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Last Updated: November 21, 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, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Endo Operations, Jubilant Generics, Norvium Bioscience, Novast Labs, Rubicon, Somerset Theraps Llc, 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-three 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
Aurobindo Pharma Ltd TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 213544-001 Mar 24, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ani Pharms TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076321-001 Sep 30, 2004 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ani Pharms TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076284-001 Jul 3, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cadila TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 208187-002 Mar 9, 2018 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.