US Patent 10,980,788: Ivosidenib Food-Effect Claims, Scope and Patent Landscape

US Patent 10,980,788 protects a narrow method of administering ivosidenib, also known as AG-120 and marketed as Tibsovo. The patent does not broadly claim the ivosidenib molecule. It claims treatment of IDH1-mutated malignancies with a once-daily 500 mg oral dose under specified food conditions, including pharmacokinetic exposure ranges and solid-dispersion formulations.

The patent was issued to Agios Pharmaceuticals on April 20, 2021. Its practical importance is that an approved generic using the same 500 mg regimen may face infringement risk even if the generic manufacturer does not practice the underlying composition-of-matter claims.

What drug and active ingredient does US 10,980,788 cover?

The claimed compound is ivosidenib, a selective inhibitor of mutant isocitrate dehydrogenase 1, or IDH1.

Item	Details
Generic name	Ivosidenib
Development code	AG-120
Brand	Tibsovo
Sponsor	Agios Pharmaceuticals
Active target	Mutant IDH1
Dose in Patent 10,980,788	500 mg orally once daily
Primary FDA indications	IDH1-mutated AML and previously treated IDH1-mutated cholangiocarcinoma
Molecular mutation focus	IDH1 R132 variants
Dosage form	Oral tablet
Patent type	Method of treatment, food-effect, pharmacokinetic and formulation claims

The compound is the stereochemically defined molecule recited in claim 1. The patent therefore covers the identified ivosidenib compound, not every IDH1 inhibitor.

The reference in the supplied claim text to a “mutant IGH1 inhibitor” is a typographical error. The relevant target is mutant IDH1.

What does claim 1 of US 10,980,788 require?

Claim 1 requires every element below:

Treatment of a malignancy.
The malignancy is characterized by a mutant IDH1 allele.
Administration of ivosidenib.
Oral administration.
A once-daily dose of 500 mg.
Administration to a subject who has not ingested a high-fat meal.

The claim is narrower than a general claim to treating IDH1-mutated cancer with ivosidenib. It requires the specific dose, route, frequency and food restriction.

A potential infringement theory would generally require evidence that the accused product or treatment regimen satisfies all of these limitations. Use of ivosidenib at a different dose, a different dosing frequency, or for a non-IDH1-mutated malignancy would not literally satisfy claim 1.

The claim also raises induced-infringement risk. A generic label that instructs physicians to administer ivosidenib at 500 mg once daily while avoiding high-fat meals could be used to argue that the label encourages practice of the patented method.

What food restrictions are protected by the patent?

Claims 2 through 5 define different food-related administration conditions.

Claim	Protected condition
1	Patient has not ingested a high-fat meal
2	Dose is administered substantially contemporaneously with non-high-fat food
3	Dose is administered without food
4	No high-fat meal for at least 60 minutes before dosing
5	Dose is administered at least 60 minutes before any high-fat meal

The claims create several overlapping administration scenarios. Claim 3 covers fasting administration. Claim 2 covers administration with food, provided the food is not a high-fat meal. Claims 4 and 5 create specific 60-minute timing limitations.

The term “high-fat meal” is a potential claim-construction issue. FDA labeling commonly uses a defined high-fat meal for pharmacokinetic studies, often based on a specified calorie and fat content. The patent claims, as supplied, do not provide the full definition. That omission could create disputes over whether a particular meal falls within the limitation.

“Substantially contemporaneously” in claim 2 is also less precise than the 60-minute limitations in claims 4 and 5. A court could interpret the term using the specification, clinical study protocols and the ordinary meaning of administration with food.

What pharmacokinetic ranges are claimed?

Claims 6 and 7 protect specific exposure ranges for ivosidenib.

Claim	Pharmacokinetic limitation
6	Cmax of 1,500 to 3,100 ng/mL
7	AUC0-t of 110,000 to 165,000 hr·ng/mL

These are dependent claims and retain the requirements of claim 1. The patient must therefore have an IDH1-mutated malignancy, receive 500 mg orally once daily, and satisfy the high-fat-meal limitation.

The pharmacokinetic claims are difficult to assess from the treatment label alone because Cmax and AUC are patient-specific results. An accused manufacturer generally does not control the patient’s resulting exposure. The claims may be more significant against a clinical sponsor, treatment protocol or formulation developer than against a generic manufacturer whose product produces variable patient exposure.

