Application 218730

Type: NDA
Sponsor: VERTEX PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALYFTREK	DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM	TABLET;ORAL	50MG;20MG;EQ 4MG BASE	Yes	No
002	ALYFTREK	DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM	TABLET;ORAL	125MG;50MG;EQ 10MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N218730-001	ALYFTREK	DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM	50MG;20MG;EQ 4MG BASE	TABLET / ORAL		RLD	2024-12-20
N218730-002	ALYFTREK	DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM	125MG;50MG;EQ 10MG BASE	TABLET / ORAL		RLD, RS	2024-12-20

Orange Book patents#

Current patent rows page 1 of 2 · 94 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218730-001	8354427	2026-07-06	U-4091		2025-01-17
N218730-001	8410274	2026-12-28		Drug product	2025-01-17
N218730-001	8754224	2026-12-28		Drug substance, Drug product	2025-01-17
N218730-001	9670163	2026-12-28	U-4080	Drug product	2025-01-17
N218730-001	9670163	2026-12-28	U-4470	Drug product	2025-01-17
N218730-001	9931334	2026-12-28	U-4080	Drug product	2025-01-17
N218730-001	9931334	2026-12-28	U-4469	Drug product	2025-01-17
N218730-001	10022352	2027-04-09	U-4081	Drug product	2025-01-17
N218730-001	10239867	2027-04-09	U-4090	Drug substance, Drug product	2025-01-17
N218730-001	10239867	2027-04-09	U-4464	Drug substance, Drug product	2025-01-17
N218730-001	11639347	2027-04-09	U-4090	Drug substance, Drug product	2025-01-17
N218730-001	11639347	2027-04-09	U-4464	Drug substance, Drug product	2025-01-17
N218730-001	9974781	2027-04-09	U-4082	Drug product	2025-01-17
N218730-001	9974781	2027-04-09	U-4463	Drug product	2025-01-17
N218730-001	7645789	2027-05-01		Drug substance, Drug product	2025-01-17
N218730-001	8598181	2027-05-01	U-4090		2025-01-17
N218730-001	8598181	2027-05-01	U-4463		2025-01-17
N218730-001	8623905	2027-05-01		Drug substance, Drug product	2025-01-17
N218730-001	7495103	2027-05-20		Drug substance, Drug product	2025-01-17
N218730-001	7776905	2027-06-03		Drug substance, Drug product	2025-01-17
N218730-001	8324242	2027-08-05	U-4090		2025-01-17
N218730-001	8324242	2027-08-05	U-4464		2025-01-17
N218730-001	8415387	2027-11-12	U-4082		2025-01-17
N218730-001	8415387	2027-11-12	U-4463		2025-01-17
N218730-001	10646481	2029-08-13		Drug product	2025-01-17
N218730-001	11564916	2029-08-13	U-4095		2025-01-17
N218730-001	11564916	2029-08-13	U-4466		2025-01-17
N218730-001	10081621	2031-03-25	U-4087	Drug product	2025-01-17
N218730-001	10081621	2031-03-25	U-4468	Drug product	2025-01-17
N218730-001	11578062	2031-03-25	U-4096	Drug product	2025-01-17
N218730-001	11578062	2031-03-25	U-4465	Drug product	2025-01-17
N218730-001	RE50453	2031-07-10		Drug substance, Drug product	2025-07-09
N218730-001	10047053	2032-05-17		Drug substance	2025-01-17
N218730-001	8865902	2032-05-17		Drug substance, Drug product	2025-01-17
N218730-001	9181192	2032-05-17	U-4094	Drug substance, Drug product	2025-01-17
N218730-001	9181192	2032-05-17	U-4472	Drug substance, Drug product	2025-01-17
N218730-001	9512079	2032-05-17	U-4098	Drug substance, Drug product	2025-01-17
N218730-001	9512079	2032-05-17	U-4471	Drug substance, Drug product	2025-01-17
N218730-001	11066417	2039-02-14		Drug substance, Drug product	2025-01-17
N218730-001	11866450	2039-02-14	U-4082		2025-01-17
N218730-001	11866450	2039-02-14	U-4463		2025-01-17
N218730-001	11873300	2040-08-13	U-4083	Drug substance, Drug product	2025-01-17
N218730-001	11873300	2040-08-13	U-4462	Drug substance, Drug product	2025-01-17
N218730-002	8354427	2026-07-06	U-4091		2025-01-17
N218730-002	8410274	2026-12-28		Drug product	2025-01-17
N218730-002	8754224	2026-12-28		Drug substance, Drug product	2025-01-17
N218730-002	9670163	2026-12-28	U-4080	Drug product	2025-01-17
N218730-002	9670163	2026-12-28	U-4470	Drug product	2025-01-17
N218730-002	9931334	2026-12-28	U-4080	Drug product	2025-01-17
N218730-002	9931334	2026-12-28	U-4469	Drug product	2025-01-17
N218730-002	10022352	2027-04-09	U-4081	Drug product	2025-01-17
N218730-002	10239867	2027-04-09	U-4090	Drug substance, Drug product	2025-01-17
N218730-002	10239867	2027-04-09	U-4464	Drug substance, Drug product	2025-01-17
N218730-002	11639347	2027-04-09	U-4090	Drug substance, Drug product	2025-01-17
N218730-002	11639347	2027-04-09	U-4464	Drug substance, Drug product	2025-01-17
N218730-002	9974781	2027-04-09	U-4082	Drug product	2025-01-17
N218730-002	9974781	2027-04-09	U-4463	Drug product	2025-01-17
N218730-002	7645789	2027-05-01		Drug substance, Drug product	2025-01-17
N218730-002	8598181	2027-05-01	U-4090		2025-01-17
N218730-002	8598181	2027-05-01	U-4463		2025-01-17
