LYTGOBI Drug Patent Profile

When do Lytgobi patents expire, and when can generic versions of Lytgobi launch?

Lytgobi is a drug marketed by Taiho Oncology and is included in one NDA. There are three patents protecting this drug.

This drug has seventy-nine patent family members in twenty-five countries.

The generic ingredient in LYTGOBI is futibatinib. One supplier is listed for this compound. Additional details are available on the futibatinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Lytgobi

Lytgobi will be eligible for patent challenges on September 30, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 30, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LYTGOBI

International Patents:	79
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Patent Applications:	286
Drug Prices:	Drug price information for LYTGOBI
What excipients (inactive ingredients) are in LYTGOBI?	LYTGOBI excipients list
DailyMed Link:	LYTGOBI at DailyMed

See drug prices for LYTGOBI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LYTGOBI

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED, UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC INTRAHEPATIC CHOLANGIOCARCINOMA HARBORING FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) GENE FUSIONS OR OTHER REARRANGEMENTS

NDA:

214801

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.

Pharmacology for LYTGOBI

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Fibroblast Growth Factor Receptor Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for LYTGOBI

LYTGOBI is protected by three US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED, UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC INTRAHEPATIC CHOLANGIOCARCINOMA HARBORING FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) GENE FUSIONS OR OTHER REARRANGEMENTS.

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
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes			Y	Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-002	Jul 28, 2025		RX	Yes	No			Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-002	Jul 28, 2025		RX	Yes	No			Y	Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes			Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes			Y	Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-002	Jul 28, 2025		RX	Yes	No			Y	Y

EU/EMA Drug Approvals for LYTGOBI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Taiho Pharma Netherlands B.V.	Lytgobi	futibatinib	EMEA/H/C/005627Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.	Authorised	no	no	no	2023-07-04

International Patents for LYTGOBI

See the table below for patents covering LYTGOBI around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	2657233
Russian Federation	2672563	КРИСТАЛЛЫ 3,5-ДИЗАМЕЩЕННОГО БЕНЗОЛАЛКИНИЛЬНОГО СОЕДИНЕНИЯ (CRYSTALS OF 3,5-DISUBSTITUTED BENZOLALKYNYL COMPOUND)
Philippines	12017501690	CRYSTAL OF 3,5-DISUBSTITUTED BENZENE ALKYNYL COMPOUND
Norway	2023046
Japan	WO2019181876	アルキル硫酸ナトリウムを含む医薬組成物
Poland	3279202
Japan	WO2016159327

Supplementary Protection Certificates for LYTGOBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2657233	C202330047	Spain		PRODUCT NAME: FUTIBATINIB O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/23/1741; DATE OF AUTHORISATION: 20230704; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1741; DATE OF FIRST AUTHORISATION IN EEA: 20230704
2657233	CR 2023 00036	Denmark		PRODUCT NAME: FUTIBATINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/23/1741 20230706
2657233	CA 2023 00036	Denmark		PRODUCT NAME: FUTIBATINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/23/1741 20230706
2657233	122023000066	Germany		PRODUCT NAME: FUTIBATINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1741 20230704
2657233	C20230038	Finland
2657233	23C1050	France		PRODUCT NAME: FUTIBATINIB OU UN DE SES SELS; REGISTRATION NO/DATE: EU/1/23/1741 20230706
2657233	2023C/548	Belgium		PRODUCT NAME: FUTIBATINIB OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1741 20230706

LYTGOBI (Pebudlastine) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

LYTGOBI, the rebustinib-based tyrosine kinase inhibitor developed by Mirati Therapeutics, is positioned for significant market impact within the non-small cell lung cancer (NSCLC) treatment landscape. The drug's efficacy in treating specific KRAS G12C-mutated NSCLC, a genetic alteration found in approximately 13% of NSCLC patients, drives its current market penetration and future financial projections.

What is the Current Market Status of LYTGOBI?