A key issue is whether the claimed ranges describe the administered regimen or the resulting measured exposure. The language supplied claims that “the Cmax” and “the AUC0-t” fall within the specified ranges. The patent specification and prosecution history would be important in determining whether the claims require actual measurement in each patient, an expected population range, or a product-level pharmacokinetic profile.

What formulations are protected?

Claim 8 covers administration of ivosidenib as part of a solid dispersion.

This claim is narrower than the food-effect claims but could reach a commercial tablet containing ivosidenib dispersed in a polymeric or other solid matrix. Solid dispersions are commonly used to improve dissolution, bioavailability or dose uniformity.

Claim 8 does not, on its face, require a particular polymer, particle size, manufacturing process or excipient. Those limitations may appear in the specification or related continuation patents. A generic product would require formulation analysis to determine whether its ivosidenib is present as a solid dispersion rather than as a conventional crystalline drug substance blended into a tablet.

The formulation claim may create a second layer of risk even if a generic company disputes the method claims. It is particularly relevant where the generic developer uses the same formulation technology as the reference product.

Which cancers and mutations are covered?

The dependent claims cover both hematologic malignancies and solid tumors.

Hematologic malignancies

Claims 9 through 12 cover:

Acute myelogenous leukemia, or AML
Myelodysplastic syndrome, or MDS
Myeloproliferative neoplasms, or MPN
Chronic myelomonocytic leukemia, or CMML
B-cell acute lymphoblastic leukemia, or B-ALL
Lymphoma
Relapsed or refractory AML

Claim 11 narrows claim 10 to AML. Claim 12 further narrows the AML population to relapsed or refractory disease.

Solid tumors

Claims 13 through 17 cover:

Glioma
Intrahepatic cholangiocarcinoma
Chondrosarcoma
Prostate cancer
Colon cancer
Melanoma
Non-small-cell lung cancer
Advanced solid tumors
Relapsed or refractory solid tumors

Claim 15 specifically covers intrahepatic cholangiocarcinoma.

IDH1 mutation subtypes

Claim 18 covers an IDH1 R132X mutation. Claim 19 identifies:

R132H
R132C
R132L
R132V
R132S
R132GF

The R132H and R132C variants are particularly relevant commercially because they are recurring oncogenic IDH1 mutations in AML, glioma and cholangiocarcinoma. A product label limited to only one mutation subtype could affect literal scope, although claim 1 broadly requires a mutant IDH1 allele and the dependent claims expand specific mutation coverage.

How does the patent compare with the core ivosidenib composition patent?

US Patent 10,980,788 is a later, narrower patent than the core composition-of-matter patent associated with ivosidenib.

Patent	Primary subject matter	Commercial effect
US 9,562,057	Ivosidenib and related IDH1 inhibitor compounds	Blocks use of the patented molecule, subject to claim scope
US 10,980,788	500 mg once-daily treatment, food conditions, PK and solid dispersion	Can delay or complicate generic use of the approved regimen
Related formulation and use patents	Dosage forms, solid-state properties, treatment populations or manufacturing	May create additional ANDA and FTO barriers

US 9,562,057 is commonly identified as a foundational Agios patent covering ivosidenib-type compounds. Its term extends into the 2030s based on the earliest effective nonprovisional filing date. US 10,980,788 has a later effective priority date and is expected to extend to approximately 2037, subject to patent-term adjustment and any applicable patent-term extension.

The patents have different infringement theories. The composition patent is directed to the drug substance. Patent 10,980,788 is directed to the way the drug is administered. A generic applicant may challenge one patent while avoiding or settling another.

What is the FDA regulatory status of Tibsovo?

The FDA approved Tibsovo in 2018 for adults with relapsed or refractory AML whose tumors have a susceptible IDH1 mutation, as detected by an FDA-approved test.[1]

The FDA later expanded the label to include:

Newly diagnosed AML in adults age 75 years or older; and
Newly diagnosed AML in adults with comorbidities that preclude use of intensive induction chemotherapy.[2]

The FDA also approved ivosidenib for previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation.[3]

The labeled dose is 500 mg orally once daily. The FDA label permits administration with or without food but instructs patients to avoid a high-fat meal around dosing. That labeling aligns materially with the administration conditions in Patent 10,980,788.[1]

What is the Orange Book status of US 10,980,788?

US 10,980,788 is an FDA-listed patent for Tibsovo-related use and administration subject matter. Its commercial relevance depends on the specific Orange Book listing, use code and expiration date recorded by FDA.

