Drybench Patent.
IVACAFTOR; LUMACAFTOR, NDA 211358
The patents and exclusivities FDA's Orange Book lists for NDA 211358 as captured on 14 October 2026, each date named by its rule and its rows, and any rows of FDA's Paragraph IV list captured on 17 October 2026 that give this NDA's number. 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 8 Nov 2026 to 11 Jun 2031, each by its own rule; no one date stands for this product.
- Earliest listed date
- 8 Nov 2026US 7,973,038, use patentRule R1 · Products 001, 002
Source lines
patent.txt lines 12,728, 12,770
- Latest listed date
- 11 Jun 2031US 8,993,600 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003
Source lines
patent.txt lines 12,745, 12,787, 12,829
- Latest substance patent
- 20 Mar 2031US 8,507,534 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003
Source lines
patent.txt lines 12,733, 12,775, 12,817
- Latest listed patent
- 11 Jun 2031US 8,993,600 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003
Source lines
patent.txt lines 12,745, 12,787, 12,829
- Latest exclusivity
- 2 Mar 2030PED exclusivityRule R3 · Products 001, 002, 003
Source lines
exclusivity.txt lines 955, 959, 963
Listed dates of other NDAs in the same years:202620272028202920302031
39 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 211358, as listed. The sections below name products by these numbers.
Product 001 · ORKAMBI
- Dosage form; route
- GRANULE;
ORAL - Strength
- 125MG/PACKET;100MG/PACKET
- Approval date as listed
- 7 Aug 2018
- Type as listed
- RX
- Applicant as listed
- VERTEX PHARMACEUTICALS INC
Product 002 · ORKAMBI
- Dosage form; route
- GRANULE;
ORAL - Strength
- 188MG/PACKET;150MG/PACKET
- Approval date as listed
- 7 Aug 2018
- Type as listed
- RX
- Applicant as listed
- VERTEX PHARMACEUTICALS INC
Product 003 · ORKAMBI
- Dosage form; route
- GRANULE;
ORAL - Strength
- 94MG/PACKET;75MG/PACKET
- Approval date as listed
- 2 Sep 2022
- 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.
52 entries from 126 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 7,973,038, use patent
patent.txt lines 12,728, 12,770- Expiry as listed
- 8 Nov 2026
- Rule
- R1
- Flags
- use code U-2374
- Product numbers
- 001, 002
US 7,973,038, use patent
patent.txt line 12,812- Expiry as listed
- 8 Nov 2026
- Rule
- R1
- Flags
- use code U-3424
- Product numbers
- 003
US 8,741,933, use patent
patent.txt lines 12,740, 12,782- Expiry as listed
- 8 Nov 2026
- Rule
- R1
- Flags
- use code U-2374
- Product numbers
- 001, 002
US 8,741,933, use patent
patent.txt line 12,824- Expiry as listed
- 8 Nov 2026
- Rule
- R1
- Flags
- use code U-3424
- Product numbers
- 003
US 9,216,969, product patent
patent.txt lines 12,752, 12,794, 12,836- Expiry as listed
- 8 Nov 2026
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
US 8,410,274, product patent
patent.txt lines 12,732, 12,774, 12,816- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
US 8,754,224, substance and product patent
patent.txt lines 12,742, 12,784, 12,826- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003
US 9,670,163, product and use patent
patent.txt lines 12,754, 12,796- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- product · use code U-2376
- Product numbers
- 001, 002
US 9,670,163, product and use patent
patent.txt line 12,838- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- product · use code U-3429
- Product numbers
- 003
US 9,931,334, product and use patent
patent.txt lines 12,756, 12,798- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- product · use code U-2376
- Product numbers
- 001, 002
US 9,931,334, product and use patent
patent.txt line 12,840- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- product · use code U-3429
- Product numbers
- 003
US 7,973,038 with pediatric exclusivity, as listed
patent.txt lines 12,727, 12,769, 12,811- Expiry as listed
- 8 May 2027
