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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Moodys
Chubb
AstraZeneca
Cerilliant
Dow
Citi
Julphar
Merck

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,383,150

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Which drugs does patent 8,383,150 protect, and when does it expire?

Patent 8,383,150 protects ESBRIET and is included in two NDAs.

This patent has forty-two patent family members in twenty-seven countries.
Summary for Patent: 8,383,150
Title:Granulate formulation of pirfenidone and pharmaceutically acceptable excipients
Abstract: A capsule formulation of pirfenidone is provided that includes pharmaceutically acceptable excipients. In one embodiment, this capsule formulation is capable of sustaining desirable pharmacokinetic responses in a patient. Further provided are methods of treating fibrotic conditions and other cytokine-mediated disorders by administering pirfenidone capsules of such formulation to a patient in need.
Inventor(s): Radhakrishnan; Ramachandran (Fremont, CA), Vladyka; Ronald (Somerset, NJ), Sultzbaugh; Kenneth (Bridge Water, NJ)
Assignee: Intermune, Inc. (Brisbane, CA)
Application Number:13/162,048
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form; Use;

Drugs Protected by US Patent 8,383,150

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y METHOD OF ADMINISTERING A DOSAGE FORM THAT INCLUDES A GRANULATE FORMULATION OF PIRFENIDONE TO TREAT AFIBROTIC CONDITION ➤ Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y METHOD OF ADMINISTERING A DOSAGE FORM THAT INCLUDES A GRANULATE FORMULATION OF PIRFENIDONE TO TREAT AFIBROTIC CONDITION ➤ Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-002 Jan 11, 2017 DISCN Yes No ➤ Sign Up ➤ Sign Up Y METHOD OF ADMINISTERING A DOSAGE FORM THAT INCLUDES A GRANULATE FORMULATION OF PIRFENIDONE TO TREAT AFIBROTIC CONDITION ➤ Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-003 Jan 11, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y METHOD OF ADMINISTERING A DOSAGE FORM THAT INCLUDES A GRANULATE FORMULATION OF PIRFENIDONE TO TREAT AFIBROTIC CONDITION ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 8,383,150

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,753,679 Capsule formulation of pirfenidone and pharmaceutically acceptable excipients ➤ Sign Up
7,767,225 Capsule formulation of pirfenidone and pharmaceutically acceptable excipients ➤ Sign Up
7,988,994 Capsule formulation of pirfenidone and pharmaceutically acceptable excipients ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Family Members for US Patent 8,383,150

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 2655 ➤ Sign Up
Australia 2006295440 ➤ Sign Up
Australia 2011201520 ➤ Sign Up
Australia 2013201986 ➤ Sign Up
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Colorcon
AstraZeneca
UBS
Mallinckrodt
Farmers Insurance
Johnson and Johnson
Chubb
QuintilesIMS

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