Details for Patent: 11,667,673

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Which drugs does patent 11,667,673 protect, and when does it expire?

Patent 11,667,673 protects TIBSOVO and is included in one NDA.

This patent has one hundred patent family members in forty-three countries.

Summary for Patent: 11,667,673

Title:	Therapeutically active compounds and their methods of use
Abstract:	Provided are methods of treating a cancer characterized by the presence of a mutant allele of IDH1/2 comprising administering to a subject in need thereof a compound described here.
Inventor(s):	Janeta Popovici-Muller, Rene M. Lemieux, Jeremy Travins, Zhenwei Cai, DaWei Cui, Ding Zhou
Assignee:	PHARMARESOURCES (SHANGHAI) CO Ltd , Servier Pharmaceuticals LLC
Application Number:	US16/893,750
Patent Claim Types: see list of patent claims	Use;

US Patent 11,667,673: Ivosidenib Patent Scope, MDS Claims, Expiration and Generic Risk

US Patent 11,667,673 protects the use of ivosidenib, marketed as Tibsovo, for treating myelodysplastic syndrome in patients with an IDH1 mutation. Its strongest commercial value is the biomarker-specific MDS indication, particularly IDH1 R132H and R132C disease. The patent does not broadly protect ivosidenib as a molecule; earlier composition and broader method-of-use patents are more important to generic entry timing.

The patent has a nominal term extending to approximately November 30, 2038, subject to adjustment, extension, terminal-disclaimer terms, and the patent’s official term calculation. The relevant product patent estate may extend through approximately December 2034 or later depending on the patent and approved-use claim at issue.

What drug does US Patent 11,667,673 protect?

The compound recited in claim 1 is ivosidenib, also known as AG-120.

Ivosidenib is a small-molecule inhibitor of mutant IDH1. It is marketed in the United States by Servier Pharmaceuticals under the brand name Tibsovo. The compound is approved for specified IDH1-mutated hematologic malignancies and cholangiocarcinoma.

Item	Information
Active ingredient	Ivosidenib
Brand	Tibsovo
Drug class	Mutant IDH1 inhibitor
Dosage form	Oral tablets
Relevant disease	Myelodysplastic syndrome
Biomarker	Susceptible IDH1 mutation
Patent analyzed	US 11,667,673
Patent type	Method-of-treatment patent
Relevant claims	Claims 1-3
Patent holder or commercial sponsor	Servier Pharmaceuticals and related entities

The claim uses a specific stereochemically defined ivosidenib compound, together with pharmaceutically acceptable salts and hydrates. This language covers the active pharmaceutical ingredient and certain pharmaceutical forms, but it does not independently claim every formulation, dosage strength, manufacturing process, or therapeutic use.

What are the claims of US 11,667,673?

Claim 1 covers a method of treating MDS in a patient with an IDH1 mutation by administering a therapeutically effective amount of ivosidenib, or a pharmaceutically acceptable salt or hydrate.

The claim has five central limitations:

1. A method of treatment.
2. A patient in need of treatment.
3. Myelodysplastic syndrome.
4. An IDH1 mutation in the patient.
5. Administration of a therapeutically effective amount of ivosidenib.

The claim does not expressly require:

• A particular dose.
• A specific dosing schedule.
• A particular route of administration.
• A specific age group.
• Relapsed or refractory disease.
• A specified percentage of mutant alleles.
• Monotherapy.
• Combination therapy.
• A particular response endpoint.
• A specific IDH1 diagnostic test.

Those omissions make claim 1 relatively broad within the MDS and IDH1-mutated patient population.

What does claim 2 add?

Claim 2 limits the mutation to an IDH1 R132X mutation. In conventional molecular notation, R132X generally identifies a substitution at IDH1 amino acid position 132, where arginine is replaced by another amino acid.

The scope of “R132X” may become important in litigation. A generic company could argue that the term is limited to specific substitutions supported by the specification or clinical evidence. The patent owner would likely argue that the notation covers the broader class of R132 substitutions.

What does claim 3 add?

Claim 3 narrows the mutation to IDH1 R132H or R132C.

These are commercially important mutations:

• R132H is a common IDH1 mutation.
• R132C is also clinically relevant and is specifically included in FDA-approved IDH1 testing and treatment contexts.

Claim 3 is narrower than claim 1 and claim 2 but may be easier to enforce because it identifies two specific, clinically recognized mutations.

What is the legal scope of the MDS method claims?

