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 fifty-six patent family members in thirty-seven 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: | 56 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 32 |
| Patent Applications: | 7 |
| What excipients (inactive ingredients) are in EXKIVITY? | EXKIVITY excipients list |
| DailyMed Link: | EXKIVITY at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity 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 |
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 See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting EXKIVITY
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
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: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| Takeda Pharms Usa | EXKIVITY | mobocertinib succinate | CAPSULE;ORAL | 215310-001 | Sep 15, 2021 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Takeda Pharms Usa | EXKIVITY | mobocertinib succinate | CAPSULE;ORAL | 215310-001 | Sep 15, 2021 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| Takeda Pharms Usa | EXKIVITY | mobocertinib succinate | CAPSULE;ORAL | 215310-001 | Sep 15, 2021 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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: See Plans and Pricing
Patent: 19206024
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2016029662
Estimated Expiration: See Plans and Pricing
Canada
Patent: 49793
Estimated Expiration: See Plans and Pricing
Chile
Patent: 16003222
Estimated Expiration: See Plans and Pricing
Patent: 17003103
Estimated Expiration: See Plans and Pricing
China
Patent: 6559991
Estimated Expiration: See Plans and Pricing
Patent: 0526912
Estimated Expiration: See Plans and Pricing
Colombia
Patent: 17000386
Estimated Expiration: See Plans and Pricing
Costa Rica
Patent: 170011
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0190407
Estimated Expiration: See Plans and Pricing
Cuba
Patent: 160185
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 21359
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 57916
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 17003553
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 4691
Estimated Expiration: See Plans and Pricing
Patent: 1692261
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 57916
Estimated Expiration: See Plans and Pricing
Patent: 09669
Estimated Expiration: See Plans and Pricing
Patent: 78584
Estimated Expiration: See Plans and Pricing
Georgia, Republic of
Patent: 202014706
Estimated Expiration: See Plans and Pricing
Patent: 0197011
Estimated Expiration: See Plans and Pricing
Patent: 0207111
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 42390
Estimated Expiration: See Plans and Pricing
Israel
Patent: 8859
Estimated Expiration: See Plans and Pricing
Patent: 4159
Estimated Expiration: See Plans and Pricing
Japan
Patent: 30205
Estimated Expiration: See Plans and Pricing
Patent: 46630
Estimated Expiration: See Plans and Pricing
Patent: 17521394
Estimated Expiration: See Plans and Pricing
Patent: 18012712
Estimated Expiration: See Plans and Pricing
Patent: 19194217
Estimated Expiration: See Plans and Pricing
Patent: 21181486
Estimated Expiration: See Plans and Pricing
Lithuania
Patent: 57916
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 1802
Estimated Expiration: See Plans and Pricing
Patent: 16016766
Estimated Expiration: See Plans and Pricing
Montenegro
Patent: 334
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 240
Estimated Expiration: See Plans and Pricing
Patent: 253
Estimated Expiration: See Plans and Pricing
Peru
Patent: 170268
Estimated Expiration: See Plans and Pricing
Philippines
Patent: 016502453
Estimated Expiration: See Plans and Pricing
Poland
Patent: 57916
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 57916
Estimated Expiration: See Plans and Pricing
Saudi Arabia
Patent: 6380531
Estimated Expiration: See Plans and Pricing
Serbia
Patent: 541
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 201913753V
Estimated Expiration: See Plans and Pricing
Patent: 201610517P
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 57916
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1608224
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 2412037
Estimated Expiration: See Plans and Pricing
Patent: 170016861
Estimated Expiration: See Plans and Pricing
Patent: 220088522
Estimated Expiration: See Plans and Pricing
Spain
Patent: 15500
Estimated Expiration: See Plans and Pricing
Tunisia
Patent: 16000560
Estimated Expiration: See Plans and Pricing
Turkey
Patent: 1903322
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 1657
Estimated Expiration: See Plans and Pricing
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 |
|---|---|---|---|
| China | 110526912 | 用于激酶抑制的杂芳基化合物 (Heteroaryl compounds for kinase inhibition) | See Plans and Pricing |
| Georgia, Republic of | P20207111 | Heteroaryl compounds for kinase inhibition | See Plans and Pricing |
| Peru | 20170268 | COMPUESTOS DE HETEROARILO PARA LA INHIBICION DE CINASA | See Plans and Pricing |
| Lithuania | 3157916 | See Plans and Pricing | |
| Hungary | E042390 | See Plans and Pricing | |
| >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 | See Plans and Pricing | 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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