truseltiq Drug Patent Profile

Which patents cover Truseltiq, and when can generic versions of Truseltiq launch?

Truseltiq is a drug marketed by Helsinn Hlthcare and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and thirty-five patent family members in forty countries.

The generic ingredient in TRUSELTIQ is infigratinib phosphate. Additional details are available on the infigratinib phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Truseltiq

Truseltiq will be eligible for patent challenges on May 28, 2025. 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 December 11, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for truseltiq

International Patents:	135
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	2
Patent Applications:	11
Drug Prices:	Drug price information for truseltiq
What excipients (inactive ingredients) are in truseltiq?	truseltiq excipients list
DailyMed Link:	truseltiq at DailyMed

See drug prices for truseltiq

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

NDA:

214622

Dosage:

CAPSULE;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.

Recent Clinical Trials for truseltiq

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
Emory University	Phase 2
United States Department of Defense	Phase 2

See all truseltiq clinical trials

US Patents and Regulatory Information for truseltiq

truseltiq is protected by four US patents and two FDA Regulatory Exclusivities.

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
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-001	May 28, 2021		DISCN	Yes	No			Y
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-002	May 28, 2021		DISCN	Yes	No			Y
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-001	May 28, 2021		DISCN	Yes	No			Y
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-002	May 28, 2021		DISCN	Yes	No
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-002	May 28, 2021		DISCN	Yes	No			Y	Y
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-001	May 28, 2021		DISCN	Yes	No			Y	Y

International Patents for truseltiq

When does loss-of-exclusivity occur for truseltiq?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Canada

Chile

China

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering truseltiq around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P20110822
Hong Kong	1171016	-{ }- -二氯- -二甲氧基-苯基 -{ -乙基-哌嗪- -基 -苯基氨基 -嘧啶- -基}- -甲基-脲及其鹽的晶型 (CRYSTALLINE FORMS OF 3-(2,6-DICHLORO-3,5-DIMETHOXY-PHENYL)-1-6-[4-(4- ETHYL-PIPERAZIN-1-YL)-PHENYLAMINO]-PYRIMIDIN-4-YL-1-METHYL-UREA AND SALTS THEREOF 3-(26--35--)-1-6-[4-(4---1-)-]-- 4--1--)
Peru	20131129	COMPUESTOS HETEROARIL-ARIL-UREAS COMO INHIBIDORES DE LA QUINASA
Australia	2009213036	Pyrimidine urea derivatives as kinase inhibitors
Singapore	153875	PYRIMIDINE UREA DERIVATIVES AS KINASE INHIBITORS
China	103121973	Pyrimidine urea derivatives as kinase inhibitors

Truseltiq Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TRUSELTIQ (Infigratinib)

Introduction to TRUSELTIQ

TRUSELTIQ (infigratinib) is an orally administered, ATP-competitive, tyrosine kinase inhibitor of the fibroblast growth factor receptor 2 (FGFR2). It was developed by QED Therapeutics, an affiliate of BridgeBio Pharma, in collaboration with the Helsinn Group. Initially approved by the FDA in May 2021 under the accelerated approval program, TRUSELTIQ was intended for the treatment of patients with previously-treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement[1][3][4].

FDA Approval and Initial Market Impact

The FDA approval of TRUSELTIQ in 2021 marked a significant milestone for BridgeBio Pharma, as it was the company's first FDA-approved therapeutic in oncology. This approval was based on a Phase 2 clinical study that demonstrated a clinically meaningful rate of tumor shrinkage and duration of response in patients with advanced CCA. The study showed an overall response rate (ORR) of 23% and a median duration of response (DOR) of 5.0 months[1].

Commercialization and Collaboration

Following the FDA approval, BridgeBio and Helsinn Group entered into a global collaboration and licensing agreement. Under this agreement, Helsinn gained exclusive commercialization rights for TRUSELTIQ in the U.S. and was responsible for its development, manufacturing, and commercialization in oncology indications worldwide, excluding mainland China, Hong Kong, and Macau. BridgeBio retained rights for skeletal dysplasias, including achondroplasia, and was eligible to receive regulatory and commercial milestone payments as well as tiered royalties on adjusted net sales from Helsinn[3].

Financial Performance

The approval and subsequent commercialization of TRUSELTIQ contributed to the financial performance of BridgeBio Pharma. In the third quarter of 2021, BridgeBio reported revenue that included sales from TRUSELTIQ, although the specific revenue figures from TRUSELTIQ were not detailed separately. The company's overall revenue for the third quarter of 2021 was $2.344 million, with significant operating costs and expenses related to research, development, and selling activities[5].