The claims are use claims rather than composition claims. Direct infringement generally depends on performance of the claimed treatment method. A physician or healthcare provider administering ivosidenib to an MDS patient with an applicable IDH1 mutation would be the most direct infringement scenario if all claim elements are satisfied.

The patent owner could also pursue induced-infringement theories against a manufacturer or distributor if evidence showed that the company actively encouraged use of ivosidenib for the patented MDS population. Label language, promotional materials, clinical trial activity, reimbursement support, and treatment guidelines could become relevant.

The claims create several potential enforcement advantages:

• They are tied to the FDA-approved disease indication.
• The IDH1 biomarker can be documented through clinical testing.
• The active ingredient is readily identifiable.
• The claims do not depend on a narrow dosing schedule.
• Claims 2 and 3 provide fallback positions if the broader mutation language is challenged.

Potential weaknesses include:

• The claims do not protect the underlying ivosidenib molecule.
• A product label that omits MDS could reduce induced-infringement exposure for this patent.
• “Therapeutically effective amount” may invite enablement or written-description arguments if a challenger disputes the breadth of the claimed population.
• “R132X” may create claim-construction disputes.
• The patent may be vulnerable to obviousness attacks based on earlier IDH1 inhibitor and MDS disclosures.

When does US Patent 11,667,673 expire?

The patent’s nominal term is associated with a November 30, 2018 priority date, producing an expected base expiration around November 30, 2038, before any patent-term adjustment or patent-term extension.

Term component	Approximate date or effect
Earliest relevant priority	November 30, 2018
Grant	June 6, 2023
Nominal 20-year term	Approximately November 30, 2038
Patent-term adjustment	Must be confirmed from the issued patent and USPTO record
Patent-term extension	Potentially available only if statutory requirements are met
Terminal disclaimer	Must be checked against related patents

The practical Orange Book expiration date may differ from the nominal calculation. A terminal disclaimer can shorten the term, while patent-term adjustment can extend it. Patent-term extension under 35 U.S.C. § 156 is possible for eligible regulatory delay, although method-of-treatment patents and the relevant regulatory history must be reviewed carefully.

What patents protect Tibsovo and ivosidenib?

US 11,667,673 is one part of the ivosidenib patent estate. The principal categories are composition patents, broad method-of-use patents, MDS-specific patents, formulation patents, and process patents.

Patent category	Commercial function	Relevance to generic entry
Composition patent	Protects ivosidenib and related compounds	Usually the strongest barrier
Broad IDH1 treatment patent	Protects use in IDH1-mutated cancers	May cover multiple diseases
MDS-specific method patent	Protects MDS treatment in IDH1-mutated patients	Relevant to MDS label
Formulation patent	Protects tablet composition, excipients, or release profile	May affect product design
Manufacturing patent	Protects synthesis, purification, or crystallization	May require design-around
Pediatric or dosing patent	Protects specific patient groups or regimens	Usually narrower

A key earlier patent commonly associated with ivosidenib is US 9,290,527, which covers IDH1 inhibitor chemistry and related compounds. Its nominal term is generally associated with a December 2034 expiration based on a December 2013 priority date, subject to patent-term adjustment, terminal disclaimers, and any applicable extension.

A broader method patent family may also cover treatment of IDH1-mutated cancers. Those patents can create overlapping protection even if a generic applicant avoids the specific MDS claims in US 11,667,673.

What is the Orange Book status of US 11,667,673?

The Orange Book determines whether an approved drug’s patents are listed by the NDA holder and whether those patents are relevant to an ANDA applicant’s certification obligations.

For a listed method-of-use patent, the central issues are:

• Whether the patent is listed for Tibsovo.
• Which approved-use code is associated with the patent.
• Whether the generic applicant seeks the patented MDS indication.
• Whether the applicant uses a section viii statement to carve out that indication.
• Whether the NDA holder sues after receiving a Paragraph IV notice.

US 11,667,673 is commercially relevant as a potential Orange Book-listed use patent for Tibsovo’s IDH1-mutated MDS indication. The definitive listing status, use code, and expiration date must be taken from the applicable FDA Orange Book edition and patent-listing file.

A use patent does not automatically prevent approval of an ANDA for every use of the drug. If the generic label omits the patented MDS indication, the applicant may attempt a section viii statement. That strategy would not eliminate exposure under the separate composition patent or other method patents covering non-MDS uses.

When does ivosidenib lose exclusivity?

Ivosidenib has multiple forms of exclusivity that operate on different dates.

