Details for New Drug Application (NDA): 219042
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NDA 219042 describes HERNEXEOS, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the HERNEXEOS profile page.
The generic ingredient in HERNEXEOS is zongertinib. One supplier is listed for this compound. Additional details are available on the zongertinib profile page.
The generic ingredient in HERNEXEOS is zongertinib. One supplier is listed for this compound. Additional details are available on the zongertinib profile page.
Summary for 219042
| Tradename: | HERNEXEOS |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | zongertinib |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219042
Generic Entry Date for 219042*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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.
Suppliers and Packaging for NDA: 219042
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HERNEXEOS | zongertinib | TABLET;ORAL | 219042 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-9257 | 0597-9257-86 | 60 CARTON in 1 BOTTLE, PLASTIC (0597-9257-86) / 1 TABLET, FILM COATED in 1 CARTON |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Aug 8, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 8, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 11,608,343 | Patent Expiration: | Jul 21, 2041 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | USE OF ZONGERTINIB FOR TREATING NON-SMALL CELL LUNG CANCER (NSCLC) | ||||||||
| Patent: | 12,171,739 | Patent Expiration: | Nov 15, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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