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    Roche is 'evaluating options' for IPF drug Esbriet as generics gain traction
    Roche is 'evaluating options' for IPF drug Esbriet as generics gain traction

    https://endpts.com/roche-is-evaluating-potential-options-for-ipf-drug-esbriet-as-generics-gain-traction/

    ENDPTS
    27 Feb 2024
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    Roche sues Novartis unit over generic lung disease drug
    Roche sues Novartis unit over generic lung disease drug

    https://www.reuters.com/legal/litigation/roche-sues-novartis-unit-over-generic-lung-disease-drug-2023-08-01/

    REUTERS
    02 Aug 2023
    Share Share
    Apotex's Generic Pirfenidone Receives Approval in the U.S.
    Apotex's Generic Pirfenidone Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212687

    FDA
    09 Jun 2023
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    Enforcement Report - Week of March 8, 2023
    Enforcement Report - Week of March 8, 2023

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-8-2023-15780.pdf

    FDA
    08 Mar 2023
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    Viatris's Pirfenidone Viatris (pirfenidone) Receives Approval in Europe
    Viatris's Pirfenidone Viatris (pirfenidone) Receives Approval in Europe

    https://www.ema.europa.eu/en/documents/overview/pirfenidone-viatris-epar-medicine-overview_en.pdf

    EMA
    17 Jan 2023
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    Viatris's Pirfenidone Receives Approval in Europe
    Viatris's Pirfenidone Receives Approval in Europe

    https://www.ema.europa.eu/en/documents/overview/pirfenidone-viatris-epar-medicine-overview_en.pdf

    EMA
    17 Jan 2023
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    Hetero's Generic Pirfenidone Receives Approval in the U.S.
    Hetero's Generic Pirfenidone Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212674

    FDA
    21 Sep 2022
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    ScieGen Pharma's Generic Pirfenidone Receives Approval in the U.S.
    ScieGen Pharma's Generic Pirfenidone Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212077

    FDA
    01 Aug 2022
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    Aizant Generic Pirfenidone Receives Approval in the U.S.
    Aizant Generic Pirfenidone Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212747

    FDA
    21 Jul 2022
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    Laurus Labs Generic Pirfenidone Receives Approval in the U.S.
    Laurus Labs Generic Pirfenidone Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212722

    FDA
    19 Jul 2022
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    Alfred E. Tiefenbacher's Pirfenidone Receives Approval in the EMA
    Alfred E. Tiefenbacher's Pirfenidone Receives Approval in the EMA

    https://www.ema.europa.eu/en/documents/overview/pirfenidone-aet-epar-medicine-overview_en.pdf

    FDA
    28 Jun 2022
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    Alfred E. Tiefenbacher' Pirfenidone AET Receives Approval in Europe
    Alfred E. Tiefenbacher' Pirfenidone AET Receives Approval in Europe

    https://www.ema.europa.eu/en/documents/overview/pirfenidone-aet-epar-medicine-overview_en.pdf

    EMA
    28 Jun 2022
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    Sandoz B2B Generic Pirfenidone Receives Approval in the U.S.
    Sandoz B2B Generic Pirfenidone Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212600

    FDA
    13 Jun 2022
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    Accord Healthcare Releases Generic Drug Proven Effective Against IPF
    Accord Healthcare Releases Generic Drug Proven Effective Against IPF

    https://www.biospace.com/article/releases/accord-healthcare-releases-generic-drug-proven-effective-against-idiopathic-pulmonary-fibrosis/

    BIOSPACE
    01 Jun 2022
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    Alembic Pharma gets USFDA approval to market Pirfenidone tablets
    Alembic Pharma gets USFDA approval to market Pirfenidone tablets

    https://www.business-standard.com/article/companies/alembic-pharma-gets-usfda-approval-to-market-pirfenidone-tablets-122052400611_1.html

    BUSINESS-STANDARD
    24 May 2022
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    Sandoz launches first US generic of Roche's Esbriet
    Sandoz launches first US generic of Roche's Esbriet

    https://www.fiercepharma.com/pharma/novartis-sandoz-keeps-engine-warm-first-us-generic-launch-roches-esbriet

    A. Liu FIERCEPHARMA
    14 May 2022
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    Sandoz launches first generic pirfenidone in US for patients with IPF
    Sandoz launches first generic pirfenidone in US for patients with IPF

    https://www.prnewswire.com/news-releases/sandoz-launches-first-generic-pirfenidone-in-us-for-patients-with-idiopathic-pulmonary-fibrosis-growing-its-respiratory-portfolio-301545367.html

