Orange Book product · Brand (NDA)

TONMYA

CYCLOBENZAPRINE HYDROCHLORIDE

Brand (NDA)NDA 219428RX TONIX

Aug 15, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 15, 2025
10 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Aug 15, 2028
in 2 yr 2 mo
Patent 10117936 expires
Listed drug product patent expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 10864175 expires
Listed drug product patent expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 9636408 expires
Listed drug product patent expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 9956188 expires
Listed drug product patent expiration.
Mar 14, 2034
in 7 yr 10 mo

Active ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Strength

2.8MG

Dosage form

TABLET

Route

SUBLINGUAL

TE code

Not listed

Application

NDA 219428

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
10117936	Mar 14, 2034	in 7 yr 10 mo	Product
10864175	Mar 14, 2034	in 7 yr 10 mo	Product
9636408	Mar 14, 2034	in 7 yr 10 mo	Product
9956188	Mar 14, 2034	in 7 yr 10 mo	Product