Repotrectinib - Generic Drug Details

What are the generic sources for repotrectinib and what is the scope of freedom to operate?

Repotrectinib is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Repotrectinib has one hundred and eight patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for repotrectinib

International Patents:	108
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	8
Patent Applications:	59
What excipients (inactive ingredients) are in repotrectinib?	repotrectinib excipients list
DailyMed Link:	repotrectinib at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH SOLID TUMORS THAT HAVE A NEUROTROPIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION, ARE LOCALLY ADVANCED OR METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY

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 repotrectinib

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

Sponsor	Phase
Zai Lab (Shanghai) Co., Ltd.	Phase 3
Bristol-Myers Squibb	Phase 3
Memorial Sloan Kettering Cancer Center	Phase 1/Phase 2

See all repotrectinib clinical trials

Pharmacology for repotrectinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inducers Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors Tropomyosin Receptor Tyrosine Kinase A Inhibitors Tropomyosin Receptor Tyrosine Kinase B Inhibitors Tropomyosin Receptor Tyrosine Kinase C Inhibitors

US Patents and Regulatory Information for repotrectinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-002	Jun 11, 2024		RX	Yes	No
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-002	Jun 11, 2024		RX	Yes	No
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes	10,294,242			Y

International Patents for repotrectinib

Country	Patent Number	Title	Estimated Expiration
Hungary	E045208
China	108026108	二芳基大环多晶型物 (DIARYL MACROCYCLE POLYMORPH)
South Korea	102402179

Repotrectinib Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Repotrectinib

Introduction to Repotrectinib

Repotrectinib, now known as Augtyro, is a next-generation tyrosine kinase inhibitor developed by Turning Point Therapeutics. It targets the ROS1 and NTRK gene mutations, making it a significant player in the treatment of non-small cell lung cancer (NSCLC) and other solid tumors[1][4].

Market Potential and Projections

The market potential for repotrectinib is substantial, particularly in the oncology sector. Here are some key projections:

• First-Line and Second-Line Settings: The market potential for repotrectinib is estimated to be $1.14 billion in the first-line setting and $455 million in the second-line setting at peak. This is expected to be realized a few quarters after its launch, potentially into 2024[1].
• Global Oncology Market: The global oncology drugs market, within which repotrectinib will operate, is valued at $231.56 billion in 2024 and is projected to reach $532.91 billion by 2031, growing at a CAGR of 12.6%[3].

Acquisition and Strategic Impact

Bristol Myers Squibb (BMS) acquired Turning Point Therapeutics for $4.1 billion, a move that significantly bolsters BMS’s pipeline of precision oncology medicines. This acquisition is part of BMS’s medium- to long-term growth strategy, positioning repotrectinib as a key asset in the company’s portfolio[1].

Clinical Efficacy and Approval

Repotrectinib has demonstrated strong clinical efficacy:

• FDA Approval: The U.S. FDA granted traditional approval to repotrectinib on November 15, 2023, for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The approval was based on the TRIDENT-1 trial, which showed an objective response rate (ORR) of 79% in ROS1 TKI-naïve patients and 38% in patients who had received prior ROS1 TKI therapy[4].
• Breakthrough Therapy Designations: Repotrectinib has earned three breakthrough-therapy designations, highlighting its potential in treating ROS1-positive NSCLC and other solid tumors[1].

Financial Performance and Funding

Before the acquisition, Turning Point Therapeutics had a robust financial position:

• Cash and Marketable Securities: As of March 31, 2022, Turning Point had $918.2 million in cash, cash equivalents, and marketable securities, sufficient to fund operations through the first half of 2024[2].
• Research and Development Expenses: The company invested heavily in R&D, with expenses of $55.1 million in the first quarter of 2022, primarily driven by the development of repotrectinib and other pipeline assets[2].

Market Dynamics and Trends

The oncology drugs market is driven by several key dynamics:

• Rising Cancer Prevalence: The increasing global prevalence of cancer is a major driver of the oncology drugs market. Lung cancer, in particular, accounts for the maximum revenue generation due to its high prevalence and mortality rates[3].
• Targeted Therapies: There is a growing demand for targeted therapies, which have higher efficacy and reduced side effects compared to traditional cytotoxic drugs. Repotrectinib, as a targeted therapy, benefits from this trend[3].
• Geographical Growth: North America currently dominates the oncology drugs market, but Asia Pacific is expected to witness the highest growth due to developing healthcare infrastructure and rising disposable incomes[3].

Competitive Landscape

Repotrectinib enters a competitive market dominated by several major pharmaceutical companies:

• Key Players: Companies like Hoffmann-La Roche Ltd., Genentech, Inc., Novartis AG, and others are significant players in the oncology drugs market. Repotrectinib will compete directly with Roche’s Rozlytrek, another ROS1 inhibitor[1][3].

Operational Highlights and Future Outlook

• Clinical Pipeline: Besides repotrectinib, Turning Point Therapeutics has other promising candidates, including elzovantinib and TPX-0046. BMS will explore the potential of these assets to further enhance its growth profile[1].
• Regulatory Pathway: The company is expected to meet with the FDA to discuss the filing and potential accelerated approval for repotrectinib. This could include a line-agnostic ROS-1 indication, allowing the therapy to be used at any stage of treatment[1].

Financial Impact of the Acquisition

The acquisition by BMS reflects a significant financial commitment:

• Premium and Share Price Impact: The deal represented a 122% premium from Turning Point's previous close, with shares skyrocketing to $74 apiece upon the news, a 116% increase[1].
• Future Revenue Streams: With repotrectinib expected to be approved in the U.S. in the second half of 2023, BMS anticipates substantial revenue streams from this asset, contributing to its long-term growth strategy[1].

Key Takeaways

• Market Potential: Repotrectinib has significant market potential, particularly in the first-line and second-line settings for ROS1-positive NSCLC.
• Clinical Efficacy: The drug has demonstrated strong clinical efficacy, earning FDA approval and breakthrough therapy designations.
• Financial Position: The acquisition by BMS and Turning Point’s previous financial position indicate a robust financial foundation for the drug’s development and commercialization.
• Market Trends: The growing demand for targeted therapies and the expanding global oncology market favor repotrectinib’s market trajectory.

FAQs

Q: What is repotrectinib and how does it work?

Repotrectinib is a next-generation tyrosine kinase inhibitor that targets the ROS1 and NTRK gene mutations, making it effective in treating ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors.

Q: Who acquired Turning Point Therapeutics and why?

Bristol Myers Squibb (BMS) acquired Turning Point Therapeutics for $4.1 billion to bolster its pipeline of precision oncology medicines and enhance its long-term growth strategy.

Q: What are the market projections for repotrectinib?

The market potential for repotrectinib is estimated to be $1.14 billion in the first-line setting and $455 million in the second-line setting at peak.

Q: What is the current status of repotrectinib's FDA approval?

Repotrectinib was granted traditional FDA approval on November 15, 2023, for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

Q: How does repotrectinib compare to other ROS1 inhibitors in the market?

Repotrectinib competes directly with Roche’s Rozlytrek and has demonstrated a longer duration of response compared to existing ROS1 agents in first-line NSCLC during clinical trials.

Cited Sources

1. FierceBiotech: "BMS strikes up Roche rivalry with $4.1B Turning Point buy"
2. Biospace: "Turning Point Therapeutics Reports First-Quarter 2022 Financial Results and Provides Operational Updates"
3. Biospace: "Oncology Drugs Market to Reach USD 532.91 Billion by 2031"
4. AACR Journals: "FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non–Small Cell Lung Cancer"