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 seventy-eight patent family members in thirty-seven countries.

Two suppliers are listed for this compound.

Summary for pralsetinib

International Patents:	78
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	7
Patent Applications:	89
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
Hoffmann-La Roche	Phase 2
Genentech, Inc.	Phase 2
Blueprint Medicines Corporation	Phase 2

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			Y	Y
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/005413 Gavreto 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
Russian Federation	2020135917	ИНГИБИТОР RET ДЛЯ ПРИМЕНЕНИЯ В ЛЕЧЕНИИ РАКА, ИМЕЮЩЕГО RET-АЛЬТЕРАЦИЮ
Lithuania	3773589
Denmark	3371171
Israel	288519	מעכבים של ret (Inhibitors of ret)
Israel	258902	מעכבים של ret (Inhibitors of ret)
Taiwan	I787018
South Africa	202006072	RET INHIBITOR FOR USE IN TREATING CANCER HAVING A RET ALTERATION

Pralsetinib Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pralsetinib

Market Overview

Pralsetinib, marketed as GAVRETO, is an oral RET kinase inhibitor used to treat malignancies with RET gene mutations. It is approved for advanced or metastatic RET-mutant medullary thyroid cancer (MTC), metastatic non-small cell lung cancer (NSCLC) with RET fusion, and advanced RET fusion-positive thyroid cancer in patients not responding to radioactive iodine therapy[1].

Market Drivers

The global pralsetinib market is driven by several key factors:

• Rising Cancer Incidence: The increasing cases of non-small cell lung cancer (NSCLC) and thyroid cancers are significant drivers of the market.
• Advanced Healthcare Infrastructure: Regions like North America and Europe, with well-developed healthcare systems, facilitate the adoption of pralsetinib.
• Regulatory Support: Streamlined regulatory processes by agencies such as the European Medicines Agency in Europe and strong public health policies contribute to market expansion[1].

Market Restraints

Despite the growth drivers, there are several restraints to consider:

• Adverse Effects: Common side effects such as increased liver enzymes, high blood pressure, exhaustion, and diarrhea, along with more severe conditions like interstitial lung disease and hepatotoxicity, can limit patient adoption.
• Variations in Healthcare Access: Differences in healthcare access across various regions can affect overall market growth[1].

Market Opportunities

The pralsetinib market presents several opportunities:

• Emerging Markets: The Asia Pacific region, particularly countries like China and India, offers significant growth potential due to economic development, rising cancer incidence, and improving healthcare infrastructure.
• Government Initiatives: Government support and initiatives to expand healthcare access and promote advanced treatments are key opportunities for market expansion[1].

Regional Market Analysis

North America

North America dominates the pralsetinib market, driven by cutting-edge research and development, strong regulatory support, and high levels of healthcare expenditure and insurance coverage. The U.S. leads in this region, with Canada following closely[1].

Europe

Europe's pralsetinib market is propelled by rising cancer cases and a well-developed healthcare system. The European Medicines Agency's streamlined regulatory processes and strong public health policies contribute to market growth. However, variations in healthcare access can affect overall growth[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. Economic development, rising cancer incidence, and improving healthcare infrastructure in countries like China and India drive this growth. Government initiatives and a growing middle class further increase demand for advanced treatments like pralsetinib[1].

Financial Trajectory

Revenue Projections

The global pralsetinib market is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2034, reaching a significant value by the end of the forecast period. In 2024, the market was valued at USD xx Billion and is expected to increase substantially over the next decade[1].

Cost Savings and Budget Impact

Adoption of pralsetinib is expected to result in modest cost savings for US payers. A budget impact analysis showed that pralsetinib could decrease the overall budget impact to a health plan by $49,985 in year 3, primarily driven by drug costs[2].

Pricing Trends

The wholesale acquisition cost (WAC) for pralsetinib is approximately $19,243 per month at the recommended starting dose. This pricing, compared to other treatments like selpercatinib, suggests that pralsetinib can offer cost savings while maintaining therapeutic efficacy[2].

Key Market Players

The pralsetinib market is dominated by a few large companies:

• Blueprint Medicines Corporation: Recently regained global commercialization and development rights to GAVRETO (pralsetinib) from Roche, excluding Greater China. This transition is expected to be completed within 12 months from the notification date in February 2023[4].
• Roche: Although the collaboration with Blueprint Medicines has been terminated, Roche's involvement in the initial commercialization and development of pralsetinib was significant[4].

Recent Developments and Strategies

Blueprint Medicines' Strategy

Blueprint Medicines is focusing on a smooth transition of the GAVRETO program and exploring options to advance and simplify its global commercialization. The company remains committed to its 2023 goals, including the U.S. launch of AYVAKIT (avapritinib) in indolent systemic mastocytosis and the advancement of its pipeline[4].

Financial Performance

Blueprint Medicines reported significant revenue growth from its product AYVAKIT (avapritinib), achieving $204.2 million in net product revenues in 2023. The company anticipates further growth, with projected revenues of $360 million to $390 million in 2024, driven primarily by the launch in indolent systemic mastocytosis[3].

Key Takeaways

• The pralsetinib market is driven by rising cancer incidence and advanced healthcare infrastructure.
• North America and Europe are key regions, with the Asia Pacific expected to be the fastest-growing segment.
• Adoption of pralsetinib is expected to result in modest cost savings for payers.
• Blueprint Medicines has regained global rights to GAVRETO and is focusing on its transition and future commercialization strategies.
• The market is projected to grow significantly over the next decade, driven by increasing demand and improving healthcare access.

FAQs

What is pralsetinib used for?

Pralsetinib is used to treat malignancies with RET gene mutations, including advanced or metastatic RET-mutant medullary thyroid cancer (MTC), metastatic non-small cell lung cancer (NSCLC) with RET fusion, and advanced RET fusion-positive thyroid cancer in patients not responding to radioactive iodine therapy[1].

Who are the key players in the pralsetinib market?

The key players in the pralsetinib market include Blueprint Medicines Corporation and Roche, although Roche has terminated its collaboration agreement with Blueprint Medicines[1][4].

What is the projected growth rate of the pralsetinib market?

The global pralsetinib market is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2034, reaching a significant value by the end of the forecast period[1].

How does pralsetinib impact healthcare costs?

Adoption of pralsetinib is expected to result in modest cost savings for US payers, with an estimated decrease in the overall budget impact to a health plan by $49,985 in year 3[2].

What are the common side effects of pralsetinib?

Common side effects of pralsetinib include increased liver enzymes, high blood pressure, exhaustion, and diarrhea. More severe conditions such as interstitial lung disease and hepatotoxicity can also occur[1].

Cited Sources:

1. We Market Research: Pralsetinib Market Size, Share, Global Trends & Forecast 2034.
2. PubMed: The budget impact of adding pralsetinib to a US health plan.
3. PR Newswire: Blueprint Medicines Reports Fourth Quarter and Full Year 2023 Results.
4. PR Newswire: Blueprint Medicines to Regain Global Rights to GAVRETO (pralsetinib) from Roche.