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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

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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

13 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study to Assess Brincidofovir Treatment of Serious Diseases or Conditions Caused by Double-stranded DNA Viruses NCT01143181	Phase 3	Completed	Jazz Pharmaceuticals	210	2010-12 → 2012-12
A Study of the Safety and Efficacy of CMX001 for the Prevention of CMV Infection in CMV-seropositive HCT Recipients NCT01769170	Phase 3	Completed	Jazz Pharmaceuticals	452	2013-08 → 2016-01
CMX001 in Post-transplant Patients With BK Virus Viruria NCT00793598	Phase 1/2	Completed	Jazz Pharmaceuticals	29	2009-11 → 2010-10
Phase 2 Study to Evaluate Brincidofovir for the Prevention of Adenovirus Disease NCT01241344	Phase 2	Completed	Jazz Pharmaceuticals	52	2010-11 → 2013-06
Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection NCT02087306	Phase 3	Completed	Jazz Pharmaceuticals	201	2014-03 → 2016-08
Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients NCT00942305	Phase 2	Completed	Jazz Pharmaceuticals	239	2009-10 → 2012-01
Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease NCT02596997	—	NO_LONGER_AVAILABLE	Jazz Pharmaceuticals	—	—
A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease NCT02439970	Phase 3	Terminated	Jazz Pharmaceuticals	5	2015-09 → 2016-01-30
The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation NCT03339401	Phase 2	Terminated	Jazz Pharmaceuticals	29	2017-12-22 → 2019-05-10
A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus NCT02439957	Phase 3	Terminated	Jazz Pharmaceuticals	6	2015-09 → 2016-07-31

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

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) · 3 use codes

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