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-two suppliers are listed for this compound.

Summary for TIZANIDINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	25
NDAs:	31
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	52
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	30
Patent Applications:	1,968
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

Recent Clinical Trials for TIZANIDINE HYDROCHLORIDE

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

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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Glossary

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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
Legacy Pharma Usa	ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447-002	Aug 29, 2002	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Inc	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	TABLET;ORAL	076416-002	Sep 29, 2003	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Inc	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	TABLET;ORAL	076286-002	Jul 3, 2002	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
Norvium Bioscience	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	CAPSULE;ORAL	091502-003	Nov 9, 2012		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	076283-001	Jul 12, 2002		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

Expired US Patents for TIZANIDINE HYDROCHLORIDE

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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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