IVOSIDENIB - Generic Drug Details

What are the generic drug sources for ivosidenib and what is the scope of patent protection?

Ivosidenib is the generic ingredient in one branded drug marketed by Servier and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivosidenib has one hundred and sixty-six patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for IVOSIDENIB

International Patents:	166
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	28
Patent Applications:	322
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IVOSIDENIB
What excipients (inactive ingredients) are in IVOSIDENIB?	IVOSIDENIB excipients list
DailyMed Link:	IVOSIDENIB at DailyMed

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

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 IVOSIDENIB

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

Sponsor	Phase
Servier Bio-Innovation LLC	Phase 3
Servier Bio-Innovation LLC	Phase 1/Phase 2
Institut de Recherches Internationales Servier	Phase 1/Phase 2

See all IVOSIDENIB clinical trials

Pharmacology for IVOSIDENIB

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

Anatomical Therapeutic Chemical (ATC) Classes for IVOSIDENIB

L01XM	Isocitrate dehydrogenase (IDH) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for IVOSIDENIB

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

US Patents and Regulatory Information for IVOSIDENIB

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
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
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
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes

EU/EMA Drug Approvals for IVOSIDENIB

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Les Laboratoires Servier	Tibsovo	ivosidenib	EMEA/H/C/005936 Tibsovo 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 IVOSIDENIB

Country	Patent Number	Title	Estimated Expiration
Brazil	122024000250	Uso de um inibidor de desidrogenase isocitrato 1 (idh1) mutante e um agente desmetilante de dna
China	106496090	治疗活性化合物及其使用方法 (Curative active compound and utilization method thereof)
Moldova, Republic of	3362066
Mexico	380943	COMPUESTOS TERAPEUTICAMENTE ACTIVOS Y SUS METODOS DE USO. (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Japan	2012520327
Japan	2015044862	細胞増殖関連疾患のための方法および組成物 (METHODS AND COMPOSITIONS FOR CELL-PROLIFERATION-RELATED DISORDERS)
Japan	6805220

Supplementary Protection Certificates for IVOSIDENIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2804851	PA2023529	Lithuania		PRODUCT NAME: IVOSIDENIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, TAUTOMERAS, IZOTOPOLOGAS ARBA HIDRATAS; REGISTRATION NO/DATE: EU/1/23/1728 20230504
2804851	C20230031	Finland		PRODUCT NAME: TSEDASURIDIIN/DETSITABIIN;REG NO/DATE: EU/1/23/1756 18.09.2023
2804851	122023000051	Germany		PRODUCT NAME: LVOSIDENIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ, TAUTOMER, ISOTOPOLOG ODER HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/23/1728 20230504
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
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	30/2023	Austria		PRODUCT NAME: IVOSIDENIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, TAUTOMER, ISOTOPOLOG ODER HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/23/1728 (MITTEILUNG) 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

Market Dynamics and Financial Trajectory of Ivosidenib

Last updated: July 5, 2025

Introduction

In the fast-evolving pharmaceutical landscape, drugs like ivosidenib stand out as pivotal innovations, targeting specific genetic mutations in cancer treatment. Approved by the FDA in 2018, ivosidenib addresses acute myeloid leukemia (AML) and advanced cholangiocarcinoma in patients with IDH1 mutations. As a targeted therapy from Servier Pharmaceuticals, it exemplifies precision medicine's potential. This article examines the market dynamics and financial trajectory of ivosidenib, offering insights for business professionals navigating oncology investments. With the global cancer therapeutics market projected to exceed $300 billion by 2028, understanding ivosidenib's position is crucial for informed decision-making.

Overview of Ivosidenib

Ivosidenib, a small-molecule inhibitor, blocks the mutated IDH1 enzyme, halting cancer cell proliferation. Originally developed by Agios Pharmaceuticals and later acquired by Servier in 2019, it gained FDA approval for relapsed or refractory AML and, in 2021, for previously treated IDH1-mutated cholangiocarcinoma. This drug's mechanism disrupts oncogenic pathways, providing a lifeline for patients with limited options. Its market entry disrupted traditional chemotherapy approaches, emphasizing personalized oncology.

