Drybench Patent.
ENTRECTINIB, NDA 212725
The patents and exclusivities FDA's Orange Book lists for NDA 212725 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 18 Jul 2038, each by its own rule; no one date stands for this product.
- Earliest listed date
- 15 Aug 2026ODE-265 exclusivityRule R3 · Products 001, 002
Source lines
exclusivity.txt lines 1,107, 1,111
- Latest listed date
- 18 Jul 2038US 11,253,515, product patentRule R1 · Products 001, 002
Source lines
patent.txt lines 14,376, 14,395
- Latest substance patent
- 18 May 2037US 10,738,037, substance and product and use patentRule R1 · Products 001, 002
Source lines
patent.txt lines 14,373, 14,392
- Latest listed patent
- 18 Jul 2038US 11,253,515, product patentRule R1 · Products 001, 002
Source lines
patent.txt lines 14,376, 14,395
- Latest exclusivity
- 20 Oct 2030ODE-448 exclusivityRule R3 · Products 001, 002
Source lines
exclusivity.txt lines 1,109, 1,113
Listed dates of other NDAs in the same years:20262028203020322033203520372038
26 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 212725, as listed. The sections below name products by these numbers.
Product 001 · ROZLYTREK
- Dosage form; route
- CAPSULE;
ORAL - Strength
- 100MG
- Approval date as listed
- 15 Aug 2019
- Type as listed
- RX
- Applicant as listed
- GENENTECH INC
Product 002 · ROZLYTREK
- Dosage form; route
- CAPSULE;
ORAL - Strength
- 200MG
- Approval date as listed
- 15 Aug 2019
- 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.
19 entries from 38 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 8,673,893, use patent
patent.txt lines 14,378, 14,397- Expiry as listed
- 8 Jul 2028
- Rule
- R1
- Flags
- use code U-2617
- Product numbers
- 001, 002
US 8,673,893, use patent
patent.txt lines 14,379, 14,398- Expiry as listed
- 8 Jul 2028
- Rule
- R1
- Flags
- use code U-2618
- Product numbers
- 001, 002
US 9,029,356, substance and product patent
patent.txt lines 14,380, 14,399- Expiry as listed
- 8 Jul 2028
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 9,085,558, product patent
patent.txt lines 14,381, 14,400- Expiry as listed
- 8 Jul 2028
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 9,255,087, use patent
patent.txt lines 14,383, 14,402- Expiry as listed
- 8 Jul 2028
- Rule
- R1
- Flags
- use code U-2617
- Product numbers
- 001, 002
US 9,255,087, use patent
patent.txt lines 14,384, 14,403- Expiry as listed
- 8 Jul 2028
- Rule
- R1
- Flags
- use code U-2618
- Product numbers
- 001, 002
US 9,616,059, use patent
patent.txt lines 14,385, 14,404- Expiry as listed
- 8 Jul 2028
- Rule
- R1
- Flags
- use code U-2618
- Product numbers
- 001, 002
US 8,299,057, substance and product patent
patent.txt lines 14,377, 14,396- Expiry as listed
- 10 Mar 2032
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 9,085,565, substance and product patent
patent.txt lines 14,382, 14,401- Expiry as listed
- 22 May 2033
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 9,649,306, use patent
patent.txt lines 14,386, 14,405- Expiry as listed
- 22 May 2033
- Rule
- R1
- Flags
- use code U-2617
- Product numbers
- 001, 002
US 9,649,306, use patent
patent.txt lines 14,387, 14,406- Expiry as listed
- 22 May 2033
- Rule
- R1
- Flags
- use code U-2618
- Product numbers
- 001, 002
US 10,231,965, use patent
patent.txt lines 14,369, 14,388- Expiry as listed
- 17 Feb 2035
- Rule
- R1
- Flags
- use code U-2617
- Product numbers
- 001, 002
US 10,231,965, use patent
patent.txt lines 14,370, 14,389- Expiry as listed
- 17 Feb 2035
- Rule
- R1
- Flags
- use code U-2618
- Product numbers
- 001, 002
US 10,561,651, use patent
patent.txt lines 14,372, 14,391- Expiry as listed
- 19 Feb 2035
- Rule
- R1
- Flags
- use code U-2745
- Product numbers
- 001, 002
US 10,738,037, substance and product and use patent
patent.txt lines 14,373, 14,392- Expiry as listed
- 18 May 2037
- Rule
- R1
- Flags
- substance · product · use code U-2946
- Product numbers
- 001, 002
US 11,091,469, use patent
patent.txt lines 14,374, 14,393- Expiry as listed
- 18 May 2037
- Rule
- R1
- Flags
- use code U-2617
- Product numbers
- 001, 002
US 11,091,469, use patent
patent.txt lines 14,375, 14,394- Expiry as listed
- 18 May 2037
- Rule
- R1
- Flags
- use code U-2618
- Product numbers
- 001, 002
US 10,398,693, product patent
patent.txt lines 14,371, 14,390- Expiry as listed
- 18 Jul 2038
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 11,253,515, product patent
patent.txt lines 14,376, 14,395- Expiry as listed
- 18 Jul 2038
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
Listed exclusivities
Each exclusivity FDA lists for NDA 212725, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
ODE-265 exclusivity
exclusivity.txt lines 1,107, 1,111- Date
- 15 Aug 2026
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-313 exclusivity
exclusivity.txt lines 1,108, 1,112- Date
- 15 Aug 2026
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
NPP exclusivity
exclusivity.txt lines 1,106, 1,110- Date
- 20 Oct 2026
- Rule
- R3
- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-448 exclusivity
exclusivity.txt lines 1,109, 1,113- Date
- 20 Oct 2030
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
Paragraph IV list rows giving NDA 212725
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 212725, 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 212725 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