Question 1

Is there a generic for Lotilaner?

Accepted Answer

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

Question 2

What is the reference-listed drug for Lotilaner?

Accepted Answer

XDEMVY (NDA 217603, TARSUS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Lotilaner?

Accepted Answer

The Orange Book lists 9 patents against Lotilaner products, with the earliest listed expiry in 2030. 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 Lotilaner have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

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

Patent	Expires	In	Type
8383659	Jan 17, 2030	in 3 yr 8 mo	SubstanceProduct
11690827	Dec 14, 2038	in 12 yr 8 mo	U-3674
11690826	Dec 14, 2038	in 12 yr 8 mo	U-3674
11197847	Dec 14, 2038	in 12 yr 8 mo	U-3674
10835517	Dec 14, 2038	in 12 yr 8 mo	U-3674
12171750	Dec 14, 2038	in 12 yr 8 mo	U-3674
11752137	Dec 14, 2038	in 12 yr 8 mo	Product
12213964	Dec 14, 2038	in 12 yr 8 mo	Product
12364685	Dec 14, 2038	in 12 yr 8 mo	Product

Lotilaner

Brand (NDA) products · solution/drops

Marketing exclusivity (1)

Listed patents (9)

Lotilaner — frequently asked questions

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