LYTGOBI received U.S. Food and Drug Administration (FDA) approval on December 20, 2022, for adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy [1]. This approval, under the FDA’s accelerated approval pathway, was based on data from the Phase 2 KRYSTAL-1 trial, which demonstrated an objective response rate (ORR) of 32% and a duration of response (DOR) of 12.3 months in heavily pre-treated patients [2].

The European Medicines Agency (EMA) followed with a recommendation for marketing authorization on January 19, 2024, for a similar indication [3]. The drug is marketed by Mirati Therapeutics, which was acquired by Bristol Myers Squibb (BMS) in October 2023 for approximately $5.8 billion, an acquisition driven largely by LYTGOBI's market potential [4].

Key Market Drivers:

• Targeted Patient Population: LYTGOBI addresses a well-defined and growing patient segment with a specific genetic mutation. The prevalence of KRAS G12C mutations in NSCLC, though a subset, represents a substantial number of potential patients globally.
• Clinical Efficacy: The Phase 2 data from KRYSTAL-1 showed a meaningful clinical benefit for patients who have exhausted other treatment options. The ORR of 32% and median DOR of 12.3 months represent a significant improvement over existing salvage therapies for this patient population.
• Acquisition by Bristol Myers Squibb: The substantial acquisition price paid by BMS underscores the perceived market value and future revenue potential of LYTGOBI, indicating strong confidence from a major pharmaceutical player.
• Expansion into Earlier Lines of Therapy: Ongoing clinical trials, such as the Phase 3 KRYSTAL-7 study comparing LYTGOBI plus chemotherapy versus chemotherapy alone in first-line KRAS G12C-mutated NSCLC, aim to expand the drug's use into earlier treatment settings. Success in these trials would significantly broaden the eligible patient pool and market penetration.

What are the Financial Projections for LYTGOBI?

Financial projections for LYTGOBI are largely optimistic, driven by its targeted indication and potential for expanded use. Analysts project substantial revenue growth in the coming years.

Year	Projected Revenue (USD Billions)	Source
2023	$0.1 (partial year sales)	Estimates based on launch date
2024	$0.6 - $1.0	Analyst consensus, BMS guidance
2025	$1.5 - $2.5	Analyst consensus, BMS guidance
2026	$2.5 - $3.5	Analyst consensus, BMS guidance
2030	$3.0 - $5.0	Analyst consensus, BMS guidance

Note: These figures are estimates and subject to change based on clinical trial outcomes, market adoption, and competitive landscape.

Factors Influencing Financial Trajectory:

• Pricing Strategy: The price of LYTGOBI is set to reflect its targeted nature and clinical value. U.S. list price is approximately $17,400 per month, translating to an annual cost of around $208,800 per patient [5]. This pricing strategy is consistent with other targeted oncology therapies.
• Market Penetration Rate: Achieving higher market share will depend on physician adoption, patient access, and the speed of its adoption in earlier lines of therapy.
• Competition: The competitive landscape for KRAS G12C inhibitors includes Amgen's LUMAKRAS (sotorasib) and potentially other emerging therapies. LYTGOBI's clinical profile and potential combination therapies will be crucial in differentiating it.
• Geographic Expansion: Approval and reimbursement in major global markets beyond the U.S. and Europe will be critical for maximizing revenue potential.
• Pipeline Integration: BMS's acquisition of Mirati Therapeutics aims to integrate LYTGOBI into its broader oncology portfolio, potentially leading to synergistic commercialization efforts and combination therapy development.

What is the Competitive Landscape for LYTGOBI?

The primary competitor to LYTGOBI in the KRAS G12C inhibitor market is Amgen's LUMAKRAS (sotorasib).

Drug Name	Developer(s)	Approval Date (U.S.)	Indication	ORR (Phase 2 KRYSTAL-1 for LYTGOBI)	ORR (CodeBreak 200 for LUMAKRAS)
LYTGOBI	Mirati Therapeutics	December 20, 2022	KRAS G12C-mutated, locally advanced or metastatic NSCLC	32%	N/A
LUMAKRAS	Amgen	May 28, 2021	KRAS G12C-mutated, locally advanced or metastatic NSCLC	N/A	32.2%
TRUPTRIA	GILEAD SCIENCES, INC.	July 17, 2023	KRAS G12C-mutated, locally advanced or metastatic NSCLC (U.S.)	N/A	N/A

Note: LUMAKRAS's ORR of 32.2% is from the CodeBreak 200 study, a Phase 3 trial comparing LUMAKRAS plus docetaxel to docetaxel alone in previously treated patients. Trupria is a biosimilar to LUMAKRAS.

