Question 1

Is there a generic for Doxecitine; doxribtimine?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Doxecitine; doxribtimine. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Doxecitine; doxribtimine?

Accepted Answer

KYGEVVI (NDA 219792, UCB INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Doxecitine; doxribtimine?

Accepted Answer

The Orange Book lists 2 patents against Doxecitine; doxribtimine products, with the earliest listed expiry in 2036. 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 Doxecitine; doxribtimine have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Doxecitine; doxribtimine. 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 Doxecitine; doxribtimine are approved?

Accepted Answer

Doxecitine; doxribtimine is approved in the following dosage form: for solution.

Patent	Expires	In	Type
10471087	Aug 07, 2036	in 10 yr 3 mo	U-4358
11649259	Aug 19, 2040	in 14 yr 5 mo	ProductU-4358

Doxecitine; doxribtimine

Brand (NDA) products · for solution

Marketing exclusivity (1)

Listed patents (2)

Doxecitine; doxribtimine — frequently asked questions

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