Details for Patent: 12,458,635

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Which drugs does patent 12,458,635 protect, and when does it expire?

Patent 12,458,635 protects TRIKAFTA (COPACKAGED), SYMDEKO (COPACKAGED), KALYDECO, and ORKAMBI, and is included in seven NDAs.

Protection for KALYDECO has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has eighty-one patent family members in thirty-two countries.

Summary for Patent: 12,458,635

Title:	Pharmaceutical composition and administrations thereof
Abstract:	The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.
Inventor(s):	William Rowe, Patricia Hurter, Christopher Young, Kirk Dinehart, Marinus Jacobus Verwijs, Kirk Overhoff, Peter D. J. Grootenhuis, Martyn Botfield, Alfredo Grossi
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US18/091,476
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,458,635
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Drugs Protected by US Patent 12,458,635

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	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-001	Apr 26, 2023		RX	Yes	No			Y			TREATMENT OF CF IN PATIENTS AGED 2 TO < 6 YEARS OLD WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 12458635 CLAIM 1
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-001	Apr 26, 2023		RX	Yes	No			Y			TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 12458635 IN CF PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes			Y			TREATMENT OF CF IN PATIENTS AGED 2 TO < 6 YEARS OLD WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 12458635 CLAIM 1
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes			Y			TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 12458635 IN CF PATIENTS AGED 2 TO
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No			Y			TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR F508DEL OR HAS AT LEAST ONE CFTR GENE MUTATION RESPONSIVE TO TEZ/IVA BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE USING THE COMPOSITION RECITED IN US 12458635 CLAIM 1

International Family Members for US Patent 12,458,635

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009282419
Australia	2010282986
Australia	2016216569
Brazil	112012008082
Brazil	PI0916877