Drybench Patent.
IVACAFTOR, NDA 207925
The patents and exclusivities FDA's Orange Book lists for NDA 207925 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.
FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.
- Orange Book captured
- 14 October 2026
- Paragraph IV list captured
- 17 October 2026
- Last checked
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.
Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.
Listed protection
Listed dates run from 29 Apr 2026 to 27 Aug 2033, each by its own rule; no one date stands for this product.
- Earliest listed date
- 29 Apr 2026ODE-236 exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 627, 633, 639
- Latest listed date
- 27 Aug 2033US 8,883,206 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004, 005 · patent.txt lines 7,519, 7,552, 7,585, 7,614, 7,642
- Latest substance patent
- 20 Nov 2027US 7,495,103 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004, 005 · patent.txt lines 7,505, 7,538, 7,571, 7,604, 7,632
- Latest listed patent
- 27 Aug 2033US 8,883,206 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004, 005 · patent.txt lines 7,519, 7,552, 7,585, 7,614, 7,642
- Latest exclusivity
- 3 Nov 2030PED exclusivityRule R3 · Products 004, 005 · exclusivity.txt lines 649, 655
60 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 207925, as listed. The sections below name products by these numbers.
Product 001 · KALYDECO
- Dosage form; route
- GRANULE;ORAL
- Strength
- 50MG/PACKET
- Approval date as listed
- 17 Mar 2015
- Type as listed
- RX
- Applicant as listed
- VERTEX PHARMACEUTICALS INC
Product 002 · KALYDECO
- Dosage form; route
- GRANULE;ORAL
- Strength
- 75MG/PACKET
- Approval date as listed
- 17 Mar 2015
- Type as listed
- RX
- Applicant as listed
- VERTEX PHARMACEUTICALS INC
Product 003 · KALYDECO
- Dosage form; route
- GRANULE;ORAL
- Strength
- 25MG/PACKET
- Approval date as listed
- 29 Apr 2019
- Type as listed
- RX
- Applicant as listed
- VERTEX PHARMACEUTICALS INC
Product 004 · KALYDECO
- Dosage form; route
- GRANULE;ORAL
- Strength
- 5.8MG/PACKET
- Approval date as listed
- 3 May 2023
- Type as listed
- RX
- Applicant as listed
- VERTEX PHARMACEUTICALS INC
Product 005 · KALYDECO
- Dosage form; route
- GRANULE;ORAL
- Strength
- 13.4MG/PACKET
- Approval date as listed
- 3 May 2023
- Type as listed
- RX
- Applicant as listed
- VERTEX PHARMACEUTICALS INC
Listed patents
Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.
45 entries from 155 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 8,354,427, use patent
patent.txt lines 7,514, 7,547- Expiry as listed
- 6 Jul 2026
- Rule
- R1
- Flags
- use code U-2528
- Product numbers
- 001, 002
US 8,354,427, use patent
patent.txt lines 7,512, 7,545, 7,578- Expiry as listed
- 6 Jul 2026
- Rule
- R1
- Flags
- use code U-1311
- Product numbers
- 001, 002, 003
US 8,354,427, use patent
patent.txt lines 7,513, 7,546, 7,579- Expiry as listed
- 6 Jul 2026
- Rule
- R1
- Flags
- use code U-1905
- Product numbers
- 001, 002, 003
US 8,354,427, use patent
patent.txt line 7,580- Expiry as listed
- 6 Jul 2026
- Rule
- R1
- Flags
- use code U-2964
- Product numbers
- 003
US 8,354,427, use patent
patent.txt lines 7,609, 7,637- Expiry as listed
- 6 Jul 2026
- Rule
- R1
- Flags
- use code U-3608
- Product numbers
- 004, 005
US 8,410,274, product patent
patent.txt lines 7,516, 7,549, 7,582, 7,611, 7,639- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005
US 8,754,224, substance and product patent
patent.txt lines 7,518, 7,551, 7,584, 7,613, 7,641- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003, 004, 005
US 9,670,163, product and use patent
patent.txt lines 7,523, 7,556- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- product · use code U-2530
- Product numbers
- 001, 002
US 9,670,163, product and use patent
patent.txt lines 7,522, 7,555, 7,588- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- product · use code U-1311
- Product numbers
- 001, 002, 003
US 9,670,163, product and use patent
patent.txt line 7,589- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- product · use code U-2966
- Product numbers
- 003
US 9,670,163, product and use patent
