Details for New Drug Application (NDA): 213973
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NDA 213973 describes QINLOCK, which is a drug marketed by Deciphera Pharms and is included in one NDA. It is available from one supplier. There are forty-one patents protecting this drug. Additional details are available on the QINLOCK profile page.
The generic ingredient in QINLOCK is ripretinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ripretinib profile page.
The generic ingredient in QINLOCK is ripretinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ripretinib profile page.
Summary for 213973
| Tradename: | QINLOCK |
| Applicant: | Deciphera Pharms |
| Ingredient: | ripretinib |
| Patents: | 41 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213973
Generic Entry Date for 213973*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 213973
Suppliers and Packaging for NDA: 213973
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QINLOCK | ripretinib | TABLET;ORAL | 213973 | NDA | Deciphera Pharmaceuticals, LLC | 73207-101 | 73207-101-30 | 1 BOTTLE in 1 CARTON (73207-101-30) / 90 TABLET in 1 BOTTLE |
| QINLOCK | ripretinib | TABLET;ORAL | 213973 | NDA | Deciphera Pharmaceuticals, LLC | 73207-101 | 73207-101-31 | 1 BOTTLE in 1 CARTON (73207-101-31) / 30 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | May 15, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 15, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH ADVANCED GASTROINTESTINAL STROMAL TUMOR (GIST) WHO HAVE RECEIVED PRIOR TREATMENT WITH 3 OR MORE KINASE INHIBITORS, INCLUDING IMATINIB | ||||||||
| Patent: | 10,966,966 | Patent Expiration: | Aug 12, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADVANCED GASTROINTESTINAL STROMAL TUMOR IN PATIENTS HAVING PROGRESSED FROM A FIRST LINE ADMINISTRATION OF IMATINIB, A SECOND LINE ADMINISTRATION OF SUNITINIB, AND A THIRD LINE ADMINISTRATION OF REGORAFENIB | ||||||||
| Patent: | 11,185,535 | Patent Expiration: | Dec 30, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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