Revenue and Expenses

• Revenue: The inclusion of TRUSELTIQ in BridgeBio's product portfolio contributed to the company's revenue. However, the specific revenue generated by TRUSELTIQ was not separately disclosed.
• Operating Costs: The company incurred substantial operating costs, including research and development expenses and selling, general, and administrative expenses. For the third quarter of 2021, these costs totaled $151.843 million[5].

Net Loss

Despite the revenue generated, BridgeBio Pharma reported a net loss for the third quarter of 2021. The net loss attributable to common stockholders was $155.935 million, reflecting the high costs associated with developing and commercializing new therapeutics[5].

Challenges and Withdrawal of FDA Approval

The market dynamics for TRUSELTIQ took a significant turn when the FDA withdrew its approval in May 2024. This decision was based on the failure to verify clinical benefit in a postmarketing trial, specifically the Phase 3 PROOF study. The PROOF study compared TRUSELTIQ to gemcitabine with cisplatin as a first-line treatment for patients with advanced/metastatic or inoperable CCA with FGFR2 gene fusions/translocations. However, the study faced difficulties in recruiting and enrolling participants, leading to its early termination and the subsequent request by QED Therapeutics to withdraw the approval of TRUSELTIQ[4].

Impact on Financial Trajectory

The withdrawal of FDA approval significantly impacted the financial trajectory of TRUSELTIQ. The drug's commercial viability was compromised, and the company faced the reality of ceasing distribution for second-line cholangiocarcinoma treatment. This development would likely result in a reduction in revenue and potentially affect the overall financial performance of BridgeBio Pharma and its partner, Helsinn Group.

Future Implications

The withdrawal of TRUSELTIQ's approval highlights the challenges and risks associated with drug development and commercialization. For BridgeBio Pharma and Helsinn Group, this means re-evaluating their strategic collaboration and focusing on other therapeutic areas where infigratinib might still hold promise, such as skeletal dysplasias.

Lessons Learned

• Clinical Trial Challenges: The difficulties in recruiting participants for the PROOF study underscore the importance of robust clinical trial design and patient enrollment strategies.
• Regulatory Risks: The accelerated approval program, while beneficial for bringing treatments to market quickly, comes with the risk of subsequent withdrawal if confirmatory trials do not meet expectations.
• Market Adaptability: Companies must be prepared to adapt to changing market conditions and regulatory decisions, ensuring they have a diversified portfolio to mitigate risks.

Key Takeaways

• TRUSELTIQ was approved by the FDA in May 2021 for the treatment of previously-treated locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.
• The drug was commercialized through a collaboration between BridgeBio Pharma and Helsinn Group.
• Despite initial financial contributions, the FDA withdrew its approval in May 2024 due to the failure to verify clinical benefit in a postmarketing trial.
• The withdrawal significantly impacts the financial trajectory and commercial viability of TRUSELTIQ.
• The incident highlights the importance of robust clinical trials and regulatory compliance in drug development.

FAQs

Q: What is TRUSELTIQ, and what is it used for?

A: TRUSELTIQ (infigratinib) is an orally administered tyrosine kinase inhibitor used for the treatment of patients with previously-treated locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.

Q: Who developed and commercialized TRUSELTIQ?

A: TRUSELTIQ was developed by QED Therapeutics, an affiliate of BridgeBio Pharma, in collaboration with the Helsinn Group.

Q: Why was the FDA approval for TRUSELTIQ withdrawn?

A: The FDA approval for TRUSELTIQ was withdrawn due to the failure to verify clinical benefit in the Phase 3 PROOF study, which was required for continued approval.

Q: What were the financial implications of TRUSELTIQ's approval and subsequent withdrawal?

A: The approval contributed to BridgeBio Pharma's revenue, but the withdrawal likely resulted in a reduction in revenue and impacted the company's financial performance.

Q: What other therapeutic areas might infigratinib still be developed for?

A: Infigratinib might still be developed for skeletal dysplasias, including achondroplasia, as BridgeBio retains rights for these indications.

Sources

1. BridgeBio Pharma’s Affiliate QED Therapeutics and Partner Helsinn Group Announce FDA Approval of TRUSELTIQ™ (infigratinib) for Patients with Cholangiocarcinoma. BridgeBio.
2. BridgeBio Pharma Reports First Quarter 2022 Financial Results and Business Update. GlobeNewswire.
3. Helsinn Group and BridgeBio Pharma Announce Update to Strategic Collaboration to Develop, Manufacture, and Commercialize Infigratinib in Oncology Indications in the U.S.. BioSpace.
4. FDA Withdraws Approval of Truseltiq for Advanced Cholangiocarcinoma. eMPR.
5. BridgeBio Pharma Reports Third Quarter 2021 Financial Results and Business Update. PR Newswire.