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FDA Orange Book · active-ingredient family

Cyclobenzaprine hydrochloride

Cyclobenzaprine hydrochloride is approved as 3 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TONMYA · NDA 219428

3

Brand (NDA)

23

Generics (ANDA)

4

Listed patents

1

Exclusivity periods

Brand (NDA) products · capsule, extended release, tablet

ProductApplicantApplicationTEApproved
TONMYARLDTONIXNDA 219428—Aug 15, 2025
AMRIXRLD×2TEVA PHARMS INTLNDA 021777ABFeb 01, 2007
FLEXERILRLD×2JANSSEN RES AND DEVNDA 017821—Approved Prior to Jan 1, 1982

Generic (ANDA) products (23)

ProductApplicantApplicationTEApproved
CYCLOBENZAPRINE HYDROCHLORIDE×3RISINGANDA 218936ABSep 12, 2024
CYCLOBENZAPRINE HYDROCHLORIDE×2NOVAST LABSANDA 214732ABAug 27, 2024
CYCLOBENZAPRINE HYDROCHLORIDE×2MACLEODS PHARMS LTDANDA 207314ABJul 22, 2024
CYCLOBENZAPRINE HYDROCHLORIDE×3UNICHEMANDA 213324ABJul 06, 2020
CYCLOBENZAPRINE HYDROCHLORIDE×2APOTEXANDA 206703—Jul 24, 2018
CYCLOBENZAPRINE HYDROCHLORIDE×3RUBICON RESEARCHANDA 208170ABMay 31, 2017
CYCLOBENZAPRINE HYDROCHLORIDE×3CHARTWELL RXANDA 078218ABJun 19, 2015
CYCLOBENZAPRINE HYDROCHLORIDE×2TWI PHARMS INCANDA 091281ABJan 31, 2013
CYCLOBENZAPRINE HYDROCHLORIDE×2KVK TECHANDA 078048ABFeb 28, 2011
CYCLOBENZAPRINE HYDROCHLORIDE×2INVAGEN PHARMSANDA 090478ABJul 23, 2010
CYCLOBENZAPRINE HYDROCHLORIDE×2AUROBINDO PHARMAANDA 078643ABSep 26, 2008
CYCLOBENZAPRINE HYDROCHLORIDE×3SUN PHARM INDS LTDANDA 078722—May 12, 2008
CYCLOBENZAPRINE HYDROCHLORIDE×2PRINSTON INCANDA 077797ABFeb 28, 2007
CYCLOBENZAPRINE HYDROCHLORIDE×3JUBILANT CADISTAANDA 077563ABApr 19, 2006
CYCLOBENZAPRINE HYDROCHLORIDE×2TP ANDA HOLDINGSANDA 073541ABApr 06, 2006
CYCLOBENZAPRINE HYDROCHLORIDE×3ACTAVIS LABS FL INCANDA 071611ABFeb 03, 2006
CYCLOBENZAPRINE HYDROCHLORIDE×3AIPING PHARM INCANDA 072854—Feb 03, 2006
CYCLOBENZAPRINE HYDROCHLORIDE×2OXFORD PHARMSANDA 077209ABFeb 03, 2006
CYCLOBENZAPRINE HYDROCHLORIDE×3RISINGANDA 073144—Feb 03, 2006
CYCLOBENZAPRINE HYDROCHLORIDEPLIVAANDA 074421—Sep 29, 1995
CYCLOBENZAPRINE HYDROCHLORIDEWATSON LABSANDA 074436—Nov 30, 1994
CYCLOBENZAPRINE HYDROCHLORIDESANDOZANDA 073683—Feb 26, 1993
CYCLOBENZAPRINE HYDROCHLORIDEWATSON LABSANDA 073143—Nov 27, 1991

Marketing exclusivity (1)

  • NPNew product exclusivity (3 years)

    Aug 15, 2028

    in 2 yr 2 mo

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10117936Mar 14, 2034in 7 yr 10 mo
Product
10864175Mar 14, 2034in 7 yr 10 mo
Product
9636408Mar 14, 2034in 7 yr 10 mo
Product
9956188Mar 14, 2034in 7 yr 10 mo
Product

Cyclobenzaprine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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