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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Cerilliant
Julphar
US Department of Justice
Teva
Accenture
Federal Trade Commission
Fish and Richardson
Queensland Health

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,609,701

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Which drugs does patent 8,609,701 protect, and when does it expire?

Patent 8,609,701 protects ESBRIET and is included in two NDAs.

This patent has fifty-three patent family members in thirty-five countries.
Summary for Patent: 8,609,701
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:13/128,569
Patent Claim Types:
see list of patent claims
Use;

Drugs Protected by US Patent 8,609,701

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 ELVATED LIVER ENZYMES IN USE OF PIRFENIDONE ➤ 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 FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION ➤ 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 ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING A SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY ➤ 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 ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE, FOLLOWED BY FULL DAILY DOSE ➤ 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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Foreign Priority and PCT Information for Patent: 8,609,701

PCT Information
PCT FiledNovember 09, 2009PCT Application Number:PCT/US2009/063702
PCT Publication Date:May 14, 2010PCT Publication Number: WO2010/054294

Non-Orange Book US Patents Family Members for Patent 8,609,701

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
8,592,462 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 8,609,701

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 503480 ➤ Try a Free Trial
Australia 2009313302 ➤ Try a Free Trial
Australia 2010212371 ➤ Try a Free Trial
Australia 2011200385 ➤ 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:

Baxter
Healthtrust
Teva
QuintilesIMS
Medtronic
Covington
Daiichi Sankyo
Dow
Fuji

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