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Last Updated: November 24, 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-three 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 3^rd, 2002.

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Summary for TIZANIDINE HYDROCHLORIDE

US Patents:	0
Applicants:	24
NDAs:	29
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	30
Patent Applications:	1,269
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIZANIDINE HYDROCHLORIDE
What excipients (inactive ingredients) are in TIZANIDINE HYDROCHLORIDE?	TIZANIDINE HYDROCHLORIDE excipients list
DailyMed Link:	TIZANIDINE HYDROCHLORIDE at DailyMed

Drug patent expirations by year for TIZANIDINE HYDROCHLORIDE

Recent Clinical Trials for TIZANIDINE HYDROCHLORIDE

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Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	Early Phase 1
Indiana University	Early Phase 1
Kuwait University	Early Phase 1

See all TIZANIDINE HYDROCHLORIDE clinical trials

Pharmacology for TIZANIDINE HYDROCHLORIDE

Drug Class	Central alpha-2 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha2-Agonists

Anatomical Therapeutic Chemical (ATC) Classes for TIZANIDINE HYDROCHLORIDE

M03BX	Other centrally acting agents
M03B	MUSCLE RELAXANTS, CENTRALLY ACTING AGENTS
M03	MUSCLE RELAXANTS
M	Musculo-skeletal system

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

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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
Graviti Pharms	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	TABLET;ORAL	218920-002	Aug 7, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	TABLET;ORAL	076371-002	Apr 9, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cadila	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	TABLET;ORAL	208187-001	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

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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.