Details for Patent: 10,081,621

Which drugs does patent 10,081,621 protect, and when does it expire?

Patent 10,081,621 protects TRIKAFTA (COPACKAGED), ALYFTREK, and SYMDEKO (COPACKAGED), and is included in four NDAs.

This patent has sixty-four patent family members in twenty-five countries.

Summary for Patent: 10,081,621

Title:	Solid forms 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
Abstract:	The present invention relates to solid forms 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 (Compound 1) in substantially crystalline form (Form A) or amorphous form, pharmaceutical compositions thereof, and methods of treatment therewith.
Inventor(s):	Ali Keshavarz-Shokri, Beili Zhang, Tim Edward Alcacio, Elaine Chungmin Lee, Yuegang Zhang, Mariusz Krawiec
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US14/676,205
Patent Claim Types: see list of patent claims	Use; Composition;

Drugs Protected by US Patent 10,081,621

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 CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-001	Apr 26, 2023		RX	Yes	No			Y			TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 8 OF 10081621 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 CYSTIC FIBROSIS IN 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 WITH ELX/IVA AND A COMP. RECITED IN CLAIM 8 OF 10081621 IN CF PATIENTS AGED 2 TO
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-001	Dec 20, 2024		RX	Yes	No			Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VNZ, D-IVA, AND A COMPOSITION ACCORDING TO CLAIM 1 OF US10081621
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-001	Dec 20, 2024		RX	Yes	No			Y			TREATMENT OF CF WITH VNZ, D-IVA, AND A COMP. RECITED IN CLAIM 8 OF 10081621 IN CF PATIENTS ≥6 Y WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN

International Family Members for US Patent 10,081,621

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2826776		301105	Netherlands
European Patent Office	2826776		122021000025	Germany
European Patent Office	2826776		LUC00207	Luxembourg
European Patent Office	2826776		PA2021508	Lithuania
European Patent Office	2826776		2021C/517	Belgium
European Patent Office	2826776		CA 2021 00013	Denmark