Details for New Drug Application (NDA): 218764
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NDA 218764 describes JASCAYD, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the JASCAYD profile page.
The generic ingredient in JASCAYD is nerandomilast. One supplier is listed for this compound. Additional details are available on the nerandomilast profile page.
The generic ingredient in JASCAYD is nerandomilast. One supplier is listed for this compound. Additional details are available on the nerandomilast profile page.
Summary for 218764
| Tradename: | JASCAYD |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | nerandomilast |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218764
Generic Entry Date for 218764*:
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: 218764
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JASCAYD | nerandomilast | TABLET;ORAL | 218764 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-2465 | 0597-2465-41 | 60 CARTON in 1 BOTTLE, PLASTIC (0597-2465-41) / 1 TABLET, FILM COATED in 1 CARTON |
| JASCAYD | nerandomilast | TABLET;ORAL | 218764 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-7313 | 0597-7313-21 | 60 CARTON in 1 BOTTLE, PLASTIC (0597-7313-21) / 1 TABLET, FILM COATED in 1 CARTON |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 9MG | ||||
| Approval Date: | Oct 7, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 7, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Oct 22, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Oct 22, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB MONOETHANESULFONATE | ||||||||
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