Drybench Patent.
ENTRECTINIB, NDA 218550
The patents and exclusivities FDA's Orange Book lists for NDA 218550 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 15 Aug 2026 to 20 Oct 2030, each by its own rule; no one date stands for this product.
- Earliest listed date
- 15 Aug 2026ODE* exclusivityRule R3 · Product 001
Source lines
exclusivity.txt lines 2,165–2,166
- Latest listed date
- 20 Oct 2030ODE-448 exclusivityRule R3 · Product 001
Source lines
exclusivity.txt line 2,167
- Latest substance patent
- None listed
- Latest listed patent
- None listed
- Latest exclusivity
- 20 Oct 2030ODE-448 exclusivityRule R3 · Product 001
Source lines
exclusivity.txt line 2,167
Products
Each product number FDA lists under NDA 218550, as listed. The sections below name products by these numbers.
Product 001 · ROZLYTREK
- Dosage form; route
- PELLETS;
ORAL - Strength
- 50MG/PACKET
- Approval date as listed
- 20 Oct 2023
- Type as listed
- RX
- Applicant as listed
- GENENTECH 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.
The Orange Book capture of 14 October 2026 lists no patent for NDA 218550.
Listed exclusivities
Each exclusivity FDA lists for NDA 218550, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
ODE* exclusivity
exclusivity.txt lines 2,165–2,166- Date
- 15 Aug 2026
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
NP exclusivity
exclusivity.txt line 2,164- Date
- 20 Oct 2026
- Rule
- R3
- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
ODE-448 exclusivity
exclusivity.txt line 2,167- Date
- 20 Oct 2030
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
Paragraph IV list rows giving NDA 218550
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 218550, 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 218550 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