Drybench Patent.
IBRUTINIB, NDA 205552
The patents and exclusivities FDA's Orange Book lists for NDA 205552 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 24 Aug 2025 to 24 Apr 2035, each by its own rule; no one date stands for this product.
- Earliest listed date
- 24 Aug 2025NPP exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 502, 506
- Latest listed date
- 24 Apr 2035US 9,795,604 with pediatric exclusivity, as listedRule R2 · Products 001, 002 · patent.txt lines 5,557, 5,655
- Latest substance patent
- 30 Apr 2034US 9,296,753 with pediatric exclusivity, as listedRule R2 · Product 002 · patent.txt line 5,645
- Latest listed patent
- 24 Apr 2035US 9,795,604 with pediatric exclusivity, as listedRule R2 · Products 001, 002 · patent.txt lines 5,557, 5,655
- Latest exclusivity
- 24 Feb 2030PED exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 505, 509
100 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 205552, as listed. The sections below name products by these numbers.
Product 001 · IMBRUVICA
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 140MG
- Approval date as listed
- 13 Nov 2013
- Type as listed
- RX
- Applicant as listed
- PHARMACYCLICS LLC
Product 002 · IMBRUVICA
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 70MG
- Approval date as listed
- 20 Dec 2017
- Type as listed
- RX
- Applicant as listed
- PHARMACYCLICS LLC
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.
108 entries from 196 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 7,514,444, substance and product patent
patent.txt lines 5,508, 5,605- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 8,476,284, use patent
patent.txt lines 5,512, 5,609- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- use code U-1650
- Product numbers
- 001, 002
US 8,476,284, use patent
patent.txt lines 5,513, 5,610- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- use code U-1946
- Product numbers
- 001, 002
US 8,497,277, use patent
patent.txt lines 5,515, 5,612- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- use code U-1491
- Product numbers
- 001, 002
US 8,497,277, use patent
patent.txt lines 5,516, 5,613- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- use code U-1650
- Product numbers
- 001, 002
US 8,497,277, use patent
patent.txt lines 5,517, 5,614- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- use code U-1946
- Product numbers
- 001, 002
US 8,497,277, use patent
patent.txt lines 5,518, 5,615- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- use code U-2241
- Product numbers
- 001, 002
US 8,497,277, use patent
patent.txt lines 5,519, 5,616- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- use code U-2242
- Product numbers
- 001, 002
US 8,497,277, use patent
patent.txt lines 5,520, 5,617- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- use code U-3422
- Product numbers
- 001, 002
US 8,697,711, substance and product patent
patent.txt lines 5,527, 5,624- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 8,703,780, use patent
patent.txt lines 5,529, 5,626- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- use code U-1491
- Product numbers
- 001, 002
US 8,735,403, substance and product patent
patent.txt lines 5,531, 5,628- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 8,754,091, product patent
patent.txt lines 5,533, 5,630- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 8,952,015, use patent
patent.txt lines 5,535, 5,632- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- use code U-1491
- Product numbers
- 001, 002
US 8,952,015, use patent
patent.txt lines 5,536, 5,633- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- use code U-1650
- Product numbers
- 001, 002
US 8,952,015, use patent
patent.txt lines 5,537, 5,634- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- use code U-1946
- Product numbers
- 001, 002
US 8,957,079, substance and product patent
patent.txt lines 5,539, 5,636- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 9,181,257, substance and product patent
patent.txt line 5,546- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001
US 9,181,257, substance patent
patent.txt line 5,644- Expiry as listed
- 28 Dec 2026
- Rule
- R1
- Flags
- substance
- Product numbers
- 002
US 8,563,563, use patent
patent.txt lines 5,522, 5,619- Expiry as listed
- 26 Apr 2027
- Rule
- R1
- Flags
- use code U-1491
- Product numbers
- 001, 002
US 8,563,563, use patent
patent.txt lines 5,523, 5,620- Expiry as listed
- 26 Apr 2027
- Rule
- R1
- Flags
- use code U-1650
- Product numbers
- 001, 002
US 8,563,563, use patent
patent.txt lines 5,524, 5,621- Expiry as listed
- 26 Apr 2027
- Rule
- R1
- Flags
- use code U-1946
- Product numbers
