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Last Updated: June 25, 2021

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GAVRETO Drug 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 is one patent protecting this drug.

This drug has twenty-two patent family members in nineteen countries.

The generic ingredient in GAVRETO is pralsetinib. 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:22
US Patents:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 22
Patent Applications: 12
What excipients (inactive ingredients) are in GAVRETO?GAVRETO excipients list
DailyMed Link:GAVRETO at DailyMed
Drug patent expirations by year 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.

US Patents and Regulatory Information for GAVRETO

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

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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
AstraZeneca
McKesson
Colorcon
Baxter

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.