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 four patents protecting this drug.

This drug has seven patent family members in six countries.

The generic ingredient in PHYRAGO is dasatinib. There are fourteen drug master file entries for this compound. Fourteen 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:	7
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	5,217
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 thirteen 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	216099-003	Dec 5, 2023		RX	Yes	No	11,298,356		Y
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-003	Dec 5, 2023		RX	Yes	No	11,202,778
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-004	Dec 5, 2023		RX	Yes	No	12,433,891
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-005	Dec 5, 2023		RX	Yes	Yes	11,202,778
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-004	Dec 5, 2023		RX	Yes	No	11,298,356		Y

International Patents for PHYRAGO

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021150981
Japan	2023513444	ダサチニブの非晶質固体分散体及びその使用
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)

Supplementary Protection Certificates for PHYRAGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169038	300567	Netherlands		PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120
1169038	C300567	Netherlands		PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 .... 009 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	CA 2013 00006	Denmark		PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122
1169038	13C0003	France		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PHYRAGO

Last updated: July 27, 2025

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Introduction

PHYRAGO, a novel therapeutic agent positioned within the pharmaceutical landscape, is generating significant industry interest. As the global pharmaceutical market evolves with increasing demand for targeted, effective, and personalized treatments, understanding its market dynamics and financial trajectory is essential for stakeholders. This analysis examines the key drivers, competitive landscape, regulatory environment, and financial prospects of PHYRAGO, offering insights to guide strategic decision-making.

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Overview of PHYRAGO

PHYRAGO is an innovative drug developed for the treatment of [Specific Condition/Disease], integrating advanced pharmacological mechanisms aimed at improving patient outcomes. Its patent protection, clinical efficacy, and safety profile have positioned it as a candidate for sustained market penetration. The drug’s approval status, currently in [Phase of Clinical Trials or Post-Approval], significantly influences its market potential and revenue prospects.

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Market Dynamics Influencing PHYRAGO

1. Growing Burden of Targeted Diseases

The prevalence of [disease/condition] has been rising globally, driven by an aging population, lifestyle factors, and increased diagnostic capabilities. According to [Source], the global incidence of [disease] has grown by X% over the past decade, fueling demand for more effective treatment options like PHYRAGO.

2. Advancements in Personalized Medicine

The shift toward precision medicine enhances the appeal of drugs like PHYRAGO, which target specific pathways or biomarkers. This tailored approach improves efficacy, reduces adverse effects, and justifies premium pricing, thus impacting market share and profitability.

3. Competitive Landscape and Differentiation

PHYRAGO faces competition from existing therapies and emerging generics. Its unique delivery mechanism or superior efficacy can confer a competitive edge. Key competitors include [list of major competitors], with market shares and growth trajectories influenced by their own R&D investments and market strategies.

4. Regulatory Environment

Regulatory agencies’ approval processes significantly influence PHYRAGO’s market entry. Accelerated approval pathways for breakthroughs, like Breakthrough Therapy designation by the FDA or PRIME status in Europe, can expedite commercialization. A favorable regulatory landscape reduces time-to-market, impacting revenue timelines.

5. Market Access and Reimbursement

Reimbursement policies and pricing negotiations are critical. Demonstrating cost-effectiveness through health economics and outcomes research (HEOR) influences payer acceptance. Countries with high healthcare expenditure, like the U.S., Germany, and Japan, represent lucrative markets; however, strict pricing controls may limit revenue.

6. Manufacturing and Supply Chain

Scalability and supply chain robustness impact revenue realization. Manufacturing complexities or raw material shortages can introduce bottlenecks, influencing supply stability and financial forecasts.

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Financial Trajectory

1. Revenue Potential

The revenue stream for PHYRAGO hinges on its market penetration, pricing strategies, and patient adherence. Early-stage projections estimate peak sales between $X billion and $Y billion, contingent on successful clinical outcomes and regulatory approval.

2. R&D and Commercialization Expenses

Development costs for PHYRAGO, encompassing R&D, clinical trials, and regulatory filings, are substantial, typically ranging from $XXX million to $X billion. Post-approval, commercialization costs, including marketing, sales force deployment, and manufacturing, substantially influence net margins.

3. Pricing Strategy and Revenue Cycle

Premium pricing models, justified by clinical advantages, can support higher margins. Conversely, price pressures from payers or biosimilar entrants may erode profitability. Reimbursement rates and coverage incentives directly impact revenue realization.

4. Investment and Funding

Funding from venture capital, pharmaceutical alliances, and public grants underpins PHYRAGO’s development. Strategic partnerships with biotech firms or licensing agreements can provide non-dilutive financing and share commercialization risks.

5. Risk Factors and Market Entry Timing

Market entry timing is crucial. Delays due to regulatory hurdles, clinical setbacks, or manufacturing issues can diminish projected revenues. Conversely, early approval and adoption accelerate revenue generation.

6. Long-Term Financial Outlook

Sustained revenue growth relies on expanding indications, geographic expansion, and lifecycle management strategies like line extensions or combination therapies. Competitive threats and patent expirations must be managed proactively to sustain market share.

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Strategic Considerations for Stakeholders

• Investors should monitor regulatory milestones and clinical trial outcomes to assess risk-reward profiles.
• Pharmaceutical companies require robust market analysis to allocate resources effectively, emphasizing early regulatory engagement and reimbursement strategies.
• Healthcare providers need to evaluate PHYRAGO’s clinical benefits relative to cost, affecting prescribing behaviors and adoption rates.
• Regulators influence market dynamics through approval pathways, impacting the speed of revenue realization.

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Future Outlook

The trajectory of PHYRAGO heavily depends on its clinical success, regulatory approval, competitive positioning, and healthcare reimbursement landscape. The increasing global disease burden and the shift to personalized medicine strongly favor its potential growth. However, market entry barriers and competitive pressures necessitate strategic planning to maximize financial returns.

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Key Takeaways

• Market growth driven by increasing disease prevalence, personalization, and advancing diagnostics bodes well for PHYRAGO’s adoption.
• Regulatory pathways and reimbursement policies are pivotal; favorable conditions can accelerate revenue streams.
• Competitive landscape and intellectual property rights will influence market share and profitability.
• Manufacturing scalability and supply chain resilience are critical to fulfilling market demand.
• Lifecycle management strategies will determine long-term revenue sustainability amidst patent expirations and emerging therapies.

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Frequently Asked Questions (FAQs)

Q1: What are the main factors influencing PHYRAGO’s market success?
A: Clinical efficacy, regulatory approval, reimbursement policies, competitive positioning, and manufacturing capacity.

Q2: How does regulatory pathway impact PHYRAGO’s financial trajectory?
A: Expedited pathways like breakthrough designations accelerate market entry, potentially increasing early revenues and market share.

Q3: What are the biggest risks to PHYRAGO’s financial outlook?
A: Clinical trial failures, regulatory delays, manufacturing disruptions, and adverse reimbursement decisions.

Q4: How do competition and generic entries influence PHYRAGO’s profitability?
A: Competition can erode market share and force price reductions, impacting profit margins over time.

Q5: What strategies can maximize PHYRAGO’s long-term value?
A: Expanding indications, geographic expansion, strategic partnerships, and lifecycle management.

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References

1. [In-depth pharmaceutical market analysis - GlobalData]
2. [Clinical trial results for PHYRAGO - ClinicalTrials.gov]
3. [Regulatory news and approval pathways - FDA and EMA]
4. [Healthcare reimbursement policies - OECD reports]
5. [Industry reports on biosimilars and generics - IQVIA]