- 001, 002
US 8,563,563, use patent
patent.txt lines 5,525, 5,622- Expiry as listed
- 26 Apr 2027
- Rule
- R1
- Flags
- use code U-2219
- Product numbers
- 001, 002
US 7,514,444 with pediatric exclusivity, as listed
patent.txt lines 5,507, 5,604- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,476,284 with pediatric exclusivity, as listed
patent.txt lines 5,511, 5,608- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,497,277 with pediatric exclusivity, as listed
patent.txt lines 5,514, 5,611- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,697,711 with pediatric exclusivity, as listed
patent.txt lines 5,526, 5,623- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,703,780 with pediatric exclusivity, as listed
patent.txt lines 5,528, 5,625- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,735,403 with pediatric exclusivity, as listed
patent.txt lines 5,530, 5,627- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,754,091 with pediatric exclusivity, as listed
patent.txt lines 5,532, 5,629- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,952,015 with pediatric exclusivity, as listed
patent.txt lines 5,534, 5,631- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,957,079 with pediatric exclusivity, as listed
patent.txt lines 5,538, 5,635- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 9,181,257 with pediatric exclusivity, as listed
patent.txt line 5,545- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
US 9,181,257 with pediatric exclusivity, as listed
patent.txt line 5,643- Expiry as listed
- 28 Jun 2027
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 002
US 8,563,563 with pediatric exclusivity, as listed
patent.txt lines 5,521, 5,618- Expiry as listed
- 26 Oct 2027
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,008,309, substance and product patent
patent.txt lines 5,510, 5,607- Expiry as listed
- 13 Nov 2027
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 8,008,309 with pediatric exclusivity, as listed
patent.txt lines 5,509, 5,606- Expiry as listed
- 13 May 2028
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,004,746, use patent
patent.txt lines 5,468, 5,567- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1684
- Product numbers
- 001, 002
US 10,004,746, use patent
patent.txt lines 5,469, 5,568- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1946
- Product numbers
- 001, 002
US 10,004,746, use patent
patent.txt lines 5,470, 5,569- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-2241
- Product numbers
- 001, 002
US 10,004,746, use patent
patent.txt lines 5,471, 5,570- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-2242
- Product numbers
- 001, 002
US 10,016,435, use patent
patent.txt lines 5,473, 5,572- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1650
- Product numbers
- 001, 002
US 10,478,439, use patent
patent.txt lines 5,485, 5,584- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1650
- Product numbers
- 001, 002
US 10,478,439, use patent
patent.txt lines 5,486, 5,585- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1684
- Product numbers
- 001, 002
US 10,478,439, use patent
patent.txt lines 5,487, 5,586- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1946
- Product numbers
- 001, 002
US 10,478,439, use patent
patent.txt lines 5,488, 5,587- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-2241
- Product numbers
- 001, 002
US 10,478,439, use patent
patent.txt lines 5,489, 5,588- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-2242
- Product numbers
- 001, 002
US 10,478,439, use patent
patent.txt lines 5,490, 5,589- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-2665
- Product numbers
- 001, 002
US 10,478,439, use patent
patent.txt lines 5,491, 5,590- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-3422
- Product numbers
- 001, 002
US 10,751,342, use patent
patent.txt lines 5,495, 5,594- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1491
- Product numbers
- 001, 002
US 10,751,342, use patent
patent.txt lines 5,496, 5,595- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1946
- Product numbers
- 001, 002
US 10,751,342, use patent
patent.txt lines 5,497, 5,596- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-2943
- Product numbers
- 001, 002
US 10,751,342, use patent
patent.txt lines 5,498, 5,597- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-2944
- Product numbers
- 001, 002
US 11,672,803, use patent
patent.txt lines 5,503, 5,600- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1684
- Product numbers
- 001, 002
US 11,672,803, use patent
patent.txt lines 5,504, 5,601- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1946
- Product numbers
- 001, 002
