Question 1

Is there a generic for Phenobarbital sodium?

Accepted Answer

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

Question 2

What is the reference-listed drug for Phenobarbital sodium?

Accepted Answer

SEZABY (NDA 215910, SUN PHARM INDS 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 Phenobarbital sodium?

Accepted Answer

The Orange Book lists 2 patents against Phenobarbital sodium products, with the earliest listed expiry in 2042. 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 Phenobarbital sodium have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Phenobarbital sodium. 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 Phenobarbital sodium are approved?

Accepted Answer

Phenobarbital sodium is approved in the following dosage form: powder.

Patent	Expires	In	Type
11857683	Apr 07, 2042	in 16 yr	ProductU-3779
12636254	Apr 07, 2042	in 16 yr	ProductU-3779

Phenobarbital sodium

Brand (NDA) products · powder

Marketing exclusivity (1)

Listed patents (2)

Phenobarbital sodium — frequently asked questions

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