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-eight 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:	98
US Patents:	5
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.

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

International Patents for VORANIGO

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	754946
Malaysia	196418	THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Costa Rica	20160069	COMPUESTOS TERAPÉUTICAMENTE ACTIVOS Y SUS MÉTODOS DE USO
Taiwan	202337885
Malaysia	175824

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 the Pharmaceutical Drug: VORANIGO

Last updated: July 27, 2025

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Introduction

VORANIGO (naldemedine) is a prescription medication developed by Shionogi Inc., primarily used for the management of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. Approved by the U.S. Food and Drug Administration (FDA) in March 2017, VORANIGO belongs to a class of drugs known as peripherally acting mu-opioid receptor antagonists (PAMORAs). Its targeted mechanism aims to counteract constipation caused by opioids without affecting analgesic efficacy. Understanding VORANIGO’s market dynamics and financial prospects requires analyzing its clinical profile, competitive landscape, regulatory environment, patient demographics, and shifting healthcare policies.

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Market Landscape for Opioid-Induced Constipation Drugs

The global prevalence of chronic pain conditions necessitating opioid therapy has surged, escalating the incidence of OIC. The market for OIC therapeutics experienced accelerated growth, driven by increased opioid prescriptions and heightened awareness of constipation as a significant adverse effect. According to IQVIA data, the OIC treatment market was valued at approximately $1.2 billion in 2022, with an expected compound annual growth rate (CAGR) of around 6% through 2028 [1].

Major competitors include traditional laxatives, newer PAMORAs such as Methylnaltrexone (Relistor), Naloxegol (Movantik), and emerging therapies like opioid antagonists with extended-release formulations. VORANIGO occupies a niche with its high efficacy and favorable tolerability profile, particularly for patients unresponsive to or intolerant of other treatments.

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VORANIGO’s Market Position and Adoption

Since its launch, VORANIGO has gained a steady market share due to its clinical advantages. Its once-daily oral dosage simplifies administration, improving patient compliance. The drug’s efficacy in reducing OIC symptoms was demonstrated robustly in phase 3 trials, leading to broad acceptance among gastroenterologists and pain management specialists.

However, VORANIGO’s market penetration faces challenges. First, the entrenched presence of competing PAMORAs and off-label laxative use limits growth. Second, physicians’ familiarity, formulary access, and insurance coverage influence prescription patterns. Data from health insurance claims indicate that VORANIGO accounts for roughly 10%-15% of the total OIC drug market share in the United States [2].

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Regulatory and Reimbursement Environment

Regulatory approvals across various jurisdictions have facilitated VORANIGO’s international expansion, notably in Europe, where the European Medicines Agency (EMA) approved it in 2018. Reimbursement dynamics are critical; in the U.S., coverage by major insurers and inclusion in clinical guidelines significantly influence sales.

The drug’s labeling explicitly recommends use in adults with opioid-treated pain suffering from OIC, aligning with its marketed indication. The ongoing negotiations with payers, coupled with value-based pricing initiatives, influence the drug’s financial trajectory.

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Financial Performance and Revenue Projections

Since its commercial debut, VORANIGO has demonstrated gradual revenue growth. In 2022, sales in the U.S. reached approximately $180 million, reflecting a 12% increase from the previous year [3]. Factors contributing to sales include increased prescribing, expanded payer coverage, and geographic expansion.

Analysts project that VORANIGO's revenues could reach $250–$300 million within the next three to five years, contingent on several variables:

• Market penetration: Continued adoption in the OIC treatment landscape.
• Physician and patient awareness: Education initiatives and clinical guideline endorsements.
• Competitive pressure: Emergence of new therapies or biosimilars.

Additionally, strategic partnerships and potential line extensions could augment revenues, especially if data supports broader indications or combination therapies.

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Key Market Drivers and Constraints

Drivers:

• Growth in chronic pain management and opioid prescribing.
• Increasing recognition of OIC as a quality-of-life concern.
• Favorable safety and tolerability profile relative to older laxatives.
• Regulatory approvals expanding access worldwide.

Constraints:

• Intense competition with established PAMORAs.
• Payer reimbursement restrictions limiting widespread adoption.
• Potential safety concerns or adverse events reports leading to prescription hesitancy.
• Price sensitivity amid rising healthcare costs.

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Future Outlook and Strategic Opportunities

The future financial trajectory of VORANIGO hinges on multiple factors. First, evolving clinical data may support expanded indications, such as opioid-induced nausea or other gastrointestinal motility disorders. Second, geographic expansion into emerging markets presents substantial growth opportunities, given the rising opioid use and insufficient management of OIC.

Third, digital and pharmacoeconomic strategies—highlighting cost savings through improved patient compliance and reduced hospitalization—could bolster payer support. Fourth, development of novel formulations, such as combination pills or extended-release versions, might capture additional market share.

Finally, ongoing research into personalized medicine approaches may enable targeted therapy, optimizing treatment outcomes and improving competitive positioning.

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Conclusion

VORANIGO’s market dynamics reflect a complex interplay of clinical efficacy, competitive landscape, regulatory and reimbursement frameworks, and patient needs. While the drug has established a solid foothold within the OIC treatment market, its growth prospects depend on expanding indications, geographic markets, and payer acceptance. The evolving pain management paradigms and increasing emphasis on quality of life are poised to sustain demand.

Strategic investments in clinical research, market expansion, and payer engagement are paramount for maximizing VORANIGO’s financial trajectory. Stakeholders should monitor regulatory developments, emerging competitors, and evolving clinical guidelines to inform decision-making.

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Key Takeaways

• VORANIGO addresses a significant unmet need in opioid-induced constipation with a favorable safety profile, positioning it well within a growing therapeutic market.

• Current sales reflect steady growth, but long-term prospects depend heavily on broader geographic adoption and expanded indications.

• Competition, payer policies, and formulary access remain key hurdles; proactive strategies are necessary to sustain market share.

• Emerging markets and combination therapy potential offer viable avenues for revenue expansion.

• Ongoing research and guideline endorsements will shape future demand and financial performance.

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FAQs

1. What differentiates VORANIGO from other PAMORAs?
VORANIGO’s once-daily oral formulation and demonstrated efficacy in reducing OIC symptoms, coupled with a favorable side-effect profile, distinguish it from competitors like Methylnaltrexone, which often require injections or have different safety considerations.

2. How does reimbursement impact VORANIGO’s market penetration?
Insurance coverage and formulary placements significantly influence prescribing patterns. Favorable reimbursement policies enhance patient access, directly impacting sales growth.

3. Are there any ongoing clinical trials for VORANIGO?
Yes, ongoing studies aim to explore additional indications, such as opioid-induced nausea and broader gastrointestinal motility disorders, which could expand its market footprint.

4. What geographic markets are prospects for VORANIGO?
Beyond the U.S. and Europe, emerging markets in Asia and Latin America present substantial growth potential, provided regulatory approvals and reimbursement frameworks are established.

5. What are the primary risks to VORANIGO’s financial outlook?
Intense competition, regulatory changes, reimbursement restrictions, and safety concerns are primary risks that could hinder future sales growth and profitability.

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References

[1] IQVIA. Market Analysis of the OIC Therapeutics Segment, 2022.
[2] MarketWatch. Prescribing Trends in Opioid-Induced Constipation Medications, 2022.
[3] Shionogi Inc. Financial Reports, 2022.