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Details for Patent: 8,013,002

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Which drugs does patent 8,013,002 protect, and when does it expire?

Patent 8,013,002 protects ESBRIET and is included in two NDAs.

This patent has forty-eight patent family members in thirty-two countries.

Summary for Patent: 8,013,002

Title:	Methods of administering pirfenidone therapy
Abstract:	The present invention relates to methods involving avoiding adverse drug interactions with fluvoxamine and pirfenidone or other moderate to strong inhibitors of CYP enzymes.
Inventor(s):	Bradford; Williamson Ziegler (Ross, CA), Szwarcberg; Javier (San Francisco, CA)
Assignee:	Intermune, Inc. (Brisbane, CA)
Application Number:	13/049,894
Patent Claim Types: see list of patent claims	Use;

Drugs Protected by US Patent 8,013,002

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						METHOD FOR ADMINISTERING PIRFENDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017		RX	Yes	No						ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017		RX	Yes	No						MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017		DISCN	Yes	No						MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE

Non-Orange Book US Patents Family Members for Patent 8,013,002

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
7,816,383	Methods of administering pirfenidone therapy
8,318,780	Methods of administering pirfenidone therapy
7,910,610	Methods of administering pirfenidone therapy

International Family Members for US Patent 8,013,002

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	3155
Austria	526024
Australia	2010212490
Australia	2011201462