Is There a Generic for Nayzilam?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Nayzilam (midazolam). The Orange Book shows its last listed patent expires January 18, 2028 and its last listed exclusivity ends May 17, 2026.

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Nayzilam products in the Orange Book

Nayzilam products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
spray, nasal	5MG/SPRAY	Marketed (Rx)	None	0	None

NDA 211321, held by UCB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Nayzilam patents

Patents listed for Nayzilam
Patent	Expires	Covers	Use code	NDA
9687495	January 18, 2028	Drug product	U-2526	211321
9289432	January 18, 2028	Drug product	U-2526	211321
8217033	January 18, 2028	Drug product	U-2526	211321
8809322	January 18, 2028	Drug product	None	211321

Nayzilam exclusivity

Exclusivity listed for Nayzilam
Code	Meaning	Expires	NDA
ODE-243	Orphan drug exclusivity	May 17, 2026	211321

Nayzilam NDC codes

50474-500

Questions

Is there a generic for Nayzilam?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Nayzilam (midazolam). The Orange Book shows its last listed patent expires January 18, 2028 and its last listed exclusivity ends May 17, 2026.

What is the generic name for Nayzilam?

The active ingredient in Nayzilam is midazolam, per the FDA Orange Book.

When does the Nayzilam patent expire?

The last patent listed for Nayzilam in the Orange Book expires January 18, 2028. 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.