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RETEVMO

selpercatinib · Capsule

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
RETEVMO
Generic name
selpercatinib
Dosage form
Capsule
Route
Oral
Marketing category
NDA · NDA
Labeler
Eli Lilly and Company
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
3
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Selpercatinib 40 mg/1 — View
Selpercatinib 80 mg/1 — View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
Oral
Presentations
5

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Breast Cancer Resistance Protein Inhibitors [MoA] MoA All 44 members
Cytochrome P450 2C8 Inhibitors [MoA] MoA All 56 members
Cytochrome P450 3A Inhibitors [MoA] MoA All 89 members
Kinase Inhibitor [EPC] EPC All 89 members
Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA] MoA 9 members — no class page
P-Glycoprotein Inhibitors [MoA] MoA All 105 members
Rearranged during Transfection (RET) Inhibitors [MoA] MoA 3 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
213246
Application type
NDA · New Drug Application
Approval date
May 8, 2020
Sponsor
ELI LILLY AND CO
Products on application
2
Submissions recorded
13
Products approved under application 213246.
Product Trade name Form Strength Ingredient Status TE Flags
213246-001 RETEVMO CAPSULE SELPERCATINIB Prescription — RLD
213246-002 RETEVMO CAPSULE SELPERCATINIB Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
10172851 October 10, 2037 001 No U-3450 June 5, 2020
10137124 October 10, 2037 001 No U-3450 June 5, 2020
10137124 October 10, 2037 001 No U-3949 June 5, 2020
10137124 October 10, 2037 001 No U-3950 June 5, 2020
10137124 October 10, 2037 001 No U-3951 June 5, 2020
10172851 October 10, 2037 001 No U-3949 June 5, 2020
10172851 October 10, 2037 001 No U-3950 June 5, 2020
10172851 October 10, 2037 001 No U-3951 June 5, 2020
10112942 October 10, 2037 001 Yes June 5, 2020
10137124 October 10, 2037 002 No U-3450 June 5, 2020
10137124 October 10, 2037 002 No U-3949 June 5, 2020
10137124 October 10, 2037 002 No U-3951 June 5, 2020
10137124 October 10, 2037 002 No U-3950 June 5, 2020
10172851 October 10, 2037 002 No U-3951 June 5, 2020
10172851 October 10, 2037 002 No U-3949 June 5, 2020
10172851 October 10, 2037 002 No U-3950 June 5, 2020
10172851 October 10, 2037 002 No U-3450 June 5, 2020
10112942 October 10, 2037 002 Yes June 5, 2020
10112942*PED April 10, 2038 001 No —
10137124*PED April 10, 2038 001 No —
10172851*PED April 10, 2038 001 No —
10172851*PED April 10, 2038 002 No —
10137124*PED April 10, 2038 002 No —
10112942*PED April 10, 2038 002 No —
12138250 October 10, 2038 001 No U-3949 December 5, 2024
12138250 October 10, 2038 001 No U-3951 December 5, 2024
12138250 October 10, 2038 001 No U-3950 December 5, 2024
12138250 October 10, 2038 001 No U-3450 December 5, 2024
10584124 October 10, 2038 001 Yes U-3450 June 5, 2020
10786489 October 10, 2038 001 No U-3450 October 26, 2020
10584124 October 10, 2038 001 Yes U-3949 June 5, 2020
10584124 October 10, 2038 001 Yes U-3950 June 5, 2020
10584124 October 10, 2038 001 Yes U-3951 June 5, 2020
10786489 October 10, 2038 001 No U-3949 October 26, 2020
10786489 October 10, 2038 001 No U-3951 October 26, 2020
10786489 October 10, 2038 001 No U-3950 October 26, 2020
12138250 October 10, 2038 002 No U-3951 December 5, 2024
12138250 October 10, 2038 002 No U-3950 December 5, 2024
12138250 October 10, 2038 002 No U-3949 December 5, 2024
12138250 October 10, 2038 002 No U-3450 December 5, 2024
10584124 October 10, 2038 002 Yes U-3450 June 5, 2020
10786489 October 10, 2038 002 No U-3450 October 26, 2020
10584124 October 10, 2038 002 Yes U-3951 June 5, 2020
10584124 October 10, 2038 002 Yes U-3950 June 5, 2020
10584124 October 10, 2038 002 Yes U-3949 June 5, 2020
10786489 October 10, 2038 002 No U-3950 October 26, 2020
10786489 October 10, 2038 002 No U-3949 October 26, 2020
10786489 October 10, 2038 002 No U-3951 October 26, 2020
12138250*PED April 10, 2039 001 No —
10786489*PED April 10, 2039 001 No —
10584124*PED April 10, 2039 001 No —
12138250*PED April 10, 2039 002 No —
10786489*PED April 10, 2039 002 No —
10584124*PED April 10, 2039 002 No —
Regulatory exclusivity periods.
Code Expires Product
ODE-301 May 8, 2027 001
ODE-302 May 8, 2027 001
ODE-303 May 8, 2027 001
ODE-301 May 8, 2027 002
ODE-302 May 8, 2027 002
ODE-303 May 8, 2027 002
NPP May 29, 2027 001
NPP May 29, 2027 002
M-311 September 27, 2027 001
M-312 September 27, 2027 001
M-311 September 27, 2027 002
M-312 September 27, 2027 002
PED November 8, 2027 001
PED November 8, 2027 001
PED November 8, 2027 001
PED November 8, 2027 002
PED November 8, 2027 002
PED November 8, 2027 002
PED November 29, 2027 001
PED November 29, 2027 002
PED March 27, 2028 001
PED March 27, 2028 001
PED March 27, 2028 002
PED March 27, 2028 002
ODE-409 September 21, 2029 001
ODE-412 September 21, 2029 001
ODE-409 September 21, 2029 002
ODE-412 September 21, 2029 002
PED March 21, 2030 001
PED March 21, 2030 001
PED March 21, 2030 002
PED March 21, 2030 002
ODE-484 May 29, 2031 001
ODE-485 May 29, 2031 001
ODE-487 May 29, 2031 001
ODE-484 May 29, 2031 002
ODE-485 May 29, 2031 002
ODE-487 May 29, 2031 002
PED November 29, 2031 001
PED November 29, 2031 001
PED November 29, 2031 001
PED November 29, 2031 002
PED November 29, 2031 002
PED November 29, 2031 002