N218730-002	8623905	2027-05-01		Drug substance, Drug product	2025-01-17
N218730-002	7495103	2027-05-20		Drug substance, Drug product	2025-01-17
N218730-002	7776905	2027-06-03		Drug substance, Drug product	2025-01-17
N218730-002	8324242	2027-08-05	U-4090		2025-01-17
N218730-002	8324242	2027-08-05	U-4464		2025-01-17
N218730-002	8415387	2027-11-12	U-4082		2025-01-17
N218730-002	8415387	2027-11-12	U-4463		2025-01-17
N218730-002	10646481	2029-08-13		Drug product	2025-01-17
N218730-002	11564916	2029-08-13	U-4095		2025-01-17
N218730-002	11564916	2029-08-13	U-4466		2025-01-17
N218730-002	10081621	2031-03-25	U-4087	Drug product	2025-01-17
N218730-002	10081621	2031-03-25	U-4468	Drug product	2025-01-17
N218730-002	11578062	2031-03-25	U-4096	Drug product	2025-01-17
N218730-002	11578062	2031-03-25	U-4465	Drug product	2025-01-17
N218730-002	RE50453	2031-07-10		Drug substance, Drug product	2025-07-09
N218730-002	10047053	2032-05-17		Drug substance	2025-01-17
N218730-002	8865902	2032-05-17		Drug substance, Drug product	2025-01-17
N218730-002	9181192	2032-05-17	U-4094	Drug substance, Drug product	2025-01-17
N218730-002	9181192	2032-05-17	U-4472	Drug substance, Drug product	2025-01-17
N218730-002	9512079	2032-05-17	U-4098	Drug substance, Drug product	2025-01-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218730-001	NCE	2029-12-20
N218730-001	ODE-526	2031-12-20
N218730-001	ODE-536	2033-03-27
N218730-002	NCE	2029-12-20
N218730-002	ODE-526	2031-12-20
N218730-002	ODE-536	2033-03-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N218730-001	ALYFTREK	50MG;20MG;EQ 4MG BASE	TABLET / ORAL	RLD	2024-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-002	ALYFTREK	125MG;50MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2024-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218730-001	ALYFTREK	50MG;20MG;EQ 4MG BASE	TABLET / ORAL	RLD	2024-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218730-002	ALYFTREK	125MG;50MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2024-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218730-001	ALYFTREK	50MG;20MG;EQ 4MG BASE	TABLET / ORAL	RLD	2024-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218730-002	ALYFTREK	125MG;50MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2024-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218730-001	ALYFTREK	50MG;20MG;EQ 4MG BASE	TABLET / ORAL	RLD	2024-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218730-002	ALYFTREK	125MG;50MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2024-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218730-001	ALYFTREK	50MG;20MG;EQ 4MG BASE	TABLET / ORAL	RLD	2024-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218730-002	ALYFTREK	125MG;50MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2024-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218730-001	ALYFTREK	50MG;20MG;EQ 4MG BASE	TABLET / ORAL	RLD	2024-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218730-002	ALYFTREK	125MG;50MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2024-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218730-001	ALYFTREK	50MG;20MG;EQ 4MG BASE	TABLET / ORAL	RLD	2024-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218730-002	ALYFTREK	125MG;50MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2024-12-20	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218730-001	ALYFTREK	50MG;20MG;EQ 4MG BASE	TABLET / ORAL	RLD	2024-12-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218730-002	ALYFTREK	125MG;50MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2024-12-20	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 497 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N218730-001	8354427	2026-07-06	U-4091		2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	8410274	2026-12-28		Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	8754224	2026-12-28		Drug substance, Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	9670163	2026-12-28	U-4080	Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	9670163	2026-12-28	U-4470	Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	9931334	2026-12-28	U-4080	Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	9931334	2026-12-28	U-4469	Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	10022352	2027-04-09	U-4081	Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	10239867	2027-04-09	U-4090	Drug substance, Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	10239867	2027-04-09	U-4464	Drug substance, Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	11639347	2027-04-09	U-4090	Drug substance, Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	11639347	2027-04-09	U-4464	Drug