INFIGRATINIB PHOSPHATE - Generic Drug Details

What are the generic drug sources for infigratinib phosphate and what is the scope of patent protection?

Infigratinib phosphate is the generic ingredient in one branded drug marketed by Helsinn Hlthcare and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Infigratinib phosphate has one hundred and thirty-five patent family members in forty countries.

Summary for INFIGRATINIB PHOSPHATE

International Patents:	135
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	1
Patent Applications:	26
DailyMed Link:	INFIGRATINIB PHOSPHATE at DailyMed

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

Constraining patent/regulatory exclusivity:

10,278,969

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 INFIGRATINIB PHOSPHATE

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
Emory University	Phase 2

See all INFIGRATINIB PHOSPHATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for INFIGRATINIB PHOSPHATE

L01EN	Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for INFIGRATINIB PHOSPHATE

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	11,160,804		Y
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-001	May 28, 2021		DISCN	Yes	No
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-001	May 28, 2021		DISCN	Yes	No	10,278,969		Y
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-002	May 28, 2021		DISCN	Yes	No	10,278,969		Y

International Patents for INFIGRATINIB PHOSPHATE

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

INFIGRATINIB PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Infigratinib Phosphate

Introduction to Infigratinib Phosphate

Infigratinib phosphate, also known as Truseltiq (BGJ-398), is an anti-neoplastic agent developed by QED Therapeutics. It is formulated as hard gelatin capsules for oral administration and targets pan-fibroblast growth factor receptors (FGFR1-3)[1][4].

Current Indications and Development Pipeline

Infigratinib phosphate is currently approved for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. However, it is also under development for various other conditions, including hematologic malignancies, adenocarcinoma of the gastroesophageal junction, hypochondroplasia, and achondroplasia[1][4].

Market Potential for Achondroplasia

Achondroplasia, the most common cause of disproportionate short stature, presents a significant market opportunity. QED Therapeutics has announced preclinical data supporting the potential of low-dose infigratinib as a treatment option for children with achondroplasia. These studies, presented at the Endocrine Society’s Annual Meeting (ENDO 2020), indicate that infigratinib could be a viable treatment with minimal safety concerns related to phosphorus levels[5].

Clinical Trials and Phase Transition Success Rate

Infigratinib phosphate is currently in Phase III clinical trials for achondroplasia. According to GlobalData, Phase III drugs for achondroplasia have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. This high success rate is promising for the drug's likelihood of approval (LoA)[1][4].

Financial Trajectory and Investment

BridgeBio Pharma, the parent company of QED Therapeutics, is well-capitalized and has a robust financial position. As of the third quarter of 2022, BridgeBio had approximately $558 million in cash, cash equivalents, and investments. This financial runway is expected to support the company through several key clinical milestones, including the readout of Phase III data for infigratinib in achondroplasia[3].

Risk-Adjusted Revenue Projections

BridgeBio's financial projections indicate significant potential revenue from infigratinib, particularly if it gains approval for achondroplasia. The company's catalyst map highlights several value inflection points, including the Phase III topline data for infigratinib in achondroplasia, which is anticipated to be a major driver of market growth and revenue[3].

Market Growth Drivers

The market for treatments like infigratinib is driven by several factors:

• Increased Adoption of Diagnostic Tools: Improved diagnostic capabilities, especially for rare genetic disorders, are increasing the demand for targeted therapies.
• Growing Awareness and Treatment Options: The expanding awareness of conditions like achondroplasia and the availability of new treatment options are driving market growth.
• Regulatory Support: Favorable regulatory environments and the high phase transition success rates for drugs in this category further support market expansion[3].

Safety and Efficacy Considerations

While infigratinib has shown promising efficacy in reducing fibroblast growth factor 23 (FGF23) and improving phosphate levels, it also comes with treatment-related adverse events (AEs). Clinical trials have reported mild to moderate AEs, with some patients experiencing dose-limiting AEs. However, these safety concerns are being closely monitored, and the overall profile suggests that the benefits may outweigh the risks, especially for life-limiting conditions[2].

Competitive Landscape

The market for FGFR inhibitors is competitive, but infigratinib's selective targeting of FGFR1-3 and its oral administration route provide it with a unique position. QED Therapeutics' focus on precision medicine for FGFR-driven diseases sets it apart and offers a competitive edge in the treatment of rare genetic disorders like achondroplasia[5].

Key Takeaways

• Strong Market Potential: Infigratinib phosphate has significant market potential, particularly for the treatment of achondroplasia.
• High Phase Transition Success Rate: The drug's Phase III status and high PTSR indicate a strong likelihood of approval.
• Robust Financial Position: BridgeBio Pharma's financial stability supports the ongoing clinical development of infigratinib.
• Growing Market Drivers: Increased diagnostic capabilities and growing awareness of rare genetic disorders are driving market growth.
• Safety and Efficacy: While safety concerns exist, the overall efficacy profile is promising, especially for life-limiting conditions.

FAQs

Q: What is infigratinib phosphate used for? A: Infigratinib phosphate is currently approved for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions. It is also under development for other conditions, including achondroplasia.

Q: What is the current clinical status of infigratinib phosphate for achondroplasia? A: Infigratinib phosphate is in Phase III clinical trials for achondroplasia.

Q: What are the key financial milestones for BridgeBio Pharma related to infigratinib? A: BridgeBio Pharma anticipates several key milestones, including the readout of Phase III data for infigratinib in achondroplasia, which is expected to be a significant value inflection point.

Q: What are the main safety concerns associated with infigratinib treatment? A: The main safety concerns include treatment-related adverse events (AEs), with some patients experiencing dose-limiting AEs. However, these are generally mild to moderate.

Q: How does infigratinib phosphate compare to other FGFR inhibitors in the market? A: Infigratinib's selective targeting of FGFR1-3 and its oral administration route provide it with a unique position in the market, setting it apart from other FGFR inhibitors.

Sources

1. GlobalData: "Infigratinib phosphate by QED Therapeutics for Achondroplasia"
2. PubMed: "Infigratinib Reduces Fibroblast Growth Factor 23 (FGF23) and ..."
3. BridgeBio: "JP Morgan Presentation"
4. GlobalData: "Likelihood of Approval and Phase Transition Success Rate Model – Infigratinib Phosphate in Achondroplasia"
5. BridgeBio: "Data Showing Potential of Low-Dose Infigratinib | BridgeBio"