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FDA Orange Book · active-ingredient family

Tizanidine hydrochloride

Tizanidine hydrochloride is approved as 3 brand and 29 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ONTRALFY · NDA 216190

3

Brand (NDA)

29

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, solution, tablet

ProductApplicantApplicationTEApproved
ONTRALFYRLDFIDELITY BIOPHARMANDA 216190—Dec 12, 2024
ZANAFLEXRLD×3LEGACY PHARMA USANDA 021447ABAug 29, 2002
ZANAFLEXRLD×2LEGACY PHARMA USANDA 020397—Feb 04, 2000

Generic (ANDA) products (29)

ProductApplicantApplicationTEApproved
TIZANIDINE HYDROCHLORIDE×2RISINGANDA 218920ABAug 07, 2024
TIZANIDINE HYDROCHLORIDE×2SENORES PHARMSANDA 213365ABMay 13, 2024
TIZANIDINE HYDROCHLORIDE×4RUBICON RESEARCHANDA 213798ABMay 27, 2020
TIZANIDINE HYDROCHLORIDE×3AUROBINDO PHARMA LTDANDA 213544ABMar 24, 2020
TIZANIDINE HYDROCHLORIDE×3ALEMBICANDA 213223ABJan 13, 2020
TIZANIDINE HYDROCHLORIDE×3ALKEM LABS LTDANDA 212196ABMar 27, 2019
TIZANIDINE HYDROCHLORIDE×3CADILA PHARMS LTDANDA 210021ABMar 26, 2019
TIZANIDINE HYDROCHLORIDE×3INGENUS PHARMS LLCANDA 210267ABMar 12, 2019
TIZANIDINE HYDROCHLORIDE×2ALKEM LABS LTDANDA 211798ABJan 25, 2019
TIZANIDINE HYDROCHLORIDE×2CADILAANDA 208187ABMar 09, 2018
TIZANIDINE HYDROCHLORIDE×3JUBILANT GENERICSANDA 209605ABAug 04, 2017
TIZANIDINE HYDROCHLORIDE×3PH HEALTHANDA 207199—Mar 14, 2017
TIZANIDINE HYDROCHLORIDE×3ZYDUS PHARMSANDA 208622ABMar 03, 2017
TIZANIDINE HYDROCHLORIDE×2PH HEALTHANDA 207170—Jan 26, 2017
TIZANIDINE HYDROCHLORIDE×2UNICHEM LABS LTDANDA 091283ABNov 28, 2012
TIZANIDINE HYDROCHLORIDE×3PHARMOBEDIENTANDA 091502—Nov 09, 2012
TIZANIDINE HYDROCHLORIDE×3APOTEX INCANDA 078868ABFeb 03, 2012
TIZANIDINE HYDROCHLORIDE×2ANI PHARMSANDA 076321—Sep 30, 2004
TIZANIDINE HYDROCHLORIDE×2APOTEXANDA 076533ABJan 16, 2004
TIZANIDINE HYDROCHLORIDE×2AUROBINDO PHARMA USAANDA 076282—Dec 16, 2003
TIZANIDINE HYDROCHLORIDE×2OXFORD PHARMSANDA 076281ABOct 20, 2003
TIZANIDINE HYDROCHLORIDE×2SUN PHARM INDS INCANDA 076416ABSep 29, 2003
TIZANIDINE HYDROCHLORIDE×2ANI PHARMSANDA 076371—Apr 09, 2003
TIZANIDINE HYDROCHLORIDE×2RISINGANDA 076354ABMar 28, 2003
TIZANIDINE HYDROCHLORIDE×2CHARTWELL RXANDA 076280—Nov 26, 2002
TIZANIDINE HYDROCHLORIDE×2EPIC PHARMA LLCANDA 076347ABOct 11, 2002
TIZANIDINE HYDROCHLORIDE×2ANI PHARMSANDA 076283—Jul 12, 2002
TIZANIDINE HYDROCHLORIDE×2ANI PHARMSANDA 076284—Jul 03, 2002
TIZANIDINE HYDROCHLORIDE×2DR REDDYS LABS INCANDA 076286ABJul 03, 2002

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12263158May 07, 2042in 16 yr 1 mo
ProductU-2779
12042484May 07, 2042in 16 yr 1 mo
ProductU-2779

Tizanidine hydrochloride — frequently asked questions

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

Agent CTA Background

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