Drybench Patent.
TUCATINIB, NDA 213411
The patents and exclusivities FDA's Orange Book lists for NDA 213411 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 19 Jan 2026 to 27 Apr 2038, each by its own rule; no one date stands for this product.
- Earliest listed date
- 19 Jan 2026I-906 exclusivityRule R3 · Products 001, 002
Source lines
exclusivity.txt lines 1,218, 1,221
- Latest listed date
- 27 Apr 2038US 12,048,698, use patentRule R1 · Products 001, 002
Source lines
patent.txt lines 14,985, 14,992
- Latest substance patent
- 17 Apr 2034US 8,648,087, substance and product patentRule R1 · Products 001, 002
Source lines
patent.txt lines 14,986, 14,993
- Latest listed patent
- 27 Apr 2038US 12,048,698, use patentRule R1 · Products 001, 002
Source lines
patent.txt lines 14,985, 14,992
- Latest exclusivity
- 19 Jan 2030ODE-422 exclusivityRule R3 · Products 001, 002
Source lines
exclusivity.txt lines 1,220, 1,223
Listed dates of other NDAs in the same years:2026202720302032203320342038
12 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 213411, as listed. The sections below name products by these numbers.
Product 001 · TUKYSA
- Dosage form; route
- TABLET;
ORAL - Strength
- 50MG
- Approval date as listed
- 17 Apr 2020
- Type as listed
- RX
- Applicant as listed
- SEAGEN INC
Product 002 · TUKYSA
- Dosage form; route
- TABLET;
ORAL - Strength
- 150MG
- Approval date as listed
- 17 Apr 2020
- Type as listed
- RX
- Applicant as listed
- SEAGEN 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.
7 entries from 14 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 9,693,989, product and use patent
patent.txt lines 14,988, 14,995- Expiry as listed
- 9 May 2027
- Rule
- R1
- Flags
- product · use code U-2788
- Product numbers
- 001, 002
US 9,457,093, product and use patent
patent.txt lines 14,987, 14,994- Expiry as listed
- 12 Oct 2032
- Rule
- R1
- Flags
- product · use code U-2788
- Product numbers
- 001, 002
US 11,504,370, use patent
patent.txt lines 14,983, 14,990- Expiry as listed
- 25 Mar 2033
- Rule
- R1
- Flags
- use code U-2788
- Product numbers
- 001, 002
US 8,648,087, substance and product patent
patent.txt lines 14,986, 14,993- Expiry as listed
- 17 Apr 2034
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 11,207,324, use patent
patent.txt lines 14,982, 14,989- Expiry as listed
- 27 Apr 2038
- Rule
- R1
- Flags
- use code U-3783
- Product numbers
- 001, 002
US 11,666,572, use patent
patent.txt lines 14,984, 14,991- Expiry as listed
- 27 Apr 2038
- Rule
- R1
- Flags
- use code U-3783
- Product numbers
- 001, 002
US 12,048,698, use patent
patent.txt lines 14,985, 14,992- Expiry as listed
- 27 Apr 2038
- Rule
- R1
- Flags
- use code U-3783
- Product numbers
- 001, 002
Listed exclusivities
Each exclusivity FDA lists for NDA 213411, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
I-906 exclusivity
exclusivity.txt lines 1,218, 1,221- Date
- 19 Jan 2026
- Rule
- R3
- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-309 exclusivity
exclusivity.txt lines 1,219, 1,222- Date
- 17 Apr 2027
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-422 exclusivity
exclusivity.txt lines 1,220, 1,223- Date
- 19 Jan 2030
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
Paragraph IV list rows giving NDA 213411
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 213411, 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 213411 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