Drybench Patent.
SELPERCATINIB, NDA 213246
The patents and exclusivities FDA's Orange Book lists for NDA 213246 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 8 May 2027 to 10 Apr 2039, each by its own rule; no one date stands for this product.
- Earliest listed date
- 8 May 2027ODE-301 exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 1,172, 1,194
- Latest listed date
- 10 Apr 2039US 12,138,250 with pediatric exclusivity, as listedRule R2 · Products 001, 002 · patent.txt lines 14,836, 14,863
- Latest substance patent
- 10 Apr 2039US 10,584,124 with pediatric exclusivity, as listedRule R2 · Products 001, 002 · patent.txt lines 14,826, 14,853
- Latest listed patent
- 10 Apr 2039US 12,138,250 with pediatric exclusivity, as listedRule R2 · Products 001, 002 · patent.txt lines 14,836, 14,863
- Latest exclusivity
- 29 Nov 2031PED exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 1,185–1,187, 1,207–1,209
40 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 213246, as listed. The sections below name products by these numbers.
Product 001 · RETEVMO
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 40MG
- Approval date as listed
- 8 May 2020
- Type as listed
- RX
- Applicant as listed
- ELI LILLY AND CO
Product 002 · RETEVMO
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 80MG
- Approval date as listed
- 8 May 2020
- Type as listed
- RX
- Applicant as listed
- ELI LILLY AND CO
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.
27 entries from 54 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 10,112,942, substance and product patent
patent.txt lines 14,815, 14,842- Expiry as listed
- 10 Oct 2037
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 10,137,124, use patent
patent.txt lines 14,817, 14,844- Expiry as listed
- 10 Oct 2037
- Rule
- R1
- Flags
- use code U-3450
- Product numbers
- 001, 002
US 10,137,124, use patent
patent.txt lines 14,818, 14,845- Expiry as listed
- 10 Oct 2037
- Rule
- R1
- Flags
- use code U-3949
- Product numbers
- 001, 002
US 10,137,124, use patent
patent.txt lines 14,819, 14,846- Expiry as listed
- 10 Oct 2037
- Rule
- R1
- Flags
- use code U-3950
- Product numbers
- 001, 002
US 10,137,124, use patent
patent.txt lines 14,820, 14,847- Expiry as listed
- 10 Oct 2037
- Rule
- R1
- Flags
- use code U-3951
- Product numbers
- 001, 002
US 10,172,851, use patent
patent.txt lines 14,822, 14,849- Expiry as listed
- 10 Oct 2037
- Rule
- R1
- Flags
- use code U-3450
- Product numbers
- 001, 002
US 10,172,851, use patent
patent.txt lines 14,823, 14,850- Expiry as listed
- 10 Oct 2037
- Rule
- R1
- Flags
- use code U-3949
- Product numbers
- 001, 002
US 10,172,851, use patent
patent.txt lines 14,824, 14,851- Expiry as listed
- 10 Oct 2037
- Rule
- R1
- Flags
- use code U-3950
- Product numbers
- 001, 002
US 10,172,851, use patent
patent.txt lines 14,825, 14,852- Expiry as listed
- 10 Oct 2037
- Rule
- R1
- Flags
- use code U-3951
- Product numbers
- 001, 002
US 10,112,942 with pediatric exclusivity, as listed
patent.txt lines 14,814, 14,841- Expiry as listed
- 10 Apr 2038
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,137,124 with pediatric exclusivity, as listed
patent.txt lines 14,816, 14,843- Expiry as listed
- 10 Apr 2038
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,172,851 with pediatric exclusivity, as listed
patent.txt lines 14,821, 14,848- Expiry as listed
- 10 Apr 2038
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,584,124, substance and use patent
patent.txt lines 14,827, 14,854- Expiry as listed
- 10 Oct 2038
- Rule
- R1
- Flags
- substance · use code U-3450
- Product numbers
- 001, 002
US 10,584,124, substance and use patent
patent.txt lines 14,828, 14,855- Expiry as listed
- 10 Oct 2038
- Rule
- R1
- Flags
- substance · use code U-3949
- Product numbers
- 001, 002
US 10,584,124, substance and use patent
patent.txt lines 14,829, 14,856- Expiry as listed
- 10 Oct 2038
- Rule
- R1
- Flags
- substance · use code U-3950
- Product numbers
- 001, 002
US 10,584,124, substance and use patent
patent.txt lines 14,830, 14,857- Expiry as listed
- 10 Oct 2038
- Rule
- R1
- Flags
- substance · use code U-3951
- Product numbers
- 001, 002
US 10,786,489, product and use patent
patent.txt lines 14,832, 14,859- Expiry as listed
- 10 Oct 2038
- Rule
- R1
- Flags
- product · use code U-3450
- Product numbers
