# United States Drug Patent 10,717,764: Scope, Claims, Expiration, Orange Book Status, and Ivosidenib Patent Landscape

U.S. Patent No. 10,717,764 protects the use of ivosidenib for treating cholangiocarcinoma in patients whose tumors contain an IDH1 mutation. Its dependent claim narrows coverage to IDH1 R132H and R132C mutations. The patent does not claim ivosidenib as a chemical compound, a formulation, or a manufacturing process. Its principal commercial value is method-of-use protection for IDH1-mutated cholangiocarcinoma.

The patent was assigned to Agios Pharmaceuticals and relates to Tibsovo, whose active ingredient is ivosidenib. The patent issued July 21, 2020, from U.S. Application No. 16/199,828. Its scheduled patent-term expiration is generally reported as November 26, 2038, subject to any applicable patent-term adjustment or extension recorded in the official prosecution and patent records [1].

What drug does U.S. Patent 10,717,764 protect?

U.S. Patent 10,717,764 protects the use of ivosidenib, also known as AG-120, in IDH1-mutated cholangiocarcinoma.

The chemical entity identified in claim 1 is:

(S)-N-((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.

This compound is ivosidenib. The claim also covers a pharmaceutically acceptable salt or hydrate of the compound.

Patent element	Scope
Active ingredient	Ivosidenib
Disease	Cholangiocarcinoma
Biomarker	IDH1 mutation
Administration	Administration to a patient in need
Dose requirement	No specific dose stated
Formulation requirement	None stated
Mutation limitation in claim 1	Any IDH1 mutation within the claim language
Mutation limitation in claim 2	IDH1 R132H or R132C
Claim category	Method of treatment
Patent owner at issuance	Agios Pharmaceuticals, Inc.
U.S. patent number	10,717,764
Issue date	July 21, 2020
Application	16/199,828

What are the claims of U.S. Patent 10,717,764?

Claim 1

Claim 1 requires four principal elements:

The patient has cholangiocarcinoma.
The cholangiocarcinoma is characterized by an IDH1 mutation.
The physician administers a therapeutically effective amount of ivosidenib.
The administered product may be ivosidenib, a pharmaceutically acceptable salt, or a hydrate.

The claim is a treatment method claim. It does not require a particular treatment line, disease stage, prior therapy, dosing schedule, route of administration, response threshold, or combination therapy.

The phrase "characterized by the presence of an IDH1 mutation" creates a biomarker-based limitation. A patient with cholangiocarcinoma but without an IDH1 mutation would fall outside the express scope of claim 1. The claim is directed to the molecularly defined subset of cholangiocarcinoma rather than to the disease across the entire patient population.

Claim 2

Claim 2 depends on claim 1 and narrows the mutation to:

IDH1 R132H; or
IDH1 R132C.

A product or treatment method that satisfies claim 2 must satisfy every limitation of claim 1 and must involve one of those two specific mutations. Other IDH1 alterations may remain within claim 1 but would not satisfy claim 2 unless they are also construed to fall within R132H or R132C, which would raise a claim-construction issue.

How broad is the scope of Patent 10,717,764?

The patent has meaningful therapeutic and diagnostic relevance but limited product-level breadth.

What the patent covers

The patent covers treatment of IDH1-mutated cholangiocarcinoma with ivosidenib. Potentially covered conduct includes:

Prescribing ivosidenib for a patient with IDH1-mutated cholangiocarcinoma.
Dispensing ivosidenib pursuant to a label directed to that population.
Manufacturing or selling ivosidenib with instructions that induce the claimed treatment.
Using ivosidenib in patients with IDH1 R132H or R132C mutations under dependent claim 2.

What the patent does not cover

The claims do not expressly cover:

Ivosidenib as a compound independent of its use.
Ivosidenib tablets as a formulation.
A specific tablet strength.
A specific dosing regimen.
A method of diagnosing an IDH1 mutation.
Treatment of acute myeloid leukemia.
Treatment of glioma or other IDH1-driven tumors.
A combination of ivosidenib with chemotherapy or immunotherapy.
A manufacturing process for ivosidenib.
A method using a different IDH1 inhibitor.

The absence of a dosage limitation can increase practical breadth. A competing product could not avoid the claim merely by using a different dose if the administered amount remains therapeutically effective and all other limitations are met.

What is the legal significance of the IDH1 mutation limitation?

The mutation limitation is central to both infringement and validity analysis.

A treatment provider or product label must direct treatment to a patient population with an IDH1 mutation to create a strong infringement case. A label limited to unselected cholangiocarcinoma patients could present a different inducement analysis, although actual prescribing practices, promotional materials, clinical trial evidence, and prescribing information would remain relevant.

