Is There a Generic for Byqlovi?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Byqlovi (clobetasol propionate). The Orange Book shows its last listed patent expires May 9, 2036 and its last listed exclusivity ends March 4, 2027.

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Byqlovi products in the Orange Book

Byqlovi products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
suspension/drops, ophthalmic	0.05%	Marketed (Rx)	None	0	None

NDA 218158, held by HARROW EYE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Byqlovi patents

Patents listed for Byqlovi
Patent	Expires	Covers	Use code	NDA
11376262	May 9, 2036	Drug product	U-19	218158
10588913	May 9, 2036	Drug product	None	218158

Byqlovi exclusivity

Exclusivity listed for Byqlovi
Code	Meaning	Expires	NDA
NP	New product	March 4, 2027	218158

Byqlovi NDC codes

Questions

Is there a generic for Byqlovi?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Byqlovi (clobetasol propionate). The Orange Book shows its last listed patent expires May 9, 2036 and its last listed exclusivity ends March 4, 2027.

What is the generic name for Byqlovi?

The active ingredient in Byqlovi is clobetasol propionate, per the FDA Orange Book.

When does the Byqlovi patent expire?

The last patent listed for Byqlovi in the Orange Book expires May 9, 2036. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.