Drybench Patent.
BOSUTINIB MONOHYDRATE, NDA 203341
The patents and exclusivities FDA's Orange Book lists for NDA 203341 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 11 Dec 2025 to 28 Aug 2034, each by its own rule; no one date stands for this product.
- Earliest listed date
- 11 Dec 2025US 7,417,148, use patentRule R1 · Products 001, 002, 003 · patent.txt lines 3,774, 3,785, 3,796
- Latest listed date
- 28 Aug 2034US 11,103,497 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 3,770, 3,781, 3,792
- Latest substance patent
- 23 May 2027US 7,767,678 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 3,777, 3,788, 3,799
- Latest listed patent
- 28 Aug 2034US 11,103,497 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 3,770, 3,781, 3,792
- Latest exclusivity
- 26 Mar 2031PED exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 310, 314, 318
15 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 203341, as listed. The sections below name products by these numbers.
Product 001 · BOSULIF
- Dosage form; route
- TABLET;ORAL
- Strength
- EQ 100MG BASE
- Approval date as listed
- 4 Sep 2012
- Type as listed
- RX
- Applicant as listed
- PF PRISM CV
Product 002 · BOSULIF
- Dosage form; route
- TABLET;ORAL
- Strength
- EQ 500MG BASE
- Approval date as listed
- 4 Sep 2012
- Type as listed
- RX
- Applicant as listed
- PF PRISM CV
Product 003 · BOSULIF
- Dosage form; route
- TABLET;ORAL
- Strength
- EQ 400MG BASE
- Approval date as listed
- 27 Oct 2017
- Type as listed
- RX
- Applicant as listed
- PF PRISM CV
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.
11 entries from 33 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 7,417,148, use patent
patent.txt lines 3,774, 3,785, 3,796- Expiry as listed
- 11 Dec 2025
- Rule
- R1
- Flags
- use code U-1283
- Product numbers
- 001, 002, 003
US 7,417,148, use patent
patent.txt lines 3,775, 3,786, 3,797- Expiry as listed
- 11 Dec 2025
- Rule
- R1
- Flags
- use code U-3707
- Product numbers
- 001, 002, 003
US 7,417,148, use patent
patent.txt lines 3,776, 3,787, 3,798- Expiry as listed
- 11 Dec 2025
- Rule
- R1
- Flags
- use code U-3708
- Product numbers
- 001, 002, 003
US 7,919,625, product patent
patent.txt lines 3,780, 3,791, 3,802- Expiry as listed
- 11 Dec 2025
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
US 7,417,148 with pediatric exclusivity, as listed
patent.txt lines 3,773, 3,784, 3,795- Expiry as listed
- 11 Jun 2026
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 7,919,625 with pediatric exclusivity, as listed
patent.txt lines 3,779, 3,790, 3,801- Expiry as listed
- 11 Jun 2026
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 7,767,678, substance and product patent
patent.txt lines 3,778, 3,789, 3,800- Expiry as listed
- 23 Nov 2026
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003
US 7,767,678 with pediatric exclusivity, as listed
patent.txt lines 3,777, 3,788, 3,799- Expiry as listed
- 23 May 2027
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 11,103,497, use patent
patent.txt lines 3,771, 3,782, 3,793- Expiry as listed
- 28 Feb 2034
- Rule
- R1
- Flags
- use code U-3216
- Product numbers
- 001, 002, 003
US 11,103,497, use patent
patent.txt lines 3,772, 3,783, 3,794- Expiry as listed
- 28 Feb 2034
- Rule
- R1
- Flags
- use code U-3217
- Product numbers
- 001, 002, 003
US 11,103,497 with pediatric exclusivity, as listed
patent.txt lines 3,770, 3,781, 3,792- Expiry as listed
- 28 Aug 2034
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
Listed exclusivities
Each exclusivity FDA lists for NDA 203341, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
I-923 exclusivity
exclusivity.txt lines 307, 311, 315- Date
- 26 Sep 2026
- Rule
- R3
- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
PED exclusivity
exclusivity.txt lines 309, 313, 317- Date
- 26 Mar 2027
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
ODE-444 exclusivity
exclusivity.txt lines 308, 312, 316- Date
- 26 Sep 2030
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
PED exclusivity
exclusivity.txt lines 310, 314, 318- Date
- 26 Mar 2031
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
Paragraph IV list rows giving NDA 203341
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 203341, 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 203341
Bosutinib · Tablets · 100 mg and 500 mg
RLD/NDA as listed: Bosulif 203341- First PIV submission
- 6 Sep 2016
- ANDAs
- 2
- 180-day status
- Non-Forfeiture Deferred
- Decision posted
- 6/22/2026 6/9/2025
- First applicant approval
- 23 May 2025
- First marketing
- 11 Jun 2026
- Last qualifying patent expiry (as listed by FDA)
- 23 Nov 2026
Bosutinib · Tablets · 400 mg
RLD/NDA as listed: Bosulif 203341- First PIV submission
- 25 Oct 2018
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 15 Jul 2026
- First applicant approval
- 12 Jun 2026
- First marketing
- 12 Jun 2026
- Last qualifying patent expiry (as listed by FDA)
- 23 Nov 2026
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