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Last Updated: January 31, 2023

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

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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
Drug patent expirations by year for EXKIVITY
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

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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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Merck
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Johnson and Johnson
Colorcon

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.