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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 sixty-two patent family members in forty-three 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 has been one patent litigation case 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:	162
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	13
Patent Applications:	115
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
Cancer Research UK	Phase 3
UNICANCER	Phase 3
Servier	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 seven 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/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 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
New Zealand	742480	Combination therapy for treating malignancies
South Africa	201803166	COMBINATION THERAPY FOR TREATING MALIGNANCIES
Philippines	12017501419	THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHOD OF USE
Canada	2942072	COMPOSITIONS PHARMACEUTIQUES ET UTILISATION DE (S)-1-(2-CHLOROPHENYLE)-2-((3,3-DI FLUOROCYCLOBUTYLE)AMINO)-2-OXOETHYLE)-1-(4-CYANOPYRIDIN-2-YL)-N-(5-FLUOROPYRIDIN-3-YL)-5-OXOPYRROLIDINE-2-CARBOXAMIDE (PHARMACEUTICAL COMPOSITIONS AND USE OF (S)-1-(2-CHLOROPHENYL)-2-((3,3-DIFLUOROCYCLOBUTYL)AMINO)-2-OXOETHYL)-1-( 4-CYANOPYRIDIN-2-YL)-N-( 5-FLUOROPYRIDIN-3-YL)-5-OXOPYRROLIDINE-2-CARBOXAMIDE)
New Zealand	627053

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	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	C02804851/01	Switzerland		PRODUCT NAME: IVOSIDENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69077 13.06.2024
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 Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TIBSOVO

Introduction to TIBSOVO

TIBSOVO, or ivosidenib, is a groundbreaking drug developed by Servier Pharmaceuticals LLC, targeting cancers with specific genetic mutations. It has recently gained significant attention for its efficacy in treating rare blood cancers, particularly those with isocitrate dehydrogenase-1 (IDH1) mutations.

FDA Approvals and Clinical Significance

TIBSOVO has received several key FDA approvals that highlight its clinical significance. Most recently, it was approved for the treatment of relapsed or refractory myelodysplastic syndromes (MDS) with an IDH1 mutation, marking the first biomarker-driven therapy for MDS[1].

Additionally, TIBSOVO was approved in combination with azacitidine for patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) who are 75 years or older or have comorbidities that preclude intensive induction chemotherapy. This approval underscores its importance in treating AML patients who are not candidates for intensive chemotherapy[4].

Clinical Trials and Efficacy

The efficacy of TIBSOVO has been demonstrated through various clinical trials. In a Phase I trial for MDS patients with an IDH1 mutation, TIBSOVO showed a complete or partial remission rate of 39%, with a median response duration of 21.4 months and a median time to complete remission of 1.9 months. Notably, six out of nine patients who required blood or platelet transfusions at the start of the study no longer needed them after treatment with TIBSOVO[1].

For AML, the AGILE trial, a Phase 3 trial, showed that TIBSOVO in combination with azacitidine significantly improved event-free survival and overall survival in patients with newly diagnosed IDH1-mutated AML who were ineligible for intensive chemotherapy[4].

Market Size and Growth Projections

The market for TIBSOVO is projected to grow steadily over the coming years. As of 2024, the TIBSOVO market size was estimated at USD 192.5 million, and it is expected to reach USD 261.9 million by 2031, exhibiting a Compound Annual Growth Rate (CAGR) of 4.8%[3].

Key Drivers of Market Growth

• Targeted Therapy Advancements: The advancement in targeted therapies, particularly those targeting specific genetic mutations like IDH1, is a significant driver of the TIBSOVO market.
• Rising Incidence of Target Conditions: The increasing incidence of MDS and AML, especially among older populations, contributes to the growing demand for effective treatments like TIBSOVO[3].

Financial Performance

Revenue and Sales

TIBSOVO has contributed significantly to Servier Pharmaceuticals' revenue. In the 2021/22 financial year, sales of TIBSOVO reached €256 million, which was a key factor in the company's overall revenue growth of 9.8%[2].

Global Sales Forecast

Global sales for TIBSOVO are expected to reach a modest $179 million by 2029, according to GlobalData’s consensus analyst forecast. However, this figure could increase if the drug receives label expansions to include solid tumors, given that IDH1 mutations are present in about 2.85% of all cancers[1].

Royalty Income

Agios, a company involved in the development of TIBSOVO, reported approximately $9.9 million in royalty income from TIBSOVO for the full year ended December 31, 2022. This indicates a steady stream of revenue from the drug's sales[5].

Market Segmentation

The TIBSOVO market can be segmented based on the type of product and its application.

• Product Type: The market is classified into 60 tablets and 30 tablets.
• Application: The primary applications are in hospitals and pharmacies[3].

Future Prospects and Clinical Trials

TIBSOVO is currently being evaluated in 13 Phase I, II, and III clinical trials globally for various solid malignancies, including bile duct cancer, osteosarcoma, rare pediatric tumors, and low-grade glioma. These ongoing trials suggest potential label expansions and further growth opportunities for the drug[1].

Regulatory Designations

TIBSOVO has received FDA breakthrough therapy and orphan drug designations, which validate Servier Pharmaceuticals' investment in researching treatments for rare disorders. These designations can expedite the regulatory process and provide additional market exclusivity, further enhancing the drug's market potential[1].

Challenges and Considerations

While TIBSOVO has shown significant promise, it is not without its challenges. One of the notable adverse responses associated with TIBSOVO is differentiation syndrome, which can be lethal if untreated. This highlights the need for careful patient monitoring and management[1].

Key Takeaways

• Clinical Significance: TIBSOVO is a groundbreaking drug approved for treating MDS and AML with IDH1 mutations.
• Market Growth: The market is projected to grow to USD 261.9 million by 2031, driven by targeted therapy advancements and rising incidence of target conditions.
• Financial Performance: TIBSOVO has contributed significantly to Servier Pharmaceuticals' revenue and is expected to continue generating substantial revenue.
• Future Prospects: Ongoing clinical trials for various solid malignancies suggest potential label expansions and further growth opportunities.

FAQs

What is TIBSOVO used for?

TIBSOVO (ivosidenib) is used for the treatment of relapsed or refractory myelodysplastic syndromes (MDS) with an IDH1 mutation and newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults who are not candidates for intensive chemotherapy[1][4].

What are the key outcomes of TIBSOVO in clinical trials?

In clinical trials, TIBSOVO has shown a complete or partial remission rate of 39% in MDS patients and significant improvements in event-free survival and overall survival in AML patients[1][4].

What is the projected market size of TIBSOVO by 2031?

The TIBSOVO market is expected to reach USD 261.9 million by 2031, exhibiting a CAGR of 4.8%[3].

What are the driving factors of the TIBSOVO market?

The driving factors include targeted therapy advancements and the rising incidence of target conditions such as MDS and AML[3].

What are the potential future applications of TIBSOVO?

TIBSOVO is currently being evaluated in clinical trials for various solid malignancies, including bile duct cancer, osteosarcoma, rare pediatric tumors, and low-grade glioma, suggesting potential label expansions[1].

Sources

1. Clinical Trials Arena: "Tibsovo unlocks new era for rare blood cancers called myelodysplastic syndromes."
2. Servier: "Servier full year 2021/22 results confirm the transformation trajectory of the group."
3. Proficient Market Insights: "Tibsovo Market projected to touch USD 261.9 million in 2031."
4. Servier: "Servier Announces FDA Approval of TIBSOVO® (ivosidenib tablets) for Newly Diagnosed IDH1-Mutated Acute Myeloid Leukemia."
5. Agios: "Agios Reports Fourth Quarter and Full Year 2022 Financial Results."