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Last Updated: March 28, 2024

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QINLOCK Drug Patent Profile


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Which patents cover Qinlock, and when can generic versions of Qinlock launch?

Qinlock is a drug marketed by Deciphera Pharms and is included in one NDA. There are twenty-two patents protecting this drug.

This drug has eighty-two patent family members in twenty countries.

The generic ingredient in QINLOCK is ripretinib. One supplier is listed for this compound. Additional details are available on the ripretinib profile page.

DrugPatentWatch® Generic Entry Outlook for Qinlock

Qinlock will be eligible for patent challenges on May 15, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 30, 2040. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for QINLOCK
International Patents:82
US Patents:22
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 33
Clinical Trials: 1
Patent Applications: 43
Drug Prices: Drug price information for QINLOCK
What excipients (inactive ingredients) are in QINLOCK?QINLOCK excipients list
DailyMed Link:QINLOCK at DailyMed
Drug patent expirations by year for QINLOCK
Drug Prices for QINLOCK

See drug prices for QINLOCK

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for QINLOCK
Generic Entry Date for QINLOCK*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for QINLOCK

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Deciphera Pharmaceuticals LLCPhase 1

See all QINLOCK clinical trials

US Patents and Regulatory Information for QINLOCK

QINLOCK is protected by twenty-two US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of QINLOCK is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting QINLOCK

Methods of treating gastrointestinal stromal tumors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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

Amorphous kinase inhibitor formulations and methods of use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods of treating gastrointestinal stromal tumors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF GASTROINTESTINAL STROMAL TUMORS IN PATIENTS SUFFERING FROM PALMER-PLANTER ERYTHRODYSESTHESIA SYNDROME

Methods of treating gastrointestinal stromal tumors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF GASTROINTESTINAL STROMAL TUMORS IN PATIENTS SUFFERING FROM HYPERTENSION

Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-- 3-yl)-2-fluorophenyl)-3-phenylurea
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods of treating gastrointestinal stromal tumors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF GASTROINTESTINAL STROMAL TUMORS IN PATIENTS BEING TREATED CONCURRENTLY WITH A CYP3A4 INHIBITOR

Methods of treating gastrointestinal stromal tumors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING GASTROINTESTINAL STROMAL TUMORS IN PATIENTS SUFFERING FROM GRADE 2 OR GRADE 3 MYALGIA WHILE BEING ADMINISTERED RIPRETINIB DAILY


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF GASTROINTESTINAL STROMAL TUMORS IN PATIENTS SUFFERING FROM A GRADE 3 ADVERSE REACTION WHILE BEING ADMINISTERED RIPRETINIB DAILY


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADVANCED GASTROINTESTINAL STROMAL TUMOR IN PATIENTS PREVIOUSLY ADMINISTERED AT LEAST THREE TYROSINE KINASE INHIBITORS, WHERE ONE OF THE KINASE INHIBITORS IS IMATINIB


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF GASTROINTESTINAL STROMAL TUMORS IN PATIENTS SUFFERING FROM GRADE 2 OR GRADE 3 ARTHRALGIA WHILE BEING ADMINISTERED RIPRETINIB DAILY


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF GASTROINTESTINAL STROMAL TUMORS IN PATIENTS HAVING PRE-EXISTING SEVERE HEPATIC IMPAIRMENT AND SUFFERING FROM AN ADVERSE EVENT WHILE BEING ADMINISTERED RIPRETINIB DAILY


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF GASTROINTESTINAL STROMAL TUMOR


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF GASTROINTESTINAL STROMAL TUMOR WITH A WILD TYPE KIT MUTATION IN PATIENTS PREVIOUSLY ADMINISTERED THREE OR MORE KINASE INHIBITORS, WHERE ONE OF THE KINASE INHIBITORS IS IMATINIB


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dihydropyridopyrimidinyl, dihydronaphthyidinyl and related compounds useful as kinase inhibitors for the treatment of proliferative diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dihydronaphthyridines and related compounds useful as kinase inhibitors for the treatment of proliferative diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dihydronaphthyridines and related compounds useful as kinase inhibitors for the treatment of proliferative diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF GASTROINTESTINAL STROMAL TUMOR

FDA Regulatory Exclusivity protecting QINLOCK

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

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
Exclusivity Expiration: ⤷  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
Deciphera Pharms QINLOCK ripretinib TABLET;ORAL 213973-001 May 15, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Deciphera Pharms QINLOCK ripretinib TABLET;ORAL 213973-001 May 15, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Deciphera Pharms QINLOCK ripretinib TABLET;ORAL 213973-001 May 15, 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 QINLOCK

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Deciphera Pharmaceuticals (Netherlands) B.V. Qinlock ripretinib EMEA/H/C/005614
Qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.
Authorised no no yes 2021-11-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for QINLOCK

When does loss-of-exclusivity occur for QINLOCK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 2354
Estimated Expiration: ⤷  Try a Trial

Patent: 2355
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 20417282
Estimated Expiration: ⤷  Try a Trial

Patent: 20419197
Estimated Expiration: ⤷  Try a Trial

Patent: 23241368
Estimated Expiration: ⤷  Try a Trial

Patent: 23248048
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2022013109
Estimated Expiration: ⤷  Try a Trial

Patent: 2022013169
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 63051
Estimated Expiration: ⤷  Try a Trial

Patent: 63053
Estimated Expiration: ⤷  Try a Trial

China

Patent: 5135308
Estimated Expiration: ⤷  Try a Trial

Patent: 5243681
Patent: 1-(4-溴-5-(1-乙基-7-(甲氨基)-2-侧氧基-1,2-二氢-1,6-萘啶-3-基)-2-氟苯基)-3-苯基脲的组合物 (Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-pendant oxy-1, 2-dihydro-1, 6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea)
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 84778
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 84778
Estimated Expiration: ⤷  Try a Trial

Patent: 84779
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 84778
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 3864
Estimated Expiration: ⤷  Try a Trial

Patent: 3866
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 23509628
Estimated Expiration: ⤷  Try a Trial

Patent: 23509629
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 22008097
Estimated Expiration: ⤷  Try a Trial

Patent: 22008103
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 220123057
Estimated Expiration: ⤷  Try a Trial

Patent: 220123058
Patent: 1--3-페닐우레아의 조성물
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 2136257
Estimated Expiration: ⤷  Try a Trial

Patent: 2136258
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QINLOCK around the world.

Country Patent Number Title Estimated Expiration
Brazil 112022013109 FORMULAÇÕES DE INIBIDOR DE QUINASE AMORFO E MÉTODOS DE USO DAS MESMAS ⤷  Try a Trial
Australia 2020419197 Amorphous kinase inhibitor formulations and methods of use thereof ⤷  Try a Trial
Mexico 2009002813 INHIBIDORES DE CINASA UTILES PARA EL TRATAMIENTO DE ENFERMEDADES PROLIFERATIVAS. (KINASE INHIBITORS USEFUL FOR THE TREATMENT OF PROLIFERATIVE DISEASES.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.