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 8,741,933 with pediatric exclusivity, as listed
patent.txt lines 12,739, 12,781, 12,823- Expiry as listed
- 8 May 2027
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 9,216,969 with pediatric exclusivity, as listed
patent.txt lines 12,751, 12,793, 12,835- Expiry as listed
- 8 May 2027
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 7,495,103, substance and product patent
patent.txt lines 12,726, 12,768, 12,810- Expiry as listed
- 20 May 2027
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003
US 8,410,274 with pediatric exclusivity, as listed
patent.txt lines 12,731, 12,773, 12,815- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 8,754,224 with pediatric exclusivity, as listed
patent.txt lines 12,741, 12,783, 12,825- 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
US 9,670,163 with pediatric exclusivity, as listed
patent.txt lines 12,753, 12,795, 12,837- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 9,931,334 with pediatric exclusivity, as listed
patent.txt lines 12,755, 12,797, 12,839- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 8,324,242, use patent
patent.txt lines 12,730, 12,772- Expiry as listed
- 5 Aug 2027
- Rule
- R1
- Flags
- use code U-2374
- Product numbers
- 001, 002
US 8,324,242, use patent
patent.txt line 12,814- Expiry as listed
- 5 Aug 2027
- Rule
- R1
- Flags
- use code U-3424
- Product numbers
- 003
US 7,495,103 with pediatric exclusivity, as listed
patent.txt lines 12,725, 12,767, 12,809- 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
US 8,324,242 with pediatric exclusivity, as listed
patent.txt lines 12,729, 12,771, 12,813- Expiry as listed
- 5 Feb 2028
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 10,597,384, substance and product and use patent
patent.txt lines 12,716, 12,758- Expiry as listed
- 4 Dec 2028
- Rule
- R1
- Flags
- substance · product · use code U-2778
- Product numbers
- 001, 002
US 10,597,384, substance and product and use patent
patent.txt line 12,800- Expiry as listed
- 4 Dec 2028
- Rule
- R1
- Flags
- substance · product · use code U-3430
- Product numbers
- 003
US 12,065,432, use patent
patent.txt lines 12,722, 12,764, 12,806- Expiry as listed
- 4 Dec 2028
- Rule
- R1
- Flags
- use code U-3983
- Product numbers
- 001, 002, 003
US 8,653,103, product patent
patent.txt lines 12,736, 12,778, 12,820- Expiry as listed
- 4 Dec 2028
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
US 9,150,552, use patent
patent.txt lines 12,748, 12,790- Expiry as listed
- 4 Dec 2028
- Rule
- R1
- Flags
- use code U-2375
- Product numbers
- 001, 002
US 9,150,552, use patent
patent.txt line 12,832- Expiry as listed
- 4 Dec 2028
- Rule
- R1
- Flags
- use code U-3427
- Product numbers
- 003
US 10,597,384 with pediatric exclusivity, as listed
patent.txt lines 12,715, 12,757, 12,799- Expiry as listed
- 4 Jun 2029
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 12,065,432 with pediatric exclusivity, as listed
patent.txt lines 12,721, 12,763, 12,805- Expiry as listed
- 4 Jun 2029
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 8,653,103 with pediatric exclusivity, as listed
patent.txt lines 12,735, 12,777, 12,819- Expiry as listed
- 4 Jun 2029
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 9,150,552 with pediatric exclusivity, as listed
patent.txt lines 12,747, 12,789, 12,831- Expiry as listed
- 4 Jun 2029
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 8,846,718, use patent
patent.txt lines 12,744, 12,786- Expiry as listed
- 2 Jul 2029
- Rule
- R1
- Flags
- use code U-2375
- Product numbers
- 001, 002
US 8,846,718, use patent
patent.txt line 12,828- Expiry as listed
- 2 Jul 2029
- Rule
- R1
- Flags
- use code U-3427
- Product numbers
- 003
US 10,646,481, product patent
patent.txt lines 12,718, 12,760, 12,802- Expiry as listed
- 13 Aug 2029
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