patent.txt lines 7,617, 7,645- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- product · use code U-3606
- Product numbers
- 004, 005
US 8,354,427 with pediatric exclusivity, as listed
patent.txt lines 7,511, 7,544, 7,577, 7,608, 7,636- Expiry as listed
- 6 Jan 2027
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
US 7,495,103, substance and product patent
patent.txt lines 7,506, 7,539, 7,572, 7,605, 7,633- Expiry as listed
- 20 May 2027
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003, 004, 005
US 8,410,274 with pediatric exclusivity, as listed
patent.txt lines 7,515, 7,548, 7,581, 7,610, 7,638- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
US 8,754,224 with pediatric exclusivity, as listed
patent.txt lines 7,517, 7,550, 7,583, 7,612, 7,640- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
US 9,670,163 with pediatric exclusivity, as listed
patent.txt lines 7,521, 7,554, 7,587, 7,616, 7,644- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
US 8,324,242, use patent
patent.txt lines 7,510, 7,543- Expiry as listed
- 5 Aug 2027
- Rule
- R1
- Flags
- use code U-2527
- Product numbers
- 001, 002
US 8,324,242, use patent
patent.txt lines 7,508, 7,541, 7,574- Expiry as listed
- 5 Aug 2027
- Rule
- R1
- Flags
- use code U-1311
- Product numbers
- 001, 002, 003
US 8,324,242, use patent
patent.txt lines 7,509, 7,542, 7,575- Expiry as listed
- 5 Aug 2027
- Rule
- R1
- Flags
- use code U-1906
- Product numbers
- 001, 002, 003
US 8,324,242, use patent
patent.txt line 7,576- Expiry as listed
- 5 Aug 2027
- Rule
- R1
- Flags
- use code U-2963
- Product numbers
- 003
US 8,324,242, use patent
patent.txt lines 7,607, 7,635- Expiry as listed
- 5 Aug 2027
- Rule
- R1
- Flags
- use code U-3609
- Product numbers
- 004, 005
US 7,495,103 with pediatric exclusivity, as listed
patent.txt lines 7,505, 7,538, 7,571, 7,604, 7,632- Expiry as listed
- 20 Nov 2027
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
US 8,324,242 with pediatric exclusivity, as listed
patent.txt lines 7,507, 7,540, 7,573, 7,606, 7,634- Expiry as listed
- 5 Feb 2028
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
US 10,646,481, product patent
patent.txt lines 7,494, 7,527, 7,560, 7,593, 7,621- Expiry as listed
- 13 Aug 2029
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005
US 11,564,916, use patent
patent.txt lines 7,498, 7,531, 7,564- Expiry as listed
- 13 Aug 2029
- Rule
- R1
- Flags
- use code U-3528
- Product numbers
- 001, 002, 003
US 11,564,916, use patent
patent.txt lines 7,597, 7,625- Expiry as listed
- 13 Aug 2029
- Rule
- R1
- Flags
- use code U-3603
- Product numbers
- 004, 005
US 12,458,635, product and use patent
patent.txt lines 7,504, 7,537, 7,570, 7,603, 7,631- Expiry as listed
- 13 Aug 2029
- Rule
- R1
- Flags
- product · use code U-4337
- Product numbers
- 001, 002, 003, 004, 005
US 10,646,481 with pediatric exclusivity, as listed
patent.txt lines 7,493, 7,526, 7,559, 7,592, 7,620- Expiry as listed
- 13 Feb 2030
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
US 11,564,916 with pediatric exclusivity, as listed
patent.txt lines 7,497, 7,530, 7,563, 7,596, 7,624- Expiry as listed
- 13 Feb 2030
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
US 12,458,635 with pediatric exclusivity, as listed
patent.txt lines 7,503, 7,536, 7,569, 7,602, 7,630- Expiry as listed
- 13 Feb 2030
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
US 10,272,046, product and use patent
patent.txt lines 7,492, 7,525- Expiry as listed
- 27 Feb 2033
- Rule
- R1
- Flags
- product · use code U-2531
- Product numbers
- 001, 002
US 10,272,046, product and use patent
patent.txt line 7,558- Expiry as listed
- 27 Feb 2033
- Rule
- R1
- Flags
- product · use code U-2967
- Product numbers
- 003
US 10,272,046, product and use patent
patent.txt lines 7,591, 7,619- Expiry as listed
- 27 Feb 2033
- Rule
- R1
- Flags
- product · use code U-3605
- Product numbers
- 004, 005
US 11,147,770, product and use patent
patent.txt lines 7,496, 7,529, 7,562- Expiry as listed
- 27 Feb 2033
- Rule
- R1
- Flags
- product · use code U-3339
- Product numbers
- 001, 002, 003
