Viewing data from:

JASCAYD

NDA

NERANDOMILAST | N218764 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC

2 strengths5 unique patents3 unique exclusivities

Patent Timeline

5 unique patents, 3 exclusivities by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Aug. 23, 2032

Nov. 26, 2029

Feb. 19, 2034

Oct. 22, 2038

Oct. 22, 2038

I-979

Dec. 19, 2028

NCE

Oct. 7, 2030

ODE-546

Oct. 7, 2032

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

6 trials from ClinicalTrials.gov — 6 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis NCT07497087	Phase 3	Not Yet Recruiting	Boehringer Ingelheim	448	2026-06-22 → 2030-03-17
FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression NCT07540988	Phase 3	Not Yet Recruiting	Boehringer Ingelheim	466	2026-08-28 → 2028-12-12
A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (FIBRONEER-chILD)NCT07366034	Phase 3	Not Yet Recruiting	Boehringer Ingelheim	35	2026-07-27 → 2031-04-14
A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis NCT07201922	Phase 3	Recruiting	Boehringer Ingelheim	80	2026-02-10 → 2029-05-23
A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases NCT06806592	Phase 3	Recruiting	Boehringer Ingelheim	400	2025-09-13 → 2027-07-30
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast NCT06238622	Phase 3	Recruiting	Boehringer Ingelheim	1,700	2024-05-06 → 2027-05-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 2, 2026	SUPPL -1	View Letter (PDF)
Oct 10, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 9MG

RLD

5 patents3 exclusivities▴

TABLET;ORAL | Approved: Oct 7, 2025

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8609670	Aug 23, 2032	—	Yes	—	—	—
8754073	Nov 26, 2029	—	Yes	Yes		—
9802954	Feb 19, 2034	—	—	—		—
11406638	Oct 22, 2038	—	—	—		—
11813266	Oct 22, 2038	—	—	—		—

Exclusivities (3)

Code	Date	Status
I-979	Dec 19, 2028	Active
NCE	Oct 7, 2030	Active
ODE-546	Oct 7, 2032	Active

#002 — 18MG

RLD

5 patents3 exclusivities▾

TABLET;ORAL | Approved: Oct 7, 2025

Change History (2)

Recent changes detected for this application.

ADDED7/1/2026

New: New record

ADDED7/1/2026

Boehringer Ingelheim received orphan drug exclusivity for Jascayd (nerandomilast) under designation ODE-546 for New Drug Application 218764.

New: New record