Question 1

Is there a generic for Cantharidin?

Accepted Answer

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

Question 2

What is the reference-listed drug for Cantharidin?

Accepted Answer

YCANTH (NDA 212905, VERRICA PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Cantharidin?

Accepted Answer

The Orange Book lists 4 patents against Cantharidin products, with the earliest listed expiry in 2035. 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 Cantharidin have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Cantharidin is approved in the following dosage form: solution.

Patent	Expires	In	Type
11052064	May 28, 2035	in 9 yr 1 mo	ProductU-3665
12233042	Aug 22, 2038	in 12 yr 4 mo	ProductU-3663
11147790	Aug 22, 2038	in 12 yr 4 mo	ProductU-3663
12290651	Feb 19, 2041	in 14 yr 11 mo	Product

Cantharidin

Brand (NDA) products · solution

Marketing exclusivity (1)

Listed patents (4)

Cantharidin — frequently asked questions

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