Claim 2 has a narrower evidentiary requirement. The patent holder would need to show that the relevant patient has an IDH1 R132H or R132C mutation. Genetic testing records, pathology reports, laboratory results, and treatment protocols could establish that fact.

The claim does not specify the testing platform or diagnostic method. Testing may therefore be performed through different validated sequencing or molecular diagnostic approaches, provided the result establishes the relevant IDH1 mutation.

When does U.S. Patent 10,717,764 expire?

The patent's nominal expiration date is November 26, 2038, based on the U.S. nonprovisional filing date associated with the patent family. The provisional priority date does not ordinarily start the 20-year patent term, while the relevant nonprovisional or international filing date generally controls term calculation.

Event	Date
Earliest reported provisional priority	November 27, 2017
U.S. nonprovisional filing	November 26, 2018
Patent issued	July 21, 2020
Nominal expiration	November 26, 2038
Patent-term adjustment	Confirm using the face of the issued patent and USPTO records

The patent term should be distinguished from regulatory exclusivity. FDA orphan-drug exclusivity for Tibsovo's cholangiocarcinoma indication was separate from patent protection and did not extend the patent's term. Patent-term extension under 35 U.S.C. § 156, if granted for an applicable patent, would also require a separate FDA and USPTO determination [2][3].

What is the FDA regulatory status of ivosidenib in cholangiocarcinoma?

The FDA approved Tibsovo for previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation after progression on prior therapy. The approval followed the ClarIDHy study and was based on improved progression-free survival compared with placebo [2].

The FDA label identifies the relevant population through an IDH1 mutation requirement and directs use of an FDA-approved test for selection. The regulatory indication therefore aligns closely with the biomarker limitation in Patent 10,717,764.

Regulatory issue	Status
Product	Tibsovo
Active ingredient	Ivosidenib
Sponsor	Servier, following transfer of Agios' oncology business
Disease	Previously treated, locally advanced or metastatic cholangiocarcinoma
Biomarker	IDH1 R132 mutation
FDA approval for cholangiocarcinoma	August 25, 2021
Treatment setting	After prior therapy
Regulatory pathway	FDA approval based on ClarIDHy data
Companion testing	IDH1 mutation testing required under the label

The FDA indication and the patent claims are not identical in every respect. The FDA label specifies a particular treatment setting and IDH1 R132 mutation framework. Patent claim 1 does not expressly require prior progression or metastatic disease. The patent may therefore reach treatment conduct outside the exact commercial label, provided the claimed elements are met.

What is the Orange Book status of Patent 10,717,764?

The patent is associated with the U.S. patent estate for Tibsovo. The FDA Orange Book should be checked for the current listing and any delisting, expiration, pediatric exclusivity, or regulatory-use-code information. Orange Book listing is commercially important because it can require an ANDA applicant to address the patent through a Paragraph IV certification or a statement that the applicant will wait until patent expiration [4].

A method-of-use listing generally depends on whether the patented use is reflected in the approved labeling. If listed, the patent can create an ANDA litigation pathway even though it does not claim the active ingredient itself.

An ANDA applicant may attempt to avoid infringement through:

A section viii statement carving out the patented cholangiocarcinoma use.
A label that omits the patented indication.
A Paragraph IV certification challenging validity, enforceability, or infringement.
A combination of a non-infringing label strategy and restrictions on promotional activity.

A section viii strategy is more difficult if the approved product's commercial value is concentrated in the patented indication or if the proposed labeling would still encourage the claimed use.

Which other patents protect ivosidenib?

Patent 10,717,764 is one part of a broader ivosidenib estate. The principal patent categories are compound patents, solid-form or formulation patents, method-of-use patents, and manufacturing or process patents.

Compound patents

The foundational compound estate covers ivosidenib and related IDH1 inhibitors. U.S. Patent No. 9,708,358 is widely associated with the ivosidenib compound family and has an earlier expiration profile than Patent 10,717,764 [5].

Compound claims are generally more valuable than a single indication claim because they can reach the active ingredient across multiple diseases and uses. A valid, enforceable compound patent can block generic commercialization regardless of whether the generic applicant avoids a particular method-of-use claim.

Method-of-use patents

Patent 10,717,764 is directed to cholangiocarcinoma. Other ivosidenib method patents may address:

IDH1-mutated acute myeloid leukemia.
Maintenance or relapse settings.
Other IDH1-mutated solid tumors.
Specific patient-selection criteria.
Treatment combinations or dosing regimens.

