Orange Book product · Brand (NDA)

VALTOCO

DIAZEPAM

Brand (NDA)NDA 211635RX NEURELIS INC

Jan 10, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 10, 2020
6 yr 6 mo ago
Today
Exclusivity ends · ODE-279
Orphan-drug exclusivity (7 years)
Jan 10, 2027
in 7 mo
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Apr 15, 2028
in 1 yr 10 mo
Patent 11241414 expires
Listed drug product patent expiration.
Mar 27, 2029
in 2 yr 10 mo
Patent 11793786 expires
Listed drug product patent expiration.
Mar 27, 2029
in 2 yr 10 mo
Patent 12268664 expires
Listed drug product patent expiration.
Mar 27, 2029
in 2 yr 10 mo
Patent 12521400 expires
Listed drug product patent expiration.
Mar 27, 2029
in 2 yr 10 mo
Patent 8895546 expires
Listed drug product patent expiration.
Mar 27, 2029
in 2 yr 10 mo
Patent 12337061 expires
Listed method-of-use patent (U-4173) expiration.
Jun 13, 2032
in 6 yr 1 mo
Patent 12324852 expires
Listed method-of-use patent (U-4173) expiration.
Oct 16, 2032
in 6 yr 5 mo
Patent 12599611 expires
Listed method-of-use patent (U-4455) expiration.
Jun 10, 2042
in 16 yr 3 mo

Active ingredient

DIAZEPAM

Strength

5MG/SPRAY

Dosage form

SPRAY

Route

NASAL

TE code

Not listed

Application

NDA 211635

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11241414	Mar 27, 2029	in 2 yr 10 mo	Product
11793786	Mar 27, 2029	in 2 yr 10 mo	Product
12268664	Mar 27, 2029	in 2 yr 10 mo	Product
12521400	Mar 27, 2029	in 2 yr 10 mo	Product
8895546	Mar 27, 2029	in 2 yr 10 mo	Product
12337061	Jun 13, 2032	in 6 yr 1 mo	U-4173
12324852	Oct 16, 2032	in 6 yr 5 mo	U-4173
12599611	Jun 10, 2042	in 16 yr 3 mo	U-4455