Exclusivity type	Approximate status
New chemical entity exclusivity	Expired or no longer the primary barrier
Orphan-drug exclusivity	Applies by disease or indication for seven years from the relevant approval
Composition patent	Expected to remain relevant through approximately 2034, subject to adjustment
MDS method patent	Expected to remain relevant through approximately 2038, subject to adjustment
Regulatory exclusivity for MDS	Depends on the specific FDA approval and orphan designation

Tibsovo received FDA approval in 2018 for relapsed or refractory AML with a susceptible IDH1 mutation. FDA later expanded its indications, including newly diagnosed AML, previously treated cholangiocarcinoma, and MDS. FDA granted accelerated approval for adult patients with relapsed or refractory MDS with a susceptible IDH1 mutation in October 2023. [2]

Orphan-drug exclusivity, when applicable, blocks approval of the same drug for the same disease or condition for seven years. It does not prevent a competing product from being approved for a different disease or indication. It also does not prevent a patent challenge.

What Paragraph IV challenges could affect Tibsovo?

An ANDA applicant seeking approval before expiration of listed patents could submit a Paragraph IV certification asserting that a patent is invalid, unenforceable, or not infringed.

The likely challenge targets are:

1. The composition patent covering ivosidenib.
2. Broad IDH1 cancer-treatment patents.
3. The MDS-specific patent, including US 11,667,673.
4. Formulation patents, if listed.
5. Any patent covering a specific tablet strength or dosing regimen.

Potential Paragraph IV arguments include:

• Obviousness based on prior IDH1 inhibitors.
• Lack of written description for a broad R132X population.
• Lack of enablement across all claimed MDS patients.
• Non-infringement through a carved-out label.
• Failure of the patent to cover the approved product or use.
• Double-patenting or terminal-disclaimer defects.
• Invalidity based on earlier clinical or patent disclosures.

If Servier files an infringement action within the statutory period after receiving a Paragraph IV notice, FDA approval may be stayed for up to 30 months, subject to statutory exceptions and court developments. The stay applies to the challenged listed patent framework, not automatically to every patent in the estate.

Which companies are challenging ivosidenib patents?

The supplied patent claims do not identify an ANDA applicant, Paragraph IV notice, or patent litigation defendant. No company can be identified as a confirmed challenger from US 11,667,673 alone.

The likely competitive pool consists of generic manufacturers with oncology portfolios and the capacity to develop an oral small-molecule product. Unlike a biologic, ivosidenib would be challenged through the ANDA pathway rather than the biosimilar pathway.

A generic applicant could pursue one of two strategies:

• Seek a full label covering all non-patented and patented indications, then challenge the listed patents.
• Seek approval with a section viii carve-out excluding MDS or another patented indication.

The second strategy could support earlier approval for non-MDS uses if the composition patent and remaining method patents do not block launch.

Is there biosimilar risk for ivosidenib?

No. Ivosidenib is a chemically synthesized small molecule, not a biologic. The relevant competitive pathway is an ANDA for a generic version, not a 351(k) biosimilar application.

The principal barriers are therefore:

• Paragraph IV litigation.
• Composition patent expiration.
• Method-of-use patents.
• FDA labeling constraints.
• Manufacturing and analytical equivalence.
• Commercial scale-up and oncology-market access.

What formulation and manufacturing rights may remain?

US 11,667,673 does not claim a tablet formulation or manufacturing process. Its claims are satisfied by use of the compound in treatment.

Separate intellectual-property barriers may cover:

• Tablet excipient combinations.
• Solid-state forms.
• Salt or hydrate forms.
• Particle-size specifications.
• Impurity controls.
• Crystallization.
• Enantiomeric purity.
• Synthetic intermediates.
• Scalable production routes.

These rights matter most if the generic applicant cannot reproduce the reference-listed drug’s physical characteristics without practicing a protected process or solid form. Process patents generally create a less direct barrier than composition patents because a manufacturer may design around them.

How does the MDS patent compare with the broader ivosidenib estate?

US 11,667,673 is narrower than a composition patent but may have a longer nominal term.

Issue	Composition patent	US 11,667,673
Protected subject matter	Ivosidenib molecule or related compounds	Treatment of IDH1-mutated MDS
Typical expiry	Approximately 2034	Approximately 2038
Infringement trigger	Making, using, selling, or importing compound	Treating covered MDS patients
Label carve-out possible	No practical carve-out for the molecule	Yes, potentially
Biomarker required	Usually no	Yes
Disease required	Usually no	MDS
Generic risk	Broadest	Indication-specific
Litigation value	High	High for the MDS label

The MDS patent can extend indication-specific protection beyond the expected composition patent term. Its practical value depends on whether the generic applicant seeks an MDS label and whether Servier can establish induced infringement through the proposed labeling and commercial conduct.

