Drybench Patent.
NILOTINIB HYDROCHLORIDE, NDA 022068
The patents and exclusivities FDA's Orange Book lists for NDA 022068 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 18 Jul 2026 to 7 Oct 2032, each by its own rule; no one date stands for this product.
- Earliest listed date
- 18 Jul 2026US 8,389,537, use patentRule R1 · Products 001, 002, 003 · patent.txt lines 999, 1,013, 1,027
- Latest listed date
- 7 Oct 2032US 9,061,029 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 1,005, 1,019, 1,033
- Latest substance patent
- 7 Oct 2032US 9,061,029 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 1,005, 1,019, 1,033
- Latest listed patent
- 7 Oct 2032US 9,061,029 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 1,005, 1,019, 1,033
- Latest exclusivity
- 23 Mar 2029PED exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 158, 160, 162
15 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 022068, as listed. The sections below name products by these numbers.
Product 001 · TASIGNA
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 200MG BASE
- Approval date as listed
- 29 Oct 2007
- Type as listed
- RX
- Applicant as listed
- NOVARTIS PHARMACEUTICALS CORP
Product 002 · TASIGNA
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 150MG BASE
- Approval date as listed
- 17 Jun 2010
- Type as listed
- RX
- Applicant as listed
- NOVARTIS PHARMACEUTICALS CORP
Product 003 · TASIGNA
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 50MG BASE
- Approval date as listed
- 22 Mar 2018
- Type as listed
- RX
- Applicant as listed
- NOVARTIS PHARMACEUTICALS CORP
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.
14 entries from 42 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 8,389,537, use patent
patent.txt lines 999, 1,013, 1,027- Expiry as listed
- 18 Jul 2026
- Rule
- R1
- Flags
- use code U-1374
- Product numbers
- 001, 002, 003
US 8,415,363, substance and product and use patent
patent.txt lines 1,001, 1,015, 1,029- Expiry as listed
- 18 Jul 2026
- Rule
- R1
- Flags
- substance · product · use code U-1374
- Product numbers
- 001, 002, 003
US 8,415,363, substance and product and use patent
patent.txt lines 1,002, 1,016, 1,030- Expiry as listed
- 18 Jul 2026
- Rule
- R1
- Flags
- substance · product · use code U-1407
- Product numbers
- 001, 002, 003
US 8,501,760, product patent
patent.txt lines 1,004, 1,018, 1,032- Expiry as listed
- 18 Jul 2026
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
US 8,389,537 with pediatric exclusivity, as listed
patent.txt lines 998, 1,012, 1,026- Expiry as listed
- 18 Jan 2027
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 8,415,363 with pediatric exclusivity, as listed
patent.txt lines 1,000, 1,014, 1,028- Expiry as listed
- 18 Jan 2027
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 8,501,760 with pediatric exclusivity, as listed
patent.txt lines 1,003, 1,017, 1,031- Expiry as listed
- 18 Jan 2027
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 8,293,756, product patent
patent.txt lines 997, 1,011, 1,025- Expiry as listed
- 25 Sep 2027
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
US 8,293,756 with pediatric exclusivity, as listed
patent.txt lines 996, 1,010, 1,024- Expiry as listed
- 25 Mar 2028
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 8,163,904, substance and product patent
patent.txt lines 995, 1,009, 1,023- Expiry as listed
- 23 Aug 2028
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003
US 8,163,904 with pediatric exclusivity, as listed
patent.txt lines 994, 1,008, 1,022- Expiry as listed
- 23 Feb 2029
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 9,061,029, substance and use patent
patent.txt lines 1,006, 1,020, 1,034- Expiry as listed
- 7 Apr 2032
- Rule
- R1
- Flags
- substance · use code U-1374
- Product numbers
- 001, 002, 003
US 9,061,029, substance and use patent
patent.txt lines 1,007, 1,021, 1,035- Expiry as listed
- 7 Apr 2032
- Rule
- R1
- Flags
- substance · use code U-3231
- Product numbers
- 001, 002, 003
US 9,061,029 with pediatric exclusivity, as listed
patent.txt lines 1,005, 1,019, 1,033- Expiry as listed
- 7 Oct 2032
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
Listed exclusivities
Each exclusivity FDA lists for NDA 022068, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
ODE-380 exclusivity
exclusivity.txt lines 157, 159, 161- Date
- 23 Sep 2028
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
PED exclusivity
exclusivity.txt lines 158, 160, 162- Date
- 23 Mar 2029
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
Paragraph IV list rows giving NDA 022068
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 022068, 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 022068
Nilotinib · Capsules · 150 mg and 200 mg
RLD/NDA as listed: Tasigna 22068- First PIV submission
- 8 Nov 2013
- ANDAs
- 1
- 180-day status
- Non-Forfeiture Deferred
- Decision posted
- 10/3/2024 1/8/2024
- First applicant approval
- 5 Jan 2024
- First marketing
- 23 May 2025
- Last qualifying patent expiry (as listed by FDA)
- 23 Aug 2028
Nilotinib · Capsules · 50 mg
RLD/NDA as listed: Tasigna 22068- First PIV submission
- 17 Oct 2019
- ANDAs
- 1
- 180-day status
- Non-Forfeiture Deferred
- Decision posted
- 10/3/2024 1/8/2024
- First applicant approval
- 5 Jan 2024
- First marketing
- 23 May 2025
- Last qualifying patent expiry (as listed by FDA)
- 7 Apr 2032
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