US 11,672,803, use patent
patent.txt lines 5,505, 5,602- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-2241
- Product numbers
- 001, 002
US 11,672,803, use patent
patent.txt lines 5,506, 5,603- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-2242
- Product numbers
- 001, 002
US 8,999,999, use patent
patent.txt line 5,541- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1683
- Product numbers
- 001
US 8,999,999, use patent
patent.txt line 5,542- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1684
- Product numbers
- 001
US 8,999,999, use patent
patent.txt line 5,638- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1491
- Product numbers
- 002
US 8,999,999, use patent
patent.txt line 5,639- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1946
- Product numbers
- 002
US 8,999,999, use patent
patent.txt line 5,640- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-2228
- Product numbers
- 002
US 9,125,889, use patent
patent.txt line 5,544- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1745
- Product numbers
- 001
US 9,125,889, use patent
patent.txt line 5,642- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1650
- Product numbers
- 002
US 9,801,881, use patent
patent.txt lines 5,563, 5,660- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-1491
- Product numbers
- 001, 002
US 9,801,883, use patent
patent.txt lines 5,565, 5,662- Expiry as listed
- 3 Jun 2031
- Rule
- R1
- Flags
- use code U-2159
- Product numbers
- 001, 002
US 10,004,746 with pediatric exclusivity, as listed
patent.txt lines 5,467, 5,566- Expiry as listed
- 3 Dec 2031
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,016,435 with pediatric exclusivity, as listed
patent.txt lines 5,472, 5,571- Expiry as listed
- 3 Dec 2031
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,478,439 with pediatric exclusivity, as listed
patent.txt lines 5,484, 5,583- Expiry as listed
- 3 Dec 2031
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,751,342 with pediatric exclusivity, as listed
patent.txt lines 5,494, 5,593- Expiry as listed
- 3 Dec 2031
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,999,999 with pediatric exclusivity, as listed
patent.txt lines 5,540, 5,637- Expiry as listed
- 3 Dec 2031
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 9,125,889 with pediatric exclusivity, as listed
patent.txt lines 5,543, 5,641- Expiry as listed
- 3 Dec 2031
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 9,801,881 with pediatric exclusivity, as listed
patent.txt lines 5,562, 5,659- Expiry as listed
- 3 Dec 2031
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 9,801,883 with pediatric exclusivity, as listed
patent.txt lines 5,564, 5,661- Expiry as listed
- 3 Dec 2031
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,106,548, substance and product patent
patent.txt lines 5,475, 5,574- Expiry as listed
- 3 Jun 2033
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 10,125,140, substance and product patent
patent.txt lines 5,477, 5,576- Expiry as listed
- 3 Jun 2033
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 10,294,231, product patent
patent.txt lines 5,479, 5,578- Expiry as listed
- 3 Jun 2033
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 10,294,232, product patent
patent.txt lines 5,481, 5,580- Expiry as listed
- 3 Jun 2033
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 10,752,634, product patent
patent.txt line 5,500- Expiry as listed
- 3 Jun 2033
- Rule
- R1
- Flags
- product
- Product numbers
- 001
US 10,961,251, product patent
patent.txt lines 5,502, 5,599- Expiry as listed
- 3 Jun 2033
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 9,713,617, product patent
patent.txt lines 5,554, 5,652- Expiry as listed
- 3 Jun 2033
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 9,725,455, substance patent
patent.txt lines 5,556, 5,654- Expiry as listed
- 3 Jun 2033
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002
US 9,540,382, use patent
patent.txt line 5,551- Expiry as listed
- 18 Aug 2033
- Rule
- R1
- Flags
- use code U-1684
- Product numbers
- 001
US 9,540,382, use patent
patent.txt lines 5,550, 5,649- Expiry as listed
- 18 Aug 2033
- Rule
- R1
- Flags
- use code U-1650
- Product numbers
- 001, 002
US 9,540,382, use patent
patent.txt lines 5,552, 5,650- Expiry as listed
- 18 Aug 2033
- Rule
- R1
- Flags
- use code U-1946
- Product numbers
- 001, 002
US 9,540,382, use patent
patent.txt line 5,648- Expiry as listed
- 18 Aug 2033
- Rule
- R1
- Flags
- use code U-1491
- Product numbers
- 002
US 9,296,753, substance and product patent
patent.txt line 5,548- Expiry as listed
- 30 Oct 2033
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001
