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.

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

US Patents:	5
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for VORANIGO

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

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

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

Supplementary Protection Certificates for VORANIGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3019483	C20265008	Finland
3019483	122026000022	Germany		PRODUCT NAME: VORASIDENIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER HYDRAT DAVON; AUTHORISATION NO/DATE: EU/1/25/1912 20250917
3019483	2026C/707	Belgium		PRODUCT NAME: VORASIDENIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/25/1912 20250919

Last updated: July 5, 2026

VORANIGO (voranigo) investment scenario and patent/IP fundamentals

Voranigo is not a drug name that can be mapped to an FDA-approved product, Orange Book entry, publicly disclosed patent estate, or identifiable corporate filer using available patent and regulatory reference frameworks. Without an unambiguous active ingredient, dosage form, sponsor/MAH, NDC, or FDA approval reference, a correct fundamentals and patent/IP investment analysis cannot be produced.

What is Voranigo and what FDA product is it (NDC, active ingredient, approval date)?

Featured-snippet answer: Not determinable from available structured regulatory/patent identifiers.

Which active ingredient does “Voranigo” correspond to?

A fundamentals analysis requires the active ingredient and FDA reference listed drug. “Voranigo” is not sufficient to uniquely tie to a single FDA product record.

What dosage forms and strengths does the approved product use?

Patent strength, exclusivity, and generic risk depend on dosage form (oral, injectable, topical), strength, and route. That mapping is not identifiable for “Voranigo.”

Who is the FDA sponsor/MAH and what is the marketing authorization holder?

License value and settlement posture are driven by the MAH, NDA/BLA holder, and litigation parties. Those entities cannot be determined for “Voranigo” as provided.

What patents protect Voranigo (Orange Book listing) and how many are there?

Featured-snippet answer: No Orange Book patent listing can be reliably identified for “Voranigo” from the provided name.

How strong is the patent estate for Voranigo?

An estate strength score needs: patent counts by category (composition, method, formulation, formulation/process), expiration dates, and reference-product linkage. None can be reliably built without a specific FDA RLD/NDC.

What formulations are protected by Voranigo patents?

Formulation and manufacturing patents are often the main barrier for generics and for “AB-rated” formulations. The formulation patent set is not derivable without the specific listed patents and assignees.

What method-of-use patents cover Voranigo?

Method-of-use coverage is tied to labeled indications and Orange Book “use” patents. That mapping cannot be established.

When does Voranigo lose exclusivity (NDA exclusivity, 5-year, 3-year, pediatric, orphan)

Featured-snippet answer: Exclusivity timelines cannot be determined for “Voranigo” as provided.

What are the exclusivity end dates that control generic and biosimilar timing?

Exclusivity end dates require the FDA approval date, exclusivity codes, and any pediatric extension. Those dates cannot be determined.

Does Voranigo have FDA orphan drug or pediatric exclusivity extensions?

Orphan/pediatric status is listed on FDA records. No product mapping is available.

What is the Orange Book status of Voranigo (patent term and listed claims)?

Orange Book status is not identifiable without the RLD link.

What patent expiration dates matter for Voranigo (composition, method, formulation, process)?

Featured-snippet answer: Expiration dates cannot be listed for “Voranigo” without a specific patent family set.

Which countries and jurisdictions hold parallel IP for Voranigo?

Investment planning typically includes US, EP/UK, JP, CA, and key ROW filings. Jurisdictional families require patent publication IDs.

How many patents cover Voranigo and when do they expire?

Counting requires a defined dataset. No dataset can be grounded to “Voranigo.”

Which companies are challenging Voranigo with Paragraph IV ANDAs (or biosimilar pathways)?

Featured-snippet answer: No Paragraph IV challenge targets can be identified for “Voranigo” from the provided name.

What generic entry risks exist for Voranigo?

Risk depends on:

• number of ANDA applicants,
• first-filer status,
• settlement terms,
• 21-month stay and forfeiture conditions,
• launch dates.

None can be evaluated.

What is the likelihood of a 180-day exclusivity trigger?

This depends on the first-filer and tentative approval timeline. Those are not identifiable.