- 001, 002
US 10,786,489, product and use patent
patent.txt lines 14,833, 14,860- Expiry as listed
- 10 Oct 2038
- Rule
- R1
- Flags
- product · use code U-3949
- Product numbers
- 001, 002
US 10,786,489, product and use patent
patent.txt lines 14,834, 14,861- Expiry as listed
- 10 Oct 2038
- Rule
- R1
- Flags
- product · use code U-3950
- Product numbers
- 001, 002
US 10,786,489, product and use patent
patent.txt lines 14,835, 14,862- Expiry as listed
- 10 Oct 2038
- Rule
- R1
- Flags
- product · use code U-3951
- Product numbers
- 001, 002
US 12,138,250, use patent
patent.txt lines 14,837, 14,864- Expiry as listed
- 10 Oct 2038
- Rule
- R1
- Flags
- use code U-3450
- Product numbers
- 001, 002
US 12,138,250, use patent
patent.txt lines 14,838, 14,865- Expiry as listed
- 10 Oct 2038
- Rule
- R1
- Flags
- use code U-3949
- Product numbers
- 001, 002
US 12,138,250, use patent
patent.txt lines 14,839, 14,866- Expiry as listed
- 10 Oct 2038
- Rule
- R1
- Flags
- use code U-3950
- Product numbers
- 001, 002
US 12,138,250, use patent
patent.txt lines 14,840, 14,867- Expiry as listed
- 10 Oct 2038
- Rule
- R1
- Flags
- use code U-3951
- Product numbers
- 001, 002
US 10,584,124 with pediatric exclusivity, as listed
patent.txt lines 14,826, 14,853- Expiry as listed
- 10 Apr 2039
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,786,489 with pediatric exclusivity, as listed
patent.txt lines 14,831, 14,858- Expiry as listed
- 10 Apr 2039
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 12,138,250 with pediatric exclusivity, as listed
patent.txt lines 14,836, 14,863- Expiry as listed
- 10 Apr 2039
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
Listed exclusivities
Each exclusivity FDA lists for NDA 213246, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
ODE-301 exclusivity
exclusivity.txt lines 1,172, 1,194- Date
- 8 May 2027
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-302 exclusivity
exclusivity.txt lines 1,173, 1,195- Date
- 8 May 2027
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-303 exclusivity
exclusivity.txt lines 1,174, 1,196- Date
- 8 May 2027
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
NPP exclusivity
exclusivity.txt lines 1,171, 1,193- Date
- 29 May 2027
- Rule
- R3
- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
M-311 exclusivity
exclusivity.txt lines 1,169, 1,191- Date
- 27 Sep 2027
- Rule
- R3
- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
M-312 exclusivity
exclusivity.txt lines 1,170, 1,192- Date
- 27 Sep 2027
- Rule
- R3
- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
PED exclusivity
exclusivity.txt lines 1,188–1,190, 1,210–1,212- Date
- 8 Nov 2027
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
PED exclusivity
exclusivity.txt lines 1,184, 1,206- Date
- 29 Nov 2027
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
PED exclusivity
exclusivity.txt lines 1,182–1,183, 1,204–1,205- Date
- 27 Mar 2028
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-409 exclusivity
exclusivity.txt lines 1,175, 1,197- Date
- 21 Sep 2029
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-412 exclusivity
exclusivity.txt lines 1,176, 1,198- Date
- 21 Sep 2029
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
PED exclusivity
exclusivity.txt lines 1,180–1,181, 1,202–1,203- Date
- 21 Mar 2030
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-484 exclusivity
exclusivity.txt lines 1,177, 1,199- Date
- 29 May 2031
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-485 exclusivity
exclusivity.txt lines 1,178, 1,200- Date
- 29 May 2031
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-487 exclusivity
exclusivity.txt lines 1,179, 1,201- Date
- 29 May 2031
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
PED exclusivity
exclusivity.txt lines 1,185–1,187, 1,207–1,209- Date
- 29 Nov 2031
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
Paragraph IV list rows giving NDA 213246
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 213246, 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 213246
Selpercatinib · Capsules · 40 mg and 80 mg
RLD/NDA as listed: Retevmo 213246- First PIV submission
- 8 May 2024
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 19 Aug 2024
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 10 Oct 2037
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