PHYRAGO Drug Patent Profile

When do Phyrago patents expire, and what generic alternatives are available?

Phyrago is a drug marketed by Handa Therap and is included in one NDA. There are three patents protecting this drug.

This drug has six patent family members in six countries.

The generic ingredient in PHYRAGO is dasatinib. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dasatinib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Phyrago

A generic version of PHYRAGO was approved as dasatinib by APOTEX on June 10^th, 2016.

Summary for PHYRAGO

International Patents:	6
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in PHYRAGO?	PHYRAGO excipients list
DailyMed Link:	PHYRAGO at DailyMed

Pharmacology for PHYRAGO

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

US Patents and Regulatory Information for PHYRAGO

PHYRAGO is protected by seven US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-001	Dec 5, 2023		RX	Yes	No	11,324,745
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-003	Dec 5, 2023		RX	Yes	No
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-004	Dec 5, 2023		RX	Yes	No
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-004	Dec 5, 2023		RX	Yes	No	11,202,778
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-005	Dec 5, 2023		RX	Yes	Yes	11,324,745
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-005	Dec 5, 2023		RX	Yes	Yes	11,298,356		Y
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-006	Dec 5, 2023		RX	Yes	No	11,324,745

International Patents for PHYRAGO

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

Country	Patent Number	Title	Estimated Expiration
Australia	2021210974	Amorphous solid dispersions of dasatinib and uses thereof
Canada	3168667	DISPERSIONS SOLIDES AMORPHES DE DASATINIB ET LEURS UTILISATIONS (AMORPHOUS SOLID DISPERSIONS OF DASATINIB AND USES THEREOF)
European Patent Office	4093379	DISPERSIONS SOLIDES AMORPHES DE DASATINIB ET LEURS UTILISATIONS (AMORPHOUS SOLID DISPERSIONS OF DASATINIB AND USES THEREOF)
Israel	294928	פיזורים מוצקים אמורפיים של dasatinib ושימושים בהם (Amorphous solid dispersions of dasatinib and uses thereof)
Japan	2023513444	ダサチニブの非晶質固体分散体及びその使用
World Intellectual Property Organization (WIPO)	2021150981

Supplementary Protection Certificates for PHYRAGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169038	122013000012	Germany		PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH GEEIGNETE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-009 EU/1/06/363/010-011 EU/1/06/363/012-015 20061120
1169038	13C0003	France		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
1169038	2013/003	Ireland		PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038	2013C/005	Belgium		PRODUCT NAME: DASATINIB SOUS TOUTES FORMES COUVERTES PAR LA PROTECTION DU BREVET DE BASE INCLUANT LES SOLVATES, LES HYDRATES, TEL QUE LA FORME MONOHYDRATEE, ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/06/363/001 20061122
1169038	6/2013	Austria		PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038	92146	Luxembourg		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1169038	CA 2013 00006	Denmark		PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122

Market Dynamics and Financial Trajectory for a New Drug: Lessons from PHYRAGO

Introduction

When a new drug enters the market, several factors influence its commercial success. Understanding these dynamics is crucial for pharmaceutical companies to navigate the complex landscape of drug development, launch, and long-term market performance. Here, we will explore the key elements that shape the market dynamics and financial trajectory of a new drug, using insights from recent pharmaceutical industry studies and examples.

Timing of Market Entry

The timing of market entry is a critical factor in determining the commercial success of a drug. Research by the Boston Consulting Group indicates that being the first to market can offer significant advantages, but it is not the only factor[1].

• First-in-Class vs. Best-in-Class: While being the first to market can capture a larger share of the market value, being the best in class but entering the market second can still achieve up to 88% of the value captured by the first-in-class and best-in-class drug.
• Fast Followers: The window for successful fast followers is narrow. Drugs that enter the market within 2 years of the first-in-class drug can achieve up to 38% of the value of a follow-on entrant that entered less than 2 years after the first-in-class molecule[1].

Therapeutic Advantage

The therapeutic advantage of a drug, or its ability to address patient needs, is another vital factor.

• Therapeutic Value Ranking: Drugs with a high therapeutic advantage but launched second can still outperform those with lower therapeutic value that were launched earlier. For instance, drugs with a middle ranking of therapeutic advantage but launched first captured 92% of the value of the best-case scenario[1].

Market Size and Competition

The size of the market and the level of competition also play significant roles.

• Large Market Potential: Even late entrants can achieve significant sales in large markets. For example, certolizumab pegol (Cimzia), introduced a decade after other TNF inhibitors, is on track to achieve almost $2 billion in peak sales due to the large market size for autoimmune disease treatments[1].
• Generic Competition: In the generic drug market, prices decline with the number of competitors. Generic prices approach long-run marginal costs when there are 8 or more competitors, highlighting the importance of early market entry and competitive pricing strategies[3].

Commercial Strategy

A highly effective commercial strategy is essential for maximizing the financial trajectory of a new drug.

