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Last Updated: October 1, 2022

GAVRETO Drug Patent Profile


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

Gavreto is a drug marketed by Genentech Inc and is included in one NDA. There are two patents protecting this drug.

This drug has forty-seven patent family members in twenty-four countries.

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

DrugPatentWatch® Generic Entry Outlook for Gavreto

Gavreto will be eligible for patent challenges on September 8, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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

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Summary for GAVRETO
International Patents:47
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 31
Patent Applications: 30
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 Generic Entry Opportunity 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 four US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GAVRETO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting GAVRETO

Inhibitors of RET
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH METASTATIC REARRANGED DURING TRANSFECTION (RET) FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA APPROVED TEST

Inhibitors of RET
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY (IF RADIOACTIVE IODINE IS APPROPRIATE)

Inhibitors of RET
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET-MUTANT MEDULLARY THYROID CANCER (MTC) WHO REQUIRE SYSTEMIC THERAPY

RET inhibitor for use in treating cancer having a RET alteration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH METASTATIC REARRANGED DURING TRANSFECTION (RET) FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA APPROVED TEST

FDA Regulatory Exclusivity protecting GAVRETO

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY (IF RADIOACTIVE IODINE IS APPROPRIATE)
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET-MUTANT MEDULLARY THYROID CANCER (MTC) WHO REQUIRE SYSTEMIC THERAPY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA APPROVED TEST
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genentech Inc GAVRETO pralsetinib CAPSULE;ORAL 213721-001 Sep 4, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Genentech Inc GAVRETO pralsetinib CAPSULE;ORAL 213721-001 Sep 4, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc GAVRETO pralsetinib CAPSULE;ORAL 213721-001 Sep 4, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc GAVRETO pralsetinib CAPSULE;ORAL 213721-001 Sep 4, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc GAVRETO pralsetinib CAPSULE;ORAL 213721-001 Sep 4, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Australia

Patent: 16348402
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2018008877
Estimated Expiration: See Plans and Pricing

Canada

Patent: 03721
Estimated Expiration: See Plans and Pricing

Chile

Patent: 18001181
Estimated Expiration: See Plans and Pricing

China

Patent: 8473468
Estimated Expiration: See Plans and Pricing

Patent: 1423416
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 18041935
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8890
Estimated Expiration: See Plans and Pricing

Patent: 1891087
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 71171
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 59287
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8902
Estimated Expiration: See Plans and Pricing

Patent: 8519
Estimated Expiration: See Plans and Pricing

Japan

Patent: 07385
Estimated Expiration: See Plans and Pricing

Patent: 26196
Estimated Expiration: See Plans and Pricing

Patent: 18535967
Estimated Expiration: See Plans and Pricing

Patent: 21036004
Estimated Expiration: See Plans and Pricing

Patent: 22058976
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 18005528
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 165
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 018500907
Estimated Expiration: See Plans and Pricing

Saudi Arabia

Patent: 8391496
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201803653Q
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1803050
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 180073689
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 57256
Estimated Expiration: See Plans and Pricing

Patent: 1720809
Estimated Expiration: See Plans and Pricing

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
Australia 2016348402 Inhibitors of RET See Plans and Pricing
South Africa 201803050 INHIBITORS OF RET See Plans and Pricing
Chile 2018001181 Inhibidores de ret See Plans and Pricing
Eurasian Patent Organization 038890 ИНГИБИТОРЫ RET (INHIBITORS OF RET) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2018213329 See Plans and Pricing
Eurasian Patent Organization 201891087 ИНГИБИТОРЫ RET See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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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.