Question 1

Is there a generic for Aceclidine hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Aceclidine hydrochloride?

Accepted Answer

VIZZ (NDA 218585, LENZ THERAP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Aceclidine hydrochloride?

Accepted Answer

The Orange Book lists 6 patents against Aceclidine hydrochloride 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 Aceclidine hydrochloride have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

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

Patent	Expires	In	Type
10052313	Mar 24, 2034	in 7 yr 11 mo	ProductU-3741
9844537	Mar 24, 2034	in 7 yr 11 mo	ProductU-3741
11179328	Mar 24, 2034	in 7 yr 11 mo	U-3741
12533347	Oct 08, 2039	in 13 yr 6 mo	U-3741
12128036	Oct 08, 2039	in 13 yr 6 mo	U-3741
12414942	Mar 15, 2044	in 18 yr	U-3741

Aceclidine hydrochloride

Brand (NDA) products · solution/drops

Marketing exclusivity (1)

Listed patents (6)

Aceclidine hydrochloride — frequently asked questions

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