US 11,147,770, product and use patent
patent.txt lines 7,595, 7,623- Expiry as listed
- 27 Feb 2033
- Rule
- R1
- Flags
- product · use code U-3604
- Product numbers
- 004, 005
US 11,752,106, product and use patent
patent.txt lines 7,500, 7,533, 7,566, 7,599, 7,627- Expiry as listed
- 27 Feb 2033
- Rule
- R1
- Flags
- product · use code U-3697
- Product numbers
- 001, 002, 003, 004, 005
US 12,214,083, product and use patent
patent.txt lines 7,502, 7,535- Expiry as listed
- 27 Feb 2033
- Rule
- R1
- Flags
- product · use code U-4126
- Product numbers
- 001, 002
US 12,214,083, product and use patent
patent.txt line 7,568- Expiry as listed
- 27 Feb 2033
- Rule
- R1
- Flags
- product · use code U-4128
- Product numbers
- 003
US 12,214,083, product and use patent
patent.txt lines 7,601, 7,629- Expiry as listed
- 27 Feb 2033
- Rule
- R1
- Flags
- product · use code U-4127
- Product numbers
- 004, 005
US 8,883,206, product patent
patent.txt lines 7,520, 7,553, 7,586, 7,615, 7,643- Expiry as listed
- 27 Feb 2033
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005
US 10,272,046 with pediatric exclusivity, as listed
patent.txt lines 7,491, 7,524, 7,557, 7,590, 7,618- Expiry as listed
- 27 Aug 2033
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
US 11,147,770 with pediatric exclusivity, as listed
patent.txt lines 7,495, 7,528, 7,561, 7,594, 7,622- Expiry as listed
- 27 Aug 2033
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
US 11,752,106 with pediatric exclusivity, as listed
patent.txt lines 7,499, 7,532, 7,565, 7,598, 7,626- Expiry as listed
- 27 Aug 2033
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
US 12,214,083 with pediatric exclusivity, as listed
patent.txt lines 7,501, 7,534, 7,567, 7,600, 7,628- Expiry as listed
- 27 Aug 2033
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
US 8,883,206 with pediatric exclusivity, as listed
patent.txt lines 7,519, 7,552, 7,585, 7,614, 7,642- Expiry as listed
- 27 Aug 2033
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
Listed exclusivities
Each exclusivity FDA lists for NDA 207925, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
ODE-236 exclusivity
exclusivity.txt lines 627, 633, 639- Date
- 29 Apr 2026
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
NPP exclusivity
exclusivity.txt lines 645, 651- Date
- 3 May 2026
- Rule
- R3
- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 004, 005
PED exclusivity
exclusivity.txt lines 631, 637, 643- Date
- 29 Oct 2026
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
PED exclusivity
exclusivity.txt lines 648, 654- Date
- 3 Nov 2026
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 004, 005
ODE-338 exclusivity
exclusivity.txt lines 628, 634, 640- Date
- 21 Dec 2027
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
M-14 exclusivity
exclusivity.txt lines 626, 632, 638, 644, 650- Date
- 22 May 2028
- Rule
- R3
- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005
PED exclusivity
exclusivity.txt lines 629, 635, 641- Date
- 21 Jun 2028
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
PED exclusivity
exclusivity.txt lines 630, 636, 642, 647, 653- Date
- 22 Nov 2028
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005
ODE-435 exclusivity
exclusivity.txt lines 646, 652- Date
- 3 May 2030
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 004, 005
PED exclusivity
exclusivity.txt lines 649, 655- Date
- 3 Nov 2030
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 004, 005
Paragraph IV list rows giving NDA 207925
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 207925, each cell as listed.
FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.
The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.
Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.
Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 207925
Ivacaftor · Oral Granules · 25 mg, 50 mg and 75 mg
RLD/NDA as listed: Kalydeco 207925- First PIV submission
- 13 Apr 2022
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 27 Feb 2033
Notes from the trace
- R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.
Patents vs FDA exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week