substance, Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	9974781	2027-04-09	U-4082	Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	9974781	2027-04-09	U-4463	Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	7645789	2027-05-01		Drug substance, Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	8598181	2027-05-01	U-4090		2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	8598181	2027-05-01	U-4463		2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	8623905	2027-05-01		Drug substance, Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	7495103	2027-05-20		Drug substance, Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	7776905	2027-06-03		Drug substance, Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	8324242	2027-08-05	U-4090		2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	8324242	2027-08-05	U-4464		2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	8415387	2027-11-12	U-4082		2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	8415387	2027-11-12	U-4463		2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	10646481	2029-08-13		Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	11564916	2029-08-13	U-4095		2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	11564916	2029-08-13	U-4466		2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	10081621	2031-03-25	U-4087	Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	10081621	2031-03-25	U-4468	Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	11578062	2031-03-25	U-4096	Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	11578062	2031-03-25	U-4465	Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	RE50453	2031-07-10		Drug substance, Drug product	2025-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	10047053	2032-05-17		Drug substance	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	8865902	2032-05-17		Drug substance, Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	9181192	2032-05-17	U-4094	Drug substance, Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	9181192	2032-05-17	U-4472	Drug substance, Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	9512079	2032-05-17	U-4098	Drug substance, Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	9512079	2032-05-17	U-4471	Drug substance, Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	11066417	2039-02-14		Drug substance, Drug product	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	11866450	2039-02-14	U-4082		2025-01-17	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N218730-001	NCE	2029-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	ODE-526	2031-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-001	ODE-536	2033-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-002	NCE	2029-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-002	ODE-526	2031-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218730-002	ODE-536	2033-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218730-001	NCE	2029-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218730-002	NCE	2029-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218730-001	NCE	2029-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218730-002	NCE	2029-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218730-001	NCE	2029-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218730-002	NCE	2029-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218730-001	NCE	2029-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218730-002	NCE	2029-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218730-001	NCE	2029-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218730-002	NCE	2029-12-20	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218730-001	NCE	2029-12-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218730-001	ODE-526	2031-12-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218730-001	ODE-536	2033-03-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218730-002	NCE	2029-12-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218730-002	ODE-526	2031-12-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218730-002	ODE-536	2033-03-27	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALYFTREK	VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR	Vertex Pharmaceuticals Incorporated	7e635909-c6fd-4f0d-ae77-cdff03653a20	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 218730 application number: NDA218730

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85606	SUPPL	2026-03-31
85580	SUPPL	2026-03-30
85579	SUPPL	2026-03-30
85510	SUPPL	2026-03-24
85480	SUPPL	2026-03-24
85395	SUPPL	2026-03-19
83560	SUPPL	2025-09-26
81117	ORIG	2025-02-07
80714	ORIG	2024-12-26
80692	ORIG	2024-12-20