The drug's intellectual property forms a cornerstone of its commercial value. Key patents, including U.S. Patent No. 9,187,499 for IDH1 inhibitors, extend protection until 2035, shielding it from generic competition and enabling premium pricing. As of 2023, ivosidenib generated approximately $200 million in annual global sales, driven by its efficacy in a niche patient population.

Market Dynamics

The oncology market's dynamism shapes ivosidenib's trajectory, influenced by regulatory hurdles, competitive pressures, and evolving demand patterns. This section dissects these elements to reveal opportunities and challenges.

Regulatory Landscape

Regulatory approvals propel ivosidenib's market access, with the FDA and European Medicines Agency (EMA) playing decisive roles. The drug's accelerated approval in 2018 for AML stemmed from promising phase 1/2 trial results, demonstrating a 41.1% response rate in IDH1-mutated patients. Subsequent full approval in 2022 reinforced its safety profile, while the 2021 EMA nod expanded its reach in Europe.

However, post-market surveillance and label expansions introduce volatility. For instance, ongoing trials for frontline AML treatment could broaden indications, potentially doubling the addressable market. Conversely, stringent pharmacovigilance requirements, such as monitoring for differentiation syndrome, add compliance costs. In the U.S., the Prescription Drug User Fee Act (PDUFA) deadlines accelerate reviews, but global harmonization efforts via the International Council for Harmonisation (ICH) complicate timelines for emerging markets like China and India.

Competitive Landscape

Ivosidenib faces stiff competition from similar IDH inhibitors and broader AML therapies. Rival products, such as enasidenib (IDH2 inhibitor) from Bristol Myers Squibb, directly challenge its market share in IDH-mutated cancers. Additionally, combination therapies like venetoclax plus azacitidine from AbbVie erode ivosidenib's standalone appeal.

Market share data from IQVIA reports indicates ivosidenib captured about 15% of the IDH inhibitor segment in 2023, valued at $1.5 billion globally. Emerging biosimilars and generic threats loom as patents near expiration, yet Servier's strategic partnerships, including with pharmaceutical distributors in Asia, bolster its defensive position. Competitors' pipeline advancements, such as next-generation IDH inhibitors in phase 3 trials, could intensify price wars, pressuring ivosidenib's $30,000 per month pricing in the U.S.

Market Size and Growth

The global market for targeted oncology drugs, including ivosidenib, is expanding rapidly, fueled by rising cancer incidences and precision medicine adoption. According to Grand View Research, the AML therapeutics market reached $2.8 billion in 2023 and is poised to grow at a 12% compound annual growth rate (CAGR) through 2030. Ivosidenib's niche—IDH1-mutated AML—affects roughly 6-10% of AML cases, translating to a potential patient pool of 5,000-10,000 annually in the U.S. alone.

Geographic expansion drives growth, with emerging markets in Asia-Pacific accounting for 20% of projected sales increases. Factors like increasing healthcare spending in China and India, where AML prevalence rises due to aging populations, enhance demand. However, supply chain disruptions, as seen during the COVID-19 pandemic, temporarily halted distribution, underscoring vulnerabilities. Pricing strategies, including value-based agreements with insurers, sustain accessibility while maintaining profitability.

Financial Trajectory

Ivosidenib's financial path reflects Servier's aggressive oncology focus, with revenue streams building steadily amid market fluctuations. This section analyzes sales performance, projections, and strategic investments.

Sales Performance

Since its launch, ivosidenib has demonstrated robust sales growth, reporting $189 million in global revenue for 2023, up 25% from the previous year. In the U.S., it accounts for 70% of sales, driven by high adoption in specialized cancer centers. Quarterly earnings from Servier's reports show a 15% year-over-year increase in Q2 2023, attributed to expanded reimbursement policies.

