FRUZAQLA Drug Patent Profile
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When do Fruzaqla patents expire, and when can generic versions of Fruzaqla launch?
Fruzaqla is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this drug.
This drug has sixty-eight patent family members in thirty-two countries.
The generic ingredient in FRUZAQLA is fruquintinib. One supplier is listed for this compound. Additional details are available on the fruquintinib profile page.
DrugPatentWatch® Generic Entry Outlook for Fruzaqla
Fruzaqla will be eligible for patent challenges on November 8, 2027. 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 November 8, 2028. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for FRUZAQLA
| International Patents: | 68 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Applications: | 72 |
| Drug Prices: | Drug price information for FRUZAQLA |
| What excipients (inactive ingredients) are in FRUZAQLA? | FRUZAQLA excipients list |
| DailyMed Link: | FRUZAQLA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FRUZAQLA
*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.
US Patents and Regulatory Information for FRUZAQLA
FRUZAQLA is protected by four US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of FRUZAQLA is ⤷ Sign Up.
This potential generic entry date is based on NEW CHEMICAL ENTITY.
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 FRUZAQLA
Crystalline forms of 6-((6,7-dimethoxyquinazolin-4-yl)oxy)-N,2-dimethylbenzofuran-3-carboxamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER WHO HAVE BEEN PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY, ANTI-VEGF THERAPY, AND, IF RAS WILD-TYPE AND MEDICALLY APPROPRIATE, ANTI-EGFR THERAPY
Crystalline forms of 6-((6,7-dimethoxyquinazolin-4-yl)oxy)-N,2-dimethylbenzofuran-3-carboxamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER WHO HAVE BEEN PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY, ANTI-VEGF THERAPY, AND, IF RAS WILD-TYPE AND MEDICALLY APPROPRIATE, ANTI-EGFR THERAPY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Use of substituted quinazoline compounds in treating angiogenesis-related diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER WHO HAVE BEEN PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY, ANTI-VEGF THERAPY, AND, IF RAS WILD-TYPE AND MEDICALLY APPROPRIATE, ANTI-EGFR THERAPY
FDA Regulatory Exclusivity protecting FRUZAQLA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | FRUZAQLA | fruquintinib | CAPSULE;ORAL | 217564-001 | Nov 8, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Takeda Pharms Usa | FRUZAQLA | fruquintinib | CAPSULE;ORAL | 217564-002 | Nov 8, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Takeda Pharms Usa | FRUZAQLA | fruquintinib | CAPSULE;ORAL | 217564-001 | Nov 8, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Takeda Pharms Usa | FRUZAQLA | fruquintinib | CAPSULE;ORAL | 217564-002 | Nov 8, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for FRUZAQLA
When does loss-of-exclusivity occur for FRUZAQLA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 09244130
Patent: Quinazoline derivatives
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0908675
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 23148
Patent: DERIVES DE QUINAZOLINE (QUINAZOLINE DERIVATIVES)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0150954
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 17222
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 97115
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 97115
Patent: DÉRIVÉS DE QUINAZOLINE COMME INHIBITEURS DE KDR (DIALKOXYQUINAZOLINE DERIVATIVES AS KDR INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 25723
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 56842
Estimated Expiration: ⤷ Sign Up
Patent: 11519956
Estimated Expiration: ⤷ Sign Up
Patent: 14177499
Patent: QUINAZOLINE DERIVATIVE
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 5566
Patent: QUINAZOLINE DERIVATIVES
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 0021
Patent: DERIVADOS DE QUINAZOLINA. (QUINAZOLINE DERIVATIVES.)
Estimated Expiration: ⤷ Sign Up
Patent: 10012168
Patent: DERIVADOS DE QUINAZOLINA. (QUINAZOLINE DERIVATIVES.)
Estimated Expiration: ⤷ Sign Up
Patent: 14001023
Patent: DERIVADOS DE QUINAZOLINA. (QUINAZOLINE DERIVATIVES.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 8900
Patent: QUINAZOLINE DERIVATIVES FOR INHIBITING VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR ACTIVITY
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 97115
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 97115
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 06261
Patent: ПРОИЗВОДНЫЕ ХИНАЗОЛИНА (QUINAZOLINE DERIVATIVES)
Estimated Expiration: ⤷ Sign Up
Patent: 10150345
Patent: ПРОИЗВОДНЫЕ ХИНАЗОЛИНА
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 97115
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1686679
Estimated Expiration: ⤷ Sign Up
Patent: 110013381
Patent: QUINAZOLINE DERIVATIVES
Estimated Expiration: ⤷ Sign Up
Patent: 160045925
Patent: 퀴나졸린 유도체 (QUINAZOLINE DERIVATIVES)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 50245
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 58724
Estimated Expiration: ⤷ Sign Up
Patent: 1002694
Patent: Quinazoline derivatives
Estimated Expiration: ⤷ Sign Up
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 FRUZAQLA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2297115 | DÉRIVÉS DE QUINAZOLINE COMME INHIBITEURS DE KDR (DIALKOXYQUINAZOLINE DERIVATIVES AS KDR INHIBITORS) | ⤷ Sign Up |
| Malaysia | 155566 | QUINAZOLINE DERIVATIVES | ⤷ Sign Up |
| Ukraine | 120371 | КРИСТАЛІЧНІ ФОРМИ 6-((6,7-ДИМЕТОКСИХІНАЗОЛІН-4-ІЛ)ОКСИ)-N,2-ДИМЕТИЛБЕНЗОФУРАН-3-КАРБОКСАМІДУ (CRYSTALLINE FORMS OF 6-((6,7-DIMETHOXYQUINAZOLIN-4-YL)OXY)-N,2- DIMETHYLBENZOFURAN-3-CARBOXAMIDE) | ⤷ Sign Up |
| Philippines | 12017500451 | CRYSTALLINE FORMS OF 6-((6,7-DIMETHOXYQUINAZOLIN-4-YL) OXY)-N, 2-DIMETHYLBENZOFURAN -3- CARBOXAMIDE | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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