What patent litigation and settlement risks exist?

The primary litigation risk is an ANDA action involving the composition patent and one or more method patents. A single generic applicant may challenge several listed patents in one notice. The resulting case could determine whether the generic can launch for non-MDS indications while excluding MDS.

Potential settlement structures include:

• A deferred generic-entry date.
• A launch license limited to non-MDS indications.
• A license subject to patent expiration.
• Restrictions on promotional activity.
• A contingent license triggered by invalidity or non-infringement findings.

No settlement terms can be inferred from the claims of US 11,667,673. Any commercial conclusion requires review of FDA patent listings, Paragraph IV notices, district-court dockets, and settlement filings.

What is the commercial exposure of the MDS patent?

The patent protects a biomarker-defined population rather than the entire MDS market. Its commercial value is tied to:

• The number of MDS patients with IDH1 mutations.
• The proportion with R132H or R132C mutations.
• Use in relapsed or refractory disease.
• Treatment duration.
• Reimbursement and testing rates.
• Physician adoption of targeted therapy.
• The timing of generic entry for other Tibsovo indications.

The MDS indication was approved under the accelerated-approval framework based on response data, including complete remission and duration-of-response measures. Confirmatory evidence and continued FDA approval status can affect the commercial value of the indication and its associated patent claims.

Key Takeaways

• US 11,667,673 is a method-of-treatment patent for ivosidenib in IDH1-mutated MDS.
• Claim 1 is broad within the defined MDS and IDH1 population because it does not require a specific dose, route, regimen, or line of therapy.
• Claim 2 covers the R132X mutation class.
• Claim 3 specifically covers IDH1 R132H and R132C.
• The patent does not protect ivosidenib as a molecule; earlier composition patents remain central to generic entry.
• The patent’s nominal expiration is approximately November 30, 2038, subject to official term adjustments and disclaimers.
• A generic applicant may attempt a section viii carve-out for MDS, but composition and other method patents could still block launch.
• Ivosidenib has generic, not biosimilar, competition risk.
• The most important unresolved commercial issue is whether the patent is currently listed in the Orange Book and whether any ANDA applicant has filed a Paragraph IV challenge.

FAQs

Can a generic company sell ivosidenib for AML while omitting MDS?

Potentially. A section viii label carve-out may exclude the patented MDS indication, but the generic must still address composition patents and other listed methods of use.

Does claim 3 cover all IDH1 mutations?

No. Claim 3 is limited to R132H and R132C. Claim 1 covers IDH1-mutated MDS more broadly, while claim 2 refers to R132X.

Does US 11,667,673 cover Tibsovo tablets?

It covers the therapeutic use of the specified ivosidenib compound. It does not expressly claim a tablet formulation, excipient system, or manufacturing process.

Can a patent on MDS treatment block approval for a generic AML product?

It can create a labeling and litigation issue, but an MDS method patent alone does not necessarily block approval for a properly carved-out AML label. Other patents may independently prevent approval or launch.

Is ivosidenib eligible for a biosimilar application?

No. Ivosidenib is a small molecule. A competing manufacturer would ordinarily use the ANDA pathway for a generic drug application.

References

1. United States Patent and Trademark Office. (2023). US Patent No. 11,667,673, methods of treating myelodysplastic syndrome.
2. U.S. Food and Drug Administration. (2023). FDA grants accelerated approval to ivosidenib for relapsed or refractory myelodysplastic syndromes.
3. U.S. Food and Drug Administration. (2024). Tibsovo (ivosidenib) prescribing information. Servier Pharmaceuticals.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book.
5. United States Patent and Trademark Office. (2016). US Patent No. 9,290,527.
6. Drug Price Competition and Patent Term Restoration Act, 21 U.S.C. §§ 355(j), 355a.
7. Patent Act, 35 U.S.C. §§ 156, 271, 282.

Drugs Protected by US Patent 11,667,673

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	11,667,673					A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHEREIN THE CANCER IS RELAPSED OR REFRACTORY MYELODYSPLASTIC SYNDROMES

International Family Members for US Patent 11,667,673

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2804851		301243	Netherlands
European Patent Office	2804851		CA 2023 00025	Denmark
European Patent Office	2804851		LUC00315	Luxembourg