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Cerilliant
QuintilesIMS
Federal Trade Commission
Merck
McKinsey
Cipla
UBS
Fish and Richardson
Boehringer Ingelheim

Generated: April 27, 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 ➤ Try a Free Trial ➤ Try a Free Trial CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS ➤ Try a Free Trial
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial 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 ➤ Try a Free Trial
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial 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 ➤ Try a Free Trial
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial 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 ➤ Try a Free Trial
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
8,609,701 Pirfenidone treatment for patients with atypical liver function ➤ Try a Free Trial
7,566,729 Modifying pirfenidone treatment for patients with atypical liver function ➤ Try a Free Trial
7,635,707 Pirfenidone treatment for patients with atypical liver function ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Family Members for US Patent 8,592,462

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2709997 ➤ Try a Free Trial
Canada 2765402 ➤ Try a Free Trial
China 102209543 ➤ Try a Free Trial
Colombia 6382132 ➤ Try a Free Trial
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
US Army
Medtronic
Merck
Cerilliant
Moodys
Fish and Richardson
Chubb
Boehringer Ingelheim

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