Approval history

Source: Drugs@FDA
Most recent submissions on application 213246.
Type No. Action Status Date Review
Supplement 17 Efficacy Approved July 14, 2026 Standard
Supplement 16 Labeling Approved November 20, 2025 Standard
Supplement 15 Efficacy Approved November 20, 2025 Priority
Supplement 14 Labeling Approved December 18, 2024 Standard
Supplement 13 Efficacy Approved September 27, 2024 Priority
Supplement 11 Efficacy Approved September 27, 2024 Standard
Supplement 9 Efficacy Approved June 12, 2024 Standard
Supplement 12 Efficacy Approved May 29, 2024 Priority
Supplement 10 Labeling Approved April 10, 2024 Standard
Supplement 8 Efficacy Approved September 21, 2022 Priority
Supplement 7 Efficacy Approved September 21, 2022 Standard
Supplement 2 Labeling Approved January 28, 2021 Standard
Original application 1 Type 1 - New Molecular Entity Approved May 8, 2020 Priority

Review documents

  • 0 · Supplement · July 29, 2026
  • 0 · Supplement · July 15, 2026
  • 0 · Supplement · March 30, 2026
  • 0 · Supplement · March 30, 2026
  • 0 · Supplement · November 21, 2025
  • 0 · Supplement · November 21, 2025
  • 0 · Supplement · November 21, 2025
  • 0 · Supplement · November 21, 2025
  • 0 · Supplement · December 19, 2024
  • 0 · Supplement · December 19, 2024
  • 0 · Supplement · September 30, 2024
  • 0 · Supplement · September 30, 2024
  • 0 · Supplement · September 30, 2024
  • 0 · Supplement · September 30, 2024
  • 0 · Supplement · June 13, 2024
  • 0 · Supplement · June 13, 2024
  • 0 · Supplement · May 30, 2024
  • 0 · Supplement · May 29, 2024
  • 0 · Supplement · April 12, 2024
  • 0 · Supplement · April 11, 2024
  • 0 · Supplement · September 28, 2022
  • 0 · Supplement · September 28, 2022
  • 0 · Supplement · September 22, 2022
  • 0 · Supplement · September 22, 2022
  • 0 · Supplement · February 1, 2021
  • 0 · Supplement · February 1, 2021
  • 0 · Original application · August 7, 2020
  • 0 · Original application · May 11, 2020
  • 0 · Original application · May 8, 2020

Adverse event reports

Source: openFDA FAERS
0
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0002-2980-26 0002-2980 Eli Lilly and Company 120 CAPSULE in 1 BOTTLE (0002-2980-26) May 8, 2020
0002-2980-60 0002-2980 Eli Lilly and Company 60 CAPSULE in 1 BOTTLE (0002-2980-60) May 8, 2020
0002-3977-60 0002-3977 Eli Lilly and Company 60 CAPSULE in 1 BOTTLE (0002-3977-60) May 8, 2020
0002-2980 0002-2980 Eli Lilly and Company — May 8, 2020
0002-3977 0002-3977 Eli Lilly and Company — May 8, 2020

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 11 sections on this page.