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Esbriet patents expiration

ESBRIET's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9561217 GENENTECH INC Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone
Jan, 2022

(2 years ago)

US7988994 GENENTECH INC Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Sep, 2026

(2 years from now)

US8753679 GENENTECH INC Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Sep, 2026

(2 years from now)

US7767225 GENENTECH INC Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Sep, 2026

(2 years from now)

US8420674 GENENTECH INC Method of providing pirfenidone therapy to a patient
Dec, 2027

(3 years from now)

US7767700 GENENTECH INC Method of providing pirfenidone therapy to a patient
Dec, 2027

(3 years from now)

US7696326 GENENTECH INC Multiple antigen glycopeptide carbohydrate, vaccine comprising the same and use thereof
Dec, 2027

(3 years from now)

US7696236 GENENTECH INC Method of providing pirfenidone therapy to a patient
Dec, 2027

(3 years from now)

US8383150 GENENTECH INC Granulate formulation of pirfenidone and pharmaceutically acceptable excipients
May, 2028

(4 years from now)

US8592462 GENENTECH INC Pirfenidone treatment for patients with atypical liver function
Apr, 2029

(4 years from now)

US7566729 GENENTECH INC Modifying pirfenidone treatment for patients with atypical liver function
Apr, 2029

(4 years from now)

US8609701 GENENTECH INC Pirfenidone treatment for patients with atypical liver function
Apr, 2029

(4 years from now)

US7635707 GENENTECH INC Pirfenidone treatment for patients with atypical liver function
Apr, 2029

(4 years from now)

US8084475 GENENTECH INC Pirfenidone therapy and inducers of cytochrome P450
Jan, 2030

(5 years from now)

US7816383 GENENTECH INC Methods of administering pirfenidone therapy
Jan, 2030

(5 years from now)

US8754109 GENENTECH INC Pirfenidone therapy and inducers of cytochrome P450
Jan, 2030

(5 years from now)

US8318780 GENENTECH INC Methods of administering pirfenidone therapy
Jan, 2030

(5 years from now)

US7910610 GENENTECH INC Methods of administering pirfenidone therapy
Jan, 2030

(5 years from now)

US8648098 GENENTECH INC Pirfenidone therapy and inducers of cytochrome P450
Jan, 2030

(5 years from now)

US8013002 GENENTECH INC Methods of administering pirfenidone therapy
Jan, 2030

(5 years from now)

US8778947 GENENTECH INC Methods of administering pirfenidone therapy
Aug, 2033

(9 years from now)

US10188637 GENENTECH INC Granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone and method of making the same
Mar, 2037

(12 years from now)

Esbriet is owned by Genentech Inc.

Esbriet contains Pirfenidone.

Esbriet has a total of 22 drug patents out of which 1 drug patent has expired.

Expired drug patents of Esbriet are:

  • US9561217

Esbriet was authorised for market use on 11 January, 2017.

Esbriet is available in tablet;oral dosage forms.

Esbriet can be used as dosing 1602 mg/day pirfenidone following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of ipf, dosage modification following grade 2 abnormality in biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, then sub-1600 mg/day, then at least 1602 mg/day, method for administering pirfenidone to avoid reduced efficacy by avoiding smoking or by avoiding another strong cyp1a2 inducer, method of administering a granulate formulation of 5-methyl-1-phenyl-2-(1h)-pyridone as recited in claim 1, to treat idiopathic pulmonary fibrosis, method of administering pirfenidone capsules to treat a fibrotic condition, dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, then at least 1600mg/day in treatment of ipf, discontinuing administration of a strong cyp1a2 inhibitor to avoid drug interactions with pirfenidone and then administering pirfenidone, pirfenidone dose escalation regimen for treatment of fibrosis as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen, dose escalation over 14 days for treatment of idiopathic pulmonary fibrosis, dosage modification following elevated liver enzymes in treatment of idiopathic pulmonary fibrosis, administration of pirfenidone and avoiding concurrent administration of ciprofloxacin at a dose of 750 mg to reduce drug interactions in treatment of a fibrotic, inflammatory, or autoimmune disorder, administering pirfenidone while avoiding co-administration of fluvoxamine to avoid drug interactions with pirfenidone, modifying pirfenidone administration from a dose of about 2400 mg/day downward by about 1600 mg/day while co-administering fluvoxamine to reduce drug interactions with fluvoxamine, method for administering pirfenidone to avoid reduced efficacy by discontinuing smoking or by discontinuing or avoiding another strong cyp1a2 inducer, method for administering pirfenidone to avoid reduced efficacy by discontinuing smoking or by discontinuing a strong cyp1a2 inducer, pirfenidone dose escalation regimen for treatment of ipf as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen, discontinuing use of a cyp1a2 inhibitor that is a moderate to strong inhibitor of both cyp1a2 and another cyp enzyme selected from cyp2c9, cyp2c19, and cyp2d6 and then administering pirfenidone.

Drug patent challenges can be filed against Esbriet from 15 October, 2018.

The generics of Esbriet are possible to be released after 28 March, 2037.

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-77) Oct 15, 2021
New Chemical Entity Exclusivity(NCE) Oct 15, 2019
Orphan Drug Exclusivity(ODE) Oct 15, 2021

Drugs and Companies using PIRFENIDONE ingredient

NCE-1 date: 15 October, 2018

Market Authorisation Date: 11 January, 2017

Treatment: Method of administering pirfenidone capsules to treat a fibrotic condition; Pirfenidone dose escalation regimen for treatment of fibrosis as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for day...

Dosage: TABLET;ORAL

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