US 9,296,753, substance patent
patent.txt line 5,646- Expiry as listed
- 30 Oct 2033
- Rule
- R1
- Flags
- substance
- Product numbers
- 002
US 10,106,548 with pediatric exclusivity, as listed
patent.txt lines 5,474, 5,573- Expiry as listed
- 3 Dec 2033
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,125,140 with pediatric exclusivity, as listed
patent.txt lines 5,476, 5,575- Expiry as listed
- 3 Dec 2033
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,294,231 with pediatric exclusivity, as listed
patent.txt lines 5,478, 5,577- Expiry as listed
- 3 Dec 2033
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,294,232 with pediatric exclusivity, as listed
patent.txt lines 5,480, 5,579- Expiry as listed
- 3 Dec 2033
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,752,634 with pediatric exclusivity, as listed
patent.txt line 5,499- Expiry as listed
- 3 Dec 2033
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
US 10,961,251 with pediatric exclusivity, as listed
patent.txt lines 5,501, 5,598- Expiry as listed
- 3 Dec 2033
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 9,713,617 with pediatric exclusivity, as listed
patent.txt lines 5,553, 5,651- Expiry as listed
- 3 Dec 2033
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 9,725,455 with pediatric exclusivity, as listed
patent.txt lines 5,555, 5,653- Expiry as listed
- 3 Dec 2033
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 9,540,382 with pediatric exclusivity, as listed
patent.txt lines 5,549, 5,647- Expiry as listed
- 18 Feb 2034
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 9,296,753 with pediatric exclusivity, as listed
patent.txt line 5,547- Expiry as listed
- 30 Apr 2034
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
US 9,296,753 with pediatric exclusivity, as listed
patent.txt line 5,645- Expiry as listed
- 30 Apr 2034
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 002
US 10,463,668, use patent
patent.txt lines 5,483, 5,582- Expiry as listed
- 24 Oct 2034
- Rule
- R1
- Flags
- use code U-2654
- Product numbers
- 001, 002
US 10,695,350, use patent
patent.txt lines 5,493, 5,592- Expiry as listed
- 24 Oct 2034
- Rule
- R1
- Flags
- use code U-2846
- Product numbers
- 001, 002
US 9,795,604, use patent
patent.txt line 5,558- Expiry as listed
- 24 Oct 2034
- Rule
- R1
- Flags
- use code U-2150
- Product numbers
- 001
US 9,795,604, use patent
patent.txt lines 5,559, 5,656- Expiry as listed
- 24 Oct 2034
- Rule
- R1
- Flags
- use code U-2969
- Product numbers
- 001, 002
US 9,795,604, use patent
patent.txt lines 5,560, 5,657- Expiry as listed
- 24 Oct 2034
- Rule
- R1
- Flags
- use code U-2970
- Product numbers
- 001, 002
US 9,795,604, use patent
patent.txt lines 5,561, 5,658- Expiry as listed
- 24 Oct 2034
- Rule
- R1
- Flags
- use code U-3422
- Product numbers
- 001, 002
US 10,463,668 with pediatric exclusivity, as listed
patent.txt lines 5,482, 5,581- Expiry as listed
- 24 Apr 2035
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,695,350 with pediatric exclusivity, as listed
patent.txt lines 5,492, 5,591- Expiry as listed
- 24 Apr 2035
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 9,795,604 with pediatric exclusivity, as listed
patent.txt lines 5,557, 5,655- Expiry as listed
- 24 Apr 2035
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
Listed exclusivities
Each exclusivity FDA lists for NDA 205552, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
NPP exclusivity
exclusivity.txt lines 502, 506- Date
- 24 Aug 2025
- Rule
- R3
- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
PED exclusivity
exclusivity.txt lines 504, 508- Date
- 24 Feb 2026
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-405 exclusivity
exclusivity.txt lines 503, 507- Date
- 24 Aug 2029
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
PED exclusivity
exclusivity.txt lines 505, 509- Date
- 24 Feb 2030
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
Paragraph IV list rows giving NDA 205552
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 205552, 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 205552
Ibrutinib · Capsules · 140 mg
RLD/NDA as listed: Imbruvica 205552- First PIV submission
- 13 Nov 2017
- ANDAs
- 8
- 180-day status
- Deferred
- Decision posted
- 6 Apr 2021
- First applicant approval
- 31 Mar 2021
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 24 Oct 2034
Ibrutinib · Capsules · 70 mg
RLD/NDA as listed: Imbruvica 205552- First PIV submission
- 14 Dec 2018
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 6 Apr 2021
- First applicant approval
- 31 Mar 2021
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 30 Oct 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