TIBSOVO Drug Patent Profile

Which patents cover Tibsovo, and when can generic versions of Tibsovo launch?

Tibsovo is a drug marketed by Servier and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-five patent family members in forty-five countries.

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

DrugPatentWatch^® Generic Entry Outlook for Tibsovo

Tibsovo was eligible for patent challenges on July 20, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 13, 2035. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TIBSOVO

International Patents:	185
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	13
Patent Applications:	823
Drug Prices:	Drug price information for TIBSOVO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIBSOVO
What excipients (inactive ingredients) are in TIBSOVO?	TIBSOVO excipients list
DailyMed Link:	TIBSOVO at DailyMed

See drug prices for TIBSOVO

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

Constraining patent/regulatory exclusivity:

10,449,184

NDA:

211192

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.

Recent Clinical Trials for TIBSOVO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
GlaxoSmithKline Research & Development Limited	Phase 3
Belgian Group of Digestive Oncology	Phase 3
Zymeworks Inc.	Phase 3

See all TIBSOVO clinical trials

Pharmacology for TIBSOVO

Drug Class	Isocitrate Dehydrogenase 1 Inhibitor
Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Isocitrate Dehydrogenase 1 Inhibitors

Paragraph IV (Patent) Challenges for TIBSOVO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIBSOVO	Tablets	ivosidenib	250 mg	211192	1	2022-07-20

US Patents and Regulatory Information for TIBSOVO

TIBSOVO is protected by thirty-one US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,449,184.

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	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	10,653,710
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	9,850,277		Y	Y

EU/EMA Drug Approvals for TIBSOVO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Les Laboratoires Servier	Tibsovo	ivosidenib	EMEA/H/C/005936Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy (see section 5.1).Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.	Authorised	no	no	yes	2023-05-04

International Patents for TIBSOVO

When does loss-of-exclusivity occur for TIBSOVO?

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

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Morocco

New Zealand

Philippines

South Africa

South Korea

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 TIBSOVO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2015229214
Australia	2019246824
Brazil	112016021232
Canada	2942072

Supplementary Protection Certificates for TIBSOVO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2804851	301243	Netherlands		PRODUCT NAME: IVOSIDENIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, TAUTOMEER, ISOTOPOLOOG OF HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1728 20230508
2804851	CA 2023 00025	Denmark		PRODUCT NAME: IVOSIDENIB ELLER ET FARMACEUTISK ACCEPTABELT SALT, TAUTOMER, ISOTOPOLOG ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/23/1728 20230508
2804851	LUC00315	Luxembourg		PRODUCT NAME: IVOSIDENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, TAUTOMER, ISOTOPOLOGUE OR HYDRATE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1728 20230508
2804851	PA2023529	Lithuania		PRODUCT NAME: IVOSIDENIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, TAUTOMERAS, IZOTOPOLOGAS ARBA HIDRATAS; REGISTRATION NO/DATE: EU/1/23/1728 20230504

TIBSOVO (ivosidenib) market dynamics, revenue trajectory, and competitive landscape: patent, exclusivity, and generic/biosimilar risks

Last updated: July 25, 2026

Executive summary: TIBSOVO (ivosidenib) is an oral targeted therapy in IDH1-mutant acute myeloid leukemia (AML) and relapsed/refractory cholangiocarcinoma (R/R CCA). Its near-to-midterm financial trajectory depends on (1) demand sustainability after launch ramps, (2) expansion from AML into broader IDH1 CCA segments, (3) payer access and site-of-care economics for oral oncology, and (4) competitive pressure from other IDH1/IDH2 inhibitors and salvage regimens. From an IP and exclusivity standpoint, the strongest “market lock” is tied to the regulatory exclusivities and the Orange Book patent estate covering ivosidenib drug product and protected indications/methods of use; the key value-at-risk for generics is tied to the earliest Paragraph IV windows and any patent challenges that could accelerate FDA approvals.

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How has TIBSOVO performed commercially since launch?

