Question 1

Is there a generic for Brincidofovir?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Brincidofovir. It is available as 2 brand (NDA) applications.

Question 2

What is the reference-listed drug for Brincidofovir?

Accepted Answer

TEMBEXA (NDA 214460, EMERGENT BIODEFENSE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Brincidofovir?

Accepted Answer

The Orange Book lists 5 patents against Brincidofovir products, with the earliest listed expiry in 2034. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Brincidofovir have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Brincidofovir. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Brincidofovir are approved?

Accepted Answer

Brincidofovir is approved in the following dosage forms: suspension, tablet.

Product	Applicant	Application	TE	Approved
TEMBEXARLD	EMERGENT BIODEFENSE	NDA 214460	—	Jun 04, 2021
TEMBEXARLD	EMERGENT BIODEFENSE	NDA 214461	—	Jun 04, 2021

Patent	Expires	In	Type
9303051	Jul 30, 2034	in 8 yr 3 mo	SubstanceProductU-3165
10112909	Oct 10, 2034	in 8 yr 5 mo	U-3165
10487061	Oct 10, 2034	in 8 yr 5 mo	ProductU-3165
8962829	Oct 10, 2034	in 8 yr 5 mo	SubstanceProduct
9371344	Oct 10, 2034	in 8 yr 5 mo	Product

Brincidofovir

Brand (NDA) products · suspension, tablet

Marketing exclusivity (2)

Listed patents (5)

Brincidofovir — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.