    PRNEWSWIRE
    12 May 2022
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    Four Drugs Recommended For Approval By Chmp At April Meeting
    Four Drugs Recommended For Approval By Chmp At April Meeting

    https://medwatch.com/News/Pharma___Biotech/article13949571.ece

    MEDWATCH
    25 Apr 2022
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    Amneal Pharm's Generic Pirfenidone Receives Approval in the U.S.
    Amneal Pharm's Generic Pirfenidone Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212570

    FDA
    25 Mar 2022
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    Teva Pharms USA's Generic Pirfenidone Receives Approval in the U.S.
    Teva Pharms USA's Generic Pirfenidone Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212759

    FDA
    25 Jan 2022
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    Accord Healthcare's Generic Pirfenidone Receives Approval in the U.S.
    Accord Healthcare's Generic Pirfenidone Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212731

    FDA
    20 Jan 2022
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    PureTech’s LYT-100 Shows 50% Reduction against GI-Related AEs vs Pirfenidone
    PureTech’s LYT-100 Shows 50% Reduction against GI-Related AEs vs Pirfenidone

    https://www.businesswire.com/news/home/20220105006009/en

    BUSINESSWIRE
    05 Jan 2022
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    Amneal's Generic Pirfenidone Receives Approval in the U.S.
    Amneal's Generic Pirfenidone Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212569

    FDA
    03 Jan 2022
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    Alembic Pharms`s Generic Clomipramine HCl Receives Approval In US
    Alembic Pharms`s Generic Clomipramine HCl Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212708

    FDA
    30 Oct 2021
    Share Share
    Alembic Pharms`s Generic Pirfenidone Receives Approval In US
    Alembic Pharms`s Generic Pirfenidone Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212708

    FDA
    30 Oct 2021
    Share Share
    Pirfenidone could offer ‘viable’ heart failure treatment
    Pirfenidone could offer ‘viable’ heart failure treatment

    https://www.pharmatimes.com/news/pirfenidone_could_offer_viable_heart_failure_treatment_1375146

    PHARMATIMES
    16 Aug 2021
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    Sandoz`s Generic Pirfenidone Receives Approval in US
    Sandoz`s Generic Pirfenidone Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212600

    FDA
    31 Mar 2021
    Share Share
    With patent concerns looming, Roche new priority review on blockbuster IPF drug
    With patent concerns looming, Roche new priority review on blockbuster IPF drug

    https://endpts.com/with-patent-concerns-looming-roche-gets-a-new-priority-review-on-blockbuster-ipf-drug/

    Jason Mast ENDPTS
    22 Jan 2021
    Share Share
    FDA Grants Priority Review to Genentech’s Esbriet (pirfenidone)
    FDA Grants Priority Review to Genentech’s Esbriet (pirfenidone)

    https://www.businesswire.com/news/home/20210120005802/en/FDA-Grants-Priority-Review-to-Genentech%E2%80%99s-Esbriet-pirfenidone-for-Unclassifiable-Interstitial-Lung-Disease

    BUSINESSWIRE
    21 Jan 2021
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    FDA Grants Priority Review to Genentech’s Esbriet (pirfenidone)
    FDA Grants Priority Review to Genentech’s Esbriet (pirfenidone)

    https://www.businesswire.com/news/home/20210120005802/en

    BUSINESSWIRE
    20 Jan 2021
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    Risk of drug-induced liver injury associated with the use of pirfenidone
    Risk of drug-induced liver injury associated with the use of pirfenidone

    https://www.hsa.gov.sg/announcements/safety-alert/risk-of-drug-induced-liver-injury-associated-with-the-use-of-pirfenidone

    HSA
    09 Dec 2020
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    Sciegen Pharms Generic Pirfenidone Receives Tentative Approval In US
    Sciegen Pharms Generic Pirfenidone Receives Tentative Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212077

    FDA
    18 Nov 2020
    Share Share
    Teva Pharma's USA Generic Pirfenidone Receives Approval in US
    Teva Pharma's USA Generic Pirfenidone Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212759

    FDA
    22 Aug 2020
    Share Share
    MSN Labs Generic Pirfenidone Receives Tentative Approval In US
    MSN Labs Generic Pirfenidone Receives Tentative Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212772

    FDA
    10 Aug 2020
    Share Share
    PureTech eyes clinical trial in long-term COVID-19 complications
    PureTech eyes clinical trial in long-term COVID-19 complications

    https://www.fiercebiotech.com/biotech/puretech-eyes-clinical-trial-long-term-covid-19-complications

