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
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
Generic Entry Date for EXKIVITY*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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 EXKIVITY
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 3A Inducers HER1 Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for EXKIVITY
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 ⤷ 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 EXKIVITY
Heteroaryl compounds for kinase inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting EXKIVITY
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
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: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | EXKIVITY | mobocertinib succinate | CAPSULE;ORAL | 215310-001 | Sep 15, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Takeda Pharms Usa | EXKIVITY | mobocertinib succinate | CAPSULE;ORAL | 215310-001 | Sep 15, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Takeda Pharms Usa | EXKIVITY | mobocertinib succinate | CAPSULE;ORAL | 215310-001 | Sep 15, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Takeda Pharms Usa | EXKIVITY | mobocertinib succinate | CAPSULE;ORAL | 215310-001 | Sep 15, 2021 | 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 |
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
Estimated Expiration: ⤷ Try a Trial
Patent: 19206024
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2016029662
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 49793
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 16003222
Estimated Expiration: ⤷ Try a Trial
Patent: 17003103
Estimated Expiration: ⤷ Try a Trial
China
Patent: 6559991
Estimated Expiration: ⤷ Try a Trial
Patent: 0526912
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 17000386
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 170011
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0190407
Estimated Expiration: ⤷ Try a Trial
Cuba
Patent: 160185
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 21359
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 57916
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 17003553
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 4691
Estimated Expiration: ⤷ Try a Trial
Patent: 1692261
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 57916
Estimated Expiration: ⤷ Try a Trial
Patent: 09669
Estimated Expiration: ⤷ Try a Trial
Patent: 78584
Estimated Expiration: ⤷ Try a Trial
Georgia, Republic of
Patent: 202014706
Estimated Expiration: ⤷ Try a Trial
Patent: 0197011
Estimated Expiration: ⤷ Try a Trial
Patent: 0207111
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 42390
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 8859
Estimated Expiration: ⤷ Try a Trial
Patent: 4159
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 30205
Estimated Expiration: ⤷ Try a Trial
Patent: 46630
Estimated Expiration: ⤷ Try a Trial
Patent: 12733
Estimated Expiration: ⤷ Try a Trial
Patent: 17521394
Estimated Expiration: ⤷ Try a Trial
Patent: 18012712
Estimated Expiration: ⤷ Try a Trial
Patent: 19194217
Estimated Expiration: ⤷ Try a Trial
Patent: 21181486
Estimated Expiration: ⤷ Try a Trial
Patent: 23052388
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 57916
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 6839
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 1802
Estimated Expiration: ⤷ Try a Trial
Patent: 16016766
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 334
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 240
Estimated Expiration: ⤷ Try a Trial
Patent: 253
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 6723
Estimated Expiration: ⤷ Try a Trial
Patent: 3986
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 170268
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 016502453
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 57916
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 57916
Estimated Expiration: ⤷ Try a Trial
Saudi Arabia
Patent: 6380531
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 541
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201913753V
Estimated Expiration: ⤷ Try a Trial
Patent: 201610517P
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 57916
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1608224
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2412037
Estimated Expiration: ⤷ Try a Trial
Patent: 2628356
Estimated Expiration: ⤷ Try a Trial
Patent: 170016861
Estimated Expiration: ⤷ Try a Trial
Patent: 220088522
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 15500
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 16000560
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1903322
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 1657
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 EXKIVITY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 248859 | תרכובות הטרואריל לעיכוב קינאז (Heteroaryl compounds for kinase inhibition) | ⤷ Try a Trial |
China | 106559991 | 用于激酶抑制的杂芳基化合物 (Heteroaryl compounds for kinase inhibition) | ⤷ Try a Trial |
Australia | 2019206024 | HETEROARYL COMPOUNDS FOR KINASE INHIBITION | ⤷ Try a Trial |
Tunisia | 2016000560 | HETEROARYL COMPOUNDS FOR KINASE INHIBITION | ⤷ Try a Trial |
>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 | ⤷ Try a Trial | PRODUCT NAME: MOBOCERTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68147 01.06.2022 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |