PRALSETINIB - Generic Drug Details

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

Pralsetinib is the generic ingredient in one branded drug marketed by Rigel Pharms and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pralsetinib has eighty-two patent family members in thirty-seven countries.

Two suppliers are listed for this compound.

Summary for PRALSETINIB

International Patents:	82
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	10
Patent Applications:	988
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRALSETINIB
What excipients (inactive ingredients) are in PRALSETINIB?	PRALSETINIB excipients list
DailyMed Link:	PRALSETINIB at DailyMed

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

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 PRALSETINIB

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

Sponsor	Phase
Fujian Medical University	PHASE4
Sun Yat-sen University	PHASE2
West China Hospital	PHASE2

See all PRALSETINIB clinical trials

Pharmacology for PRALSETINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Rearranged during Transfection (RET) Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PRALSETINIB

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for PRALSETINIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes

EU/EMA Drug Approvals for PRALSETINIB

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Gavreto	pralsetinib	EMEA/H/C/005413Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.	Authorised	no	no	no	2021-11-18

International Patents for PRALSETINIB

Country	Patent Number	Title	Estimated Expiration
Japan	6807385
Peru	20210096	INHIBIDOR DE RET PARA USO EN TRATAR CANCER QUE TIENE UNA ALTERACION DE RET
European Patent Office	3371171	INHIBITEURS DE RET (INHIBITORS OF RET)
South Africa	202006072	RET INHIBITOR FOR USE IN TREATING CANCER HAVING A RET ALTERATION
European Patent Office	4292594	INHIBITEURS DE RET (INHIBITORS OF RET)

Market Dynamics and Financial Trajectory for PRALSETINIB

Last updated: July 29, 2025

Introduction

PRALSETINIB (commercially known as Gavreto) marks a significant development in targeted oncology therapeutics, specifically as a first-in-class RET (rearranged during transfection) tyrosine kinase inhibitor. Approved by the U.S. Food and Drug Administration (FDA) in 2020 for the treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC), PRALSETINIB exemplifies precision medicine, targeting genetic alterations that drive specific tumor subtypes. Its market trajectory depends on its clinical efficacy, competitive landscape, regulatory environment, and evolving indications. This analysis dissects the current market dynamics and provides projections of its financial trajectory over the coming years.

Market Overview

The global oncology therapeutics market is forecasted to reach approximately $250 billion by 2026, driven by rapid advances in personalized medicine, expansion of targeted therapies, and increased diagnosis of molecularly defined cancers [1]. Within this landscape, RET-altered cancers represent a niche yet increasingly important segment owing to the gene’s prevalence in NSCLC, thyroid cancers, and other solid tumors.

PRALSETINIB's initial indication is for RET fusion-positive NSCLC, with subsequent potential expansion into other RET-driven malignancies such as medullary thyroid carcinoma (MTC) and RET-mutant endocrine tumors. It benefits from the unmet clinical need for effective RET inhibitors, especially after the limited options available previously.

Clinical and Regulatory Milestones

Since its FDA approval, PRALSETINIB has demonstrated promising efficacy, with overall response rates (ORRs) ranging from approximately 60% to 70% in targeted populations [2]. Its oral administration facilitates patient compliance relative to traditional chemotherapy or invasive therapies.

Regulatory agencies elsewhere, such as the European Medicines Agency (EMA), are in process of review, signaling potential for wider global market access. The drug's hallmark clinical trials, especially ARROW, have confirmed its activity in RET fusion-positive cancers, fueling demand and prescribing patterns [3].

Competitive Landscape

PRALSETINIB operates within a competitive arena featuring therapies such as selpercatinib (Retevmo), developed by Eli Lilly, which gained FDA approval in 2020 for similar indications. Both agents share common features, with slight differences in efficacy, safety profiles, and dosing.

The competitive intensity influences market share, pricing strategies, and clinician preferences. As of today, both PRALSETINIB and selpercatinib are positioned as first-line options for RET fusion-positive NSCLC, with ongoing head-to-head comparisons and real-world evidence shaping future adoption.

Other emerging agents and research initiatives may introduce downstream or resistance-evading therapies, complicating the competitive landscape.

Market Penetration and Adoption Drivers

1. Diagnostic Precision: The adoption of comprehensive next-generation sequencing (NGS) testing is paramount. Increased utilization enhances identification of RET alterations, expanding eligible patient pools.

