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Last Updated: November 2, 2024

Tizanidine hydrochloride - Generic Drug Details


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What are the generic sources for tizanidine hydrochloride and what is the scope of patent protection?

Tizanidine hydrochloride is the generic ingredient in two branded drugs marketed by Alembic, Alkem Labs Ltd, Apotex Inc, Appco, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Endo Operations, Jubilant Generics, Norvium Bioscience, Novast Labs, Rubicon, Zydus Pharms, Legacy Pharma Usa, Ani Pharms, Apotex, Aurobindo Pharma Usa, Cadila, Chartwell Rx, Dr Reddys Labs Inc, Epic Pharma Llc, Graviti Pharms, Oxford Pharms, Rising, Sun Pharm Inds Inc, and Unichem Labs Ltd, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for tizanidine hydrochloride. Fifty-two suppliers are listed for this compound.

Recent Clinical Trials for tizanidine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityEarly Phase 1
Indiana UniversityEarly Phase 1
Kuwait UniversityEarly Phase 1

See all tizanidine hydrochloride clinical trials

Pharmacology for tizanidine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for tizanidine hydrochloride
Paragraph IV (Patent) Challenges for TIZANIDINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZANAFLEX Capsules tizanidine hydrochloride 2 mg, 4 mg and 6 mg 021447 1 2007-08-10

US Patents and Regulatory Information for tizanidine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cadila Pharms Ltd TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 210021-002 Mar 26, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Operations TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 207199-001 Mar 14, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 208622-001 Mar 3, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Legacy Pharma Usa ZANAFLEX tizanidine hydrochloride CAPSULE;ORAL 021447-002 Aug 29, 2002 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 091502-002 Nov 9, 2012 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 211798-002 Jan 25, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for tizanidine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Legacy Pharma Usa ZANAFLEX tizanidine hydrochloride CAPSULE;ORAL 021447-001 Aug 29, 2002 ⤷  Sign Up ⤷  Sign Up
Legacy Pharma Usa ZANAFLEX tizanidine hydrochloride CAPSULE;ORAL 021447-003 Aug 29, 2002 ⤷  Sign Up ⤷  Sign Up
Legacy Pharma Usa ZANAFLEX tizanidine hydrochloride CAPSULE;ORAL 021447-002 Aug 29, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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