Details for Patent: 9,012,496

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Which drugs does patent 9,012,496 protect, and when does it expire?

Patent 9,012,496 protects ALYFTREK, SYMDEKO (COPACKAGED), and TRIKAFTA (COPACKAGED), and is included in three NDAs.

This patent has eight patent family members in seven countries.

Summary for Patent: 9,012,496

Title:	Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide and administration thereof
Abstract:	A pharmaceutical composition comprising Compound 1, (R)-1-(2,2-difluorobenzo[d][1,3]dioxo-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide, and at least one excipient selected from: a filler, a disintegrant, a surfactant, a glidant and a lubricant, the composition being suitable for oral administration to a patient in need thereof to treat a CFTR mediated disease such as Cystic Fibrosis. Methods for treating a patient in need thereof include administering the pharmaceutical composition of Compound 1 are also disclosed.
Inventor(s):	Rossitza Gueorguieva Alargova, Craig Antony Dunbar, Irina Nikolaevna Kadiyala
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US13/942,617
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,012,496
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Drugs Protected by US Patent 9,012,496

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes	9,012,496					TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 9,012,496 FURTHER COMPRISING VNZ
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No	9,012,496					TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR THE F508DEL MUTATION AND A SECOND MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes	9,012,496					TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR THE F508DEL MUTATION AND A SECOND MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No	9,012,496					TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR; AND ANOTHER COMPOSITION COMPRISING IVACAFTOR
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019		RX	Yes	Yes	9,012,496					TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR; AND ANOTHER COMPOSITION COMPRISING IVACAFTOR
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019		RX	Yes	Yes	9,012,496					TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR; AND ANOTHER COMPOSITION COMPRISING IVACAFTOR

International Family Members for US Patent 9,012,496

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	092857
Australia	2013290444
Australia	2018208694
Canada	2878057
European Patent Office	2872122
Hong Kong	1209318