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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

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

ODE*

Nov. 8, 2027

M-311

Mar. 27, 2028

M-312

Mar. 27, 2028

ODE*

Mar. 21, 2030

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

11 trials from ClinicalTrials.gov — 1 recruiting, 9 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation NCT04280081	Phase 2	Active	Eli Lilly and Company	77	2020-03-16 → 2027-11
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)NCT03155620	Phase 2	Active	National Cancer Institute (NCI)	1,377	2017-07-31 → 2027-01-06
A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer NCT04211337	Phase 3	Active	Loxo Oncology, Inc.	291	2020-02-11 → 2027-11
Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)NCT03944772	Phase 2	Active	AstraZeneca	247	2019-06-25 → 2025-05-06
Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial)NCT04268550	Phase 2	Active	SWOG Cancer Research Network	124	2020-04-08 → 2026-12-01
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors NCT03899792	Phase 1/2	Active	Eli Lilly and Company	36	2019-06-13 → 2029-05
Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial NCT04320888	Phase 2	Active	National Cancer Institute (NCI)	1	2021-05-03 → 2026-06-30
A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer NCT04194944	Phase 3	Active	Eli Lilly and Company	261	2020-02-17 → 2030-06
A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)NCT03157128	Phase 1/2	Active	Eli Lilly and Company	857	2017-05-02 → 2027-02
The Drug Rediscovery Protocol (DRUP Trial)NCT02925234	Phase 2	Recruiting	The Netherlands Cancer Institute	1,550	2016-08 → 2027-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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

7 letters from Drugs@FDA

Date	Submission	Document
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

4 patents9 exclusivities▴

TABLET;ORAL | Approved: Apr 10, 2024

Patents (4) · 12 use codes

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	—	—		—
12138250	Oct 10, 2038PED: Apr 10, 2039	PED	—	—		—

Exclusivities (9)

Code	Date	Status
M-311	Sep 27, 2027	Active
M-312	Sep 27, 2027	Active
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

4 patents9 exclusivities▾

TABLET;ORAL | Approved: Apr 10, 2024

#003 — 120MG

RLD

4 patents9 exclusivities▾

TABLET;ORAL | Approved: Apr 10, 2024

#004 — 160MG

RLD

4 patents9 exclusivities▾

TABLET;ORAL | Approved: Apr 10, 2024