Is There a Generic for Valtoco?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Valtoco (diazepam). The Orange Book shows its last listed patent expires June 10, 2042 and its last listed exclusivity ends April 15, 2028.

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Valtoco products in the Orange Book

Valtoco products and approved generics
Form and route	Strength	Brand status	Brand TE	Generic TE codes
spray, nasal	10MG/SPRAY	Marketed (Rx)	None	None
spray, nasal	5MG/SPRAY	Marketed (Rx)	None	None
spray, nasal	7.5MG/SPRAY	Marketed (Rx)	None	None

NDA 211635, held by NEURELIS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Valtoco patents

Patents listed for Valtoco
Patent	Expires	Covers	Use code	NDA
12521400	March 27, 2029	Drug product	None	211635
11793786	March 27, 2029	Drug product	None	211635
12268664	March 27, 2029	Drug product	None	211635
8895546	March 27, 2029	Drug product	None	211635
11241414	March 27, 2029	Drug product	None	211635
12337061	June 13, 2032	Method of use	U-4173	211635
12324852	October 16, 2032	Method of use	U-4173	211635
12599611	June 10, 2042	Method of use	U-4455	211635

Valtoco exclusivity

Exclusivity listed for Valtoco
Code	Meaning	Expires	NDA
ODE-279	Orphan drug exclusivity	January 10, 2027	211635
NPP	New patient population	April 15, 2028	211635

Valtoco NDC codes

Questions

Is there a generic for Valtoco?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Valtoco (diazepam). The Orange Book shows its last listed patent expires June 10, 2042 and its last listed exclusivity ends April 15, 2028.

What is the generic name for Valtoco?

The active ingredient in Valtoco is diazepam, per the FDA Orange Book.

When does the Valtoco patent expire?

The last patent listed for Valtoco in the Orange Book expires June 10, 2042. 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.