The enforceability of each method patent depends on its exact claims, FDA listing status, prosecution history, and whether the generic label induces the patented use.

Formulation and solid-form patents

A formulation or solid-form patent can protect:

A crystalline form of ivosidenib.
Tablet composition.
Excipient ratios.
Stability characteristics.
Particle-size distribution.
Manufacturing steps used to produce the commercial product.

These patents can create additional barriers even after an earlier compound patent expires. They may be vulnerable to invalidity challenges based on anticipation, obviousness, lack of written description, or enablement, depending on the claimed solid form or formulation.

How strong is the patent estate for ivosidenib?

The estate has a mixed strength profile.

Patent category	Strategic value	Main vulnerability
Compound patent	Broadest product protection	Earlier expiration and validity challenges
Cholangiocarcinoma method patent	Direct protection for the approved indication	Label carve-out and inducement disputes
Mutation-specific method patent	Strong patient-selection linkage	Narrower patient population
Formulation patent	Can delay substitution after compound expiry	Design-around and obviousness arguments
Manufacturing patent	May constrain cost-effective production	Alternative synthetic routes

Patent 10,717,764 is stronger as a targeted indication patent than as a stand-alone barrier to all generic ivosidenib sales. Its practical value depends on three factors:

Whether it is listed in the Orange Book.
Whether a generic applicant must market ivosidenib for IDH1-mutated cholangiocarcinoma.
Whether the applicant can implement a legally effective section viii carve-out.

The patent's biomarker limitation gives it a clear clinical boundary. The absence of a required dose or formulation limitation makes design-around through dosage changes less credible. A generic manufacturer would more likely rely on a labeling strategy, a Paragraph IV invalidity challenge, or a non-infringement position based on the intended use.

What Paragraph IV challenges and litigation affect this patent?

A Paragraph IV certification against Patent 10,717,764 could challenge:

Anticipation by earlier clinical or patent disclosures.
Obviousness of treating IDH1-mutated cholangiocarcinoma with ivosidenib.
Written description and enablement of the mutation-defined patient population.
Whether the proposed ANDA label induces infringement.
Whether the patent is properly listed for the approved product and indication.

No specific publicly documented Paragraph IV judgment or settlement involving Patent 10,717,764 is established by the claim text alone. The FDA Orange Book, FDA Paragraph IV notice records, PACER, and district court docket records control the current litigation position [4][6].

An ANDA filing containing a Paragraph IV certification can trigger up to 30 months of FDA approval stay under the Hatch-Waxman framework if the patent owner or exclusive licensee brings a timely infringement action [7]. The stay does not automatically establish patent validity. It delays approval while the litigation proceeds, subject to statutory exceptions.

Are biosimilars relevant to ivosidenib?

No. Ivosidenib is a chemically synthesized small molecule, not a biologic. Biosimilar provisions under the Public Health Service Act do not govern its generic competition.

The relevant pathway is an abbreviated new drug application under section 505(j) of the Federal Food, Drug, and Cosmetic Act. Competitive risk therefore comes from generic manufacturers, not biosimilar developers. The key barriers are active patents, Orange Book listings, exclusivity, manufacturing capacity, and the ability to obtain approval with an appropriate label [2][4].

What generic launch scenarios exist for ivosidenib?

Full-label generic launch

A full-label launch would expose the generic to the strongest infringement risk if Patent 10,717,764 remains enforceable and listed. It would also implicate any unexpired compound or formulation patents.

Section viii carve-out

A generic could seek approval without the patented cholangiocarcinoma use if the FDA accepts a labeling carve-out. This strategy would preserve access to non-patented indications while omitting the protected use.

The commercial value of such a launch depends on the size of the remaining indications and whether physicians use the generic off-label for cholangiocarcinoma. Off-label prescribing can create inducement disputes if the manufacturer promotes or otherwise encourages the patented use.

Paragraph IV launch

A generic could challenge the patent before its expiration. The expected dispute would focus on obviousness, written description, enablement, and induced infringement. A successful challenge could permit earlier full-label entry. A failed challenge could result in approval delay and damages exposure.

Post-expiration launch

Absent a successful challenge or settlement, full generic entry would become substantially easier after expiration of the relevant compound, formulation, and method-of-use patents. The latest surviving patent, rather than Patent 10,717,764 alone, would control the practical launch date.

How does Patent 10,717,764 compare with a compound patent?

Patent 10,717,764 is narrower than a compound patent but may have a later expiration date.

