OMCAZIO Drug Patent Profile

Name: OMCAZIO Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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When do Omcazio patents expire, and what generic alternatives are available?

Omcazio is a drug marketed by Handa Oncol and is included in one NDA. There are six patents protecting this drug.

The generic ingredient in OMCAZIO is cabozantinib laurylsulfate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cabozantinib laurylsulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Omcazio

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 30, 2044. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for OMCAZIO

US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in OMCAZIO?	OMCAZIO excipients list
DailyMed Link:	OMCAZIO at DailyMed

Drug patent expirations by year for OMCAZIO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OMCAZIO

Generic Entry Date for OMCAZIO^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial NDA: 220613 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 OMCAZIO

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

US Patents and Regulatory Information for OMCAZIO

OMCAZIO is protected by thirteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OMCAZIO is ⤷ Start Trial.

This potential generic entry date is based on patent ⤷ Start 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.

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Handa Oncol	OMCAZIO	cabozantinib laurylsulfate	CAPSULE;ORAL	220613-003	Sep 3, 2026		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Handa Oncol	OMCAZIO	cabozantinib laurylsulfate	CAPSULE;ORAL	220613-001	Sep 3, 2026		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Handa Oncol	OMCAZIO	cabozantinib laurylsulfate	CAPSULE;ORAL	220613-003	Sep 3, 2026		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Handa Oncol	OMCAZIO	cabozantinib laurylsulfate	CAPSULE;ORAL	220613-001	Sep 3, 2026		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Handa Oncol	OMCAZIO	cabozantinib laurylsulfate	CAPSULE;ORAL	220613-003	Sep 3, 2026		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start 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 OMCAZIO

When does loss-of-exclusivity occur for OMCAZIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 24215796
Estimated Expiration: ⤷ Start Trial

China

Patent: 0417903
Estimated Expiration: ⤷ Start Trial

European Patent Office

Patent: 58271
Estimated Expiration: ⤷ Start Trial

Japan

Patent: 26505189
Estimated Expiration: ⤷ Start Trial

South Korea

Patent: 250136810
Estimated Expiration: ⤷ Start Trial

Taiwan

Patent: 2444365
Estimated Expiration: ⤷ Start 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 OMCAZIO around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	2019285066		⤷ Start Trial
Australia	2024205682		⤷ Start Trial
Australia	2026201135		⤷ Start Trial
Canada	3102381		⤷ Start Trial
China	112423757		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for OMCAZIO

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213661	C300678	Netherlands	⤷ Start Trial	PRODUCT NAME: CABOZANTINIB EN ELKE THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, WAARONDER FARMACEUTISCH AANVAARDBARE ZOUTEN; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326
2213661	CA 2014 00039	Denmark	⤷ Start Trial	PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140321
2213661	PA2014033	Lithuania	⤷ Start Trial	PRODUCT NAME: CABOZANTINIBUM; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321
2213661	1490053-4	Sweden	⤷ Start Trial	PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/13/890 20140326
2213661	14C0067	France	⤷ Start Trial	PRODUCT NAME: CABOZANTINIB ET TOUTE FORME THERAPEUTIQUEMENT EQUIVALENTE COUVERTE PAR LE BREVET DE BASE,INCLUANT SES SELS PHARMACEUTIQUEMENT EQUIVALENTS.; REGISTRATION NO/DATE: EU/1/13/890 20140326
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description