At-a-glance performance drivers

• Population expansion: TIBSOVO is used in IDH1-mutant AML (including frontline for older/unfit patients under the label history) and in R/R IDH1-mutant cholangiocarcinoma. Commercial performance has historically tracked uptake in each disease where diagnostic confirmation (IDH1 mutation testing) is embedded in treatment pathways.
• Oral targeted-therapy economics: Revenues are shaped by dosing adherence, distribution channel mix (specialty pharmacy vs. oncology practice dispensing), and payer management of high-cost oral oncolytics (prior authorizations, step therapy, and copay programs).
• Line-of-therapy positioning: In AML, uptake depends on comparator regimens (hypomethylating agents with or without venetoclax, intensive chemotherapy where eligible, and other targeted approaches). In CCA, uptake depends on sequencing after first-line and after gemcitabine/cisplatin in eligible patients and on diagnostic turn-around time.
• Therapeutic momentum from clinical follow-on data: Persistent label relevance and protocol expansions influence real-world adoption, including physician confidence in tolerability and response durability.

Financial trajectory framing For business planning, TIBSOVO’s revenue trend should be modeled as:

1. Launch ramp in AML with steady conversion of IDH1-positive referrals and trial-to-real-world transfer.
2. Incremental CCA contribution as testing penetration increases and competing targeted options influence sequencing.
3. Price and net-to-gross: oral oncology typically experiences significant rebates driven by payer formularies and contracting structures; net revenue can diverge from gross list-price.
4. Competitive displacement risk: growth can flatten if competitors show superior durability, tolerability, or convenience, or if combination regimens shift practice away from monotherapy.

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What market dynamics impact TIBSOVO demand in IDH1-mutant AML?

Key commercial variables in AML

• Diagnostic dependency: TIBSOVO is for IDH1-mutant disease; demand is bounded by testing rates and the speed of mutation profiling.
• Comparator shift and treatment paradigm changes: AML regimens have evolved toward venetoclax-based combinations for many patient segments; targeted therapies must show clinical advantage within those sequencing frameworks.
• Prior authorization and payer criteria: oral oncology access can be restrictive, often keyed to line-of-therapy, performance status, and mutation confirmation.
• Safety and discontinuation risk: real-world persistence is sensitive to differentiation between manageable adverse events (for example, differentiation syndrome risk management and cytopenia management) and early discontinuations.

Where demand is usually strongest

• Large oncology centers with biomarker infrastructure.
• Practices with established IDH1 testing workflows.
• Patient populations where clinicians favor targeted oral therapy to avoid intensive inpatient treatment burdens.

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What market dynamics impact TIBSOVO demand in relapsed/refractory cholangiocarcinoma (R/R CCA)?

CCA specific commercial drivers

• High unmet need with post-first-line sequencing: TIBSOVO uptake depends on how frequently IDH1 testing is performed after progression on chemotherapy.
• Diagnostic testing and access: CCA is diagnostically intensive. Access depends on biomarker panel availability and reimbursement for molecular testing.
• Treatment setting and administration: oral targeted therapy can be easier to administer than chemotherapy, but uptake still hinges on copay support and payer coverage.

Competitive pressure in CCA

• CCA treatment space includes targeted agents where actionable alterations exist (FGFR2 fusion, IDH1 mutation, HER2 amplification). Even when TIBSOVO captures an IDH1-positive niche, overall market share can shift due to broader biomarker-driven testing patterns and combination strategies.

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Who are the main competitors to TIBSOVO, and how do they affect pricing and share?

Competitive categories

• Other IDH1 inhibitors (same pathway; direct competition for IDH1-mutant patients).
• IDH2 inhibitors in AML where relevant (competitive substitution when IDH mutation profiles overlap across testing panels).
• Venetoclax-based regimens and hypomethylating agents as alternative sequencing choices in AML.
• Chemotherapy and targeted alternatives in CCA based on actionable biomarkers and patient eligibility.

Competitive implications

• Formulary negotiation: direct pathway competitors increase payer leverage and can compress net pricing.
• Clinical positioning: if competitors show superior response duration or reduced toxicity, TIBSOVO can face displacement even with similar efficacy endpoints.
• Combination adoption: if clinical practice moves toward IDH inhibitors in combination regimens, monotherapy share can decline unless TIBSOVO has a recognized combination advantage.

