Vorasidenib - Generic Drug Details

What are the generic drug sources for vorasidenib and what is the scope of patent protection?

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

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

One supplier is listed for this compound.

Summary for vorasidenib

International Patents:	96
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	6
Patent Applications:	35
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
Servier Bio-Innovation LLC	Phase 1
Katy Peters, MD, PhD	Phase 1
Servier	Phase 1

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
Servier	VORANIGO	vorasidenib	TABLET;ORAL	218784-002	Aug 6, 2024		RX	Yes	Yes

International Patents for vorasidenib

Country	Patent Number	Title	Estimated Expiration
Lithuania	3019483
South Africa	201600667	THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Philippines	12021551649	THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE

Market Dynamics and Financial Trajectory for Vorasidenib

Introduction to Vorasidenib

Vorasidenib, developed by Servier, is a groundbreaking oral, selective dual inhibitor targeting mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes. This drug is specifically designed for treating IDH-mutant diffuse glioma, a malignant and incurable brain tumor. Here, we delve into the market dynamics and financial trajectory of vorasidenib.

Market Growth and Potential

The IDH inhibitor market, where vorasidenib is poised to make a significant impact, is anticipated to exhibit substantial growth. According to DelveInsight's analysis, the IDH inhibitor market is expected to grow at a significant Compound Annual Growth Rate (CAGR) by 2034. This growth is driven by the increasing occurrence of IDH-mutated cancers and the rising adoption of targeted therapies like vorasidenib[1].

Regulatory Milestones

Vorasidenib has recently achieved several critical regulatory milestones. In February 2024, the FDA and EMA accepted the regulatory submissions for vorasidenib, with the FDA assigning a Prescription Drug User Fee Act (PDUFA) action date of August 20, 2024. The European Commission's approval is anticipated in the second half of 2024. Additionally, vorasidenib was granted Fast Track Designation (FTD) by the FDA in February 2023 and Breakthrough Therapy Designation, highlighting its potential as a breakthrough treatment[1].

Clinical Trials and Efficacy

The Phase III INDIGO clinical trial demonstrated the efficacy of vorasidenib in patients with residual or recurrent IDH mutant low-grade glioma. The trial achieved its primary endpoint of progression-free survival (PFS) and the key secondary endpoint of time to the next intervention. The median PFS was 27.7 months with vorasidenib compared to 11.1 months with the placebo, indicating a significant improvement in patient outcomes[4].

Financial Projections and Deals

The financial trajectory of vorasidenib is promising, with several significant deals and projections. Agios Pharmaceuticals, the original developer of vorasidenib, sold the rights to this drug to Servier as part of a larger deal in 2020. Recently, Agios agreed to sell the royalty rights on vorasidenib to Royalty Pharma for $905 million, with Royalty Pharma expecting the drug to generate over $1 billion in annual U.S. sales and more than $150 million in yearly royalties. This deal is expected to provide a substantial royalty stream through 2038[3].

Market Impact and Competition

Vorasidenib is set to transform the IDH inhibitors market landscape by offering the first targeted therapy for IDH-mutant diffuse glioma. This will not only expand the treatment options for patients but also create new standards of care. Other key players in the IDH inhibitor market include Bayer with BAY1436032 and existing drugs like TIBSOVO (ivosidenib) and IDHIFA (enasidenib mesylate). The market dynamics are expected to be highly competitive, with multiple companies vying for market share through innovative therapies and strategic partnerships[1].

Servier's Financial Performance and Ambitions

Servier, the company behind vorasidenib, has shown significant financial growth and ambition. For the 2022-2023 financial year, Servier's consolidated revenue increased by 9.2% to €5.327 billion, driven by a 48.1% increase in sales volume for oncology drugs like Tibsovo. Servier aims to reach €6 billion in revenue by 2025 and €8 billion by 2030, with an EBITDA margin of over 30%. The success of vorasidenib will be crucial in achieving these targets, especially given the growing importance of oncology revenues, which now account for 20.2% of Servier's consolidated revenue[2].

Global Sales and Revenue Projections

Given the FDA and EMA approvals anticipated in 2024, vorasidenib is expected to generate substantial revenue globally. Royalty Pharma's projections indicate that the drug could achieve over $1 billion in annual U.S. sales, with significant royalties expected. This revenue will contribute to Servier's overall financial performance and help the company achieve its ambitious targets[3].

Conclusion

Vorasidenib is poised to be a game-changer in the treatment of IDH-mutant diffuse glioma, with significant market and financial implications. The drug's strong clinical performance, coupled with favorable regulatory milestones and substantial financial projections, positions it as a key player in the evolving IDH inhibitor market. As the market continues to grow, vorasidenib is expected to play a pivotal role in transforming the treatment landscape for patients with IDH-mutated cancers.

Key Takeaways

• Market Growth: The IDH inhibitor market is expected to grow significantly, driven by the increasing occurrence of IDH-mutated cancers.
• Regulatory Approvals: Vorasidenib has received key regulatory approvals and designations, including FDA and EMA submissions.
• Clinical Efficacy: The drug has shown significant improvements in progression-free survival in clinical trials.
• Financial Projections: Vorasidenib is projected to generate over $1 billion in annual U.S. sales and substantial royalties.
• Market Impact: It will be the first targeted therapy for IDH-mutant diffuse glioma, transforming the treatment landscape.
• Company Performance: Servier's financial growth and ambitions are closely tied to the success of vorasidenib.

FAQs

What is vorasidenib, and what is it used for?

Vorasidenib is an oral, selective dual inhibitor targeting mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes, used for treating IDH-mutant diffuse glioma.

What are the key regulatory milestones for vorasidenib?

Vorasidenib has received FDA and EMA regulatory submissions, with an FDA PDUFA action date of August 20, 2024, and anticipated European Commission approval in the second half of 2024.

How effective is vorasidenib in clinical trials?

In the Phase III INDIGO trial, vorasidenib achieved a median progression-free survival of 27.7 months compared to 11.1 months with the placebo, indicating significant efficacy.

What are the financial projections for vorasidenib?

Vorasidenib is projected to generate over $1 billion in annual U.S. sales and more than $150 million in yearly royalties, providing a substantial revenue stream through 2038.

Who are the key players involved in the development and marketing of vorasidenib?

The key players include Servier, the developer and marketer, and Agios Pharmaceuticals, the original developer. Royalty Pharma has also acquired royalty rights to the drug.

Cited Sources

1. GlobeNewswire: "IDH Inhibitor Market to Exhibit Significant Growth Rate During the Study Period 2020-2034 - DelveInsight" (July 29, 2024)
2. Servier: "Servier confirms its 2025 trajectory to achieve its 2030 ambition" (February 7, 2024)
3. BioPharma Dive: "Agios cashes in on cancer drug again with $905M Royalty Pharma deal" (May 28, 2024)
4. OncLive: "Vorasidenib Breaks Through as the First Systemic Therapy for Select Patients With Glioma" (September 6, 2024)

Last updated: 2024-12-17