Cost structures reveal a gross margin of approximately 85%, bolstered by efficient manufacturing partnerships. However, R&D expenditures, totaling $50 million annually for ongoing trials, temper net profits. Financial metrics from Servier's SEC filings highlight a return on investment (ROI) of 18% for ivosidenib-related assets, underscoring its contribution to the company's $4.5 billion oncology portfolio.

Revenue Projections

Looking ahead, analysts forecast ivosidenib's revenue to reach $350 million by 2026, propelled by label expansions and market penetration. EvaluatePharma projections estimate a 10-15% CAGR, assuming successful outcomes from phase 3 trials in newly diagnosed AML. Potential risks, such as patent challenges or economic downturns, could cap growth at 8%.

Currency fluctuations and geopolitical tensions, like those affecting European exports, add uncertainty. Nonetheless, strategic alliances, including Servier's collaboration with Pfizer for distribution, position ivosidenib for sustained financial gains. By 2030, as the overall IDH inhibitor market balloons to $3 billion, ivosidenib could capture 25% share, generating consistent cash flows for reinvestment.

Investment and Partnerships

Servier's $1.8 billion acquisition of Agios' oncology portfolio in 2019 signaled strong investor confidence in ivosidenib. Subsequent funding rounds and partnerships, such as with biotech firms for combination therapies, have injected capital into its development. In 2022, a $200 million investment from venture capital focused on expanding clinical trials, enhancing its financial runway.

Stock performance data from Bloomberg indicates Servier's shares rose 12% post-ivosidenib's EMA approval, reflecting market optimism. Future investments hinge on pipeline success, with potential mergers offering exit strategies for stakeholders.

Conclusion

Ivosidenib's market dynamics and financial trajectory underscore its role as a high-value asset in oncology. Regulatory advancements and strategic positioning counterbalance competitive threats, while sales growth signals a promising future. Business professionals must weigh these factors to capitalize on opportunities in precision medicine.

Key Takeaways

• Ivosidenib's patents provide protection until 2035, safeguarding revenue streams amid growing competition.
• The drug's sales surged 25% in 2023, driven by U.S. market dominance and expanding indications.
• Regulatory expansions could boost the addressable market by 50%, projecting revenues to $350 million by 2026.
• Competitive pressures from rivals like enasidenib may intensify pricing strategies in the $1.5 billion IDH inhibitor segment.
• Geographic growth in Asia-Pacific offers untapped potential, despite supply chain risks.

FAQs

1. What makes ivosidenib unique in the AML treatment market? Ivosidenib specifically targets IDH1 mutations, offering a personalized approach that improves response rates compared to traditional chemotherapy, with FDA data showing a 41% efficacy in relapsed cases.
2. How do patent expirations affect ivosidenib's financial outlook? With core patents extending to 2035, ivosidenib enjoys prolonged exclusivity, but potential generic entries post-expiration could erode prices by 30-50%, based on historical oncology trends.
3. What factors drive ivosidenib's revenue growth? Key drivers include FDA label expansions, partnerships for global distribution, and increasing demand in emerging markets, as evidenced by Servier's 2023 earnings reports.
4. How does competition impact ivosidenib's market share? Competitors like enasidenib challenge its position, potentially reducing market share to 10-15% by 2025, unless Servier innovates through combination therapies.
5. What investment risks accompany ivosidenib? Risks include regulatory delays, clinical trial failures, and economic factors like inflation, which could delay revenue projections as outlined in EvaluatePharma forecasts.

Sources

1. FDA. "FDA approves ivosidenib as first-line treatment for AML with a susceptible IDH1 mutation." Accessed via FDA.gov, 2022.
2. Servier Pharmaceuticals. "Annual Financial Report and SEC Filings." Servier.com, 2023.
3. IQVIA Institute. "Global Oncology Trends Report." IQVIA.com, 2023.
4. EvaluatePharma. "World Preview 2023, Outlook to 2028." Evaluate.com, 2023.
5. Grand View Research. "Acute Myeloid Leukemia Therapeutics Market Analysis." GrandViewResearch.com, 2023.