The listed patent is not a conventional product-by-process patent. It is a method-of-use patent tied to an approved ivosidenib regimen. An ANDA applicant seeking approval before expiration would generally need to address the patent through one of the statutory certification pathways.

Certification	Practical consequence
Paragraph I	No patent information listed
Paragraph II	Patent has expired
Paragraph III	Applicant will wait until patent expiration
Paragraph IV	Applicant asserts the patent is invalid, unenforceable or not infringed
Section viii statement	Applicant omits a patented indication from the label

For Patent 10,980,788, a Paragraph IV certification would be the principal challenge route if the applicant seeks approval before the patent’s expected 2037 expiration. A section viii strategy could be available only if the proposed label can omit the patented dosing conditions and still obtain approval for a noninfringing use.

When does ivosidenib lose regulatory exclusivity?

Ivosidenib’s major regulatory exclusivity periods began with the 2018 AML approval.

Exclusivity	Approximate period
New chemical entity exclusivity	Five years from July 20, 2018
Orphan-drug exclusivity for the original AML indication	Seven years from July 20, 2018
Later indication exclusivity	Depends on the specific approval and statutory designation

The five-year new chemical entity period expired in 2023. The original orphan exclusivity period extended into 2025. Regulatory exclusivity does not eliminate later-expiring patents. Patent 10,980,788 remains the more relevant barrier for an early generic launch if it is listed and enforceable.

Which companies are likely to challenge the ivosidenib patent estate?

Potential challengers include major ANDA developers with oncology portfolios, including Teva, Sandoz, Sun Pharmaceutical, Dr. Reddy’s Laboratories, Lupin, Cipla and Hikma. The existence of a challenge by any particular company requires confirmation from FDA, PACER or an ANDA litigation filing.

The most likely challenge sequence is:

A generic company files an ANDA for ivosidenib tablets.
The applicant sends a Paragraph IV notice to Agios and other patent owners.
The patent holder files an action under the Hatch-Waxman Act within 45 days.
FDA approval is generally subject to a 30-month stay, unless the litigation is resolved earlier or the stay is otherwise altered.
The parties may litigate validity, enforceability and infringement or enter a settlement.

A settlement could permit an agreed launch date before the listed patent expires. Financial terms, authorized-generic rights and supply arrangements would materially affect the competitive outcome.

What generic launch risks exist?

A generic launch before the expected 2037 expiration faces four principal risks.

Infringement risk

The approved label likely directs use of 500 mg once daily and avoidance of high-fat meals. That creates a potential induced-infringement theory for claims 1 through 5.

Formulation risk

If the reference product or generic uses a solid-dispersion formulation, claim 8 could add a formulation-based infringement claim.

Validity risk

The strongest potential validity issues include:

Obviousness based on prior ivosidenib dosing and food-effect studies.
Written-description support for the broad list of malignancies and mutation subtypes.
Enablement of treatment across all listed cancers.
Indefiniteness of “high-fat meal” and “substantially contemporaneously.”
Whether the PK ranges are sufficiently tied to the claimed regimen.
Double-patenting over earlier Agios patents.

Label-carveout risk

A generic may attempt to omit patented cancer indications or food instructions. That strategy is difficult where the approved product’s principal indication uses the same 500 mg regimen and food restrictions covered by the patent.

How strong is the patent estate for ivosidenib?

The estate is structurally strong but claim-specific.

The composition patent provides the broadest protection because it targets the active molecule. Patent 10,980,788 adds later-term protection for the commercial dosing regimen. Formulation, solid-state and method-of-use patents may create additional barriers.

The weakness of Patent 10,980,788 is its narrow combination of limitations. A challenger can attack the patent by separating:

The drug substance from the dosing method.
The dosing method from the food restriction.
The food restriction from the PK result.
The approved indication from the broader list of malignancies.

The patent is strongest against a generic that copies the approved label exactly. It is weaker against a product using a materially different dose, formulation or indication, provided the alternative does not induce practice of the patented method.

What licensing and commercial arrangements affect ivosidenib?

Agios developed ivosidenib and commercializes Tibsovo in the United States. Servier obtained rights to develop and commercialize ivosidenib outside the United States and Canada under a collaboration arrangement. The agreement transferred substantial ex-U.S. commercial responsibility to Servier while preserving Agios’ U.S. commercial position.[4]

The collaboration matters to patent enforcement because ownership, exclusive licenses, sublicenses and royalty rights can affect standing, settlement authority and the parties named in Hatch-Waxman litigation.

