Is There a Generic for Dextenza?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Dextenza (dexamethasone). The Orange Book shows its last listed patent expires April 26, 2041 and its last listed exclusivity ends April 7, 2028.

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Dextenza products in the Orange Book

Dextenza products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
insert, ophthalmic	0.4MG	Marketed (Rx)	None	0	None

NDA 208742, held by OCULAR THERAPEUTIX INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Dextenza patents

Patents listed for Dextenza
Patent	Expires	Covers	Use code	NDA
8563027	February 12, 2030	Method of use	U-2487	208742
8409606	May 14, 2030	Drug product	None	208742
12150896	October 7, 2036	Method of use	U-1680	208742
12150896	October 7, 2036	Method of use	U-3455	208742
11458041	November 16, 2037	Method of use	U-1680	208742
11458041	November 16, 2037	Method of use	U-3455	208742
12144889	April 26, 2041	Method of use	U-1680	208742

Dextenza exclusivity

Exclusivity listed for Dextenza
Code	Meaning	Expires	NDA
NPP	New patient population	April 7, 2028	208742

Dextenza NDC codes

70382-204

Questions

Is there a generic for Dextenza?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Dextenza (dexamethasone). The Orange Book shows its last listed patent expires April 26, 2041 and its last listed exclusivity ends April 7, 2028.

What is the generic name for Dextenza?

The active ingredient in Dextenza is dexamethasone, per the FDA Orange Book.

When does the Dextenza patent expire?

The last patent listed for Dextenza in the Orange Book expires April 26, 2041. 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.