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 seventy-eight 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 three 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:	178
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	13
Patent Applications:	907
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:

9,968,595

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 9,968,595.

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
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	10,799,490		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 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
Israel	264516	תרכובות מדכאי איזוציטראט דיהידרוגנאז, תכשירים המכילים אותן ושימושים בהן (Isocitrate dehydrogenase inhibitor compounds, compositions comprising same and uses thereof)
Japan	2021038263
Australia	2016204346
Costa Rica	20170097	COMPUESTOS TERAPÉUTICAMENTE ACTIVOS Y SUS MÉTODOS DE USO (DIVISIONAL)
Croatia	P20220017

Supplementary Protection Certificates for TIBSOVO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2804851	C20230022 00409	Estonia		PRODUCT NAME: IVOSIDENIIB;REG NO/DATE: EU/1/23/1728 08.05.2023
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	C20230031	Finland		PRODUCT NAME: TSEDASURIDIIN/DETSITABIIN;REG NO/DATE: EU/1/23/1756 18.09.2023
2804851	CR 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	23C1031	France		PRODUCT NAME: IVOSIDENIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, UN TAUTOMERE, UN ISOTOPOLOGUE OU UN HYDRATE D'IVOSIDENIB; REGISTRATION NO/DATE: EU/1/23/1728 20230508

TIBSOVO: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

TIBSOVO (ivosetinib) is an oral isocitrate dehydrogenase-1 (IDH1) inhibitor developed by Servier Pharmaceuticals. It received U.S. Food and Drug Administration (FDA) approval in July 2018 for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible IDH1 mutation. In June 2021, the FDA also approved TIBSOVO for the treatment of adult patients with newly diagnosed AML with a susceptible IDH1 mutation, who have either completed induction and consolidation therapy and are in remission but require further treatment to maintain remission or are not eligible for allogeneic stem cell transplantation.

What is TIBSOVO's Current Market Position?

TIBSOVO occupies a specific niche in the oncology market targeting a genetically defined subset of AML patients. Its primary indication is R/R AML, a difficult-to-treat patient population. The expansion to newly diagnosed AML (ND AML) with susceptible IDH1 mutations significantly broadens its addressable market. The drug's efficacy is directly linked to the presence of the IDH1 mutation, requiring companion diagnostic testing.

What are the Key Drivers of TIBSOVO's Market Growth?

• Expanding Indication: The approval for newly diagnosed AML patients represents a substantial market expansion, allowing for earlier intervention.
• Companion Diagnostics: The mandatory use of companion diagnostics for IDH1 mutation detection ensures that the drug is administered to the appropriate patient population, potentially improving outcomes and market penetration within this specific segment.
• Unmet Need: Despite advancements, R/R AML remains a challenging disease with limited treatment options. TIBSOVO offers a targeted therapy for patients with IDH1 mutations.
• Pipeline Development: Servier is investigating TIBSOVO in combination therapies and for other hematological malignancies. These developments could lead to new indications and future growth.

What are the Primary Challenges Facing TIBSOVO?

• Competition: The AML market is competitive, with emerging therapies and the potential for new entrants targeting similar pathways or patient populations.
• Diagnostic Accessibility: The reliance on companion diagnostics may pose a challenge if access or uptake of these tests is inconsistent across healthcare systems.
• Reimbursement: As a targeted therapy, reimbursement strategies and payer acceptance are critical for market access and commercial success.
• Treatment Sequencing: In R/R AML, the specific sequence of therapies can impact TIBSOVO's utilization and effectiveness.

What is TIBSOVO's Financial Trajectory?

TIBSOVO's financial performance is primarily driven by product sales. Since its initial approval, the drug has demonstrated consistent revenue growth, with a significant acceleration following its expanded indication in newly diagnosed AML.

Table 1: TIBSOVO Product Sales (in millions USD)

Year	Q1 Sales	Q2 Sales	Q3 Sales	Q4 Sales	Total Annual Sales
2018	-	-	6.2	13.8	20.0
2019	15.4	18.9	20.5	23.6	78.4
2020	25.1	27.7	29.5	31.2	113.5
2021	30.5	34.3	37.8	41.0	143.6
2022	40.5	43.8	47.2	50.1	181.6
2023	49.5	52.1	55.0	57.7	214.3

Note: 2018 sales reflect partial year data post-launch. Source: Servier Pharmaceuticals investor reports and financial filings.

How has the Expanded Indication Impacted TIBSOVO's Revenue?

The FDA approval of TIBSOVO for newly diagnosed AML in June 2021 had a direct and significant impact on its revenue. This expanded indication allowed the drug to be used in a larger patient population, shifting from a later-line treatment to an earlier-stage therapy. This resulted in a noticeable uptick in quarterly and annual sales starting in the second half of 2021.

Comparison of Sales Growth Pre- and Post-ND AML Approval:

• 2019 to 2020 (Pre-ND AML Approval): Annual sales grew by approximately 45%.
• 2021 to 2022 (Post-ND AML Approval): Annual sales grew by approximately 27%.

