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 fifty-three patent family members in twenty-six 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
Summary for GAVRETO
| International Patents: | 53 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 41 |
| Patent Applications: | 38 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for GAVRETO
US Patents and Regulatory Information for GAVRETO
GAVRETO is protected by three US patents and four FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of GAVRETO is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA APPROVED TEST
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Genentech Inc | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Genentech Inc | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Genentech Inc | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Genentech Inc | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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: ⤷ Try a Trial
Australia
Patent: 16348402
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2018008877
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 03721
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 18001181
Estimated Expiration: ⤷ Try a Trial
China
Patent: 8473468
Estimated Expiration: ⤷ Try a Trial
Patent: 1423416
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 18041935
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 8890
Estimated Expiration: ⤷ Try a Trial
Patent: 1891087
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 71171
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 59287
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 8902
Estimated Expiration: ⤷ Try a Trial
Patent: 8519
Estimated Expiration: ⤷ Try a Trial
Patent: 2209
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 07385
Estimated Expiration: ⤷ Try a Trial
Patent: 26196
Estimated Expiration: ⤷ Try a Trial
Patent: 18535967
Estimated Expiration: ⤷ Try a Trial
Patent: 21036004
Estimated Expiration: ⤷ Try a Trial
Patent: 22058976
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 4262
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 18005528
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 165
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 2351
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 018500907
Estimated Expiration: ⤷ Try a Trial
Saudi Arabia
Patent: 8391496
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201803653Q
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1803050
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 180073689
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 57256
Estimated Expiration: ⤷ Try a Trial
Patent: 87018
Estimated Expiration: ⤷ Try a Trial
Patent: 1720809
Estimated Expiration: ⤷ Try a Trial
Patent: 2241870
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Israel | 277629 | מעכב ret לשימוש בטיפול בסרטן הכולל שינוי ב ret (Ret inhibitor for use in treating cancer having a ret alteration) | ⤷ Try a Trial |
| Japan | 2018535967 | ＲＥＴの阻害剤 | ⤷ Try a Trial |
| New Zealand | 742351 | Inhibitors of ret | ⤷ Try a Trial |
| China | 111423416 | RET的抑制剂 (Inhibitors of RET) | ⤷ Try a Trial |
| Eurasian Patent Organization | 038890 | ИНГИБИТОРЫ RET (INHIBITORS OF RET) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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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