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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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis NCT07679893	Phase 2	Not Yet Recruiting	Mannkind Corporation	210	2026-06-30 → 2028-12

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

Medicare Part D Spending

CMS annual spending data for Ofev (2023)

Total Spending

$1.8B

Total Claims

140,681

Beneficiaries

20,444

Avg Cost/Unit

$220.84

Spending Trend

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

YoY Change:+6.5%

5yr CAGR:+6.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain19 active DMFs

17 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

CIPLA LTDNINTEDANIB ESYLATE

DMF 325042018

VERANOVA LPNINTEDANIB ESYLATE

DMF 325112018

OLON SPANINTEDANIB ESYLATE HEMIHYDRATE

DMF 325292018

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

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)

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