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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 sixty-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:	69
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Patent Applications:	46
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 two 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	214801-001	Sep 30, 2022		RX	Yes	Yes
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	214801-001	Sep 30, 2022		RX	Yes	Yes

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/005627 Lytgobi 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
Spain	2812785
Japan	5355825
Hong Kong	1198164	-雙取代炔基苯化合物及其鹽 (3,5-DISUBSTITUTED ALKYNYLBENZENE COMPOUND AND SALT THEREOF 35-)
Brazil	112017019809	cristal de composto de benzeno alquinila 3,5-dissubstituído
South Korea	101917557

Supplementary Protection Certificates for LYTGOBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2657233	2023C/548	Belgium		PRODUCT NAME: FUTIBATINIB OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND 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	301254	Netherlands		PRODUCT NAME: FUTIBATINIB OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1741 20230706
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

LYTGOBI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lytgobi

Introduction

Lytgobi, developed by Taiho Oncology, a subsidiary of Otsuka Pharmaceutical, has recently gained accelerated approval from the FDA for the treatment of bile duct cancer, specifically in patients with FGFR2 gene rearrangements. This approval marks a significant milestone in the treatment of this rare and aggressive form of cancer. Here, we delve into the market dynamics and financial trajectory of Lytgobi.

Approval and Clinical Trials

Lytgobi received its accelerated approval based on data from the phase 2 FOENIX-CCA2 study, which demonstrated an objective response rate of 42% and a median duration of response of 9.7 months among patients with FGFR2 gene rearrangements[4].

Market Competition

The market for FGFR inhibitors in bile duct cancer is not new, and Lytgobi enters a space already occupied by other drugs. Incyte's Pemazyre was the first to gain approval in 2020, and BridgeBio's Truseltiq followed shortly after. These drugs have established a presence, with Pemazyre generating $68.5 million in sales in 2021[4].

Pricing Strategy

While the pricing for Lytgobi has not been announced, it is expected to be competitive with existing treatments. Pemazyre is priced at around $17,000 per treatment cycle, leading to a total cost of between $136,000 and $153,000 for an average treatment duration of six months. Truseltiq, on the other hand, is priced slightly lower, around $21,500 per cycle, or approximately $64,500 per month[4]. Lytgobi's pricing is anticipated to be closer to Truseltiq's, with a potential premium due to its novel mechanism of action.

Sales Projections

According to GlobalData's consensus analyst forecasts, Lytgobi's sales in the US are expected to reach $50 million by 2028. This is significantly lower than Pemazyre's projected sales of $108 million, largely due to Pemazyre's first-to-market advantage and its patent protection until 2035[1].

Clinical Benefit and Confirmatory Trials

The continued approval of Lytgobi will depend on the verification of its clinical benefit in confirmatory trials. This is a critical factor, as the initial approval was based on phase 2 data, and further validation is necessary to ensure long-term market presence[4].

Market Opportunity

Lytgobi targets a specific subset of bile duct cancer patients, approximately 10% to 16% of those with intrahepatic cholangiocarcinoma who have FGFR2 gene rearrangements. This niche market, while small, represents a significant opportunity for a drug that can offer improved outcomes for these patients[4].

Financial Impact on Otsuka Pharmaceutical

Otsuka Pharmaceutical's financial performance is driven by its global products, including Lytgobi. The company aims for record-high revenue and profit in the fiscal year 2023, with a focus on expanding its pharmaceutical business and investing in research and development. Lytgobi is expected to contribute to this growth, although its impact will be modest compared to other flagship products like REXULTI/RXULTI[2][3].

Global Reach and Business Strategy

Otsuka Pharmaceutical is expanding its global reach, addressing social and healthcare issues in various regions. The approval of Lytgobi aligns with this strategy, as it provides a new treatment option for patients worldwide. The company's solid financial foundation and strong earnings power will support the launch and marketing of Lytgobi[3].

Regulatory Environment

The regulatory environment, particularly in Japan, the US, and Europe, is increasingly focused on treatment costs and the launch of higher-priced drugs. This environment may influence the pricing and reimbursement strategies for Lytgobi, as well as the overall market dynamics[2].

Patient and Market Impact

For patients with bile duct cancer, Lytgobi offers a new therapeutic option with a demonstrated response rate and duration. This approval is positive news for a patient population with limited treatment choices. However, the drug's market impact will depend on its ability to compete with existing treatments and its performance in confirmatory trials[4].

Key Takeaways

• Approval and Clinical Trials: Lytgobi received accelerated FDA approval based on phase 2 trial data showing a 42% objective response rate.
• Market Competition: Lytgobi competes with Pemazyre and Truseltiq in the FGFR inhibitor market for bile duct cancer.
• Pricing Strategy: Expected pricing is competitive, potentially closer to Truseltiq's with a premium for its novel mechanism.
• Sales Projections: Projected US sales of $50 million by 2028, lower than Pemazyre's due to first-to-market advantage.
• Clinical Benefit and Confirmatory Trials: Continued approval depends on verifying clinical benefit in confirmatory trials.
• Market Opportunity: Targets a specific subset of bile duct cancer patients with FGFR2 gene rearrangements.
• Financial Impact: Contributes to Otsuka Pharmaceutical's growth, though modestly compared to other products.
• Global Reach and Business Strategy: Aligns with Otsuka's global expansion and focus on addressing healthcare needs.

FAQs

What is Lytgobi and how was it approved?

Lytgobi is a drug developed by Taiho Oncology for the treatment of bile duct cancer in patients with FGFR2 gene rearrangements. It received accelerated FDA approval based on data from the phase 2 FOENIX-CCA2 study.

How does Lytgobi compare to other FGFR inhibitors in the market?

Lytgobi competes with Pemazyre and Truseltiq, with a similar mechanism of action but potentially different pricing and market positioning.

What are the sales projections for Lytgobi?

According to GlobalData, Lytgobi's sales in the US are expected to reach $50 million by 2028, which is lower than Pemazyre's projected sales due to Pemazyre's first-to-market advantage.

Why is pricing for Lytgobi important?

Pricing for Lytgobi will be crucial in determining its market competitiveness. It is expected to be priced competitively with Truseltiq, with a potential premium due to its novel mechanism of action.

What are the regulatory challenges for Lytgobi?

The regulatory environment, particularly the focus on treatment costs and higher-priced drugs, may influence Lytgobi's pricing and reimbursement strategies.

How does Lytgobi fit into Otsuka Pharmaceutical's business strategy?

Lytgobi aligns with Otsuka Pharmaceutical's strategy of expanding its global reach and addressing specific healthcare needs, contributing to the company's overall growth and financial performance.

Sources

1. GlobalData: "Approval of Lytgobi for Cholangiocarcinoma" - Clinical Trials Arena.
2. Otsuka Pharmaceutical: "Integrated Report 2022" - Otsuka Pharmaceutical.
3. Otsuka Pharmaceutical: "Integrated Report 2024" - Otsuka Pharmaceutical.
4. Fierce Pharma: "Otsuka's Taiho Oncology bags approval for bile duct cancer med Lytgobi" - Fierce Pharma.