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 five patents protecting this drug.

This drug has one hundred and four patent family members in forty-one 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 July 11, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VORANIGO

International Patents:	104
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	844
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:

10,172,864

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.

Pharmacology for VORANIGO

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

US Patents and Regulatory Information for VORANIGO

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

This potential generic entry date is based on patent 10,172,864.

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	218784-001	Aug 6, 2024		RX	Yes	No
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 VORANIGO

When does loss-of-exclusivity occur for VORANIGO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

San Marino

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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

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

Country	Patent Number	Title	Estimated Expiration
Argentina	096902
Argentina	131555
Australia	2014289744
Australia	2019201179

Supplementary Protection Certificates for VORANIGO

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
3019483	C20265008	Finland
3019483	301370	Netherlands		PRODUCT NAME: VORASIDENIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/25/1912 20250919
3019483	CR 2026 00011	Denmark		PRODUCT NAME: VORASIDENIB ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/25/1912 20250919

Last updated: June 18, 2026

VORANIGO market dynamics and financial trajectory (2024–2026)

Voranigo (vorasidenib) is positioned as an oral targeted therapy for glioma, with revenue trajectory driven by U.S. uptake after FDA approvals, center adoption among neuro-oncology prescribers, payer coverage outcomes, and exclusivity/patent overhang for competing IDH inhibitors. Near-term sales are most sensitive to (1) speed of formulary placement for Medicare and commercial plans, (2) alignment of dosing and monitoring workflows in real-world practice, and (3) sequencing against existing IDH-targeted agents and chemoradiation in earlier- versus later-line treatment settings. Financial trajectory is constrained by the typical launch ramp pattern for precision oncology drugs plus post-launch demand shocks from competing trial readouts and label expansions that reallocate treatment share.

What is Voranigo (vorasidenib) and how is it used in glioma care?

Voranigo is vorasidenib, a small-molecule IDH inhibitor used in glioma settings defined by its regulatory labels. Market dynamics for an IDH inhibitor are shaped by how clinicians choose targeted therapy relative to standard-of-care (surgery, radiation, temozolomide, and maintenance) and by whether the label supports earlier-line adoption or is confined to post-progression use.

What glioma populations drive prescriptions for IDH inhibitors?

The revenue pool for IDH inhibitors typically depends on:

• Molecularly confirmed IDH mutation status (diagnostic testing penetration).
• Tumor location, grade, and line of therapy eligibility.
• Treatment goals (delaying progression vs shrinking tumors).
• Local practice guidelines and neuro-oncology center experience.

How does oral administration change payer and patient adoption?

Oral oncology agents face distinct market dynamics:

• Pharmacy benefit coverage and prior authorization burden.
• Patient assistance program design and affordability outcomes.
• Adherence and persistence, tied to tolerability and monitoring requirements.

How do launch dynamics and adoption curves affect Voranigo revenue?

Precision oncology launches follow predictable adoption phases: initial prescriber concentration, then broader center and health-system penetration as formularies open and real-world pathways stabilize.

Key adoption levers for Voranigo

• Diagnostic workflow maturity: IDH test availability and turnaround times.
• Real-world tolerability and dose management: adverse event profiles influence discontinuation.
• Physician confidence: familiarity with response monitoring and imaging intervals.
• Payer coverage speed: time to formulary placement is a primary driver of early net-to-gross.

Financial trajectory markers investors track

• Growth in treated patients by line-of-therapy, not just prescriptions.
• Persistence and discontinuation rates at 3 and 6 months.
• Share shifts among IDH inhibitors and broader glioma regimens.
• Contracting outcomes: rebates tied to outcomes or tier placement.

What patents protect VORANIGO (vorasidenib) and how strong is the estate?

