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, Jubilant Generics, Mylan Pharms Inc, Novast Labs, Par Pharm Inc, Rubicon, Zydus Pharms, Ani Pharms, Apotex, Aurobindo Pharma Usa, Cadila, Casi Pharms Inc, Dr Reddys Labs Inc, Epic Pharma Llc, Oxford Pharms, Rising, Sun Pharm Inds Inc, and Unichem Labs Ltd. and is included in twenty-seven NDAs.
The generic ingredient in TIZANIDINE HYDROCHLORIDE is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Forty-eight 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 CASI PHARMS INC on June 27th, 2002.
Summary for TIZANIDINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 22 |
| NDAs: | 27 |
| Finished Product Suppliers / Packagers: | 46 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 29 |
| Patent Applications: | 3,698 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | TABLET;ORAL | 076284-002 | Jul 3, 2002 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Zydus Pharms | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | CAPSULE;ORAL | 208622-002 | Mar 3, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Cadila | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | TABLET;ORAL | 208187-002 | Mar 9, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Rising | TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | TABLET;ORAL | 076354-001 | Mar 28, 2003 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
