EXKIVITY Drug Patent Profile
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When do Exkivity patents expire, and what generic alternatives are available?
Exkivity is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug.
This drug has sixty-two patent family members in thirty-nine countries.
The generic ingredient in EXKIVITY is mobocertinib succinate. One supplier is listed for this compound. Additional details are available on the mobocertinib succinate profile page.
DrugPatentWatch® Generic Entry Outlook for Exkivity
Exkivity will be eligible for patent challenges on September 15, 2025. 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 May 13, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for EXKIVITY
| International Patents: | 62 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 54 |
| Patent Applications: | 7 |
| Drug Prices: | Drug price information for EXKIVITY |
| What excipients (inactive ingredients) are in EXKIVITY? | EXKIVITY excipients list |
| DailyMed Link: | EXKIVITY at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EXKIVITY
*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 EXKIVITY
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Cytochrome P450 3A Inducers HER1 Antagonists |
US Patents and Regulatory Information for EXKIVITY
EXKIVITY is protected by two US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of EXKIVITY is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ 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.
Patents protecting EXKIVITY
Heteroaryl compounds for kinase inhibition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 20 EXON INSERTION MUTATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER PLATINUM-BASED CHEMOTHERAPY
Heteroaryl compounds for kinase inhibition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting EXKIVITY
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 20 INSERTION MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, WHOSE DISEASE HAS PROGRESSED ON OR AFTER PLATINUM-BASED CHEMOTHERAPY
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 | EXKIVITY | mobocertinib succinate | CAPSULE;ORAL | 215310-001 | Sep 15, 2021 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Takeda Pharms Usa | EXKIVITY | mobocertinib succinate | CAPSULE;ORAL | 215310-001 | Sep 15, 2021 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Takeda Pharms Usa | EXKIVITY | mobocertinib succinate | CAPSULE;ORAL | 215310-001 | Sep 15, 2021 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Takeda Pharms Usa | EXKIVITY | mobocertinib succinate | CAPSULE;ORAL | 215310-001 | Sep 15, 2021 | DISCN | Yes | No | ⤷ 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 EXKIVITY
When does loss-of-exclusivity occur for EXKIVITY?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 15277786
Patent: Heteroaryl compounds for kinase inhibition
Estimated Expiration: ⤷ Sign Up
Patent: 19206024
Patent: HETEROARYL COMPOUNDS FOR KINASE INHIBITION
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2016029662
Patent: compostos de heteroaril para inibição de quinase
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 49793
Patent: COMPOSES HETEROARYLE D'INHIBITION DE LA KINASE (HETEROARYL COMPOUNDS FOR KINASE INHIBITION)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 16003222
Patent: Compuestos de heteroarilo para la inhibición de cinasa
Estimated Expiration: ⤷ Sign Up
Patent: 17003103
Patent: Compuestos de heteroarilo para la inhibición de cinasa
Estimated Expiration: ⤷ Sign Up
China
Patent: 6559991
Patent: 用于激酶抑制的杂芳基化合物 (Heteroaryl compounds for kinase inhibition)
Estimated Expiration: ⤷ Sign Up
Patent: 0526912
Patent: 用于激酶抑制的杂芳基化合物 (Heteroaryl compounds for kinase inhibition)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 17000386
Patent: Compuestos de heteroarilo para la inhibición de cinasa
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 170011
Patent: COMPUESTOS DE HETEROARILO PARA LA INHIBICIÓN DE CINASA
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0190407
Estimated Expiration: ⤷ Sign Up
Cuba
Patent: 160185
Patent: COMPUESTOS DE HETEROARILO PARA LA INHIBICIÓN DE CINASA
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 21359
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 57916
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 17003553
Patent: COMPUESTOS DE HETEROARILO PARA LA INHIBICIÓN DE CINASA
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 4691
Patent: ГЕТЕРОАРИЛЬНЫЕ СОЕДИНЕНИЯ ДЛЯ ИНГИБИРОВАНИЯ КИНАЗ (HETEROARYL COMPOUNDS FOR KINASE INHIBITION)
Estimated Expiration: ⤷ Sign Up
Patent: 1692261
Patent: ГЕТЕРОАРИЛЬНЫЕ СОЕДИНЕНИЯ ДЛЯ ИНГИБИРОВАНИЯ КИНАЗ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 57916
Patent: COMPOSÉS HÉTÉROARYLE D'INHIBITION DE LA KINASE (HETEROARYL COMPOUNDS FOR KINASE INHIBITION)
Estimated Expiration: ⤷ Sign Up
Patent: 09669
Patent: COMPOSÉS HÉTÉROARYLES POUR INHIBITION DE KINASE (HETEROARYL COMPOUNDS FOR KINASE INHIBITION)
Estimated Expiration: ⤷ Sign Up
Patent: 78584
Patent: PROCÉDÉ DE PRÉPARATION DE DÉRIVÉS DE 2-CHLORO-4-HÉTÉROARYL-PYRIDIMIDINES (PRODUCTION PROCESS OF 2-CHLORO-4-HETEROARYL-PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Sign Up
Georgia, Republic of
Patent: 202014706
Patent: Heteroaryl compounds for kinase inhibition
Estimated Expiration: ⤷ Sign Up
Patent: 0197011
Patent: HETEROARYL COMPOUNDS FOR KINASE INHIBITION
Estimated Expiration: ⤷ Sign Up
Patent: 0207111
Patent: Heteroaryl compounds for kinase inhibition
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 42390
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 8859
Patent: תרכובות הטרואריל לעיכוב קינאז (Heteroaryl compounds for kinase inhibition)
Estimated Expiration: ⤷ Sign Up
Patent: 4159
Patent: תרכובות הטרואריל לעיכוב קינאז (Heteroaryl compounds for kinase inhibition)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 30205
Estimated Expiration: ⤷ Sign Up
Patent: 46630
Estimated Expiration: ⤷ Sign Up
Patent: 12733
Estimated Expiration: ⤷ Sign Up
Patent: 17521394
Patent: キナーゼ阻害のためのヘテロアリール化合物
Estimated Expiration: ⤷ Sign Up
Patent: 18012712
Patent: キナーゼ阻害のためのヘテロアリール化合物 (HETEROARYL COMPOUNDS FOR KINASE INHIBITION)
Estimated Expiration: ⤷ Sign Up
Patent: 19194217
Patent: キナーゼ阻害のためのヘテロアリール化合物 (HETEROARYL COMPOUNDS FOR KINASE INHIBITION)
Estimated Expiration: ⤷ Sign Up
Patent: 21181486
Patent: キナーゼ阻害のためのヘテロアリール化合物 (HETEROARYL COMPOSITION FOR KINASE INHIBITION)
Estimated Expiration: ⤷ Sign Up
Patent: 23052388
Patent: キナーゼ阻害のためのヘテロアリール化合物
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 57916
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 6839
Patent: HETEROARYL COMPOUNDS FOR KINASE INHIBITION
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 1802
Patent: COMPUESTOS DE HETEROARILO PARA LA INHIBICION DE CINASA. (HETEROARYL COMPOUNDS FOR KINASE INHIBITION.)
