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Last Updated: December 23, 2024

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 thirty-five patents protecting this drug. Additional details are available on the QINLOCK profile page.

The generic ingredient in QINLOCK is ripretinib. 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:35
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.

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:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 15, 2020TE: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
Regulatory Exclusivity Expiration:May 15, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:10,966,966Patent Expiration:Aug 12, 2040Product 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

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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.