Details for New Drug Application (NDA): 218764
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. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the nerandomilast profile page.
The generic ingredient in JASCAYD is nerandomilast. There is one drug master file entry for this compound. 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:
TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS (IPF) IN ADULT PATIENTS 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 | 1 BOTTLE, PLASTIC in 1 CARTON (0597-2465-41) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
| JASCAYD | nerandomilast | TABLET;ORAL | 218764 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-7313 | 0597-7313-21 | 1 BOTTLE, PLASTIC in 1 CARTON (0597-7313-21) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
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 | ||||||||
| Regulatory Exclusivity Expiration: | Oct 7, 2032 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS (IPF) IN ADULT PATIENTS | ||||||||
| Regulatory Exclusivity Expiration: | Dec 19, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PROGRESSIVE PULMONARY FIBROSIS (PPF) IN ADULT PATIENTS | ||||||||
Complete Access Available with Subscription
