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RETEVMO

NDA

SELPERCATINIB | N218160 | ELI LILLY AND CO

4 strengths4 unique patents9 unique exclusivities

Patent Timeline

4 unique patents, 5 exclusivities by expiration date

Active (4)TodayPED (+6 mo)Exclusivity

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

ODE*

Nov. 29, 2031

M-311

Nov. 29, 2031

M-312

Nov. 29, 2031

ODE*

Nov. 29, 2031

ODE*

Nov. 29, 2031

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$5822.43

Highest Price

$22654.38

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00002-5340-60RETEVMO 40MG TAB,ORAL	$5822.43	Big4	Eli Lilly & Company	09/28/2030
00002-5340-60RETEVMO 40MG TAB,ORAL	$7551.46	FSS	Eli Lilly & Company	09/28/2030
00002-5562-60RETEVMO 160MG TAB,ORAL	$17583.33	Big4	Eli Lilly & Company	09/28/2030
00002-5562-60RETEVMO 160MG TAB,ORAL	$22654.38	FSS	Eli Lilly & Company	09/28/2030
00002-6082-60RETEVMO 80MG TAB,ORAL	$8739.45	Big4	Eli Lilly & Company	09/28/2030
00002-6082-60RETEVMO 80MG TAB,ORAL	$11327.19	FSS	Eli Lilly & Company	09/28/2030
00002-6120-60RETEVMO 120MG TAB,ORAL	$17601.05	Big4	Eli Lilly & Company	09/28/2030
00002-6120-60RETEVMO 120MG TAB,ORAL	$22654.38	FSS	Eli Lilly & Company	09/28/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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

8 letters from Drugs@FDA

Date	Submission	Document
Jul 15, 2026	SUPPL -7	View Letter (PDF)
Nov 21, 2025	SUPPL -5	View Letter (PDF)
Nov 21, 2025	SUPPL -6	View Letter (PDF)
Dec 19, 2024	SUPPL -4	View Letter (PDF)
Sep 30, 2024	SUPPL -3	View Letter (PDF)
Sep 30, 2024	SUPPL -2	View Letter (PDF)
Jun 13, 2024	SUPPL -1	View Letter (PDF)
Apr 12, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 40MG

RLD

13 patents9 exclusivities▴

TABLET;ORAL | Approved: Apr 10, 2024

Patents (13)

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	—	—		—
10137124	Oct 10, 2037PED: Apr 10, 2038	PED	—	—		—
10137124	Oct 10, 2037PED: Apr 10, 2038	PED	—	—		—
10137124	Oct 10, 2037PED: Apr 10, 2038	PED	—	—		—
10172851	Oct 10, 2037PED: Apr 10, 2038	PED	—	—		—
10172851	Oct 10, 2037PED: Apr 10, 2038	PED	—	—		—
10172851	Oct 10, 2037PED: Apr 10, 2038	PED	—	—		—
10172851	Oct 10, 2037PED: Apr 10, 2038	PED	—	—		—
12138250	Oct 10, 2038PED: Apr 10, 2039	PED	—	—		—
12138250	Oct 10, 2038PED: Apr 10, 2039	PED	—	—		—
12138250	Oct 10, 2038PED: Apr 10, 2039	PED	—	—		—
12138250	Oct 10, 2038PED: Apr 10, 2039	PED	—	—		—

Exclusivities (9)

Code	Date	Status
M-311	Sep 27, 2027	< 1 year
M-312	Sep 27, 2027	< 1 year
ODE*	May 29, 2031	Active
ODE*	May 8, 2027	< 1 year
ODE*	Sep 21, 2029	Active
PED	Mar 21, 2030	Active
PED	Mar 27, 2028	Active
PED	Nov 29, 2031	Active
PED	Nov 8, 2027	Active

#002 — 80MG

RLD

13 patents9 exclusivities▾

TABLET;ORAL | Approved: Apr 10, 2024

#003 — 120MG

RLD

13 patents9 exclusivities▾

TABLET;ORAL | Approved: Apr 10, 2024

#004 — 160MG

RLD

13 patents9 exclusivities▾

TABLET;ORAL | Approved: Apr 10, 2024