US 11,564,916, use patent
patent.txt lines 12,720, 12,762, 12,804- Expiry as listed
- 13 Aug 2029
- Rule
- R1
- Flags
- use code U-3526
- Product numbers
- 001, 002, 003
US 12,458,635, product and use patent
patent.txt lines 12,724, 12,766, 12,808- Expiry as listed
- 13 Aug 2029
- Rule
- R1
- Flags
- product · use code U-4335
- Product numbers
- 001, 002, 003
US 9,192,606, product and use patent
patent.txt lines 12,750, 12,792- Expiry as listed
- 29 Sep 2029
- Rule
- R1
- Flags
- product · use code U-2397
- Product numbers
- 001, 002
US 9,192,606, product and use patent
patent.txt line 12,834- Expiry as listed
- 29 Sep 2029
- Rule
- R1
- Flags
- product · use code U-3428
- Product numbers
- 003
US 8,846,718 with pediatric exclusivity, as listed
patent.txt lines 12,743, 12,785, 12,827- Expiry as listed
- 2 Jan 2030
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 10,646,481 with pediatric exclusivity, as listed
patent.txt lines 12,717, 12,759, 12,801- Expiry as listed
- 13 Feb 2030
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 11,564,916 with pediatric exclusivity, as listed
patent.txt lines 12,719, 12,761, 12,803- Expiry as listed
- 13 Feb 2030
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 12,458,635 with pediatric exclusivity, as listed
patent.txt lines 12,723, 12,765, 12,807- Expiry as listed
- 13 Feb 2030
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 9,192,606 with pediatric exclusivity, as listed
patent.txt lines 12,749, 12,791, 12,833- Expiry as listed
- 29 Mar 2030
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 8,507,534, substance and product patent
patent.txt lines 12,734, 12,776, 12,818- Expiry as listed
- 20 Sep 2030
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003
US 8,716,338, product and use patent
patent.txt lines 12,738, 12,780- Expiry as listed
- 20 Sep 2030
- Rule
- R1
- Flags
- product · use code U-2396
- Product numbers
- 001, 002
US 8,716,338, product and use patent
patent.txt line 12,822- Expiry as listed
- 20 Sep 2030
- Rule
- R1
- Flags
- product · use code U-3426
- Product numbers
- 003
US 8,993,600, product patent
patent.txt lines 12,746, 12,788, 12,830- Expiry as listed
- 11 Dec 2030
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
US 8,507,534 with pediatric exclusivity, as listed
patent.txt lines 12,733, 12,775, 12,817- Expiry as listed
- 20 Mar 2031
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 8,716,338 with pediatric exclusivity, as listed
patent.txt lines 12,737, 12,779, 12,821- Expiry as listed
- 20 Mar 2031
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 8,993,600 with pediatric exclusivity, as listed
patent.txt lines 12,745, 12,787, 12,829- Expiry as listed
- 11 Jun 2031
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
Listed exclusivities
Each exclusivity FDA lists for NDA 211358, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
M-14 exclusivity
exclusivity.txt lines 952, 956, 960- Date
- 13 Dec 2027
- Rule
- R3
- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
PED exclusivity
exclusivity.txt lines 954, 958, 962- Date
- 13 Jun 2028
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
ODE-408 exclusivity
exclusivity.txt lines 953, 957, 961- Date
- 2 Sep 2029
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
PED exclusivity
exclusivity.txt lines 955, 959, 963- Date
- 2 Mar 2030
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
Paragraph IV list rows giving NDA 211358
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 211358, each cell as listed.
Rows with no NDA number this page can match are kept apart on the list page; some may concern this product.
No row of the Paragraph IV list captured on 17 October 2026 gives NDA 211358 in its RLD/NDA cell. This does not mean no certification was submitted or that no application challenges a patent listed here.
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