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Last Updated: November 2, 2024

TIZANIDINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Tizanidine Hydrochloride, and what generic alternatives are available?

Tizanidine Hydrochloride is a drug 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, 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 twenty-nine NDAs.

The generic ingredient in TIZANIDINE HYDROCHLORIDE is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tizanidine Hydrochloride

A generic version of TIZANIDINE HYDROCHLORIDE was approved as tizanidine hydrochloride by DR REDDYS LABS INC on July 3rd, 2002.

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Drug patent expirations by year for TIZANIDINE HYDROCHLORIDE
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
Ani Pharms TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076371-001 Apr 9, 2003 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Somerset Theraps Llc TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 213365-002 May 13, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Usa TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076282-002 Dec 16, 2003 DISCN 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

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