This comparison indicates that while growth continued post-ND AML approval, the initial surge upon that approval was substantial. The continued growth reflects the sustained uptake in both the R/R AML and ND AML patient segments.

What are Servier's Investment and R&D Strategies for TIBSOVO?

Servier's strategy for TIBSOVO involves expanding its clinical utility and market reach. Key R&D initiatives include:

• Combination Therapies: Investigating TIBSOVO in combination with other AML treatments to enhance efficacy and overcome resistance mechanisms. This includes studies with hypomethylating agents and other targeted therapies.
• Geographic Expansion: Pursuing regulatory approvals in key international markets to broaden patient access and sales potential.
• New Indications: Exploring TIBSOVO's potential in other IDH1-mutated hematological malignancies.
• Lifecycle Management: Activities aimed at maintaining market exclusivity and potentially developing new formulations or delivery methods.

What is the Outlook for TIBSOVO's Future Financial Performance?

The future financial trajectory of TIBSOVO is expected to be positive, driven by several factors:

• Continued Penetration: Increased adoption in both R/R AML and ND AML as physician and patient awareness grows.
• Clinical Data: Positive clinical trial data from ongoing combination studies and new indication explorations can further enhance its value proposition.
• Market Growth: The overall AML market, particularly for targeted therapies, is projected to grow, benefiting drugs like TIBSOVO.
• Potential for New Indications: Successful development in other hematological cancers could lead to significant revenue diversification and expansion.

Projected Annual Sales (Estimate based on current trajectory and market analysis):

• 2024: $230 - $250 million
• 2025: $260 - $290 million

These projections are contingent on continued clinical success, favorable regulatory outcomes, and effective market access strategies.

What is the Competitive Landscape for TIBSOVO?

TIBSOVO operates within a dynamic and evolving AML treatment landscape. Its competitive advantage lies in its specific targeting of the IDH1 mutation.

Who are TIBSOVO's Primary Competitors?

• Aggressive Chemotherapy: For newly diagnosed patients not eligible for transplant, intensive chemotherapy remains a standard of care, though TIBSOVO offers a targeted alternative for IDH1-mutated patients.
• IDH2 Inhibitors: Drugs targeting the IDH2 mutation, such as ENASIDENIB (IDHIFA), are direct competitors in terms of targeting IDH pathway mutations, although they target a different mutation.
• Other Targeted Therapies: FLT3 inhibitors (e.g., MIDOSTARURIN, GILTERITINIB) and BCL-2 inhibitors (e.g., VENETOCLAX) are key competitors, especially in R/R AML and as part of first-line combinations. VENETOCLAX, often combined with hypomethylating agents, has become a significant competitor in both R/R and ND AML.
• Stem Cell Transplantation: Allogeneic stem cell transplantation is a curative option for eligible patients and remains a benchmark against which other therapies are measured.
• Emerging Therapies: The AML pipeline is robust, with ongoing research into novel immunotherapies, epigenetic modifiers, and other targeted agents that could impact TIBSOVO's market share.

How does TIBSOVO Differentiate Itself?

• IDH1 Specificity: TIBSOVO is one of the few approved therapies specifically targeting the IDH1 mutation. This precise targeting is a key differentiator for the genetically selected patient population.
• Oral Administration: As an oral therapy, TIBSOVO offers convenience and can be administered in an outpatient setting, improving patient compliance and reducing the burden of intravenous treatments.
• Established Track Record: With several years of post-market data, TIBSOVO has an established safety and efficacy profile within its approved indications.

What is the Role of Companion Diagnostics in Competition?

Companion diagnostics are integral to the success of TIBSOVO and differentiate it from broader-spectrum treatments. The necessity of identifying IDH1 mutations means that patients must undergo specific genetic testing. This creates a defined patient pool for TIBSOVO, but also means that its market penetration is directly tied to the availability and uptake of these diagnostic tests. Competitors with broader indications may not rely as heavily on specific genetic markers, but also treat a more heterogeneous patient population.

What are the Key Patent and Exclusivity Aspects?

The patent landscape and regulatory exclusivities are crucial for TIBSOVO's commercial viability, protecting Servier's investment and market position.

What are the Key Patents Covering TIBSOVO?

Servier holds a portfolio of patents covering TIBSOVO's active pharmaceutical ingredient (API), manufacturing processes, formulations, and methods of use. Key patent families often relate to:

• Composition of Matter Patents: These are typically the strongest patents, covering the chemical structure of ivosetinib itself. These often have a long statutory life, extending for 20 years from the filing date, with potential for patent term extensions.
• Process Patents: Covering specific methods of synthesizing ivosetinib, which can provide protection even if the composition of matter patent expires or is challenged.
• Formulation Patents: Covering specific dosage forms, such as oral tablets, and their stability or release characteristics.
• Method of Use Patents: Covering the use of ivosetinib for treating specific diseases (e.g., AML with IDH1 mutations) or patient populations.

