You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 23, 2024

~ Buy the GAVRETO (pralsetinib) Drug Profile, 2024 PDF Report in the Report Store ~

GAVRETO Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Gavreto, and what generic alternatives are available?

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

< Available with Subscription >

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for GAVRETO?
  • What are the global sales for GAVRETO?
  • What is Average Wholesale Price for GAVRETO?
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
Drug patent expirations by year for GAVRETO
Drug Prices for GAVRETO

See drug prices for GAVRETO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GAVRETO
Generic Entry Date for GAVRETO*:
Constraining patent/regulatory exclusivity:
NDA:
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

US Patents and Regulatory Information for GAVRETO

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GAVRETO is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 6548
Patent: INHIBIDORES DE RET
Estimated Expiration: ⤷  Subscribe

Australia

Patent: 16348402
Patent: Inhibitors of RET
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2018008877
Patent: inibidores de ret
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 03721
Patent: INHIBITEURS DE RET POUR LE TRAITEMENT DU CANCER (INHIBITORS OF RET TO TREAT CANCER)
Estimated Expiration: ⤷  Subscribe

Chile

Patent: 18001181
Patent: Inhibidores de ret
Estimated Expiration: ⤷  Subscribe

China

Patent: 8473468
Patent: RET的抑制剂 (INHIBITORS OF RET)
Estimated Expiration: ⤷  Subscribe

Patent: 1423416
Patent: RET的抑制剂 (Inhibitors of RET)
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0231681
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 71171
Estimated Expiration: ⤷  Subscribe

Ecuador

Patent: 18041935
Patent: INHIBIDORES DE RET
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 8890
Patent: ИНГИБИТОРЫ RET (INHIBITORS OF RET)
Estimated Expiration: ⤷  Subscribe

Patent: 1891087
Patent: ИНГИБИТОРЫ RET
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 71171
Patent: INHIBITEURS DE RET (INHIBITORS OF RET)
Estimated Expiration: ⤷  Subscribe

Patent: 92594
Patent: INHIBITEURS DE RET (INHIBITORS OF RET)
Estimated Expiration: ⤷  Subscribe

Patent: 31585
Patent: INHIBITEURS DE RET (INHIBITORS OF RET)
Estimated Expiration: ⤷  Subscribe

Finland

Patent: 71171
Estimated Expiration: ⤷  Subscribe

France

Patent: C1016
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 59287
Patent: RET的抑制劑 (INHIBITORS OF RET)
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 64659
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 8902
Patent: מעכבים של ret (Inhibitors of ret)
Estimated Expiration: ⤷  Subscribe

Patent: 8519
Patent: מעכבים של ret (Inhibitors of ret)
Estimated Expiration: ⤷  Subscribe

Patent: 2209
Patent: מעכבים של ret (Inhibitors of ret)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 07385
Estimated Expiration: ⤷  Subscribe

Patent: 26196
Estimated Expiration: ⤷  Subscribe

Patent: 18535967
Patent: RETの阻害剤
Estimated Expiration: ⤷  Subscribe

Patent: 21036004
Patent: RETの阻害剤 (INHIBITORS OF RET)
Estimated Expiration: ⤷  Subscribe

Patent: 22058976
Patent: RETの阻害剤
Estimated Expiration: ⤷  Subscribe

Lithuania

Patent: 71171
Estimated Expiration: ⤷  Subscribe

Malaysia

Patent: 4262
Patent: INHIBITORS OF RET
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 18005528
Patent: INHIBIDORES DE RET. (INHIBITORS OF RET.)
Estimated Expiration: ⤷  Subscribe

Morocco

Patent: 165
Patent: INHIBITEURS DE RET
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 2351
Patent: Inhibitors of ret
Estimated Expiration: ⤷  Subscribe

Philippines

Patent: 018500907
Patent: INHIBITORS OF RET
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 71171
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 71171
Estimated Expiration: ⤷  Subscribe

Saudi Arabia

Patent: 8391496
Patent: RET مثبطات (Inhibitors of Ret)
Estimated Expiration: ⤷  Subscribe

Serbia

Patent: 069
Patent: INHIBITORI RET-A (INHIBITORS OF RET)
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 201803653Q
Patent: INHIBITORS OF RET
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 71171
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 1803050
Patent: INHIBITORS OF RET
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 180073689
Patent: RET의 저해제
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 69185
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 57256
Estimated Expiration: ⤷  Subscribe

Patent: 87018
Estimated Expiration: ⤷  Subscribe

Patent: 1720809
Patent: Inhibitors of RET
Estimated Expiration: ⤷  Subscribe

Patent: 2241870
Patent: Inhibitors of RET
Estimated Expiration: ⤷  Subscribe

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 ⤷  Subscribe
Lithuania 3773589 ⤷  Subscribe
Denmark 3371171 ⤷  Subscribe
Israel 288519 מעכבים של ret (Inhibitors of ret) ⤷  Subscribe
Israel 258902 מעכבים של ret (Inhibitors of ret) ⤷  Subscribe
Taiwan I787018 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

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.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.