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Serving leading biopharmaceutical companies globally:

Novartis
Medtronic
Covington
Baxter
US Department of Justice
Argus Health
Express Scripts
Citi
Fuji
Daiichi Sankyo

Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,592,462

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Which drugs does patent 8,592,462 protect, and when does it expire?

Patent 8,592,462 protects ESBRIET and is included in two NDAs.

This patent has fifty-three patent family members in thirty-five countries.
Summary for Patent: 8,592,462
Title:Pirfenidone treatment for patients with atypical liver function
Abstract: Methods are provided for administering pirfenidone to a patient that has exhibited abnormal biomarkers of liver function in response to pirfenidone administration. The methods include administering to a patient pirfenidone at doses lower than the full target dosage for a time period, followed by administering to the patient pirfenidone at the full target dosage. The methods also include administering pirfenidone at the full target dose with no reduction and administering permanently reduced doses of pirfenidone.
Inventor(s): Bradford; Williamson Ziegler (Ross, CA), Szwarcberg; Javier (San Francisco, CA)
Assignee: Intermune, Inc. (Brisbane, CA)
Application Number:13/312,746
Patent Claim Types:
see list of patent claims
Use;

Drugs Protected by US Patent 8,592,462

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 CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS ➤ Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 RX Yes No ➤ Sign Up ➤ Sign Up 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 ➤ Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 RX Yes No ➤ Sign Up ➤ Sign Up DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF ➤ Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 RX Yes No ➤ Sign Up ➤ Sign Up DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY, FOLLOWING BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF ➤ Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 RX Yes No ➤ Sign Up ➤ Sign Up DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 LIVER ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF ➤ Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 RX Yes No ➤ Sign Up ➤ Sign Up DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400MG/DAY DOSE, FOLLOWED BY ADMINISTERING 2403MG/DAY IN TREATMENT OF IPF ➤ Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 RX Yes No ➤ Sign Up ➤ Sign Up DOSING 2403 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF ➤ Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 RX Yes No ➤ Sign Up ➤ Sign Up DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY DOSE IN TREATMENT OF IPF ➤ Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 RX Yes No ➤ Sign Up ➤ Sign Up 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, FOLLOWED BY FULL DAILY DOSE IN TREATMENT OF IPF ➤ Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 RX Yes No ➤ Sign Up ➤ Sign Up DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF ➤ 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 8,592,462

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
7,566,729 Modifying pirfenidone treatment for patients with atypical liver function ➤ Sign Up
7,635,707 Pirfenidone treatment for patients with atypical liver function ➤ Sign Up
8,609,701 Pirfenidone treatment for patients with atypical liver function ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 8,592,462

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2709997 ➤ Sign Up
Canada 2765402 ➤ Sign Up
China 102209543 ➤ Sign Up
Colombia 6382132 ➤ Sign Up
Costa Rica 20110243 ➤ Sign Up
Cuba 20110100 ➤ Sign Up
Cyprus 1111595 ➤ Sign Up
Cyprus 1115862 ➤ Sign Up
Germany 602009000986 ➤ Sign Up
Denmark 2191831 ➤ 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:

Deloitte
Fish and Richardson
Queensland Health
Dow
Chinese Patent Office
Argus Health
Cipla
Moodys
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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