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-three 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: | 53 |
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 |
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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma Ltd | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | CAPSULE;ORAL | 213544-001 | Mar 24, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ani Pharms | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | TABLET;ORAL | 076321-001 | Sep 30, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ani Pharms | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | TABLET;ORAL | 076284-001 | Jul 3, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cadila | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | TABLET;ORAL | 208187-002 | 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 |
Expired US Patents for tizanidine hydrochloride
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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