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Details for Patent: 8,354,427

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Which drugs does patent 8,354,427 protect, and when does it expire?

Patent 8,354,427 protects KALYDECO and is included in two NDAs.

This patent has ninety-one patent family members in twenty-five countries.

Summary for Patent: 8,354,427

Title:	Modulators of ATP-binding cassette transporters
Abstract:	The present invention relates to modulators of ATP-Binding Cassette ("ABC") transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator, compositions thereof, and methods therewith. The present invention also relates to methods of treating ABC transporter mediated diseases using such modulators.
Inventor(s):	Van Goor; Fredrick (San Diego, CA)
Assignee:	Vertex Pharmaceutical Incorporated (Cambridge, MA)
Application Number:	12/635,927
Patent Claim Types: see list of patent claims	Use;

Drugs Protected by US Patent 8,354,427

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
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-001	Mar 17, 2015		RX	Yes	No						METHOD OF TREATING CYSTIC FIBROSIS
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-001	Mar 17, 2015		RX	Yes	No						METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS, THE PATIENT HAVING A R117H MUTATION IN CFTR, USING N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-002	Mar 17, 2015		RX	Yes	Yes						METHOD OF TREATING CYSTIC FIBROSIS
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-002	Mar 17, 2015		RX	Yes	Yes						METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS, THE PATIENT HAVING A R117H MUTATION IN CFTR, USING N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE

Non-Orange Book US Patents Family Members for Patent 8,354,427

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
8,101,767	Modulators of ATP-binding cassette transporters
8,324,242	Modulators of ATP-binding cassette transporters
8,614,327	Modulators of ATP-binding cassette transporters
2,014,187,770

International Patents Family Members for US Patent 8,354,427

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2005258320
Australia	2010249302
Australia	2010251787
Australia	2010251789