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TEMBEXA

NDA

BRINCIDOFOVIR | N214461 | EMERGENT BIODEFENSE OPERATIONS LANSING INC

1 strength5 unique patents1 unique exclusivity

Patent Timeline

5 unique patents, 1 exclusivity by expiration date

Active (5)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

Oct. 10, 2034

Jul. 30, 2034

Oct. 10, 2034

Oct. 10, 2034

Oct. 10, 2034

ODE-354

Jun. 4, 2028

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
Aug 4, 2021	SUPPL -1	View Letter (PDF)
Jun 7, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

RLD

5 patents1 exclusivity▴

TABLET;ORAL | Approved: Jun 4, 2021

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8962829	Oct 10, 2034	—	Yes	Yes	—	—
9303051	Jul 30, 2034	—	Yes	Yes		—
9371344	Oct 10, 2034	—	—	Yes	—	—
10112909	Oct 10, 2034	—	—	—		—
10487061	Oct 10, 2034	—	—	Yes		—

Exclusivities (1)

Code	Date	Status
ODE-354	Jun 4, 2028	Active

Change History (1)

Recent changes detected for this application.

MODIFIEDPatent Expiration7/1/2026

TEMBEXA (brincidofovir) patent 9,303,051 expiration date extended from Aug 2031 to Jul 2034 in the Orange Book.

Old: Aug 31, 2031

New: Jul 30, 2034