Question 1

Is there a generic for Articaine hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Articaine hydrochloride?

Accepted Answer

CYKLX (NDA 218643, THEA PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Articaine hydrochloride?

Accepted Answer

The Orange Book lists 3 patents against Articaine hydrochloride products, with the earliest listed expiry in 2039. 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 Articaine hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Articaine hydrochloride. 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 Articaine hydrochloride are approved?

Accepted Answer

Articaine hydrochloride is approved in the following dosage form: solution/drops.

Patent	Expires	In	Type
12403126	Mar 27, 2039	in 12 yr 11 mo	ProductU-4422
11826347	Mar 27, 2039	in 12 yr 11 mo	ProductU-4423
11096922	Mar 27, 2039	in 12 yr 11 mo	ProductU-4423

Articaine hydrochloride

Brand (NDA) products · solution/drops

Marketing exclusivity (1)

Listed patents (3)

Articaine hydrochloride — frequently asked questions

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