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 fifty-three patent family members in twenty-six countries.
One supplier is listed for this compound.
Summary for pralsetinib
| International Patents: | 53 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 41 |
| Clinical Trials: | 7 |
| Patent Applications: | 89 |
| What excipients (inactive ingredients) are in pralsetinib? | pralsetinib excipients list |
| DailyMed Link: | pralsetinib at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for pralsetinib
Generic Entry Date for pralsetinib*:
Constraining patent/regulatory exclusivity:
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.
Recent Clinical Trials for pralsetinib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hoffmann-La Roche | Phase 2 |
| Blueprint Medicines Corporation | Phase 2 |
| Genentech, Inc. | Phase 2 |
Pharmacology for pralsetinib
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Rearranged during Transfection (RET) Inhibitors |
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 | ⤷ 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 | 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 | ||||
| >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 |
|---|---|---|---|
| Peru | 20210096 | INHIBIDOR DE RET PARA USO EN TRATAR CANCER QUE TIENE UNA ALTERACION DE RET | ⤷ Try a Trial |
| Japan | 6807385 | ⤷ Try a Trial | |
| Japan | 2022022391 | ＲＥＴ変化を有する癌の処置において使用するためのＲＥＴ阻害剤 | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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