NERANDOMILAST - Generic Drug Details
What are the generic sources for nerandomilast and what is the scope of freedom to operate?
Nerandomilast
is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for NERANDOMILAST
| International Patents: | 115 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 10 |
| What excipients (inactive ingredients) are in NERANDOMILAST? | NERANDOMILAST excipients list |
| DailyMed Link: | NERANDOMILAST at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NERANDOMILAST
Generic Entry Date for NERANDOMILAST*:
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.
Recent Clinical Trials for NERANDOMILAST
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Gipfel Life Sciences GmbH | PHASE2 |
| Rein Therapeutics | PHASE2 |
| Boehringer Ingelheim | PHASE1 |
Anatomical Therapeutic Chemical (ATC) Classes for NERANDOMILAST
US Patents and Regulatory Information for NERANDOMILAST
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | JASCAYD | nerandomilast | TABLET;ORAL | 218764-002 | Oct 7, 2025 | RX | Yes | Yes | 11,813,266 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Boehringer Ingelheim | JASCAYD | nerandomilast | TABLET;ORAL | 218764-002 | Oct 7, 2025 | RX | Yes | Yes | 11,406,638 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Boehringer Ingelheim | JASCAYD | nerandomilast | TABLET;ORAL | 218764-001 | Oct 7, 2025 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Boehringer Ingelheim | JASCAYD | nerandomilast | TABLET;ORAL | 218764-001 | Oct 7, 2025 | RX | Yes | No | ⤷ 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 NERANDOMILAST
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2018357775 | ⤷ Start Trial | |
| Australia | 2024203045 | ⤷ Start Trial | |
| Brazil | 112020003973 | ⤷ Start Trial | |
| Canada | 3079299 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