Issue	Patent 10,717,764	Ivosidenib compound patent
Claim type	Treatment method	Chemical compound
Disease limitation	Cholangiocarcinoma	Generally none
Biomarker limitation	IDH1 mutation	Generally none
Product coverage	Indirect, through use	Direct
Design-around potential	Label or indication carve-out	Low if compound claim survives
Typical commercial effect	Protects an indication	Blocks broad generic product sales
Reported expiration profile	Approximately November 2038	Earlier, approximately 2034 for the foundational estate
Main dispute	Induced infringement and obviousness	Compound validity, infringement, and patent term

The later expiration of a method patent does not necessarily make it the strongest patent. A generic may be unable to market freely before the compound patent expires, while after compound-patent expiry the method patent may be avoidable through a label carve-out.

What is the commercial exposure associated with this patent?

Tibsovo revenue is not generally reported by product indication in public financial disclosures. Patent 10,717,764 therefore cannot be assigned a standalone revenue figure from public company reporting.

Its commercial exposure is tied to:

The prevalence of IDH1-mutated cholangiocarcinoma.
The share of patients receiving second-line therapy.
The duration of ivosidenib treatment.
The ability to maintain the patented indication after compound-patent expiry.
Whether a generic can obtain a section viii carve-out.
The extent of off-label use and promotional conduct.

The patent is commercially material because it aligns with an FDA-approved, biomarker-selected indication. Its value is lower than that of a valid compound patent because it does not independently cover all sales of ivosidenib.

Key Takeaways

U.S. Patent 10,717,764 covers treating IDH1-mutated cholangiocarcinoma with ivosidenib.
Claim 2 is limited to IDH1 R132H and R132C mutations.
The patent does not claim ivosidenib as a compound, tablet, formulation, or manufacturing process.
The patent issued July 21, 2020, and has a nominal expiration around November 26, 2038.
Its claim scope closely tracks the FDA-approved biomarker-selected cholangiocarcinoma use but does not expressly require prior therapy or metastatic disease.
Generic competition would likely focus on a section viii carve-out, Paragraph IV litigation, or both.
Biosimilar competition is irrelevant because ivosidenib is a small-molecule drug.
The broader ivosidenib estate, including compound and formulation patents, must be assessed before determining the effective generic launch date.
Public revenue reports do not separately quantify cholangiocarcinoma sales attributable to Patent 10,717,764.

FAQs

Does Patent 10,717,764 cover IDH1-mutated glioma?

No. The claims expressly require cholangiocarcinoma. Treatment of glioma would not satisfy claim 1 solely because the tumor contains an IDH1 mutation.

Does the patent cover IDH1 R132G or R132S mutations?

Claim 1 is not expressly limited to R132H or R132C, while claim 2 is. Whether a particular non-R132H or non-R132C mutation falls within claim 1 depends on the construction of "IDH1 mutation" and the patent's specification and prosecution history.

Can a generic sell ivosidenib for acute myeloid leukemia while omitting cholangiocarcinoma?

Potentially. A generic may pursue a section viii carve-out for the patented cholangiocarcinoma use, subject to FDA approval and the remaining patent estate. The product's label and promotional conduct would remain central to infringement risk.

Is an IDH1 diagnostic patent required to enforce Patent 10,717,764?

No. Patent 10,717,764 is a treatment method patent. It does not require ownership of a separate diagnostic patent, although testing evidence may be needed to establish that the patient met the mutation limitation.

Does FDA approval extend Patent 10,717,764 automatically?

No. FDA approval and patent term are separate systems. Any patent-term extension or adjustment must be established through the applicable statutory and administrative records.

References

U.S. Patent and Trademark Office. (2020). U.S. Patent No. 10,717,764, Methods of treating cholangiocarcinoma.
U.S. Food and Drug Administration. (2021). Tibsovo (ivosidenib) prescribing information.
U.S. Patent and Trademark Office. (n.d.). Patent term adjustment and patent term extension records.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book.
U.S. Patent and Trademark Office. (2017). U.S. Patent No. 9,708,358.
U.S. Courts. (n.d.). PACER case locator and federal court docket records.
U.S. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417.

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	10,717,764	⤷ Start Trial				A METHOD OF TREATING PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA CHARACTERIZED BY AN IDH1 MUTATION	⤷ 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

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2804851	⤷ Start Trial	301243	Netherlands	⤷ Start Trial
European Patent Office	2804851	⤷ Start Trial	CA 2023 00025	Denmark	⤷ Start Trial
European Patent Office	2804851	⤷ Start Trial	LUC00315	Luxembourg	⤷ Start Trial
European Patent Office	2804851	⤷ Start Trial	PA2023529	Lithuania	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,717,764

Which drugs does patent 10,717,764 protect, and when does it expire?

Summary for Patent: 10,717,764