib’s dual inhibition compare to other IDH inhibitors?
It targets both mutant IDH1 and IDH2, offering broadened activity in gliomas, unlike selective inhibitors like ivosidenib.

3. What are the primary challenges to vorasidenib’s market success?
Clinical efficacy validation, regulatory approvals, competition from other agents, and reimbursement strategies.

4. Which geographic markets hold the most potential?
North America and Europe dominate with early adoption, while Asia Pacific and Latin America show growth opportunities with increased diagnostics.

5. Will vorasidenib be used in cancers other than gliomas?
Potentially, if clinical trials in other IDH-mutant tumors (leukemia, cholangiocarcinoma) demonstrate efficacy, global indications could expand.

---

References

1. ClinicalTrials.gov. NCT04164901 – Vorasidenib in low-grade glioma.
2. MarketWatch. Glioma market analysis, 2022.
3. EvaluatePharma. Oncology drug forecasts, 2022.
4. FDA. Orphan drug designation policies.
5. BioCentury. IDH inhibitor pipeline, 2023.