Viewing data from:

PIRFENIDONE

ANDA

PIRFENIDONE | A212722 | LAURUS LABS LTD

3 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. Laurus Labs Ltd. et al 1:2019cv00104 15 patentsANDA 212722pirfenidone	D. Del.	2019-01-17	Terminated 2020-01-02	—

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$2.24

per ea

Lowest NADAC/Unit

$0.8608

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70954087010PIRFENIDONE 801 MG TABLET	$2.24	EA	Generic	—	2026-06-17
42385092690PIRFENIDONE 801 MG TABLET	$2.24	EA	Generic	—	2026-06-17
70954086930PIRFENIDONE 267 MG TABLET	$0.8608	EA	Generic	—	2026-06-17
42385092499PIRFENIDONE 267 MG TABLET	$0.8608	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$1179.80

Highest Price

$1206.53

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70954-0869-30PIRFENIDONE 267MG TAB,ORAL	$1179.80	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
70954-0870-10PIRFENIDONE 801MG TAB,ORAL	$1206.53	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Aug 30, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 267MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 19, 2022

No patent or exclusivity listings for this strength.

#002 — 534MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 19, 2022

#003 — 801MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 19, 2022