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 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
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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: | 34 |
| Drug Prices: | Drug price information for GAVRETO |
| What excipients (inactive ingredients) are in GAVRETO? | GAVRETO excipients list |
| DailyMed Link: | GAVRETO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GAVRETO
*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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of GAVRETO is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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)
RET inhibitor for use in treating cancer having a RET alteration
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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)
FDA Regulatory Exclusivity protecting GAVRETO
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA APPROVED TEST
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Rigel Pharms | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rigel Pharms | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rigel Pharms | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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: ⤷ Sign Up
Australia
Patent: 16348402
Patent: Inhibitors of RET
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2018008877
Patent: inibidores de ret
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 03721
Patent: INHIBITEURS DE RET POUR LE TRAITEMENT DU CANCER (INHIBITORS OF RET TO TREAT CANCER)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 18001181
Patent: Inhibidores de ret
Estimated Expiration: ⤷ Sign Up
China
Patent: 8473468
Patent: RET的抑制剂 (INHIBITORS OF RET)
Estimated Expiration: ⤷ Sign Up
Patent: 1423416
Patent: RET的抑制剂 (Inhibitors of RET)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0231681
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 71171
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 18041935
Patent: INHIBIDORES DE RET
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 8890
Patent: ИНГИБИТОРЫ RET (INHIBITORS OF RET)
Estimated Expiration: ⤷ Sign Up
Patent: 1891087
Patent: ИНГИБИТОРЫ RET
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 71171
Patent: INHIBITEURS DE RET (INHIBITORS OF RET)
Estimated Expiration: ⤷ Sign Up
Patent: 92594
Patent: INHIBITEURS DE RET (INHIBITORS OF RET)
Estimated Expiration: ⤷ Sign Up
Patent: 31585
Patent: INHIBITEURS DE RET (INHIBITORS OF RET)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 71171
Estimated Expiration: ⤷ Sign Up
France
Patent: C1016
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 59287
Patent: RET的抑制劑 (INHIBITORS OF RET)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 64659
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 8902
Patent: מעכבים של ret (Inhibitors of ret)
Estimated Expiration: ⤷ Sign Up
Patent: 8519
Patent: מעכבים של ret (Inhibitors of ret)
Estimated Expiration: ⤷ Sign Up
Patent: 2209
Patent: מעכבים של ret (Inhibitors of ret)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 07385
Estimated Expiration: ⤷ Sign Up
Patent: 26196
Estimated Expiration: ⤷ Sign Up
Patent: 18535967
Patent: ＲＥＴの阻害剤
Estimated Expiration: ⤷ Sign Up
Patent: 21036004
Patent: ＲＥＴの阻害剤 (INHIBITORS OF RET)
Estimated Expiration: ⤷ Sign Up
Patent: 22058976
Patent: ＲＥＴの阻害剤
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 71171
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 4262
Patent: INHIBITORS OF RET
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 18005528
Patent: INHIBIDORES DE RET. (INHIBITORS OF RET.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 165
Patent: INHIBITEURS DE RET
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 2351
Patent: Inhibitors of ret
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 018500907
Patent: INHIBITORS OF RET
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 71171
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 71171
Estimated Expiration: ⤷ Sign Up
Saudi Arabia
Patent: 8391496
Patent: RET مثبطات (Inhibitors of Ret)
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 069
Patent: INHIBITORI RET-A (INHIBITORS OF RET)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201803653Q
Patent: INHIBITORS OF RET
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 71171
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1803050
Patent: INHIBITORS OF RET
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 180073689
Patent: RET의 저해제
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 69185
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 57256
Estimated Expiration: ⤷ Sign Up
Patent: 87018
Estimated Expiration: ⤷ Sign Up
Patent: 1720809
Patent: Inhibitors of RET
Estimated Expiration: ⤷ Sign Up
Patent: 2241870
Patent: Inhibitors of RET
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| European Patent Office | 3371171 | INHIBITEURS DE RET (INHIBITORS OF RET) | ⤷ Sign Up |
| European Patent Office | 3773589 | INHIBITEUR DE RET DESTINÉ À ÊTRE UTILISÉ DANS LE TRAITEMENT DU CANCER PRÉSENTANT UNE ALTÉRATION DU RET (RET INHIBITOR FOR USE IN TREATING CANCER HAVING A RET ALTERATION) | ⤷ Sign Up |
| European Patent Office | 4331585 | INHIBITEURS DE RET (INHIBITORS OF RET) | ⤷ Sign Up |
| Lithuania | 3773589 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
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