Does biosimilar risk apply to ivosidenib?

No. Ivosidenib is a chemically synthesized small-molecule drug, not a biologic. The relevant competitive pathway is an ANDA for a generic drug under section 505(j) of the Federal Food, Drug, and Cosmetic Act, not a biosimilar application under section 351(k) of the Public Health Service Act.[5]

The main competitive threats are generic ivosidenib tablets, authorized-generic arrangements, label carve-outs and competing IDH inhibitors.

How does ivosidenib compare with competing IDH inhibitors?

Drug	Target	Main development or commercial position
Ivosidenib	Mutant IDH1	AML and cholangiocarcinoma
Olutasidenib	Mutant IDH1	Relapsed or refractory AML
Enasidenib	Mutant IDH2	IDH2-mutated AML
Vorasidenib	Mutant IDH1 and IDH2	IDH-mutated glioma development and approval pathway

Ivosidenib’s patent exposure is distinct from competitors because its estate centers on the AG-120 molecule and the 500 mg food-effect regimen. A competing IDH1 inhibitor does not infringe Patent 10,980,788 merely because it treats an IDH1-mutated malignancy.

Key Takeaways

US 10,980,788 is a method-of-treatment patent for ivosidenib, not a broad composition patent.
The independent claim requires a mutant IDH1 malignancy, 500 mg orally once daily, and no recent high-fat meal.
Dependent claims cover non-high-fat food, fasting administration, 60-minute meal timing, PK exposure ranges and solid-dispersion formulations.
AML and cholangiocarcinoma are the most commercially relevant covered indications.
The patent’s expected term extends into approximately 2037, subject to patent-term adjustment and any applicable term extension.
Generic ivosidenib applicants face potential Paragraph IV litigation and induced-infringement exposure from copying the FDA-approved label.
Ivosidenib has generic, not biosimilar, competition risk.
The composition patent and later method patents operate together, creating layered protection around Tibsovo.

FAQs

What is the expiration date of US Patent 10,980,788?

The patent is expected to expire in approximately 2037 based on its later priority date, subject to the official USPTO term calculation, patent-term adjustment and any applicable extension.

Does Patent 10,980,788 cover all IDH1 inhibitors?

No. It specifically identifies ivosidenib as the claimed inhibitor. Other IDH1 inhibitors, including olutasidenib, are outside the literal compound limitation.

Can a generic avoid this patent by administering less than 500 mg?

A materially different dose may avoid literal infringement of claim 1, but the generic would need FDA approval for that dose and must assess other patents covering the compound, formulation or alternative regimen.

Does taking ivosidenib with food infringe the patent?

It may. Claim 2 covers administration substantially contemporaneously with food when the food is not high-fat. Claim 3 covers administration without food. The exact result depends on the meal composition, timing and claim construction.

Is the 2037 patent a barrier to all generic ivosidenib approval?

Not necessarily. A generic applicant may challenge validity, enforceability or infringement through Paragraph IV certification, or attempt a section viii label carve-out. The commercial result depends on litigation, settlement and the final FDA-approved label.

References

U.S. Food and Drug Administration. (2024). Tibsovo (ivosidenib) prescribing information. FDA.
U.S. Food and Drug Administration. (2022). FDA approves ivosidenib for newly diagnosed AML with a susceptible IDH1 mutation. FDA.
U.S. Food and Drug Administration. (2021). FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma. FDA.
Agios Pharmaceuticals, Inc. (2024). Annual report on Form 10-K. U.S. Securities and Exchange Commission.
U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. FDA.
United States Patent and Trademark Office. (2021). U.S. Patent No. 10,980,788: Methods of treating cancer using IDH1 inhibitors. USPTO.
United States Patent and Trademark Office. (2017). U.S. Patent No. 9,562,057: Mutant IDH1 inhibitors. USPTO.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				A METHOD OF TREATING PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL	⤷ Start Trial
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				A METHOD OF TREATING RELAPSED OR REFRACTORY MYELODYSPLASTIC SYNDROMES CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL	⤷ Start Trial
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				TREATING NEWLY DIAGNOSED AML CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE OF IVOSIDENIB TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL, IN COMBINATION WITH AZACITIDINE	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Details for Patent: 10,980,788

Which drugs does patent 10,980,788 protect, and when does it expire?

Summary for Patent: 10,980,788