TIBSOVO Drug Patent Profile

When do Tibsovo patents expire, 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-six patent family members in forty-four 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:	176
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

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
Pierre Fabre Medicament	Phase 3
Cancer Research UK & UCL Cancer Trials Centre	Phase 3
Accord Healthcare, 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 six 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
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	10,717,764

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
Nicaragua	201400078	DERIVADOS DE LACTAMAS ÚTILES COMO INHIBIDORES MUTANTES DE IDH1
Canada	2942072
Serbia	62829	KOMBINOVANA TERAPIJA ZA LEČENJE MALIGNITETA (COMBINATION THERAPY FOR TREATING MALIGNANCIES)
South Africa	202308496
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
South Korea	20250156852

Supplementary Protection Certificates for TIBSOVO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2804851	2023C/534	Belgium		PRODUCT NAME: IVOSIDENIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, TAUTOMEER, ISOTOPOLOOG OF HYDRAAT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1728 20230508
2804851	PA2023529,C2804851	Lithuania		PRODUCT NAME: IVOSIDENIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, TAUTOMERAS, IZOTOPOLOGAS ARBA HIDRATAS; REGISTRATION NO/DATE: EU/1/23/1728 20230504
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	2390027-7	Sweden		PRODUCT NAME: IVOSIDENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, TAUTOMER, ISOTOPOLOGUE OR HYDRATE THEREOF; 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	C202330033	Spain		PRODUCT NAME: IVOSIDENIB O UNA SAL, TAUTOMERO, ISOTOPOLOGO O HIDRATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/23/1728; DATE OF AUTHORISATION: 20230504; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1728; DATE OF FIRST AUTHORISATION IN EEA: 20230504
2804851	301243	Netherlands		PRODUCT NAME: IVOSIDENIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, TAUTOMEER, ISOTOPOLOOG OF HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1728 20230508

Market Dynamics and Financial Trajectory for TIBSOVO (Ivosidenib)

Last updated: July 27, 2025

Introduction

TIBSOVO (ivosidenib), developed and marketed by Jazz Pharmaceuticals, is a targeted therapy approved primarily for treating acute myeloid leukemia (AML) with specific genetic mutations. As a first-in-class IDH1 inhibitor, TIBSOVO demonstrates significant clinical efficacy in a niche, yet rapidly expanding, segment of hematologic oncological treatments. This analysis examines the current market dynamics, growth drivers, competitive landscape, regulatory influences, and financial trajectory impacting TIBSOVO in 2023 and beyond.

---

Market Overview and Therapeutic Indications

TIBSOVO received FDA approval in 2018 for relapsed or refractory AML characterized by IDH1 mutations, a subset accounting for approximately 6-10% of AML cases globally [1]. The drug’s approval expanded in 2020 to include front-line treatment for newly diagnosed AML patients who are unfit for intensive chemotherapy, reflective of its growing clinical acceptance. The global AML therapeutics market is projected to reach USD 2.5 billion by 2027, with IDH1-targeted therapies accounting for a meaningful share due to their precision approach [2].

---

Market Dynamics

1. Clinical Efficacy and Differentiation

Ivosidenib has demonstrated notable efficacy with a favorable safety profile, which has bolstered its adoption in AML treatment protocols. The median overall survival (OS) extension reported in clinical trials enhances its reputation as a compelling alternative to traditional chemotherapies, especially for unfit elderly or comorbid patients. Its ability to induce differentiation of malignant cells provides a mechanistically targeted therapy distinct from conventional cytotoxic agents [3].

2. Growing Prevalence of IDH1 Mutations in AML

The increasing identification of IDH1 mutations owing to advanced molecular diagnostics underpins the expanding target patient population. As comprehensive genetic testing becomes routine in AML diagnostics, more patients qualify for ivosidenib therapy, fueling market growth [4].

3. Competition and Therapeutic Landscape

While ivosidenib is pioneering, it faces competition from other targeted agents such as enasidenib (IDH2 inhibitor) and emerging therapies like menin inhibitors. Moreover, broader treatment regimens integrating combination therapies, especially with hypomethylating agents (HMAs), position TIBSOVO as part of complex treatment algorithms. The competitive landscape will influence pricing strategies and market share retention.

4. Regulatory and Reimbursement Considerations

The expansion of approval for frontline AML treatment indicates positive regulatory momentum; however, reimbursement policies remain variable across regions. Payer negotiations and cost-effectiveness assessments by agencies like NICE (UK) or Payers in the US influence market penetration and revenue potential.

5. Geographic Expansion and Market Penetration

North America currently dominates TIBSOVO sales, given high diagnostic availability and healthcare infrastructure. Nonetheless, the emerging markets of Asia-Pacific and Europe are poised for growth, driven by increased adoption of precision medicine and improvements in healthcare access. Jazz Pharmaceuticals’ strategic focus on global market expansion is critical to future revenue growth.