The commercial durability of Voranigo depends on patent term, exclusivity linkages to FDA approvals, and the scope of claims around:

• Active ingredient (composition of matter) protection.
• Drug substance or formulation (salt form, polymorph, dosage form, stability).
• Manufacturing process (crystallization, purification, scale-up controls).
• Method-of-use claims (specific glioma populations or endpoints).

How strong is patent protection in small-molecule precision oncology?

In small-molecule categories, the estate usually concentrates in:

• Composition of matter patents (longest runway).
• Additional patents on formulation and methods (incremental barriers to entry).
• Potential “late” patents covering pediatric or specific use expansions.

What is the entry risk from generics or “authorized” competitors?

For a covered small molecule, generic entry risk is shaped by:

• Whether patents are listed in the FDA Orange Book and which listed patents are challenged.
• Whether the label is narrow enough that paragraph IV challenges are less attractive.
• Whether manufacturing/IP barriers raise switching costs for payers.

When does VORANIGO lose exclusivity?

Exclusivity timing is determined by:

• Patent expiration dates for composition and secondary patents.
• FDA exclusivity (if applicable to the approval type).
• Data and marketing exclusivity windows that delay FDA approvals even without patent barriers.

How to model “effective exclusivity” for revenue planning

Revenue planners typically model effective loss as the later of:

• Statutory exclusivity expiration, and
• Patent expiration for the last materially enforceable Orange Book-listed claim.

Which companies could challenge VORANIGO with a generic or biosimilar pathway?

Vorasidenib is a small molecule; biosimilar pathways are not applicable. Competitive entry instead hinges on generic small-molecule submissions via ANDA-type routes, including paragraph IV certification strategies that target specific Orange Book-listed patents.

What drives the likelihood of paragraph IV challenges?

• Patent list density and claim strength for the listed weak points.
• Expected launch competition from other IDH inhibitors.
• Contract leverage and ability to negotiate authorized supply.
• Litigation settlement economics and probability of stay.

What generic entry risks exist for VORANIGO?

Generic entry risk is assessed across three dimensions:

1. Legal: number of asserted Orange Book patents and likelihood of injunction.
2. Regulatory: labeling latitude and whether a competitor can file promptly.
3. Commercial: payer preference for the original product during any settlement stay.

Common settlement and launch patterns

Small-molecule settlements often include:

• “30-month stay” triggers after first paragraph IV filing.
• Carve-outs for specific manufacturing or labeling differences.
• Licensing or nonexclusive arrangements that can preserve some branded volume.

What is the Orange Book status of VORANIGO?

Orange Book status determines:

• Which patents are tied to the approved NDA for vorasidenib.
• Whether competitors can use the listed patents in paragraph IV filings.
• How many patents are actually at risk at the time of launch forecasting.

How Orange Book listings influence litigation exposure

A higher count of listed patents increases:

• Litigation complexity and duration risk.
• Settlement leverage.
• The number of potential “target” patents competitors choose to challenge.

What patent litigation affects VORANIGO and how does it shape market pricing?

Patent disputes influence pricing indirectly by:

• Delaying competitor launches.
• Extending branded share via injunction pressure.
• Shaping payer contracting terms during uncertainty.

What litigation timeline matters commercially

• Complaint filing date and early motion outcomes.
• Claim construction milestones.
• Settlement announcements and consent orders.
• Any final written decisions that end stay periods.

How does VORANIGO compare with other IDH inhibitors in glioma?

Voranigo’s competitive set is defined by other IDH-targeted therapies and broader glioma management strategies. Market share shifts depend on:

• Label differences (grade, line of therapy, molecular eligibility).
• Efficacy and safety differentials in trial endpoints used by payers and clinicians.
• Dosing convenience and monitoring burden.
• Contracting and formulary tier placement.

Which “share wrestlers” drive switching risk?

Switching risk is highest where:

• Patient eligibility overlaps fully under labeled indications.
• Payers prefer the drug with the better net price after rebates.
• Tolerability profiles lead to fewer dose interruptions.

What FDA regulatory milestones influence VORANIGO market dynamics?

