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AUGTYRO Drug Patent Profile

Which patents cover Augtyro, and what generic alternatives are available?

Augtyro is a drug marketed by Bristol and is included in one NDA. There are three patents protecting this drug.

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

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

DrugPatentWatch^® Generic Entry Outlook for Augtyro

Augtyro will be eligible for patent challenges on November 15, 2027. 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 June 13, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AUGTYRO

International Patents:	108
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	34
Drug Prices:	Drug price information for AUGTYRO
What excipients (inactive ingredients) are in AUGTYRO?	AUGTYRO excipients list
DailyMed Link:	AUGTYRO at DailyMed

See drug prices for AUGTYRO

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

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

NDA:

218213

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.

Pharmacology for AUGTYRO

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 AUGTYRO

AUGTYRO is protected by four US patents and five FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

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
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes			Y	Y

International Patents for AUGTYRO

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

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

AUGTYRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Augtyro

Introduction to Augtyro

Augtyro, scientifically known as repotrectinib, is a groundbreaking tyrosine kinase inhibitor (TKI) approved by the FDA for the treatment of non-small cell lung cancer (NSCLC) in patients with ROS1 gene alterations. This drug was developed by Turning Point Therapeutics and acquired by Bristol Myers Squibb through a $4 billion buyout[1][4].

Market Opportunity and Competition

Augtyro enters a market currently dominated by Pfizer’s Xalkori and Roche’s Rozlytrek, which also target ROS1-positive NSCLC. However, Bristol Myers Squibb believes Augtyro has the potential to outperform these competitors due to its superior efficacy and longer duration of response. The ROS1 market is estimated to be around $500 million to $600 million annually, and Bristol Myers Squibb anticipates that Augtyro could roughly double the size of this market[1].

Clinical Efficacy and Safety

Clinical trials, particularly the TRIDENT-1 study, have shown promising results for Augtyro. Patients who had never received a ROS1-targeting drug experienced a median of 36 months without disease progression or death. This is significantly longer than the median duration of response reported for Xalkori (11 months) and Rozlytrek (18 months for 38% of patients)[1].

Regulatory Approvals

Augtyro has received FDA approval, and it has also been approved in China, along with other products, as part of Zai Lab’s portfolio expansion[2][5].

Financial Performance and Projections

Revenue Growth

Bristol Myers Squibb does not expect Augtyro to be among its top-selling drugs, but it is part of the company's broader strategy to renew its pipeline as patents for long-lived products like Revlimid, Abraxane, and Eliquis expire. The company forecasts significant revenue from other new products, such as Camzyos, Sotyktu, and Opdualag, each expected to generate $4 billion in sales by 2030[1].

Market Impact

The approval and launch of Augtyro contribute to Bristol Myers Squibb's overall revenue growth. While specific revenue figures for Augtyro are not yet detailed, the drug's potential to double the ROS1 market size indicates a substantial financial impact. Zai Lab, which has also secured approvals for Augtyro in China, reported a 45% year-over-year growth in net product revenue to $100.1 million in Q2 2024, though this figure includes revenue from multiple products[2][5].

Pricing Dynamics

The pricing of Augtyro, like other prescription drugs, is influenced by economic demand rather than production costs. The initial high prices of innovative drugs are often driven by their efficacy and the lack of alternative treatments. As more competitors enter the market and generic versions become available, prices tend to decline. This dynamic is illustrated by the market evolution of direct-acting antivirals (DAAs) for hepatitis C, which saw significant price reductions over time due to increased competition[3].

Competitive Landscape

Augtyro faces competition from existing ROS1-targeting drugs but is positioned to gain market share due to its superior clinical outcomes. The entry of new drugs into the market will continue to shape the competitive landscape, with Bristol Myers Squibb and other companies like Zai Lab expanding their oncology pipelines to address various cancer types[1][2].

Expansion and Pipeline Development

Bristol Myers Squibb and Zai Lab are actively expanding their oncology pipelines. Zai Lab has announced the expansion of its pipeline with a new ROR1 ADC program and expects at least four regulatory submissions to the NMPA within the next 12 months. This strategic expansion aims to capture a larger share of the growing oncology market[2][5].

