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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 sixty-four patent family members in thirty-nine 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 Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,609,701
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	Submissiondate
Genentech Inc	ESBRIET	pirfenidone	CAPSULE;ORAL	022535-001	Oct 15, 2014		RX	Yes	Yes						CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELVATED LIVER ENZYMES IN USE OF PIRFENIDONE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017		RX	Yes	No						FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017		RX	Yes	No						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
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017		RX	Yes	No						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
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017		RX	Yes	No						DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017		RX	Yes	No						DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017		RX	Yes	No						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

Foreign Priority and PCT Information for Patent: 8,609,701

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

International Family Members for US Patent 8,609,701

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	503480
Australia	2009313302
Australia	2010212371
Australia	2011200385
Australia	2012205256
Brazil	PI0921022
Canada	2709997