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GAVRETO Drug Patent Profile

When do Gavreto patents expire, and when can generic versions of Gavreto launch?

Gavreto is a drug marketed by Rigel Pharms and is included in one NDA. There are four patents protecting this drug.

This drug has seventy-eight patent family members in thirty-seven countries.

The generic ingredient in GAVRETO is pralsetinib. Two suppliers are listed for this compound. Additional details are available on the pralsetinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Gavreto

Gavreto was eligible for patent challenges on September 8, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 1, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for GAVRETO

International Patents:	78
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	41
Patent Applications:	39
Drug Prices:	Drug price information for GAVRETO
What excipients (inactive ingredients) are in GAVRETO?	GAVRETO excipients list
DailyMed Link:	GAVRETO at DailyMed

See drug prices for GAVRETO

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

Constraining patent/regulatory exclusivity:

10,030,005

NDA:

213721

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.

Pharmacology for GAVRETO

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

US Patents and Regulatory Information for GAVRETO

GAVRETO is protected by five US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,030,005.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
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	11,273,160
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

EU/EMA Drug Approvals for GAVRETO

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 GAVRETO

When does loss-of-exclusivity occur for GAVRETO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Croatia

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Philippines

Poland

Portugal

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering GAVRETO around the world.

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

GAVRETO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GAVRETO

Introduction to GAVRETO

GAVRETO (pralsetinib) is an FDA-approved targeted therapy for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and advanced or metastatic thyroid cancer. It is a once-daily, small molecule, oral kinase inhibitor of wild-type RET and oncogenic RET fusions[1][4].

Acquisition and Transition

In February 2024, Rigel Pharmaceuticals acquired the U.S. rights to GAVRETO from Blueprint Medicines Corporation, following the termination of the collaboration agreement between Blueprint and Roche. This acquisition marked a significant expansion of Rigel's commercial portfolio, leveraging their existing infrastructure in both institutional and community settings[1][4].

Market Position and Demand

GAVRETO addresses a specific niche in the lung cancer market, where NSCLC is the most common type, accounting for 80-85% of all lung cancer diagnoses. RET fusions represent about 1-2% of the NSCLC patient population, providing a targeted market for GAVRETO[1].

Financial Performance

Pre-Acquisition Sales

Under Blueprint Medicines, GAVRETO generated approximately $28 million in U.S. net product sales in 2023. This figure was a key indicator of the drug's market potential and demand[1].

Post-Acquisition Sales

Since the acquisition, GAVRETO has shown promising sales figures. In the second quarter of 2024, GAVRETO generated $1.9 million in net product sales, with the product becoming commercially available from Rigel on June 27, 2024. By the third quarter, GAVRETO sales had surged to $7.1 million, surpassing analyst estimates and contributing significantly to Rigel's revenue growth[2][3].

Revenue Growth and Projections

Rigel Pharmaceuticals has seen a significant increase in its quarterly revenue, driven in part by the integration of GAVRETO. Total revenues for the six months ended June 30, 2024, were $66.4 million, with GAVRETO contributing $1.9 million during its initial commercial period. The strong sales performance of GAVRETO has aligned with the forecasted $28 million for the fiscal year 2023 under Blueprint Medicines[2][3].

Analyst Outlook and Market Reception

Citi has maintained a positive outlook on Rigel Pharmaceuticals, increasing the stock price target to $49.00 from $40.00, driven by the strong sales performance of GAVRETO. This adjustment reflects the firm's confidence in Rigel's current performance and future growth potential, including the contribution from its product pipeline, particularly GAVRETO and the promising R289 program[3].

Synergies with Existing Portfolio

The acquisition of GAVRETO is highly synergistic with Rigel's current product portfolio, which includes TAVALISSE and REZLIDHIA. This synergy leverages Rigel's existing commercial infrastructure, enabling the company to expand into solid tumors. The integration has allowed Rigel to maintain financial discipline while expanding its commercial reach and advancing development programs[1][2][4].

Milestones and Royalties

As part of the acquisition agreement, Rigel will make payments to Blueprint Medicines, including $15 million upfront, with $10 million payable on the first commercial sale and $5 million due on the first anniversary of the deal’s closing date. Additionally, Blueprint is entitled to up to $97.5 million in commercial milestones and up to $5 million in future regulatory milestones, along with tiered royalties ranging from 10% to 30% on GAVRETO sales[4].

Clinical and Development Update

The successful transfer of the New Drug Application (NDA) for GAVRETO and its commercial availability have been key milestones. Rigel continues to advance its clinical and development activities, including the IRAK 1/4 inhibitor program (R289), which has been incorporated into Citi's financial model for Rigel Pharmaceuticals, further boosting the company's growth prospects[2][3].

Financial Health and Market Position

Rigel Pharmaceuticals has achieved net income breakeven for the first time in Q3 2024, indicating a disciplined approach to finances. The company's stock performance has been remarkable, with a 169.84% price return over the past year and a 124.2% return over the last six months, reflecting the positive reception of its product pipeline and financial health[3].

Key Takeaways

• Acquisition and Transition: Rigel Pharmaceuticals acquired the U.S. rights to GAVRETO from Blueprint Medicines, leveraging its existing commercial infrastructure.
• Market Demand: GAVRETO targets a specific niche in NSCLC, with RET fusions representing 1-2% of the patient population.
• Financial Performance: GAVRETO has shown strong sales figures post-acquisition, contributing significantly to Rigel's revenue growth.
• Analyst Outlook: Positive outlook with increased stock price target due to GAVRETO's performance and Rigel's overall growth potential.
• Synergies and Milestones: Highly synergistic with Rigel's portfolio, with significant milestones and royalties involved in the acquisition agreement.

FAQs

Q: What is GAVRETO used for? A: GAVRETO (pralsetinib) is used for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and advanced or metastatic thyroid cancer.

Q: Who acquired the U.S. rights to GAVRETO? A: Rigel Pharmaceuticals acquired the U.S. rights to GAVRETO from Blueprint Medicines Corporation in February 2024.

Q: How much did GAVRETO generate in U.S. net product sales in 2023? A: GAVRETO generated approximately $28 million in U.S. net product sales in 2023 under Blueprint Medicines.

Q: What is the current commercial status of GAVRETO under Rigel Pharmaceuticals? A: GAVRETO became commercially available from Rigel in the U.S. on June 27, 2024, following the successful transfer of the New Drug Application (NDA).

Q: What are the financial projections and analyst outlook for GAVRETO? A: GAVRETO's strong sales performance has aligned with forecasted figures, and analysts have increased the stock price target for Rigel Pharmaceuticals, reflecting confidence in the company's growth potential.

Sources

1. Rigel Pharmaceuticals Acquires U.S. Rights to GAVRETO - Rigel Pharmaceuticals Press Release, February 22, 2024.
2. Rigel Reports Second Quarter 2024 Financial Results and Provides Business Update - Rigel Pharmaceuticals Press Release, August 6, 2024.
3. Citi raises Rigel Pharma stock target, buy rating on strong Gavreto sales - Investing.com, November 11, 2024.
4. Blueprint's Cancer Drug Gavreto Finds New Home at Rigel after Roche Split - BioSpace, February 23, 2024.
5. Blueprint Medicines Reports Fourth Quarter and Full Year 2023 Results - PR Newswire, February 15, 2024.