Adverse Events and Safety Profile

While Augtyro presents a significant advancement in treating ROS1-positive NSCLC, it is not without potential adverse events. The drug has been associated with increased alanine transaminase (ALT) and aspartate aminotransferase (AST) levels in a substantial portion of patients. However, the overall benefit-risk profile positions Augtyro as a promising option for patients with limited treatment alternatives[4].

Cash Position and Financial Health

Zai Lab, which has partnered to bring Augtyro to market in China, reported a strong cash position of $730 million as of June 30, 2024, despite a slight decrease from the previous quarter. This financial health supports the company's ongoing research and development efforts, including the expansion of its oncology pipeline[2][5].

Market Forecast and Growth

The approval of Augtyro is part of a broader trend in the pharmaceutical industry where innovative drugs drive market growth. The hyperuricemia drugs market, for example, is expected to grow at a CAGR of 8.52% from 2024 to 2030, reaching nearly $9 billion by 2030. Similar growth is anticipated in the oncology sector, driven by advancements in targeted therapies like Augtyro[4].

Conclusion

Augtyro represents a significant advancement in the treatment of ROS1-positive NSCLC, with the potential to double the size of the ROS1 market. Its superior clinical efficacy and longer duration of response position it favorably against existing competitors. As the pharmaceutical landscape continues to evolve with new innovations and increased competition, Augtyro is expected to contribute substantially to the financial trajectory of Bristol Myers Squibb and its partners.

Key Takeaways

• Market Opportunity: Augtyro has the potential to double the ROS1 market size, estimated at $500 million to $600 million annually.
• Clinical Efficacy: Augtyro shows superior efficacy and a longer duration of response compared to existing ROS1-targeting drugs.
• Regulatory Approvals: Approved by the FDA and in China, with further regulatory submissions anticipated.
• Financial Performance: Part of Bristol Myers Squibb's pipeline renewal strategy, with significant revenue potential.
• Pricing Dynamics: Prices influenced by economic demand and expected to decline with increased competition.
• Competitive Landscape: Faces competition but is positioned to gain market share due to its clinical outcomes.
• Expansion and Pipeline Development: Companies are expanding their oncology pipelines to capture a larger market share.

FAQs

Q: What is Augtyro, and how does it differ from other ROS1-targeting drugs? A: Augtyro, or repotrectinib, is a tyrosine kinase inhibitor approved for treating ROS1-positive NSCLC. It differs from other ROS1-targeting drugs like Xalkori and Rozlytrek by showing a longer duration of response and higher efficacy in clinical trials.

Q: Who developed Augtyro, and how was it acquired by Bristol Myers Squibb? A: Augtyro was developed by Turning Point Therapeutics and acquired by Bristol Myers Squibb through a $4 billion buyout.

Q: What is the estimated market size for ROS1-targeting drugs, and how does Augtyro fit into this market? A: The ROS1 market is estimated to be around $500 million to $600 million annually, and Bristol Myers Squibb believes Augtyro could roughly double this market size.

Q: What are the potential adverse events associated with Augtyro? A: Augtyro has been associated with increased alanine transaminase (ALT) and aspartate aminotransferase (AST) levels in a significant portion of patients.

Q: How does the pricing of Augtyro compare to other innovative drugs, and what factors influence its pricing? A: The pricing of Augtyro, like other innovative drugs, is influenced by economic demand rather than production costs. Prices are expected to decline as more competitors enter the market and generic versions become available.

Sources

1. Biopharma Dive: "FDA approves new Bristol Myers drug for lung cancer"
2. Stock Titan: "Zai Lab Announces Second Quarter 2024 Financial Results and Recent Corporate Updates"
3. AJMC: "The Price of Progress: Understanding Innovation and Affordability of Prescription Drugs"
4. Maximize Market Research: "Hyperuricemia Drugs Market: Growth, Size, forecast, Statistics"
5. Zai Laboratory: "Zai Lab Announces Second Quarter 2024 Financial Results and Recent Corporate Updates"