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PIRFENIDONE

ANDA

PIRFENIDONE | A212709 | APOTEX INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ESBRIET(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Genentech, Inc. et al v. Apotex Inc. et al 1:2019cv00123 16 patentsANDA 212709pirfenidone	D. Del.	2019-01-22	Terminated 2021-10-29	—

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

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 PHARMOVA 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

1 letter from Drugs@FDA

Date	Submission	Document
Oct 4, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 267MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 31, 2023

No patent or exclusivity listings for this strength.

#002 — 801MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 31, 2023