VORANIGO Drug Patent Profile

Which patents cover Voranigo, and what generic alternatives are available?

Voranigo is a drug marketed by Servier and is included in one NDA. There are four patents protecting this drug.

This drug has ninety-two patent family members in thirty-six countries.

The generic ingredient in VORANIGO is vorasidenib. One supplier is listed for this compound. Additional details are available on the vorasidenib profile page.

DrugPatentWatch^® Generic Entry Outlook for Voranigo

Voranigo will be eligible for patent challenges on August 6, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 6, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VORANIGO

International Patents:	92
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in VORANIGO?	VORANIGO excipients list
DailyMed Link:	VORANIGO at DailyMed

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

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

NDA:

218784

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.

US Patents and Regulatory Information for VORANIGO

VORANIGO is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	218784-001	Aug 6, 2024		RX	Yes	No	11,844,758
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	9,579,324			Y
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

International Patents for VORANIGO

See the table below for patents covering VORANIGO around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	7499377
Ukraine	122387	ТЕРАПЕВТИЧНО АКТИВНІ СПОЛУКИ ТА СПОСОБИ ЇХ ЗАСТОСУВАННЯ (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Japan	2021501766	共結晶、その医薬組成物、およびそれを伴う治療方法
Peru	20160524	COMPUESTOS TERAPEUTICAMENTE ACTIVOS Y SUS METODOS DE USO
Taiwan	201524964	Therapeutically active compounds and their methods of use

VORANIGO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Voranigo

Introduction to Voranigo

Voranigo, developed by Agios Pharmaceuticals and now owned by Servier Pharmaceuticals, is a groundbreaking drug that has recently received FDA approval for the treatment of patients with grade 2 gliomas carrying mutations in the IDH gene. This approval marks a significant milestone in cancer care, particularly for those affected by IDH-mutant glioma.

Clinical Significance and Market Need

Voranigo is the first targeted and systemic therapy for patients with grade 2 astrocytoma or oligodendroglioma with susceptible IDH1 or IDH2 mutations. The drug's approval is backed by data from the Phase III INDIGO study, which demonstrated a clinically meaningful improvement in progression-free survival versus placebo, reducing the risk of progression or death by 61%[4].

This therapeutic advancement fills a critical gap in the treatment landscape for glioma patients, who have had limited options for over two decades. The strong clinical data supporting Voranigo's approval positions it as a game-changer in the field of oncology.

Market Potential and Projections

The market potential for Voranigo is substantial. Royalty Pharma, which acquired the royalty rights to Voranigo, projects that the drug will achieve peak annual sales of over $1 billion, generating more than $150 million in annual royalties[1].

The global personalized medicine market, within which Voranigo operates, is expected to grow significantly. By 2026, this market is projected to reach $2.45 trillion, with a compound annual growth rate (CAGR) of 11.5%[3].

Financial Trajectory

Milestone Payments and Royalties

The FDA approval of Voranigo triggers several significant financial milestones. Servier is obligated to pay Agios a $200 million milestone payment upon approval. Additionally, Agios will receive a $905 million payment from Royalty Pharma, which had previously acquired the royalty rights to Voranigo. Agios retains a 3% royalty entitlement on annual net sales of Voranigo that exceed $1 billion[1][4].

Pricing and Revenue Expectations

Voranigo is priced at $39,881 per month, translating to $478,572 annually. Servier is working with commercial and government payers to ensure strong coverage based on the robust clinical data supporting the drug's approval. This pricing strategy, combined with the drug's efficacy and market demand, is expected to drive substantial revenue[1].

Impact on Servier and Agios

For Servier, the approval of Voranigo represents a major success, particularly given the company's strategic shift towards rare diseases. The acquisition of Agios's oncology business in 2021 for $1.8 billion has proven to be a lucrative move, with Voranigo being a key asset in this portfolio[1].

For Agios, the milestone payments and ongoing royalties from Voranigo sales will provide a significant financial boost. This aligns with Agios's strategy of monetizing its assets through royalty deals, as seen with previous transactions involving Idhifa and Tibsovo[1].

Companion Diagnostics and Market Access

Servier is collaborating with Thermo Fisher Scientific to develop a companion diagnostic to identify patients eligible for Voranigo treatment. This strategic partnership will enhance the drug's market access by ensuring that only patients who are likely to benefit from the treatment receive it, thereby optimizing its therapeutic impact and cost-effectiveness[1].

Competitive Landscape

Voranigo's approval sets a new standard in the treatment of IDH-mutant gliomas, making it a leader in this niche market. The drug's unique mechanism of action as a brain-penetrant small molecule inhibitor of the IDH1 and IDH2 enzyme differentiates it from other treatments. Servier's commitment to researching the applicability of IDH-mutant inhibition in other cancers further solidifies its competitive position[1][4].

Future Development and Expansion

Beyond its current indication, Servier is exploring the potential of vorasidenib (Voranigo's active ingredient) in other solid tumors, either alone or in combination with other therapies such as Merck’s Keytruda (pembrolizumab). This expansion strategy could further broaden the market reach and revenue potential of Voranigo[4].

Key Takeaways

• FDA Approval: Voranigo is the first targeted therapy approved for grade 2 IDH-mutant glioma.
• Market Potential: Projected peak annual sales of over $1 billion and significant royalties.
• Financial Milestones: $200 million milestone payment to Agios and $905 million payment from Royalty Pharma.
• Pricing: $39,881 per month, with strong coverage expected from payers.
• Companion Diagnostics: Collaboration with Thermo Fisher Scientific to enhance market access.
• Competitive Advantage: Unique mechanism of action and strong clinical data differentiate Voranigo in the market.
• Future Development: Potential expansion into other solid tumors and combination therapies.

FAQs

Q: What is Voranigo, and what is it used for? A: Voranigo is an oral treatment approved by the FDA for the treatment of patients with grade 2 gliomas carrying mutations in the IDH gene.

Q: Who developed Voranigo, and who owns it now? A: Voranigo was originally developed by Agios Pharmaceuticals and is now owned by Servier Pharmaceuticals after Agios sold its oncology business to Servier in 2021.

Q: What are the financial projections for Voranigo? A: Voranigo is projected to achieve peak annual sales of over $1 billion, generating more than $150 million in annual royalties.

Q: How much does Voranigo cost, and what is the pricing strategy? A: Voranigo is priced at $39,881 per month, or $478,572 annually. Servier is working with payers to ensure strong coverage.

Q: What are the future development plans for Voranigo? A: Servier is exploring the use of vorasidenib (Voranigo's active ingredient) in other solid tumors, either alone or in combination with other therapies.

Cited Sources

1. MedCity News: "Big Servier Acquisition Pays Off as FDA Approves Drug for Two Types of Brain Cancer"[1]
2. BioSpace: "Servier Gets FDA Approval for First Targeted Therapy for Grade 2 IDH-Mutant Glioma"[4]
3. DCF.FM: "Vor Biopharma Inc. (VOR) - VRIO Analysis"[3]
4. Royalty Pharma: "Royalty Pharma Reports Third Quarter 2024 Results"[5]