For targeted oncology drugs, FDA-related milestones affect demand through:

• Timing of label expansions that enlarge the addressable patient pool.
• Safety communications that modify dosing guidance.
• Postmarketing requirements that influence clinician confidence and monitoring.

What changes after an FDA label update?

• Updated eligibility criteria can expand or narrow the covered population.
• Inclusion/exclusion shifts drive prescriber behavior.
• Payers update coverage policies and prior authorization rules.

How do payer coverage, hospital formularies, and oncology contracting affect VORANIGO financial trajectory?

Net sales are driven by discounts and rebates, which are typically negotiated around:

• Specialty pharmacy benefit design.
• Outcomes-based or utilization-based rebate constructs.
• Managed care contracting and health-system group purchasing.

What is the net-to-gross risk profile for an oral oncology drug?

Oral targeted therapies can see:

• Higher rebate pressure due to class competition.
• Prior authorization delays at launch.
• Co-pay support impacts that are important for adherence in Medicare Part D and commercial plans.

What is VORANIGO’s revenue exposure and what are the main downside drivers?

Revenue exposure is determined by treated patient growth, persistence, and pricing. Downside typically comes from:

• Slower center adoption.
• Payer delays in formulary placement.
• Greater-than-expected discontinuation from tolerability issues.
• Competitive substitution by alternative IDH inhibitors or different glioma regimens after new trial data.

What are the main upside drivers?

• Faster diagnostic penetration and broader label-driven eligibility.
• Better real-world persistence and tolerability than trials.
• Strong contracting outcomes that increase formulary penetration.

What commercial landscape signals matter for VORANIGO (2025–2026)?

For 2025–2026, commercial signals are dominated by:

• Launch pacing versus other precision oncology drugs entering the same patient journey.
• Pricing durability under managed care negotiation.
• Trial readouts from competing IDH inhibitors and combination regimens that can shift sequencing.

How to benchmark trajectory versus comparable oncology launches

Benchmarking uses:

• Weeks-to-formulary placement and time to access in major payer formularies.
• Prescriber concentration early versus normalized center spread by month.
• Persistence and dose-interruption metrics collected via claims and specialty pharmacy feeds.

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Key Takeaways

• Voranigo’s financial trajectory is governed by adoption speed among neuro-oncology centers, payer contracting outcomes, and real-world persistence.
• Patent and Orange Book status determine how long branded share can be defended against generic entry.
• Competitive pressure is driven by overlapping label eligibility among IDH inhibitors, plus sequencing shifts based on emerging clinical data.
• Revenue downside risk concentrates in formulary access delays, discontinuation, and substitution after competitive trial readouts.

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FAQs

1) What factors most influence early-year net sales for oral oncology drugs like Voranigo?
Formulary placement timelines, prior authorization patterns, rebate rate pressure, specialty pharmacy distribution, and patient persistence.

2) How do IDH diagnostic testing rates change VORANIGO demand?
Higher IDH testing penetration expands the eligible population and increases the addressable pool for clinicians treating molecularly defined glioma.

3) What settlement structures typically delay generic entry for small-molecule oncology drugs?
Paragraph IV-driven 30-month stays, consent decrees, and patent-specific carve-outs that coordinate launch timing.

4) How does label breadth affect payer coverage decisions for VORANIGO?
Broader eligibility can expand covered lives and reduce prior authorization friction, while narrower labels can constrain access despite strong efficacy.

5) What monitoring and tolerability factors determine discontinuation risk for targeted glioma therapies?
Dose interruption frequency, adverse event severity, laboratory monitoring burden, and imaging cadence that affects clinician confidence in ongoing therapy.

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Approval Reports and Labeling for vorasidenib (Voranigo). U.S. Food and Drug Administration.

DrugChatter Q&A for VORANIGO

Voranigo vorasidenib sponsor company?
Voranigo mechanism of action?