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How does TIBSOVO’s patent and Orange Book status affect generic entry risk?

Featured snippet answer: Generic entry risk is driven by (1) the earliest Orange Book-listed expiration for ivosidenib drug product and (2) the earliest protected indication/method-of-use patent expiration. If Orange Book coverage includes formulation and method-of-use patents, FDA approval pathways can be constrained even after data exclusivity ends.

What to map for the IP wall

• Drug substance and composition of matter patents tied to the ivosidenib molecule.
• Drug product/formulation patents (tablet composition, coatings, polymorph/form stability, and manufacturing-related claims).
• Method-of-use patents for IDH1-mutant AML and IDH1-mutant CCA treatment.
• Regulatory exclusivities: data exclusivity and any statutory patent-term adjustment impact on effective exclusivity windows.
• Orphan drug exclusivity (if applicable to any indication in the label history): can block generic approval even when patents expire, depending on the regulatory posture.

Paragraph IV challenge mechanics

• Generics can file to trigger potential settlement leverage around patent carve-outs and “carve-in” timing.
• The commercial clock can shift if courts or PTO decisions narrow claim scope or if settlements create non-adjudicated “entry dates.”

Information required to complete the Orange Book and litigation map The prompt requests market dynamics and financial trajectory, but an accurate generic entry and patent-by-patent exclusivity calendar requires a current Orange Book listing and associated litigation docket information for TIBSOVO. Without those exact listings and dates in the working dataset, a precise “earliest generic date” cannot be produced in a way that holds up for litigation, licensing, or investment decisions.

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When does TIBSOVO lose exclusivity: a timeline investors actually price in?

Featured snippet answer: Investors price the earliest of (a) patent expiration for the strongest Orange Book-listed claims, (b) regulatory exclusivity expiration that can delay approval, and (c) any settlement-driven “no earlier than” dates following Paragraph IV litigation.

What a full exclusivity timeline must include

1. Patent expiration dates (with patent term adjustment where applicable).
2. Regulatory exclusivity end dates (data exclusivity, orphan exclusivity if applicable).
3. Any FDA supplements that add protected indications or that change the patent landscape via new Orange Book listings.
4. Litigation milestones that affect entry scheduling (filing, claim construction decisions, settlements, final judgments).

Why the timeline matters Even when molecule-level patents expire, method-of-use and formulation patents can delay generic entry for specific labeled indications, leading to slower erosion of revenues rather than an abrupt step-down.

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What generic entry risks exist for TIBSOVO, and what would the launch scenario look like?

Launch scenario components

• Indication-specific launch: a generic may launch only for specific indications if the rest remain covered by enforceable method-of-use patents.
• Narrow carve-outs: settlement agreements can define entry scope, including labeling carve-outs and “at-risk” launch design.
• Formulation/manufacturing constraints: formulation patents can block substitution unless generic product is designed around claim scope or is found not infringent.

Commercial impact shape

• Gradual erosion is typical when multiple patents remain in-force or when only one indication is at risk.
• Abrupt decline occurs when a single strong patent family is the last barrier and is invalidated or expires earlier than peers.

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How does TIBSOVO’s financial trajectory compare with other oncology targeted oral drugs?

Comparable business patterns

• High launch volatility: Orals with narrow biomarker-defined populations can show fast initial uptake driven by trial visibility, then stabilize as testing grows and payer coverage matures.
• Net price pressure over time: specialty oncology drugs often see more aggressive rebate structures after formulary wins and after competitors enter.
• Therapeutic switching: performance in subsequent lines matters in AML and CCA; once standard-of-care moves, growth can slow without new trial readouts or combination uptake.

What to benchmark

• Net revenue per treated patient (net of rebates) and persistence.
• Share of tested IDH1-positive market based on sequencing patterns.
• Time-to-access: payer approval and patient start rates.

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What litigation and settlement dynamics could change TIBSOVO’s revenue outlook?

Featured snippet answer: The revenue outlook can shift materially if Paragraph IV litigation results in early expiration designations, claim narrowing, or settlement “entry date” agreements that allow earlier generic access.

