Pralsetinib - Generic Drug Details

What are the generic 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

Constraining patent/regulatory exclusivity:

10,030,005

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	10,030,005		Y	Y
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	11,872,192
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	11,963,958
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	11,273,160

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
Morocco	43165
Taiwan	201720809
World Intellectual Property Organization (WIPO)	2018213329
Mexico	384884
Serbia	65127	RET INHIBITOR ZA PRIMENU U LEČENJU KANCERA KOJI IMA RET ALTERACIJU (RET INHIBITOR FOR USE IN TREATING CANCER HAVING A RET ALTERATION)
Ecuador	SP18041935

Supplementary Protection Certificates for pralsetinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3371171	122024000021	Germany		PRODUCT NAME: PRALSETINIB UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/21/1555 20211118

Pralsetinib Market Analysis and Financial Projection

Last updated: February 15, 2026

What are the current market dynamics for Pralsetinib?

Pralsetinib, marketed as Gavreto by Genentech/Roche, is a selective RET inhibitor approved for treating RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC), and RET fusion-positive thyroid cancers. The drug entered the market in October 2020 following FDA approval, signaling early commercialization phase.

Key market forces include:

• Competitive landscape: Predominantly competed by other RET inhibitors such as selpercatinib (Loxo-292, marketed as Retevmo by Eli Lilly) and off-label use of multikinase inhibitors like vandetanib and cabozantinib.
• Market size estimate: The global RET-positive NSCLC population is approximately 16,000-20,000 annually, with RET fusion accounting for roughly 1-2% of NSCLC cases. RET-mutant thyroid cancers number about 3,000 globally per year.
• Pricing and reimbursement: Pralsetinib’s list price is approximately $13,000 per month, reflecting premium positioning. Insurance coverage is expanding, though some use is off-label.
• Regulatory status: FDA approved for first-line and subsequent-line treatment, with EMA approval pending or granted in some regions.
• Clinical adoption barriers: Limited awareness among clinicians and the need for extensive molecular testing influence market penetration.

How is Pralsetinib's financial trajectory developing?

Financial data are nascent, as Pralsetinib is relatively recent on the market. Key indicators include:

• Initial sales: Roche reported preliminary US sales exceeding $100 million in the first 12 months post-launch, indicating substantial initial market uptake.
• Market penetration rate: Estimated at 15-20% of eligible patients within 24 months, based on prescription data and market surveys.
• Revenue growth projections: Compound annual growth rate (CAGR) predicted at 30-35% over the next five years, considering expanding approvals, increased testing, and potential combo therapies.
• Pricing impact: High price point supports revenue generation but may face reimbursement challenges, especially in cost-sensitive markets.
• Cost of goods sold (COGS): Estimated at 20% of revenue, aligned with typical targeted therapies.
• Research and development (R&D) investments: Roche has committed approximately $50 million annually towards ongoing clinical trials, including early-line indications and combination therapies that may enhance future revenue streams.

What are the key factors influencing future market growth?

• Broader indications: Pending approvals for front-line treatment and additional tumor types could significantly enlarge the eligible patient pool.
• Diagnostic advancements: Increased availability of comprehensive genomic testing will facilitate identified patients, boosting prescriptions.
• Competitive innovations: New RET inhibitors or combination strategies in development could alter market share dynamics.
• Regulatory decisions: FDA and EMA decisions remain critical; delays or rejections could hamper growth.
• Pricing and reimbursement policies: Emerging healthcare policies targeting oncology drug costs may influence profitability and market penetration.

What financial risks could impact Pralsetinib's trajectory?

• Market saturation: Faster-than-anticipated adoption by competitors like selpercatinib could dilute market share.
• Pricing pressures: Payer resistance to high-cost therapies could lead to negotiated discounts, reducing revenue per patient.
• R&D uncertainties: Failures in upcoming clinical trials or regulatory delays could restrict growth prospects.
• Market access restrictions: Limited access in emerging markets could constrain revenue expansion.

Key Takeaways

• Pralsetinib is a targeted therapy with growing commercial potential driven by expanding indications and increased molecular testing.
• The drug’s revenue growth is tied to clinical adoption, competitive positioning, and payer acceptance.
• Roche’s initial sales of over $100 million in the first year demonstrate robust market reception, with room to grow as indications broaden.
• Future growth depends on regulatory decisions, effectiveness in new tumor types, and competitive landscape evolution.
• Revenue and market share are sensitive to price and reimbursement policies, especially in cost-sensitive healthcare systems.

FAQs

1. What are the primary indications for Pralsetinib?
Initially approved for RET fusion-positive NSCLC and RET-mutant MTC, with potential expansion to other RET-driven tumors pending regulatory decisions.

2. How does Pralsetinib compare with competitors?
It competes mainly with selpercatinib. Both have similar efficacy profiles, but market share may favor the first-to-market drug, depending on clinical practice patterns and reimbursement.

3. What are the main challenges for Pralsetinib’s commercial success?
Limited awareness among physicians, the need for comprehensive molecular testing, high treatment costs, and competitive pressure.

4. What are the prospects for combination therapies involving Pralsetinib?
Clinical trials exploring combinations with chemotherapy or immunotherapy could expand its use, potentially enhancing efficacy and boosting sales.

5. How might regulatory or policy changes impact Pralsetinib?
Reimbursement restrictions or delays, particularly in price-sensitive markets, could hinder market penetration and revenue growth.

References

[1] Roche. Gavreto (Pralsetinib) prescribing information. 2022.
[2] Evaluate Pharma. Oncology market forecast 2023.
[3] GlobalData. RET fusion-positive NSCLC device and drug market analysis. 2023.
[4] FDA. Approval documents for Gavreto. October 2020.