PRALSETINIB - Generic Drug Details
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What are the generic drug sources for pralsetinib and what is the scope of freedom to operate?
Pralsetinib
is the generic ingredient in one branded drug marketed by Rigel Pharms and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Pralsetinib has seventy-eight patent family members in thirty-seven countries.
Two suppliers are listed for this compound.
Summary for PRALSETINIB
International Patents: | 78 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
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 |
Genentech, Inc. | Phase 2 |
Blueprint Medicines Corporation | Phase 2 |
Pharmacology for PRALSETINIB
Drug Class | Kinase Inhibitor |
Mechanism of Action | Rearranged during Transfection (RET) Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rigel Pharms | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Rigel Pharms | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | 11,273,160 | ⤷ Subscribe | ⤷ Subscribe | ||||
Rigel Pharms | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | 10,030,005 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Rigel Pharms | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | 11,963,958 | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 |
---|---|---|---|
Russian Federation | 2020135917 | ИНГИБИТОР RET ДЛЯ ПРИМЕНЕНИЯ В ЛЕЧЕНИИ РАКА, ИМЕЮЩЕГО RET-АЛЬТЕРАЦИЮ | ⤷ Subscribe |
Lithuania | 3773589 | ⤷ Subscribe | |
Denmark | 3371171 | ⤷ Subscribe | |
Israel | 288519 | מעכבים של ret (Inhibitors of ret) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
PRALSETINIB Market Analysis and Financial Projection Experimental
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