ZANAFLEX Drug Patent Profile

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When do Zanaflex patents expire, and when can generic versions of Zanaflex launch?

Zanaflex is a drug marketed by Legacy Pharma Usa and is included in two NDAs.

The generic ingredient in ZANAFLEX 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 Zanaflex

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

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Summary for ZANAFLEX

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	174
Clinical Trials:	10
Patent Applications:	3,843
Drug Prices:	Drug price information for ZANAFLEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZANAFLEX
What excipients (inactive ingredients) are in ZANAFLEX?	ZANAFLEX excipients list
DailyMed Link:	ZANAFLEX at DailyMed

Drug patent expirations by year for ZANAFLEX

Recent Clinical Trials for ZANAFLEX

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

Sponsor	Phase
Henry Ford Health System	Phase 4
University of California, San Diego	Phase 2
National Center for Advancing Translational Science (NCATS)	Phase 2

See all ZANAFLEX clinical trials

Pharmacology for ZANAFLEX

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

Paragraph IV (Patent) Challenges for ZANAFLEX

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 ZANAFLEX

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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	021447-001	Aug 29, 2002	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Legacy Pharma Usa	ZANAFLEX	tizanidine hydrochloride	TABLET;ORAL	020397-002	Feb 4, 2000		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Legacy Pharma Usa	ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447-002	Aug 29, 2002	AB	RX	Yes	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 ZANAFLEX

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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

International Patents for ZANAFLEX

See the table below for patents covering ZANAFLEX around the world.

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005023252		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration