Case	Court	Filed	Status	Judge
GENENTECH, INC. et al v. SANDOZ, INC. et al 2:2023cv04085 1 patentpirfenidone	D.N.J.	2023-07-31	Active	—
Genentech, Inc. et al v. Shilpa Medicare Limited 1:2020cv00624	D. Del.	2020-05-08	Terminated 2021-08-23	—
Genentech, Inc. et al v. Torrent Pharmaceuticals Ltd. et al 1:2019cv00324	D. Del.	2019-02-14	Terminated 2019-08-14	—
Genentech, Inc. et al v. Aizant Drug Research Solutions Pvt. Ltd. 1:2019cv00223	D. Del.	2019-02-01	Terminated 2020-01-02	—
Genentech, Inc. et al v. InvaGen Pharmaceuticals, Inc., et al. 1:2019cv00219	D. Del.	2019-02-01	Terminated 2021-11-23	—
Genentech, Inc. et al v. MSN Laboratories Private Limited et al 1:2019cv00205	D. Del.	2019-01-31	Terminated 2020-01-02	—
Genentech, Inc. et al v. Sandoz, Inc. 1:2019cv00203	D. Del.	2019-01-31	Terminated 2022-04-19	—
Genentech, Inc. et al v. Amneal Pharmaceuticals LLC et al 1:2019cv00195	D. Del.	2019-01-30	Terminated 2021-06-23	—
Genentech, Inc. et al v. Amneal Pharmaceuticals LLC et al 1:2019cv00190	D. Del.	2019-01-30	Terminated 2021-06-23	—
Genentech, Inc. et al v. Hetero Labs Limited et al 1:2019cv00178	D. Del.	2019-01-29	Terminated 2019-06-28	—
Genentech, Inc. et al v. Alembic Pharmaceuticals, Ltd., et al 1:2019cv00177	D. Del.	2019-01-29	Terminated 2020-01-02	—
Genentech, Inc. et al v. Granules Pharmaceuticals, Inc. et al 1:2019cv00164	D. Del.	2019-01-28	Terminated 2019-07-12	—
Genentech, Inc. et al v. Macleods Pharmaceuticals Ltd. et al 1:2019cv00154	D. Del.	2019-01-28	Terminated 2021-09-08	—
Genentech, Inc. et al v. Accord Healthcare, Inc. 1:2019cv00141	D. Del.	2019-01-25	Terminated 2019-12-20	—
Genentech, Inc. et al v. Shilpa Medicare Limited 1:2019cv00130	D. Del.	2019-01-23	Terminated 2021-08-23	—
Genentech, Inc. et al v. ScieGen Pharmaceuticals Inc. 1:2019cv00132	D. Del.	2019-01-23	Terminated 2019-08-20	—
Genentech, Inc. et al v. Apotex Inc. et al 1:2019cv00120 19 patentsANDA 212687pirfenidone	D. Del.	2019-01-22	Terminated 2021-10-29	—
Genentech, Inc. v. Lupin Ltd. et al. 1:2019cv00109 19 patentsANDA 212404pirfenidone	D. Del.	2019-01-18	Terminated 2021-10-15	—
Genentech, Inc. et al v. Aurobindo Pharma Limited et al 1:2019cv00103 19 patentsANDA 212597pirfenidone	D. Del.	2019-01-17	Terminated 2021-10-20	—
Genentech, Inc., et al. v. Sandoz, Inc., et al. 1:2019cv00078 19 patentsANDA 212724pirfenidone	D. Del.	2019-01-14	Terminated 2022-04-19	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

63 trials from ClinicalTrials.gov — 1 recruiting, 45 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)NCT03109288	Phase 1/2	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	250	2017-08-11 → 2029-01-01
Expanded Access Program (EAP): Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone NCT02141087	—	APPROVED_FOR_MARKETING	Genentech, Inc.	—	—
Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis)NCT00001959	Phase 2	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	21	1999-12 → 2008-10
Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF NCT02579603	Phase 4	Completed	Boehringer Ingelheim	105	2015-10-16 → 2017-01-31
Oral Pirfenidone for the Pulmonary Fibrosis of Hermansky-Pudlak Syndrome NCT00001596	Phase 2	Completed	William Gahl, M.D.	35	2005-09 → 2016-05-09
Pirfenidone for Restrictive Chronic Lung Allograft Dysfunction NCT03359863	Phase 2	Completed	University of California, San Francisco	10	2018-03-07 → 2021-10-28
A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)NCT01872689	Phase 2	Completed	Hoffmann-La Roche	505	2013-10-13 → 2017-11-06
Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease NCT02408744	Phase 1/2	Completed	University of Guadalajara	30	2009-09 → 2013-09
Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis NCT00080223	Phase 2	Completed	Genentech, Inc.	83	2003-08-31 → 2015-04-30
Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy NCT02689778	Phase 3	Completed	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	62	2016-03 → 2019-12

