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

5 trials from ClinicalTrials.gov, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
This Study in Healthy Men Tests How Itraconazole Influences the Amount of BI 1015550 in the Blood NCT03403439	Phase 1	Completed	Boehringer Ingelheim	16	2018-05-03 → 2018-07-20
This Study Tests Different Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF). The Study Tests How BI 1015550 is Taken up by the Body and How Well it is Tolerated.NCT03422068	Phase 1	Completed	Boehringer Ingelheim	15	2018-03-16 → 2019-07-10
This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 1015550 Are Taken up in the Body and How Well They Are Tolerated.NCT03542344	Phase 1	Completed	Boehringer Ingelheim	16	2018-06-04 → 2018-08-24
This Study Tests How Healthy Men Tolerate Different Doses of BI1015550. The Study Also Tests How BI 1015550 is Taken up by the Body NCT03230487	Phase 1	Completed	Boehringer Ingelheim	42	2017-08-10 → 2018-01-16
Relative Bioavailability of BI 1015550 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects NCT03302078	Phase 1	Completed	Boehringer Ingelheim	12	2017-10-16 → 2017-12-13

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$12337.89

Highest Price

$12352.96

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00597-2465-41JASCAYD 9MG TAB	$12337.89	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-2465-41JASCAYD 9MG TAB	$12337.89	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-7313-21JASCAYD 18MG TAB	$12352.96	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-7313-21JASCAYD 18MG TAB	$12352.96	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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) · 6 use codes

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