HERNEXEOS Drug Patent Profile
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Which patents cover Hernexeos, and what generic alternatives are available?
Hernexeos is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are two patents protecting this drug.
This drug has one hundred and six patent family members in forty-four countries.
The generic ingredient in HERNEXEOS is zongertinib. One supplier is listed for this compound. Additional details are available on the zongertinib profile page.
DrugPatentWatch® Generic Entry Outlook for Hernexeos
Hernexeos will be eligible for patent challenges on August 8, 2029. 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 August 8, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for HERNEXEOS?
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Summary for HERNEXEOS
| International Patents: | 106 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Applications: | 8 |
| What excipients (inactive ingredients) are in HERNEXEOS? | HERNEXEOS excipients list |
| DailyMed Link: | HERNEXEOS at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for HERNEXEOS
Generic Entry Date for HERNEXEOS*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY NDA:
Dosage:
TABLET;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 HERNEXEOS
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Breast Cancer Resistance Protein Inhibitors HER2/Neu/cerbB2 Antagonists |
US Patents and Regulatory Information for HERNEXEOS
HERNEXEOS is protected by two US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of HERNEXEOS is ⤷ Start Trial.
This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | HERNEXEOS | zongertinib | TABLET;ORAL | 219042-001 | Aug 8, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Boehringer Ingelheim | HERNEXEOS | zongertinib | TABLET;ORAL | 219042-001 | Aug 8, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Boehringer Ingelheim | HERNEXEOS | zongertinib | TABLET;ORAL | 219042-001 | Aug 8, 2025 | 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 HERNEXEOS
See the table below for patents covering HERNEXEOS around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 121779 | ⤷ Start Trial | |
| Australia | 2021260721 | ⤷ Start Trial | |
| Brazil | 112022021514 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for HERNEXEOS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1971601 | C01971601/01 | Switzerland | ⤷ Start Trial | PRODUCT NAME: TUCATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67798 07.05.2020 |
| 1971601 | 301113 | Netherlands | ⤷ Start Trial | PRODUCT NAME: TUCATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: 67798 20200507 |
| 1971601 | CA 2021 00025 | Denmark | ⤷ Start Trial | PRODUCT NAME: TUCATINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; NAT. REG. NO/DATE: EU/1/20/1526 20210212; FIRST REG. NO/DATE: CH 67798 20200507 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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