Estimated Expiration: ⤷ Sign Up
Patent: 16016766
Patent: COMPUESTOS DE HETEROARILO PARA LA INHIBICION DE CINASA. (HETEROARYL COMPOUNDS FOR KINASE INHIBITION.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 334
Patent: HETEROARILNA JEDINJENJA ZA INHIBICIJU KINAZA (HETEROARYL COMPOUNDS FOR KINASE INHIBITION)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 240
Patent: COMPOSÉS HÉTÉROARYLE D'INHIBITION DE LA KINASE
Estimated Expiration: ⤷ Sign Up
Patent: 253
Patent: PROCÉDÉ DE PRÉPARATION DE DÉRIVÉS DE 2-CHLORO-4-HÉTÉROARYL-PYRIDIMIDINES
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 6723
Patent: Heteroaryl compounds for kinase inhibition
Estimated Expiration: ⤷ Sign Up
Patent: 3986
Patent: Heteroaryl compounds for kinase inhibition
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 170268
Patent: COMPUESTOS DE HETEROARILO PARA LA INHIBICION DE CINASA
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 016502453
Patent: HETEROARYL COMPOUNDS FOR KINASE INHIBITION
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 57916
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 57916
Estimated Expiration: ⤷ Sign Up
Saudi Arabia
Patent: 6380531
Patent: مركبات أريل غير متجانس لتثبيط الكيناز (HETEROARYL COMPOUNDS FOR KINASE INHIBITION)
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 541
Patent: HETEROARILNA JEDINJENJA ZA INHIBICIJU KINAZA (HETEROARYL COMPOUNDS FOR KINASE INHIBITION)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201913753V
Patent: HETEROARYL COMPOUNDS FOR KINASE INHIBITION
Estimated Expiration: ⤷ Sign Up
Patent: 201610517P
Patent: HETEROARYL COMPOUNDS FOR KINASE INHIBITION
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 57916
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1608224
Patent: HETEROARYL COMPOUNDS FOR KINASE INHIBITION
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2412037
Estimated Expiration: ⤷ Sign Up
Patent: 2628356
Estimated Expiration: ⤷ Sign Up
Patent: 170016861
Patent: 키나제 저해를 위한 헤테로아릴 화합물 (HETEROARYL COMPOUNDS FOR KINASE INHIBITION)
Estimated Expiration: ⤷ Sign Up
Patent: 220088522
Patent: 키나제 저해를 위한 헤테로아릴 화합물 (HETEROARYL COMPOUNDS FOR KINASE INHIBITION)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 15500
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 16000560
Patent: HETEROARYL COMPOUNDS FOR KINASE INHIBITION
Estimated Expiration: ⤷ Sign Up
Turkey
Patent: 1903322
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 1657
Patent: ГЕТЕРОАРИЛЬНІ СПОЛУКИ ДЛЯ ІНГІБУВАННЯ КІНАЗ (HETEROARYL COMPOUNDS FOR KINASE INHIBITION)
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 EXKIVITY around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Colombia | 2017000386 | Compuestos de heteroarilo para la inhibición de cinasa | ⤷ Sign Up |
| Philippines | 12016502453 | HETEROARYL COMPOUNDS FOR KINASE INHIBITION | ⤷ Sign Up |
| Costa Rica | 20170011 | COMPUESTOS DE HETEROARILO PARA LA INHIBICIÓN DE CINASA | ⤷ Sign Up |
| New Zealand | 726723 | Heteroaryl compounds for kinase inhibition | ⤷ Sign Up |
| Poland | 3157916 | ⤷ Sign Up | |
| Peru | 20170268 | COMPUESTOS DE HETEROARILO PARA LA INHIBICION DE CINASA | ⤷ Sign Up |
| Brazil | 112016029662 | compostos de heteroaril para inibição de quinase | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EXKIVITY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3157916 | C03157916/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: MOBOCERTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68147 01.06.2022 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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