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

Medicare Part D Spending

CMS annual spending data for Esbriet (2024)

Total Spending

$42.1M

Total Claims

4,228

Beneficiaries

719

Avg Cost/Unit

$63.83

Spending Trend

$617.9M(2019)→$671.0M(2020)→$662.2M(2021)→$409.9M(2022)→$93.4M(2023)→$42.1M(2024)

YoY Change:-6.5%

5yr CAGR:+0.4%

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

API Supply Chain27 active DMFs1 inactive

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

SIGNA SA DE CVPIRFENIDONE EP

DMF 151682000

HONOUR LAB LTDPIRFENIDONE

DMF 297002015

LUPIN LTDPIRFENIDONE

DMF 303512016

GRANULES INDIA LTDPIRFENIDONE

DMF 309222016

SHILPA PHARMA LIFESCIENCES LTDPIRFENIDONE

DMF 309522016

ALIVUS LIFE SCIENCES LTDPIRFENIDONE

DMF 310722016

MSN LIFE SCIENCES PRIVATE LTDPIRFENIDONE

DMF 312642016

MATRIX PHARMACORP PRIVATE LTDPIRFENIDONE

DMF 312742016

PROCOS SPAPIRFENIDONE

DMF 318152017

OPTIMUS DRUGS PRIVATE LTDPIRFENIDONE

DMF 320152017

COHANCE LIFESCIENCES LTDPIRFENIDONE

DMF 322012017

DIPHARMA FRANCIS SRLPIRFENIDONE

DMF 322242018

RAKS PHARMA PVT LTDPIRFENIDONE USP

DMF 323042017

JUBILANT BIOSYS LTDPIRFENIDONE

DMF 323842018

CIPLA LTDPIRFENIDONE

DMF 324232018

MICRO LABS LTDPIRFENIDONE USP

DMF 326542018

MACLEODS PHARMACEUTICALS LTDPIRFENIDONE

DMF 326572018

VERANOVA LPPIRFENIDONE

DMF 326802018

APITORIA PHARMA PRIVATE LTDPIRFENIDONE

DMF 326962018

LAURUS LABS LTDPIRFENIDONE

DMF 327392018

ALEMBIC PHARMACEUTICALS LTDPIRFENIDONE

DMF 327722018

CHEMO IBERICA SAPIRFENIDONE

DMF 327962018

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)PIRFENIDONE

DMF 335992019

SMS PHARMACEUTICALS LTDPIRFENIDONE

DMF 379252022

HONOUR LAB LTDPIRFENIDONE (PROCESS-II)

DMF 403312024

CHEMECA DRUGS PRIVATE LTDPIRFENIDONE USP

DMF 403592024

SNJ LABS PVT LTDPIRFENIDONE USP

DMF 426402025

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLInactivePIRFENIDONE

DMF 51701983

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Feb 27, 2023	SUPPL -16	View Letter (PDF)
Feb 15, 2022	SUPPL -15	View Letter (PDF)
Aug 1, 2019	SUPPL -12	View Letter (PDF)
Jan 18, 2017	SUPPL -5	View Letter (PDF)
Oct 22, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 267MG

RLDAB

19 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 15, 2014

Patents (19) · 19 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
7566729	Apr 22, 2029	—	—	—	—
7635707	Apr 22, 2029	—	—	—	—
7696236	Dec 18, 2027	—	—	—	—
7767225	Sep 22, 2026	—	—	Yes	—
7767700	Dec 18, 2027	—	—	—	—
7816383	Jan 8, 2030	—	—	—	—
7910610	Jan 8, 2030	—	—	—	—
7988994	Sep 22, 2026	—	—	Yes	—
8013002	Jan 8, 2030	—	—	—	—
8084475	Jan 8, 2030	—	—	—	—
8318780	Jan 8, 2030	—	—	—	—
8383150	May 10, 2028	—	—	Yes	—
8420674	Dec 18, 2027	—	—	Yes	—
8592462	Apr 22, 2029	—	—	—	—
8609701	Apr 22, 2029	—	—	—	—
8648098	Jan 8, 2030	—	—	—	—
8753679	Sep 22, 2026	—	—	Yes	—
8754109	Jan 8, 2030	—	—	—	—
8778947	Aug 30, 2033	—	—	—	—