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-two 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 3rd, 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 |
Recent Clinical Trials for ZANAFLEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Henry Ford Health System | Phase 4 |
| National Center for Advancing Translational Science (NCATS) | Phase 2 |
| University of California, San Diego | Phase 2 |
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
| 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 | |||
| Legacy Pharma Usa | ZANAFLEX | tizanidine hydrochloride | CAPSULE;ORAL | 021447-003 | Aug 29, 2002 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Legacy Pharma Usa | ZANAFLEX | tizanidine hydrochloride | TABLET;ORAL | 020397-001 | Nov 27, 1996 | AB | RX | Yes | Yes | ⤷ 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
| 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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2005023252 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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