• Launch Preparation: A strong launch preparation, including marketing, sales, and distribution, can significantly impact the drug's initial and long-term sales. For example, Travere Therapeutics' commercial progress with FILSPARI (sparsentan) included receiving 511 new patient start forms in the first quarter of 2024 and achieving $19.8 million in net product sales during the same period[2].
• Regulatory Pathways: Engaging with regulators to evaluate potential regulatory pathways can also influence the drug's market performance. Travere Therapeutics' efforts to convert FILSPARI from accelerated approval to full approval demonstrate the importance of ongoing regulatory engagement[2].

Financial Performance Metrics

Several financial metrics are crucial for evaluating the success of a new drug.

• Net Product Sales: The total revenue generated from the sale of the drug is a key indicator. For instance, FILSPARI's net product sales totaled $19.8 million in the first quarter of 2024, contributing to a total of $49.0 million since its launch[2].
• Research and Development Expenses: R&D expenses are significant for pharmaceutical companies. Effective management of these expenses can impact the overall financial health of the company. Travere Therapeutics reported substantial R&D expenses, which are common in the pharmaceutical industry[2].

Patient Adoption and Market Penetration

Patient adoption and market penetration rates are vital for the long-term success of a drug.

• Patient Start Forms: The number of patient start forms (PSFs) received is an indicator of market penetration. FILSPARI received 1,963 PSFs since its launch, indicating growing adoption[2].
• Clinical Guidelines: Inclusion in clinical guidelines can enhance market penetration. Travere Therapeutics anticipates the inclusion of FILSPARI in the draft Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Management of Glomerular Diseases, which can further boost adoption[2].

Regulatory Approvals and Reviews

Regulatory approvals and reviews significantly influence the market dynamics of a new drug.

• Priority Review: The FDA's Priority Review designation can expedite the approval process, as seen with FILSPARI's supplemental New Drug Application (sNDA) to convert from accelerated approval to full approval[2].
• PDUFA Target Action Date: The PDUFA target action date provides a timeline for regulatory decisions, helping companies plan their commercial strategies. FILSPARI has a PDUFA target action date of September 5, 2024[2].

Additional Factors Influencing Market Dynamics

Several additional factors can impact the market dynamics of a new drug.

• Cycling of Therapies: In some therapeutic areas, drugs with the same mechanism of action are tested as alternatives when an initial therapy fails. This cycling can benefit late entrants, as seen in the markets for selective serotonin reuptake inhibitors and TNF inhibitors[1].
• Supply Chain and Production Issues: Drug shortages and production issues can affect market performance. Maintaining a healthy balance of competition, price, cost, and reimbursement is critical to support a robust supply chain[4].

Case Study: FILSPARI (Sparsentan)

FILSPARI, developed by Travere Therapeutics, provides a recent example of how these factors interplay.

• Accelerated Approval: FILSPARI received accelerated approval from the FDA in February 2023 for reducing proteinuria in adults with primary IgAN at risk of rapid disease progression[2].
• Commercial Launch: The drug's commercial launch resulted in significant patient adoption, with 511 new patient start forms received in the first quarter of 2024[2].
• Regulatory Engagement: The company's ongoing engagement with regulators, including the Priority Review for full approval, demonstrates the importance of regulatory strategies in market dynamics[2].

Key Takeaways

• Timing and Therapeutic Advantage: Being first to market and having a high therapeutic advantage are crucial but not the only factors for success.
• Commercial Strategy: Effective launch preparation, regulatory engagement, and patient adoption strategies are vital.
• Regulatory Approvals: Priority Reviews and PDUFA target action dates can significantly impact the commercial trajectory.
• Market Size and Competition: Large market potential and competitive pricing strategies can influence long-term success.
• Additional Factors: Cycling of therapies, supply chain issues, and regulatory pathways can also affect market dynamics.

FAQs

What is the impact of being first to market on a drug's commercial success?

Being first to market can capture a larger share of the market value, but it is not sufficient for success if the drug has low therapeutic value. Drugs that are first in class but have only a middle ranking of therapeutic advantage can still capture up to 92% of the value of the best-case scenario[1].

How does the number of competitors affect generic drug prices?

Generic drug prices decline with the number of competitors and begin to approach long-run marginal costs when there are 8 or more competitors[3].

What role does regulatory approval play in a drug's market dynamics?

Regulatory approvals, such as Priority Reviews and PDUFA target action dates, can expedite the approval process and significantly impact the commercial strategy and timeline of a drug[2].

How important is market size for a drug's financial trajectory?

A large market size can allow even late entrants to achieve significant sales. For example, certolizumab pegol (Cimzia) achieved substantial sales despite being introduced a decade after other TNF inhibitors[1].

What are some additional factors that can influence a drug's market dynamics?

Additional factors include the cycling of therapies, supply chain and production issues, and the inclusion in clinical guidelines, all of which can impact patient adoption and market penetration[1][4].

Sources

1. What matters most in commercial success: first-in-class or best-in-class - The Boston Consulting Group[1]
2. Travere Therapeutics Reports First Quarter 2024 Financial Results - Travere Therapeutics[2]
3. Generic Drug Industry Dynamics - Federal Trade Commission[3]
4. Drug Shortages: Root Causes and Recommended Solutions - McKesson[4]