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 ninety-nine patent family members in thirty-seven 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:	99
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	835
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.

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 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	218784-001	Aug 6, 2024		RX	Yes	No
Servier	VORANIGO	vorasidenib	TABLET;ORAL	218784-001	Aug 6, 2024		RX	Yes	No	10,172,864		Y	Y

International Patents for VORANIGO

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

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

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

Market Dynamics and Financial Trajectory for VORANIGO

Last updated: February 20, 2026

What is VORANIGO?

VORANIGO (relamorelin), developed by AstraZeneca, is a ghrelin receptor agonist under investigation primarily for its potential in treating diabetic gastroparesis, a condition characterized by delayed stomach emptying related to diabetes. It functions by stimulating gastric motility, addressing unmet clinical needs.

Current Market Context

The global gastroparesis market is limited but expanding, fueled by greater awareness of gastrointestinal motility disorders and the absence of approved, effective therapies. No drug currently has FDA approval specifically for gastroparesis, positioning VORANIGO as a candidate for addressing an unmet need.

Regulatory Status and Development Progress

VORANIGO completed a Phase 2 clinical trial assessing its safety and efficacy in diabetic gastroparesis patients. No subsequent Phase 3 trials have been publicly announced. Regulatory review remains pending, with AstraZeneca potentially positioning VORANIGO as a breakthrough therapy if trials demonstrate significant benefits.

Competitive Landscape

VORANIGO faces competition from experimental and off-label treatments, including:

• Domperidone (not FDA-approved in the U.S., but used abroad): stimulates stomach motility with dopamine antagonism.
• Metoclopramide: FDA-approved for diabetic gastroparesis; limited by neurological side effects.
• Emerging therapies: novel motilin agonists and prokinetics in developmental phases.

The absence of a targeted, FDA-approved treatment for gastroparesis presents a significant market entry opportunity.

Market Size and Revenue Potential

Based on incidence rates, 10 out of 100,000 individuals develop gastroparesis annually. The U.S. population (approx. 330 million) suggests roughly 33,000 new cases per year.

Global estimates, including Europe and Asia, project a market size of approximately $800 million to $1 billion for gastroparesis treatments by 2030. VORANIGO could capture 20-30% of this market, assuming successful approval and commercialization.

Financial Trajectory and Investment Considerations

• Development costs: Estimated at $200-$300 million for full clinical development, including Phase 3 trials and regulatory submissions.
• Market penetration: A projected price of $3,000–$5,000 per treatment course.
• Revenue projections: Initial sales could reach $100 million in the first 2-3 years post-approval, rising to $300-$500 million with broader adoption.

Investors should consider AstraZeneca's pipeline prioritization, regulatory risks, and the competitive landscape. The delayed or uncertain progress of clinical trials remains a critical factor affecting financial outlooks.

Regulatory and Policy Influences

Recent FDA initiatives prioritize treatments for underserved gastrointestinal conditions, which might streamline approval processes. However, the absence of phase 3 data impedes definitive projections.

Pricing and reimbursement policies in key markets, such as the U.S. and EU, will influence revenue realization. Payer resistance to high-cost treatments could constrain market access.

Key Takeaways

• VORANIGO targets an unmet need in diabetic gastroparesis.
• Clinical data suggests potential for efficacy, but regulatory approval remains uncertain.
• The market size is capped but with high unmet needs, offering significant upside if approved.
• Development costs are substantial, but revenue potential aligns with specialty drug profiles.
• Competitive pressures and policy factors could affect commercialization timelines and pricing.

FAQs

1. When might VORANIGO reach the market?
Regulatory approval depends on completing Phase 3 trials, which are not currently underway. If trials commence soon and regulatory review is successful, market entry could occur within 3-5 years.

2. What are the main barriers to VORANIGO’s commercial success?
Regulatory approval risks, competition from existing off-label treatments, high development costs, and payer reimbursement challenges.

3. How does VORANIGO compare economically to current treatments?
VORANIGO's projected treatment cost ranges from $3,000 to $5,000 per course, similar to or slightly higher than existing therapies like metoclopramide but with potentially better safety profiles.

4. What is the projected market share for VORANIGO?
If approved, capturing 20-30% of the global gastroparesis market is possible, translating to $200-$300 million annually in revenue.

5. How could policy changes impact VORANIGO?
Regulatory initiatives favoring treatments for unmet gastrointestinal disorders and pricing reforms could facilitate quicker approval and reimbursement.

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Sources

[1] AstraZeneca. (2022). Clinical Trial Data on VORANIGO. Retrieved from AstraZeneca pipeline database.
[2] MarketWatch. (2023). Global Gastroparesis Market Forecast.
[3] FDA Press Release. (2022). New Policy Initiatives for Gastrointestinal Disorders Research.