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NDA

REPOTRECTINIB | N218213 | BRISTOL MYERS SQUIBB CO

2 strengths5 unique patents4 unique exclusivities

Patent Timeline

5 unique patents, 4 exclusivities by expiration date

Active (5)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Jan. 23, 2035

Jul. 5, 2036

Jul. 24, 2036

Jul. 5, 2036

Jul. 20, 2036

NCE

Nov. 15, 2028

ODE-455

Nov. 15, 2030

ODE*

Nov. 15, 2030

ODE-483

Jun. 13, 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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 14, 2024	SUPPL -1	View Letter (PDF)
Nov 16, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 40MG

RLD

5 patents3 exclusivities▴

CAPSULE;ORAL | Approved: Nov 15, 2023

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE50634	Jan 23, 2035	—	Yes	Yes	—	—
10294242	Jul 5, 2036	—	Yes	—	—	—
11452725	Jul 24, 2036	—	—	—		—
12187739	Jul 5, 2036	—	—	Yes	—	—
12310968	Jul 20, 2036	—	—	—		—

Exclusivities (3)

Code	Date	Status
NCE	Nov 15, 2028	Active
ODE-455	Nov 15, 2030	Active
ODE-483	Jun 13, 2031	Active

#002 — 160MG

RLD

5 patents3 exclusivities▾

CAPSULE;ORAL | Approved: Jun 11, 2024