Common litigation-driven outcomes

• Settlement with authorized generic or shared entry date: compresses post-entry pricing.
• Stipulated dismissal or covenant-not-to-sue: reduces uncertainty and accelerates planning, sometimes without invalidating patents.
• Adverse claim construction: can narrow the enforceable patent scope and increase generic freedom.

Data needed for a precise litigation map A complete, correct litigation and settlement narrative requires: docket numbers, court decisions, claim construction outcomes, and settlement terms. Those case-specific facts are not included in the provided prompt context.

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What should revenue models assume about TIBSOVO net sales drivers vs. IP risk?

Revenue model structure

• Base demand: number of IDH1-positive patients treated under the label.
• Access layer: payer coverage and net price.
• Switching/competition: estimated displacement rate based on competitor launches and guideline changes.
• IP constraint: revenue ceiling before any generic threat expands.

Risk weighting

• In most biomarker oncology products, access and competition dominate near-term revenue volatility.
• IP erosion events dominate the step-change risk (post-exclusivity) but occur less frequently.

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Key tables and metrics to track for TIBSOVO (investor and licensing use)

Commercial KPIs

KPI	Why it moves revenue	How to monitor
IDH1 testing rate growth	Expands eligible addressable patients	Genomic testing volume and payer coverage trends
Patient start rate after approval	Converts prescriptions to treatment	Pharmacy claims and patient services metrics
Net-to-gross and rebate rate	Drives net sales more than list price	Specialty pharmacy contracting and payer behavior
Persistence	Oral therapies depend on tolerability	Treatment duration and discontinuation patterns
Share by line of therapy	AML and CCA sequencing changes drive demand	Oncology prescribing and real-world evidence

IP and exclusivity KPIs

KPI	Why it matters	What to document
Orange Book earliest expiration	Determines the earliest legal launch timing	Patent-by-patent expiration dates and exclusivity listings
Method-of-use vs drug product coverage	Controls whether launch is indication-limited	Claim scope and carve-out patterns
Paragraph IV case status	Shifts market-entry probabilities	Filing dates, court orders, settlements

(A complete, TIBSOVO-specific Orange Book patent table cannot be generated from the prompt content without the actual Orange Book and litigation datasets.)

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Key Takeaways

• TIBSOVO’s financial trajectory is primarily governed by biomarker-driven demand, payer access and net price, and competitive substitution in AML and R/R CCA.
• Commercial growth is most sensitive to IDH1 testing penetration and treatment sequencing rather than manufacturing constraints.
• The timing of generic entry depends on an accurate mapping of the Orange Book patent estate and any Paragraph IV litigation/settlement outcomes; that mapping is necessary to determine revenue step-down risk.
• For planning, revenue models should separate near-term demand and access volatility from less frequent but high-impact exclusivity events.

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FAQs

1. Does TIBSOVO face biosimilar-like competition? TIBSOVO is an oral small-molecule; biosimilar pathways are not relevant. Competitive threats are from other small-molecule generics and competing targeted therapies.
2. Which segment drives more of TIBSOVO revenue, AML or CCA? It depends on label penetration, testing rates, and payer access; the relative split changes with real-world adoption and competing regimens in each indication.
3. How do prior authorizations typically affect TIBSOVO starts? Oral oncology drugs often experience delays and denials based on line of therapy and biomarker confirmation; start rates are usually constrained by prior auth throughput.
4. What happens to TIBSOVO revenues after generic approval in one indication? Erosion can be indication-limited if method-of-use or formulation patents remain enforceable for other labeled indications, producing slower aggregate revenue decline.
5. How do combinations and new standards-of-care alter TIBSOVO’s market outlook? If practice shifts away from monotherapy or toward different combinations, TIBSOVO may lose share unless supported by updated clinical guidance and label expansion.

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References

1. U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. FDA. Drug Approval Package: TIBSOVO (ivosidenib).
3. FDA. Label and prescribing information for TIBSOVO (ivosidenib).
4. U.S. FDA. Oncology (CDER) review documents and regulatory history for ivosidenib.

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