    Nick P. Taylor FIERCE BIOTECH
    30 May 2020
    Share Share
    Amneal Pharmaceuticals` Generic Pirfenidone Receive Approval in U.S
    Amneal Pharmaceuticals` Generic Pirfenidone Receive Approval in U.S

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212569

    FDA
    26 Mar 2020
    Share Share
    Amneal Pharmaceuticals` Generic Pyridostigmine Receive Tentative Approval in U.S
    Amneal Pharmaceuticals` Generic Pyridostigmine Receive Tentative Approval in U.S

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212569

    FDA
    24 Mar 2020
    Share Share
    Roche pushes to kick-start lung therapy Esbriet after big writedown
    Roche pushes to kick-start lung therapy Esbriet after big writedown

    https://www.roche.com/investors/updates/inv-update-2020-03-03.htm

    PRESS RELEASE
    04 Mar 2020
    Share Share
    FDA Grants Breakthrough Therapy Designation for Genentech’s Esbriet pirfenidone
    FDA Grants Breakthrough Therapy Designation for Genentech’s Esbriet pirfenidone

    https://www.businesswire.com/news/home/20200302006109/en

    BUSINESSWIRE
    02 Mar 2020
    Share Share
    Shilpa Medicare's Generic Pirfenidone Receives Tentative Approval in US
    Shilpa Medicare's Generic Pirfenidone Receives Tentative Approval in US

    https://www.flickr.com/photos/185636032@N04/49112403246/

    FDA
    31 Jan 2020
    Share Share
    Apotex's Generic Pirfenidone Receives Tentative Approval in US
    Apotex's Generic Pirfenidone Receives Tentative Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212687

    FDA
    30 Oct 2019
    Share Share
    Apotex`s Generic Pirfenidone Receives Tentative Approval in US
    Apotex`s Generic Pirfenidone Receives Tentative Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212709

    FDA
    01 Oct 2019
    Share Share
    Boehringer Ingelheim's Ofev wins FDA approval for use in scleroderma patients
    Boehringer Ingelheim's Ofev wins FDA approval for use in scleroderma patients

    https://endpts.com/boehringer-ingelheims-ofev-wins-fda-approval-for-use-in-scleroderma-patients/

    Natalie Grover ENDPOINTSNEWS
    10 Sep 2019
    Share Share
    Genentech Plans Legal Battle to Protect Esbriet from Generic Competition
    Genentech Plans Legal Battle to Protect Esbriet from Generic Competition

    https://www.biospace.com/article/genentech-plans-legal-battle-to-protect-esbriet-from-generic-competition/

    Alex Keown
    05 Feb 2019
    Share Share
    Esbriet® (pirfenidone) : Genentech vs. Teva Pharmaceuticals
    Esbriet® (pirfenidone) : Genentech vs. Teva Pharmaceuticals

    https://insight.rpxcorp.com/litigation_documents/13210783

    PATENT LITIGATION
    30 Jan 2019
    Share Share
    Esbriet® (pirfenidone) : Genentech vs. Accord Healthcare
    Esbriet® (pirfenidone) : Genentech vs. Accord Healthcare

    https://insight.rpxcorp.com/litigation_documents/13212084

    PATENT LITIGATION
    30 Jan 2019
    Share Share
    Esbriet® (pirfenidone) : Genentech vs. Macleods Pharmaceuticals
    Esbriet® (pirfenidone) : Genentech vs. Macleods Pharmaceuticals

    https://insight.rpxcorp.com/litigation_documents/13214079

    PATENT LITIGATION
    30 Jan 2019
    Share Share
    Esbriet® (pirfenidone) : Genentech vs. ScieGen Pharmaceuticals
    Esbriet® (pirfenidone) : Genentech vs. ScieGen Pharmaceuticals

    https://insight.rpxcorp.com/litigation_documents/13210392

    PATENT LITIGATION
    29 Jan 2019
    Share Share
    Esbriet® (pirfenidone) : Genentech vs. Laurus Labs
    Esbriet® (pirfenidone) : Genentech vs. Laurus Labs

    https://www.pharmacompass.com/pdf/news/esbriet-pirfenidone-genentech-vs-laurus-labs-1547794916.pdf

    PATENT LITIGATION
    15 Jan 2019
    Share Share
    Tium Bio Licenses out Lung Disease Drug Candidate for US$74 Mil
    Tium Bio Licenses out Lung Disease Drug Candidate for US$74 Mil

    http://www.businesskorea.co.kr/news/articleView.html?idxno=28204

    Choi Moon-hee KOREA BUSINESS
    11 Jan 2019
    Share Share
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