Details for New Drug Application (NDA): 213721
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NDA 213721 describes GAVRETO, which is a drug marketed by Rigel Pharms and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the GAVRETO profile page.
The generic ingredient in GAVRETO is pralsetinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pralsetinib profile page.
The generic ingredient in GAVRETO is pralsetinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pralsetinib profile page.
Summary for 213721
| Tradename: | GAVRETO |
| Applicant: | Rigel Pharms |
| Ingredient: | pralsetinib |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213721
Generic Entry Date for 213721*:
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.
Pharmacology for NDA: 213721
| Mechanism of Action | Rearranged during Transfection (RET) Inhibitors |
Suppliers and Packaging for NDA: 213721
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GAVRETO | pralsetinib | CAPSULE;ORAL | 213721 | NDA | Rigel Pharmaceuticals, Inc. | 71332-006 | 71332-006-12 | 120 CAPSULE in 1 BOTTLE (71332-006-12) |
| GAVRETO | pralsetinib | CAPSULE;ORAL | 213721 | NDA | Rigel Pharmaceuticals, Inc. | 71332-006 | 71332-006-60 | 60 CAPSULE in 1 BOTTLE (71332-006-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Sep 4, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 1, 2027 | ||||||||
| Regulatory Exclusivity 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) | ||||||||
| Regulatory Exclusivity Expiration: | Dec 1, 2027 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
| Regulatory Exclusivity Expiration: | Sep 4, 2027 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA APPROVED TEST | ||||||||
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