Viewing data from:

RETEVMO

NDA

SELPERCATINIB | N213246 | ELI LILLY AND CO

2 strengths6 unique patents12 unique exclusivities

Patent Timeline

6 unique patents, 11 exclusivities by expiration date

Active (6)TodayPED (+6 mo)Exclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Apr. 10, 2038

Apr. 10, 2038

Apr. 10, 2038

Apr. 10, 2039

Apr. 10, 2039

Apr. 10, 2039

ODE-301

Nov. 8, 2027

ODE-302

Nov. 8, 2027

ODE-303

Nov. 8, 2027

NPP

Nov. 8, 2027

M-311

Nov. 8, 2027

M-312

Nov. 8, 2027

ODE-409

Nov. 8, 2027

ODE-412

Nov. 8, 2027

ODE-484

Nov. 8, 2027

ODE-485

Nov. 8, 2027

ODE-487

Nov. 8, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Retevmo (2023)

Total Spending

$57.7M

Total Claims

3,254

Beneficiaries

479

Avg Cost/Unit

$167.30

Spending Trend

$6.9M(2020)→$26.3M(2021)→$44.2M(2022)→$57.7M(2023)

YoY Change:+4.5%

5yr CAGR:+0.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MSN LABORATORIES PRIVATE LTDSELPERCATINIB

DMF 388332023

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Nov 21, 2025	SUPPL -16	View Letter (PDF)
Nov 21, 2025	SUPPL -15	View Letter (PDF)
Dec 19, 2024	SUPPL -14	View Letter (PDF)
Sep 30, 2024	SUPPL -11	View Letter (PDF)
Sep 30, 2024	SUPPL -13	View Letter (PDF)
Jun 13, 2024	SUPPL -9	View Letter (PDF)
May 30, 2024	SUPPL -12	View Letter (PDF)
Apr 12, 2024	SUPPL -10	View Letter (PDF)
Sep 22, 2022	SUPPL -8	View Letter (PDF)
Sep 22, 2022	SUPPL -7	View Letter (PDF)
Feb 1, 2021	SUPPL -2	View Letter (PDF)
May 11, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 40MG

RLD

6 patents12 exclusivities▴

CAPSULE;ORAL | Approved: May 8, 2020

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10112942	Oct 10, 2037PED: Apr 10, 2038	PED	Yes	Yes	—	—
10137124	Oct 10, 2037PED: Apr 10, 2038	PED	—	—		—
10172851	Oct 10, 2037PED: Apr 10, 2038	PED	—	—		—
10584124	Oct 10, 2038PED: Apr 10, 2039	PED	Yes	—		—
10786489	Oct 10, 2038PED: Apr 10, 2039	PED	—	Yes		—
12138250	Oct 10, 2038PED: Apr 10, 2039	PED	—	—		—

Exclusivities (12)

Code	Date	Status
M-311	Sep 27, 2027	Active
M-312	Sep 27, 2027	Active
NPP	May 29, 2027	< 1 year
ODE-301	May 8, 2027	< 1 year
ODE-302	May 8, 2027	< 1 year
ODE-303	May 8, 2027	< 1 year
ODE-409	Sep 21, 2029	Active
ODE-412	Sep 21, 2029	Active
ODE-484	May 29, 2031	Active
ODE-485	May 29, 2031	Active
ODE-487	May 29, 2031	Active
PED	Nov 8, 2027	Active

#002 — 80MG

RLD

6 patents12 exclusivities▾

CAPSULE;ORAL | Approved: May 8, 2020