2. Clinical Efficacy and Safety Profile: Demonstrated superior or equivalent efficacy and manageable safety profiles influence prescriber confidence. PRALSETINIB’s tolerability favors its adoption.

3. Insurance and Reimbursement: Reimbursement policies hinge on clinical evidence, pharmacoeconomic evaluations, and formulary positioning. Positive health economics foster market penetration.

4. Physician Awareness: Educational initiatives, peer-reviewed publications, and clinical guidelines play roles in awareness updates, influencing prescribing behaviors.

Market Challenges

• Resistance Development: Tumor development of resistance mutations may limit long-term efficacy, necessitating combination therapies or next-generation inhibitors.

• Pricing and Access: High drug prices pose reimbursement challenges, especially in markets with stringent cost-containment measures.

• Competitive Dynamics: Competition from other RET inhibitors, notably selpercatinib, may influence market share and revenue potential.

• Regulatory Risks: Future approvals for additional indications depend on confirmatory studies; delays could constrain growth.

Financial Trajectory and Revenue Projections

Current Revenue Baseline

Initially modest, PRALSETINIB’s revenue hinges on the number of diagnosed RET fusion-positive NSCLC patients and physicians' adoption rate. For FY 2022, analyst estimates place sales at approximately $150–200 million globally, predominantly in the U.S. [4].

Short-term Outlook (2023–2025)

With increased awareness, improved diagnostic access, and expanding indications, revenues are projected to grow at a compound annual growth rate (CAGR) of 20-25%. Market expansion into thyroid cancers and other solid tumors could double the addressable patient population, potentially boosting revenues to over $800 million by 2025.

Long-term Perspective (2026 and beyond)

Sustained growth depends on approval in additional indications, real-world efficacy, and successful management of resistance issues. If PRALSETINIB maintains competitive positioning and secures coverage, revenues could approach $1.5–2 billion globally by 2030, contingent on the emergence of combination regimens and broader tumor applicability.

Strategic Factors Influencing Financial Trajectory

• Partnerships and Licensing: Collaborations for co-promotion or expanded access in emerging markets will augment revenues.

• Pricing Strategies: Premium pricing in early years with tiered approaches as competition and biosimilars evolve.

• Pipeline and R&D: Ongoing development of next-generation RET inhibitors to preempt resistance and address unmet needs.

• Global Market Expansion: Focus on Asian markets, Europe, and emerging economies with increasing oncology care investments.

Regulatory and Patent Landscape

Patent protection extends into the late 2020s, providing exclusivity that sustains high margins. However, biosimilar or generic challenges could emerge, influencing pricing and profitability post-expiry.

Regulatory approval for expanded indications, particularly in thyroid cancers and other RET-driven tumors, is crucial for revenue diversification. The upcoming results from phase 3 trials will determine future approvals and market access.

Conclusion

PRALSETINIB's market dynamics are shaped by its clinical positioning as a targeted RET inhibitor, competitive landscape, diagnostic integration, and strategic regulatory pursuits. Its financial trajectory possesses substantial upside, driven by expanding indications and increasing adoption. Nevertheless, residual challenges such as resistance development, pricing pressures, and competitive responses necessitate vigilant monitoring and strategic agility.

Key Takeaways

• PRALSETINIB has established a promising niche in the targeted cancer therapy market, with significant growth potential owing to expanding indications and improved diagnostic practices.

• Competitive dynamics, especially against selpercatinib, will influence market share; differentiation hinges on efficacy, safety, and clinician preference.

• Revenue growth is projected at a CAGR of approximately 20-25% over the next three years, with potential to reach revenues of $1.5–2 billion globally by 2030.

• Market success depends on regulatory approvals for new indications, resistance mitigation strategies, and health economic considerations affecting reimbursement.

• Strategic initiatives—including pipeline development, global expansion, and partnerships—are essential to sustain and augment the financial trajectory.

Sources

1. MarketsandMarkets. "Oncology Therapeutics Market by Type, Application, and Region – Global Forecast to 2026."
2. FDA. "GAVRETO (Pralsetinib) Approval Letter." 2020.
3. ARROW trial publications. "Efficacy and Safety of Pralsetinib in RET-Altered Tumors."
4. Industry analyst reports. "Pharmaceutical Sales Forecasts for Targeted Oncology Agents."