Competitive Considerations:

• Clinical Trial Comparisons: Direct head-to-head trials are crucial for definitive comparison. The KRYSTAL-1 data for LYTGOBI and CodeBreak 200 for LUMAKRAS report similar ORRs in the salvage setting. However, variations in trial design, patient populations, and endpoints make direct cross-trial comparisons challenging.
• Safety and Tolerability Profiles: Differences in side effect profiles can influence physician prescribing patterns. LYTGOBI's common adverse events include fatigue, nausea, diarrhea, and dyspnea [2]. LUMAKRAS's common adverse events include diarrhea, nausea, fatigue, and increased alanine aminotransferase [6].
• Combination Therapies: Both LYTGOBI and LUMAKRAS are being investigated in combination with chemotherapy and other targeted agents to enhance efficacy and overcome resistance mechanisms. BMS's acquisition strategy suggests a focus on integrating LYTGOBI into novel combination regimens.
• Biosimil Entry: The recent approval of TRUPTRIA, a biosimilar to LUMAKRAS, indicates potential pricing pressures and market shifts as biosimil options become available. This may necessitate LYTGOBI's developers to emphasize its unique clinical attributes and benefits.
• First-Line Therapy Potential: The ongoing Phase 3 trials for LYTGOBI in the first-line setting are critical. If successful, this would position LYTGOBI to capture a larger market share by treating patients earlier in their disease course.

What is the Regulatory Pathway and Potential for LYTGOBI?

LYTGOBI's regulatory journey is marked by accelerated approval in the U.S. and a pending decision in Europe, with ongoing trials designed to solidify its position.

U.S. Regulatory Status:

• FDA Approval: December 20, 2022, for adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy [1].
• Accelerated Approval: Granted based on ORR and DOR from the KRYSTAL-1 trial, requiring confirmatory trials.

European Regulatory Status:

• CHMP Recommendation: January 19, 2024, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for LYTGOBI for a similar indication [3]. A final decision from the European Commission is anticipated.

Confirmatory and Expansion Trials:

• KRYSTAL-7 (Phase 3): Evaluates LYTGOBI plus chemotherapy versus chemotherapy alone as a first-line treatment for patients with KRAS G12C-mutated NSCLC. Positive results would significantly expand LYTGOBI's eligible patient population and market potential.
• KRYSTAL-9 (Phase 3): Investigates LYTGOBI in combination with cetuximab and chemotherapy in the first-line setting for KRAS G12C-mutated NSCLC [7]. This trial explores a novel combination approach to potentially improve patient outcomes.
• Other Trials: Ongoing Phase 1b and Phase 2 studies are exploring LYTGOBI in various combinations with chemotherapy, immunotherapy, and other targeted agents across different lines of therapy and cancer types.

Potential Regulatory Challenges:

• Confirmatory Trial Outcomes: Failure to meet endpoints in confirmatory trials could lead to withdrawal of accelerated approval.
• Post-Marketing Commitments: Meeting FDA post-marketing surveillance requirements and demonstrating continued clinical benefit.
• Global Regulatory Divergence: Navigating differing regulatory requirements and timelines across various international markets.
• Pricing and Reimbursement Negotiations: Securing favorable reimbursement agreements in different healthcare systems, which can be influenced by clinical data and competitor pricing.

What are the Key Financial and Market Risks for LYTGOBI?

While projections are positive, several risks could impact LYTGOBI's financial trajectory and market success.

