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 eighty 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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Questions you can ask:
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Summary for GAVRETO
International Patents: | 80 |
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 |


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
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 ⤷ Try for Free.
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.
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: ⤷ Try for Free
Australia
Patent: 16348402
Patent: Inhibitors of RET
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 2018008877
Patent: inibidores de ret
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 03721
Patent: INHIBITEURS DE RET POUR LE TRAITEMENT DU CANCER (INHIBITORS OF RET TO TREAT CANCER)
Estimated Expiration: ⤷ Try for Free
Chile
Patent: 18001181
Patent: Inhibidores de ret
Estimated Expiration: ⤷ Try for Free
China
Patent: 8473468
Patent: RET的抑制剂 (INHIBITORS OF RET)
Estimated Expiration: ⤷ Try for Free
Patent: 1423416
Patent: RET的抑制剂 (Inhibitors of RET)
Estimated Expiration: ⤷ Try for Free
Croatia
Patent: 0231681
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 71171
Estimated Expiration: ⤷ Try for Free
Ecuador
Patent: 18041935
Patent: INHIBIDORES DE RET
Estimated Expiration: ⤷ Try for Free
Eurasian Patent Organization
Patent: 8890
Patent: ИНГИБИТОРЫ RET (INHIBITORS OF RET)
Estimated Expiration: ⤷ Try for Free
Patent: 1891087
Patent: ИНГИБИТОРЫ RET
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 71171
Patent: INHIBITEURS DE RET (INHIBITORS OF RET)
Estimated Expiration: ⤷ Try for Free
Patent: 92594
Patent: INHIBITEURS DE RET (INHIBITORS OF RET)
Estimated Expiration: ⤷ Try for Free
Patent: 31585
Patent: INHIBITEURS DE RET (INHIBITORS OF RET)
Estimated Expiration: ⤷ Try for Free
Finland
Patent: 71171
Estimated Expiration: ⤷ Try for Free
France
Patent: C1016
Estimated Expiration: ⤷ Try for Free
Hong Kong
Patent: 59287
Patent: RET的抑制劑 (INHIBITORS OF RET)
Estimated Expiration: ⤷ Try for Free
Hungary
Patent: 64659
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 8902
Patent: מעכבים של ret (Inhibitors of ret)
Estimated Expiration: ⤷ Try for Free
Patent: 8519
Patent: מעכבים של ret (Inhibitors of ret)
Estimated Expiration: ⤷ Try for Free
Patent: 2209
Patent: מעכבים של ret (Inhibitors of ret)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 07385
Estimated Expiration: ⤷ Try for Free
Patent: 26196
Estimated Expiration: ⤷ Try for Free
Patent: 18535967
Patent: RETの阻害剤
Estimated Expiration: ⤷ Try for Free
Patent: 21036004
Patent: RETの阻害剤 (INHIBITORS OF RET)
Estimated Expiration: ⤷ Try for Free
Patent: 22058976
Patent: RETの阻害剤
Estimated Expiration: ⤷ Try for Free
Lithuania
Patent: 71171
Estimated Expiration: ⤷ Try for Free
Malaysia
Patent: 4262
Patent: INHIBITORS OF RET
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 18005528
Patent: INHIBIDORES DE RET. (INHIBITORS OF RET.)
Estimated Expiration: ⤷ Try for Free
Morocco
Patent: 165
Patent: INHIBITEURS DE RET
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 2351
Patent: Inhibitors of ret
Estimated Expiration: ⤷ Try for Free
Philippines
Patent: 018500907
Patent: INHIBITORS OF RET
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 71171
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 71171
Estimated Expiration: ⤷ Try for Free
Saudi Arabia
Patent: 8391496
Patent: RET مثبطات (Inhibitors of Ret)
Estimated Expiration: ⤷ Try for Free
Serbia
Patent: 069
Patent: INHIBITORI RET-A (INHIBITORS OF RET)
Estimated Expiration: ⤷ Try for Free
Singapore
Patent: 201803653Q
Patent: INHIBITORS OF RET
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 71171
Estimated Expiration: ⤷ Try for Free
South Africa
Patent: 1803050
Patent: INHIBITORS OF RET
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 180073689
Patent: RET의 저해제
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 69185
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 57256
Estimated Expiration: ⤷ Try for Free
Patent: 87018
Estimated Expiration: ⤷ Try for Free
Patent: 1720809
Patent: Inhibitors of RET
Estimated Expiration: ⤷ Try for Free
Patent: 2241870
Patent: Inhibitors of RET
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
South Africa | 201803050 | INHIBITORS OF RET | ⤷ Try for Free |
European Patent Office | 4353317 | 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) | ⤷ Try for Free |
European Patent Office | 3371171 | INHIBITEURS DE RET (INHIBITORS OF RET) | ⤷ Try for Free |
Portugal | 3773589 | ⤷ Try for Free | |
European Patent Office | 3624802 | ⤷ Try for Free | |
Denmark | 3371171 | ⤷ Try for Free | |
Brazil | 112020020273 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for GAVRETO
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