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Data / Drug companies / Pirfenidone

Pirfenidone: 26 companies and 62 products in the FDA NDC directory

Pirfenidone is listed in the FDA National Drug Code Directory by 26 companies, with 62 products in commercial distribution. 58 of the products (93.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, coated; capsule, and the newest product started marketing on November 2, 2026.

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Companies listing it
26
Products
62
Generic (ANDA) products
58 (93.5%)
Application numbers
18
Routes
Oral
Brand names
Esbriet
openFDA record search
api.fda.gov

Companies that list pirfenidone

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Laurus Labs Limited4tablet, film coated; capsuleGeneric drugs (ANDA)July 19, 2022
Amneal Pharmaceuticals NY LLC3tablet, film coated; capsuleGeneric drugs (ANDA)March 29, 2022
Amneal Pharmaceuticals NY LLC3tablet, film coated; capsuleGeneric drugs (ANDA)February 28, 2023
Aurobindo Pharma Limited3tablet; capsuleGeneric drugs (ANDA)April 20, 2026
AvKARE3tablet, film coated; capsuleGeneric drugs (ANDA)October 18, 2023
Cipla USA Inc.3tablet, coated; capsuleGeneric drugs (ANDA)August 2, 2022
Exelan Pharmaceuticals Inc.3tablet, coated; capsuleGeneric drugs (ANDA)August 2, 2022
Sandoz Inc3tablet, film coated; capsuleGeneric drugs (ANDA)January 9, 2023
ScieGen Pharmaceuticals, Inc.3tablet; capsuleGeneric drugs (ANDA)August 1, 2022
Accord Healthcare Inc.2tablet, film coatedGeneric drugs (ANDA)May 27, 2022
Alembic Pharmaceuticals Inc.2tablet, coatedGeneric drugs (ANDA)June 10, 2022
Alembic Pharmaceuticals Limited2tablet, coatedGeneric drugs (ANDA)June 10, 2022
Ani Pharmaceuticals, Inc.2tablet, film coatedGeneric drugs (ANDA)July 19, 2022
Apotex Corp.2tabletGeneric drugs (ANDA)April 9, 2024
Bryant Ranch Prepack2tablet, coatedGeneric drugs (ANDA)June 10, 2022
Bryant Ranch Prepack2tablet, coatedGeneric drugs (ANDA)June 10, 2022
Camber Pharmaceuticals, Inc.2tablet, film coatedGeneric drugs (ANDA)September 21, 2022
CivicaScript LLC2tablet, film coatedGeneric drugs (ANDA)November 2, 2026
Genentech, Inc.2tablet, coatedNew drug applications (NDA)January 11, 2017
Golden State Medical Supply, Inc.2tabletGeneric drugs (ANDA)May 31, 2023
Legacy Pharma USA Inc.2tablet, coatedNew drug applications (NDA)May 31, 2025
Major Pharmaceuticals2tablet, film coatedGeneric drugs (ANDA)May 24, 2022
Micro Labs Limited2tablet, film coatedGeneric drugs (ANDA)December 1, 2022
NorthStar RxLLC2tablet, film coatedGeneric drugs (ANDA)May 24, 2022
Novadoz Pharmaceuticals LLC2tablet, film coatedGeneric drugs (ANDA)September 7, 2022
Teva Pharmaceuticals, Inc.2tablet, film coatedGeneric drugs (ANDA)May 11, 2022

Dosage forms

Dosage formProductsShare
Tablet, film coated2946.8%
Tablet, coated1625.8%
Capsule914.5%
Tablet812.9%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)5893.5%
New drug applications (NDA)46.5%

Pharmacologic classes

ClassProducts
Pyridone62

Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.