Is Voranigo subject to biosimilar competition (BLA/Biosimilar pathway) instead of generics?

Biosimilar analysis requires a biologic mapping. No biologic identity is established.

What Voranigo patent litigation affects market entry (ANDA suits, PTAB, ITC)?

Featured-snippet answer: Litigation status cannot be determined for “Voranigo” from the provided name.

Which courts and docket timelines drive Voranigo settlement risk?

ANDA litigation depends on district court cases, claim lists, and scheduling. None can be mapped.

Have there been any PTAB IPR challenges to Voranigo patents?

PTAB challenges require patent numbers and petitioner identities. Not determinable.

Was there any ITC or other IP enforcement relating to Voranigo?

That requires identifiable parties and patents.

How does Voranigo compare with competitors (same indication, same mechanism, same delivery system)?

Featured-snippet answer: Not possible without the active ingredient and indication for Voranigo.

What is Voranigo’s mechanism of action and therapeutic class?

Competitive positioning requires MoA, class, and clinical differentiation. The drug cannot be uniquely identified.

What competitive set captures Voranigo revenue exposure?

Revenue exposure depends on:

• market size for indication,
• share shifts by mechanism,
• payer preference,
• administration and adherence factors. None can be estimated without identity.

What pricing and reimbursement fundamentals apply to Voranigo?

Drug economics depend on payer mix, average net price, WAC-to-net spreads, and access hurdles.

What is the investment scenario for Voranigo (revenue drivers, launch risk, exclusivity moat)?

Featured-snippet answer: No investment scenario can be constructed for “Voranigo” without an identifiable FDA product and IP estate.

Base case value drivers

A defensible base case requires:

• forecasted net sales,
• expected generic/biosimilar entry date(s),
• patent exclusivity end dates and “design-around” probability,
• expected share and price erosion curve. Not identifiable.

Downside risks

Downside typically includes:

• faster-than-expected Paragraph IV resolutions,
• unfavorable claim construction or injunction outcomes,
• settlement that accelerates generic entry,
• manufacturing/IP barriers failing. Not identifiable.

Upside levers

Upside levers include:

• additional indications,
• label expansions enabling extended market life,
• successful defense of formulation/process patents,
• strong real-world adoption. Not identifiable.

What are the licensing and settlement dynamics for Voranigo (deals, co-promotion, generics settlements)?

Featured-snippet answer: No deal or settlement record can be reliably identified for “Voranigo.”

What licensing deals could strengthen the IP moat for Voranigo?

This requires knowledge of sublicenses, field-of-use expansions, and assignment or exclusive license transfers.

What settlement agreements set generic launch dates for Voranigo?

Settlement terms are public in litigation dockets or press releases when identifiable; no product mapping exists.

Which parties hold controlling rights (assignees, exclusive licensees)?

Fundamentals depend on who controls prosecution, enforcement, and term management.

How do manufacturing/IP barriers affect generics entry for Voranigo?

Featured-snippet answer: Not determinable without the identity of Voranigo and its manufacturing/process patent set.

What process patents or scale-up patents protect Voranigo?

Process patents are often the main barrier to “at-risk” manufacturing when composition patents are weak or design-around is feasible.

What controls exist for active ingredient synthesis or formulation manufacturing?

This depends on listed chemistry, process, and stability claims.

Key Takeaways

• Voranigo cannot be mapped to an identifiable FDA product and patent estate from the provided name alone, so no accurate Orange Book/exclusivity/patent expiration, Paragraph IV, litigation, or investment valuation timeline can be produced.
• Investment diligence requires a product identifier (active ingredient + FDA reference product) to tie IP families and exclusivity to a specific market risk profile.

FAQs

1. What does “Voranigo” refer to in FDA terms (RLD/NDC/active ingredient)?
2. How do investors evaluate a drug’s patent moat when Orange Book listings are unclear?
3. What evidence most strongly predicts Paragraph IV generic launch risk for a branded drug?
4. How are settlement agreements typically reflected in generic entry timelines?
5. What patent categories usually provide the highest “last-mile” protection for oral small molecules versus injectables?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drugs@FDA. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm