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OFEV

NDA

NINTEDANIB ESYLATE | N205832 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC

2 strengths4 unique patents2 unique exclusivities

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Expired (2)Active (2)TodayPED (+6 mo)Exclusivity

2026

2027

2028

2029

2030

Today

Apr. 1, 2026

Dec. 7, 2029

Dec. 4, 2029

Jul. 8, 2026

ODE-261

Mar. 6, 2027

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Apotex Inc. v. Boehringer Ingelheim Pharmaceuticals, Inc. et al 1:2024cv00577	D. Del.	2024-05-13	Terminated 2025-02-28	—
Cipla Ltd. v. Boehringer Ingelheim Pharmaceuticals Inc. et al 1:2022cv00300 5 patentsANDA 212609nintedanib esylate	D. Del.	2022-03-04	Terminated 2022-07-18	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from AdventaPharma DWC-LLC FDA-2025-P-5582 · 3 docket documents AdventaPharma DWC-LLC filed this citizen petition on October 24, 2025, requesting that the FDA require all six Abbreviated New Drug Application holders of nintedanib (the generic version of Ofev) to complete comprehensive risk assessments, meet Acceptable Intake limits for N-nitrosamine Drug Substan	505(q) Stay Request	2025-10-24	Partially Denied	AdventaPharma DWC-LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

78 trials from ClinicalTrials.gov — 1 recruiting, 2 active, 53 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer NCT03377023	Phase 1/2	Active	H. Lee Moffitt Cancer Center and Research Institute	66	2018-02-02 → 2026-08
Nintedanib and Azacitidine in Treating Participants With HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia NCT03513484	Phase 1	Active	Northwestern University	44	2018-11-14 → 2027-01
Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation NCT03805477	Phase 2	Recruiting	University Hospital, Basel, Switzerland	20	2019-03-20 → 2026-12
Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis (EAP)NCT02171156	—	APPROVED_FOR_MARKETING	Boehringer Ingelheim	—	—
Trial Of Pembrolizumab And Nintedanib NCT02856425	Phase 1	Completed	Gustave Roussy, Cancer Campus, Grand Paris	196	2016-11-10 → 2026-01-10
Study of Nintedanib Plus Bevacizumab in Advanced Solid Tumors NCT02835833	Phase 1	Completed	University of Alabama at Birmingham	21	2016-06-09 → 2018-06-14
Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers NCT02191865	Phase 1	Completed	Boehringer Ingelheim	33	2014-07 → 2015-01
Nintedanib Plus Docetaxel in Japanese Patients With Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy NCT02300298	Phase 1	Completed	Boehringer Ingelheim	10	2014-12-24 → 2017-10-27
Influence of Bosentan on the Pharmacokinetics of Nintedanib NCT02667704	Phase 1	Completed	Boehringer Ingelheim	13	2016-02 → 2016-03
Management of Progressive Disease in Idiopathic Pulmonary Fibrosis NCT03939520	Phase 4	Completed	Hospices Civils de Lyon	279	2020-06-11 → 2026-01-09

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

VA Federal Supply Schedule

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

Lowest Price

$9798.56

Highest Price

$13120.64

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00597-0143-60OFEV 100MG CAP	$13120.64	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0143-60OFEV 100MG CAP	$9881.91	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0145-60OFEV 150MG CAP	$13120.64	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0145-60OFEV 150MG CAP	$9798.56	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027

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

Medicare Part D Spending

CMS annual spending data for Ofev (2024)

Total Spending

$2.1B

Total Claims

161,717

Beneficiaries

23,929

Avg Cost/Unit

$216.45

Spending Trend

$789.5M(2019)→$1.2B(2020)→$1.5B(2021)→$1.8B(2022)→$1.8B(2023)→$2.1B(2024)

YoY Change:-2.0%

5yr CAGR:+4.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain20 active DMFs

18 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDNINTEDANIB ESYLATE

DMF 315262017

ALIVUS LIFE SCIENCES LTDNINTEDANIB ESYLATE

DMF 321522017

FORMOSA LABORATORIES INCNINTEDANIB

DMF 324082018

OLON SPANINTEDANIB ESYLATE HEMIHYDRATE

DMF 325292018

CIPLA LTDNINTEDANIB ESYLATE

DMF 325042018

VERANOVA LPNINTEDANIB ESYLATE

DMF 325112018

FORMOSA LABORATORIES INCNINTEDANIB ESYLATE

DMF 326432018

SUN PHARMACEUTICAL INDUSTRIES LTDNINTEDANIB ESYLATE

DMF 328662018

HUBEI CHENGTIAN PHARMACEUTICAL CO LTDNINTEDANIB ESYLATE

DMF 331522018

FERMION OYNINTEDANIB ESYLATE

DMF 333612019

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDNINTEDANIB ESYLATE, NON-STERILE, BULK DRUG SUBSTANCE

DMF 343322019

MSN LABORATORIES PRIVATE LTDNINTEDANIB

DMF 345502020

HETERO LABS LTDNINTEDANIB ESYLATE

DMF 355822021

TAPI NL BVNINTEDANIB ESYLATE

DMF 378722022

SICHUAN KELUN PHARMACEUTICAL CO LTDNINTEDANIB ESYLATE

DMF 379862023

SHANDONG ANHONG PHARMACEUTICAL CO LTDNINTEDANIB ESYLATE

DMF 382982023

MACLEODS PHARMACEUTICALS LTDNINTEDANIB ESYLATE

DMF 386062024

CHEMO IBERICA SANINTEDANIB ESYLATE

DMF 391582023

BDR LIFESCIENCES PRIVATE LTDNINTEDANIB ESYLATE

DMF 402082024

BIOCON LTDNINTEDANIB ESYLATE

DMF 413542025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Oct 15, 2024	SUPPL -28	View Letter (PDF)
Jun 20, 2024	SUPPL -27	View Letter (PDF)
Jan 18, 2022	SUPPL -16	View Letter (PDF)
Nov 2, 2020	SUPPL -14	View Letter (PDF)
Mar 10, 2020	SUPPL -13	View Letter (PDF)
Sep 9, 2019	SUPPL -12	View Letter (PDF)
Nov 15, 2018	SUPPL -10	View Letter (PDF)
Feb 2, 2018	SUPPL -9	View Letter (PDF)
Dec 18, 2017	SUPPL -7	View Letter (PDF)
Aug 15, 2017	SUPPL -5	View Letter (PDF)
Feb 13, 2017	SUPPL -4	View Letter (PDF)
Feb 5, 2016	SUPPL -1	View Letter (PDF)
Oct 21, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 100MG BASE

RLDAB

4 patents2 exclusivities▴

CAPSULE;ORAL | Approved: Oct 15, 2014

Patents (4) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
6762180	Oct 1, 2025PED: Apr 1, 2026	PED	Yes	Yes	—	—
9907756	Jun 7, 2029PED: Dec 7, 2029	PED	—	Yes	—	—
10105323	Jun 4, 2029PED: Dec 4, 2029	PED	—	Yes	—	—
10154990	Jan 8, 2026PED: Jul 8, 2026	PED	—	—		—

Exclusivities (2)

Code	Date	Status
ODE-261	Sep 6, 2026	< 1 year
PED	Mar 6, 2027	< 1 year

#002 — EQ 150MG BASE

RLDAB

4 patents2 exclusivities▾

CAPSULE;ORAL | Approved: Oct 15, 2014