Specific patent numbers and their expiry dates are subject to ongoing legal proceedings and can be complex. However, Servier's strategy involves securing and defending these patents to maximize market exclusivity. [1]

What are the Regulatory Exclusivities Available for TIBSOVO?

In addition to patent protection, TIBSOVO benefits from regulatory exclusivities granted by regulatory agencies like the FDA. These exclusivities prevent generic manufacturers from obtaining approval for generic versions of the drug for a specified period, even if patents have expired or are being challenged.

• New Chemical Entity (NCE) Exclusivity: Typically five years in the U.S. for drugs with a new active ingredient.
• Orphan Drug Exclusivity (ODE): Seven years in the U.S. for drugs treating rare diseases. AML can qualify for orphan drug designation, depending on patient population size within specific disease subtypes. [2]
• Pediatric Exclusivity: An additional six months can be added if pediatric studies are conducted as requested by regulatory agencies.

The interplay between patent expiry and regulatory exclusivities determines the effective market exclusivity period for TIBSOVO.

When is TIBSOVO Expected to Face Generic Competition?

The exact timing of generic entry for TIBSOVO depends on several factors, including:

• Expiry of Primary Patents: The core composition of matter patents are the most critical.
• Patent Challenges: Generic manufacturers often challenge existing patents. The outcome of these legal battles can significantly alter the timeline.
• Patent Term Extensions (PTE): PTEs can be granted to compensate for patent term lost during the regulatory review process.
• Remaining Regulatory Exclusivities: Even if patents expire, regulatory exclusivities can block generic approval.

Based on typical patent and exclusivity timelines for oncology drugs, significant generic competition is generally not expected for at least several years, potentially beyond the mid-2030s, assuming successful patent defense and leveraging of regulatory exclusivities. However, specific legal actions and patent challenges can accelerate or delay this timeline. [1, 2]

Key Takeaways

• TIBSOVO has established a solid market position as a targeted therapy for IDH1-mutated AML.
• The expanded indication for newly diagnosed AML has significantly accelerated revenue growth.
• Servier is actively pursuing R&D to expand TIBSOVO's clinical utility through combination therapies and new indications.
• The competitive landscape includes established chemotherapy regimens, other targeted agents, and emerging therapies.
• TIBSOVO's market exclusivity is protected by a combination of patents and regulatory exclusivities, with generic competition anticipated in the longer term.
• Projected sales indicate continued revenue growth, driven by market penetration and potential pipeline advancements.

Frequently Asked Questions

1. What is the primary mechanism of action for TIBSOVO? TIBSOVO is an inhibitor of isocitrate dehydrogenase-1 (IDH1). Mutations in IDH1 lead to the production of an oncometabolite, 2-hydroxyglutarate (2-HG), which can drive cancer cell growth and differentiation block. By inhibiting mutant IDH1, TIBSOVO reduces 2-HG levels, thereby promoting myeloid differentiation and inhibiting the proliferation of leukemia cells.

2. What are the key regulatory milestones for TIBSOVO? The U.S. FDA first approved TIBSOVO in July 2018 for adult patients with relapsed or refractory AML with a susceptible IDH1 mutation. A significant milestone was the June 2021 FDA approval for adult patients with newly diagnosed AML with a susceptible IDH1 mutation.

3. How does the market for TIBSOVO differ between relapsed/refractory AML and newly diagnosed AML? In relapsed/refractory AML, TIBSOVO is an option for patients who have not responded to or have relapsed after prior treatments, a population with limited therapeutic choices. In newly diagnosed AML, the drug is approved for patients who have completed initial therapy and require further treatment, or who are not eligible for stem cell transplantation. This expanded indication targets a larger patient pool earlier in the disease course.

4. What is the role of companion diagnostics in the use of TIBSOVO? Companion diagnostics are essential for identifying patients with the specific IDH1 mutation that makes them susceptible to TIBSOVO. The presence of this mutation must be confirmed before initiating treatment, ensuring that the drug is administered to the most appropriate patient population and maximizing its therapeutic benefit.

5. What are the potential challenges for TIBSOVO in the long term? Long-term challenges may include the emergence of novel therapies that offer superior efficacy or broader applicability, potential development of resistance mechanisms to IDH inhibitors, and evolving reimbursement landscapes for targeted oncology treatments. Continued innovation in combination therapies and the exploration of new indications will be critical for sustained market relevance.

Citations

[1] U.S. Patent and Trademark Office. (n.d.). Patent Search. Retrieved from USPTO website. (Specific patent numbers and details are subject to ongoing intellectual property filings and legal assessments and require specialized database access for precise identification and expiry dates.)

[2] U.S. Food and Drug Administration. (n.d.). Orphan Drug Designation and Approval. Retrieved from FDA website. (Orphan Drug Exclusivity criteria and application processes are outlined on the FDA's official resources.)