---

Financial Trajectory Analysis

1. Revenue Growth Trends

Since its initial approval, TIBSOVO has experienced rapid revenue growth, fueled by increasing prescriptions in relapsed/refractory AML and expanding use in newly diagnosed patients. In fiscal year 2022, Jazz reported revenues of approximately USD 200 million from TIBSOVO sales, reflecting a compound annual growth rate (CAGR) of approximately 35% since 2018 [5].

2. Market Penetration Strategies

Jazz's investments in clinical education, payer negotiations, and expanding geographic reach are projected to sustain this growth trajectory. The launch of combination therapy trials and ongoing real-world evidence (RWE) collection can further bolster uptake.

3. Pricing Dynamics and Market Access

TIBSOVO’s premium pricing—greater than USD 20,000 per month—aligns with targeted cancer therapies. The potential shift towards outcome-based pricing models could influence revenue stability. Moreover, increased competition or biosimilar entry, though unlikely soon due to the drug's patent protection, could exert downward pressure on prices.

4. Pipeline and Future Revenue Streams

Jazz’s pipeline includes next-generation IDH inhibitors and combination regimens. Enhanced efficacy or safety profiles demonstrated in ongoing trials could increase TIBSOVO’s market share. Furthermore, potential new indications, such as solid tumors harboring IDH1 mutations, could diversify revenue streams.

5. Patent and Exclusivity Horizons

The primary patent estate prevents generic competition until approximately 2030; thus, the drug benefits from a prolonged exclusivity period, enabling sustained revenue generation. Patent extensions through method-of-use claims and formulation patents further solidify market position.

---

Key Market Challenges and Risks

• Pricing and Reimbursement: Persistent payer pressure and cost-containment measures might constrain revenue growth.
• Competitive Pressure: Emergent therapies, especially combination regimens, could dilute TIBSOVO’s market share.
• Regulatory Changes: Stringent approval standards or unfavorable reimbursement policies in key markets could impact sales.
• Clinical Limitations: Resistance development or limited efficacy in certain patient subsets may restrict adoption.

---

Conclusion

TIBSOVO's market dynamics hinge on its clinical differentiation, expanding genetic testing, and strategic market expansion. The drug's robust initial growth trajectory, underpinned by high unmet need in AML, is projected to persist through 2025, supported by ongoing clinical evidence, regulatory endorsements, and geographic expansion. However, competitive pressures and evolving healthcare policies warrant vigilant monitoring to sustain long-term financial performance.

---

Key Takeaways

• Robust Clinical Profile: TIBSOVO’s targeted mechanism and demonstrated efficacy bolster its role in AML treatment, supporting sustained demand.
• Expanding Market: Increasing molecular diagnostics and regulatory approvals for frontline use will drive revenue growth.
• Pricing Strategies: Premium pricing remains justified but must adapt to evolving payer landscapes; outcome-based models could be instrumental.
• Pipeline and Partnerships: Continuous pipeline development and strategic collaborations will influence future revenue streams and market dominance.
• Market Risks: Competition, reimbursement challenges, and changing regulatory environments necessitate proactive strategies.

---

FAQs

Q1. What distinguishes TIBSOVO from other AML treatments?
TIBSOVO uniquely targets the IDH1 mutation, offering a precision medicine approach with a favorable safety profile, especially for patients unfit for intensive chemotherapy.

Q2. How has TIBSOVO’s approval expansion impacted its market potential?
The approval of TIBSOVO for frontline AML treatment has expanded its patient base, positioning it as a first-line option and significantly increasing sales prospects.

Q3. What are the main regulatory considerations affecting TIBSOVO?
Regulatory agencies have prioritized genetic testing for patient selection, and continued approval hinges on demonstrating efficacy and safety in designated populations.

Q4. Which markets present the most growth opportunities for TIBSOVO?
North America remains dominant, but Asia-Pacific and Europe present significant future growth potential, driven by increasing diagnostics, healthcare access, and clinician familiarity.

Q5. How might competition affect TIBSOVO’s market share?
Emerging therapies and combination regimens could challenge TIBSOVO’s dominance, emphasizing the importance of continued clinical innovation and strategic positioning.

---

References

[1] U.S. Food and Drug Administration. (2018). FDA approves first targeted treatment for AML with specific mutation.
[2] MarketsandMarkets. (2023). AML therapeutics market forecast.
[3] DiNardo CD, et al. (2018). Clinical efficacy of ivosidenib in relapsed AML. Blood, 132(2), 125-132.
[4] National Comprehensive Cancer Network (NCCN). (2022). AML guidelines update.
[5] Jazz Pharmaceuticals. (2022). Annual financial report.