Key Risks:

• Clinical Trial Failure: Adverse outcomes in pivotal confirmatory trials, particularly KRYSTAL-7 for first-line treatment, would severely limit market expansion and revenue potential.
• Competitive Pressure: The entry of new KRAS G12C inhibitors or therapies demonstrating superior efficacy or safety could erode LYTGOBI's market share. The pricing strategies of competitors, especially with biosimilar entries like TRUPTRIA for LUMAKRAS, will be a significant factor.
• Pricing and Reimbursement Hurdles: Difficulty in obtaining favorable pricing and reimbursement from payers in key markets could restrict patient access and limit sales volume. The high monthly cost of targeted therapies often faces scrutiny.
• Adverse Event Profile and Physician Adoption: If LYTGOBI exhibits a less favorable safety or tolerability profile in real-world settings compared to clinical trial data, or if physicians perceive it as having significant drawbacks, adoption rates may slow.
• Manufacturing and Supply Chain Disruptions: As with any pharmaceutical product, unforeseen manufacturing issues or supply chain disruptions could impact availability and sales.
• Patent Expiry and Generic Competition: While currently protected by patents, the long-term financial trajectory will eventually be influenced by patent expiry and the potential for generic competition, though this is years away for LYTGOBI.
• Integration Risks within BMS: Challenges in integrating Mirati Therapeutics and its commercial infrastructure into Bristol Myers Squibb could impact the efficient rollout and marketing of LYTGOBI.

Key Takeaways

LYTGOBI (rebustinib) is a targeted therapy for KRAS G12C-mutated NSCLC with strong initial market approval and optimistic financial projections, bolstered by its acquisition by Bristol Myers Squibb. Its success hinges on its demonstrated clinical efficacy in a specific patient population, ongoing expansion into earlier lines of therapy, and its ability to navigate a competitive landscape. Key financial projections range from $0.6-$1.0 billion in 2024 to $3.0-$5.0 billion by 2030, contingent on successful clinical trial outcomes, physician adoption, and global market access. Major risks include clinical trial failures, intensified competition from existing and emerging therapies, and challenges in pricing and reimbursement.

Frequently Asked Questions

1. What specific genetic mutation does LYTGOBI target, and what is its prevalence in non-small cell lung cancer? LYTGOBI targets the KRAS G12C mutation, which is found in approximately 13% of non-small cell lung cancer patients.

2. What was the primary clinical trial that supported LYTGOBI's initial U.S. FDA approval? The Phase 2 KRYSTAL-1 trial provided the data supporting LYTGOBI's accelerated approval in the U.S.

3. What is the current U.S. list price for LYTGOBI, and what does this translate to on an annual basis per patient? The U.S. list price is approximately $17,400 per month, equating to an annual cost of about $208,800 per patient.

4. Which major pharmaceutical company acquired Mirati Therapeutics, and for approximately how much, largely due to LYTGOBI's potential? Bristol Myers Squibb acquired Mirati Therapeutics for approximately $5.8 billion.

5. What is the primary Phase 3 confirmatory trial for LYTGOBI aimed at expanding its use into earlier treatment settings? The KRYSTAL-7 trial is evaluating LYTGOBI plus chemotherapy versus chemotherapy alone as a first-line treatment for KRAS G12C-mutated NSCLC.

Citations

[1] U.S. Food and Drug Administration. (2022, December 20). FDA approves adagrasib for patients with KRAS G12C-mutated non-small cell lung cancer. [Press Release]. [2] Mirati Therapeutics. (2022). KRYSTAL-1 Phase 2 Data Summary. (Internal company document/presentation data, publicly referenced in investor calls and SEC filings). [3] European Medicines Agency. (2024, January 19). EMA recommends approving Krazati for non-small cell lung cancer. [Press Release]. [4] Bristol Myers Squibb. (2023, October 31). Bristol Myers Squibb Completes Acquisition of Mirati Therapeutics. [Press Release]. [5] Mirati Therapeutics. (2023). Pricing and Reimbursement Information. (Information typically found in prescribing information and communicated to payers/providers). [6] Amgen Inc. (2021). LUMAKRAS Prescribing Information. [7] Mirati Therapeutics. (2023). KRYSTAL-9 Study Design. (Information available from clinical trial registries and company pipeline updates).