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Last Updated: March 28, 2024

Tizanidine hydrochloride - Generic Drug Details


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What are the generic sources for tizanidine hydrochloride and what is the scope of freedom to operate?

Tizanidine hydrochloride is the generic ingredient in two branded drugs marketed by Alembic, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Jubilant Generics, Mylan Pharms Inc, Novast Labs, Par Pharm Inc, Rubicon, Zydus Pharms, Legacy Pharma Usa, Ani Pharms, Apotex, Aurobindo Pharma Usa, Cadila, Casi Pharms Inc, Dr Reddys Labs Inc, Epic Pharma Llc, Oxford Pharms, Rising, Sun Pharm Inds Inc, and Unichem Labs Ltd, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for tizanidine hydrochloride. Forty-eight 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
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
Rubicon TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 213798-003 May 27, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm Inc TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 207199-002 Mar 14, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cadila TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 208187-002 Mar 9, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rubicon TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 213798-001 May 27, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Pharms Inc TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 091502-002 Nov 9, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Legacy Pharma Usa ZANAFLEX tizanidine hydrochloride TABLET;ORAL 020397-001 Nov 27, 1996 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Legacy Pharma Usa ZANAFLEX tizanidine hydrochloride CAPSULE;ORAL 021447-002 Aug 29, 2002 ⤷  Try a Trial ⤷  Try a Trial
Legacy Pharma Usa ZANAFLEX tizanidine hydrochloride CAPSULE;ORAL 021447-003 Aug 29, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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