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Last Updated: November 30, 2022

Pralsetinib - Generic Drug Details


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What are the generic sources for pralsetinib and what is the scope of patent protection?

Pralsetinib is the generic ingredient in one branded drug marketed by Genentech Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for pralsetinib
International Patents:47
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 34
Clinical Trials: 7
Patent Applications: 82
What excipients (inactive ingredients) are in pralsetinib?pralsetinib excipients list
DailyMed Link:pralsetinib at DailyMed
Recent Clinical Trials for pralsetinib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Hoffmann-La RochePhase 2
Genentech, Inc.Phase 2
Blueprint Medicines CorporationPhase 2

See all pralsetinib clinical trials

Pharmacology for pralsetinib

US Patents and Regulatory Information for pralsetinib

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 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 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
>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 pralsetinib

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 pralsetinib

Country Patent Number Title Estimated Expiration
European Patent Office 3371171 INHIBITEURS DE RET (INHIBITORS OF RET) See Plans and Pricing
Russian Federation 2020135917 ИНГИБИТОР RET ДЛЯ ПРИМЕНЕНИЯ В ЛЕЧЕНИИ РАКА, ИМЕЮЩЕГО RET-АЛЬТЕРАЦИЮ See Plans and Pricing
Mexico 2018005528 INHIBIDORES DE RET. (INHIBITORS OF RET.) See Plans and Pricing
Israel 258902 מעכבים של ret (Inhibitors of ret) See Plans and Pricing
Canada 3003721 INHIBITEURS DE RET (INHIBITORS OF RET) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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