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Last Updated: May 31, 2020

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TIZANIDINE HYDROCHLORIDE Drug Profile


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Which patents cover Tizanidine Hydrochloride, and what generic alternatives are available?

Tizanidine Hydrochloride is a drug marketed by Alembic Pharms Ltd, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Jubilant Generics, Mylan Pharms Inc, Novast Labs, Par Pharm Inc, Zydus Pharms, Ani Pharms Inc, Apotex, Casi Pharms Inc, Dr Reddys Labs Inc, Epic Pharma Llc, Mylan, Oxford Pharms, Sun Pharm Inds Inc, and Unichem Labs Ltd. and is included in twenty-six NDAs.

The generic ingredient in TIZANIDINE HYDROCHLORIDE is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.

US ANDA 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.

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Drug patent expirations by year for TIZANIDINE HYDROCHLORIDE
Recent Clinical Trials for TIZANIDINE HYDROCHLORIDE

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SponsorPhase
Mustafa Kemal UniversityPhase 4
Montefiore Medical CenterPhase 4
Ataturk UniversityPhase 4

See all TIZANIDINE HYDROCHLORIDE clinical trials

Recent Litigation for TIZANIDINE HYDROCHLORIDE

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District Court Litigation
Case NameDate
ERFINDERGEMEINSCHAFT UROPEP GbR v. Eli Lilly and Company2015-07-01
ACORDA THERAPEUTICS, INC. v. APOTEX INC.2007-10-11
Santilli v. Classen Immunotherapies Inc.2005-10-24

See all TIZANIDINE HYDROCHLORIDE litigation

Pharmacology for TIZANIDINE HYDROCHLORIDE
Synonyms for TIZANIDINE HYDROCHLORIDE
(5-chlorobenzo[2,3-c]1,2,5-thiadiazol-4-yl)-2-imidazolin-2-ylamine, chloride
2,1,3-Benzothiadiazol-4-amine, 5-chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-, monohydrochloride
2,1,3-benzothiadiazol-4-amine,5-chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-, monohydrochloride
5-(Chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine hydrochloride
5-chloranyl-N-(4,5-dihydro-1H-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine hydrochloride
5-Chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole hydrochloride
5-Chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride
5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazolehydrochloride
5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride
5-Chloro-4-[(4,5-dihydro-1H-imidazol-2-yl)amino]-2,1,3-benzothiadiazole Hydrochloride
5-Chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine hydrochloride
5-Chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine--hydrogen chloride (1/1)
5-chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine;hydrochloride
5-Chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-2,1,3-benzothiadiazole-4-amine hydrochloride
5-Chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-2,1,3benzothiadiazole-4-amine hydrochloride
5-chloro-N-(4,5-dihydro-1H-imidazol-2-yl)benzo[c][1,2,5]thiadiazol-4-amine hydrochloride
64461-82-1
A828535
AB0015475
AB2000107
AC-22546
AK00022647
AKOS005267234
AN-021
AN-021A
AN021
ARONIS24403
B53E3NMY5C
BCP28540
BRN0618691
C9H8ClN5S.HCl
C9H9Cl2N5S
CCG-220602
CCG-222418
CHEBI:9609
CHEMBL1200329
CPD000499584
CS-2091
D00776
DB-011661
DS 103-282
DS-103-282
DS-103282
DS-103282 ch
DTXSID9046990
EN300-49853
FT-0656022
HY-B0194A
KS-0000478D
KS-1120
LP01114
LS-40461
M962
MFCD00798231
MLS001076686
MLS001306412
MLS001333593
NC00654
NCGC00261799-01
NE33269
NVD-422
Q27274381
s1437
SAM002548961
SAM002643509
SBB080814
SC-12218
SCHEMBL41199
Sirdalud
SMR000499584
SR-01000765392
SR-01000765392-4
SW199068-2
Tizanidine (hydrochloride)
Tizanidine Hcl
Tizanidine hydrochloride (JP17/USAN)
Tizanidine hydrochloride [USAN:JAN]
Tizanidine hydrochloride [USAN:USP:JAN]
Tizanidine hydrochloride, >=98% (HPLC), powder
Tizanidine hydrochloride, 500 mug/mL in methanol, certified reference material
Tizanidine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Tizanidine hydrochloride, United States Pharmacopeia (USP) Reference Standard
tizanidine monohydrochloride
Tizanidine-hydrochloride
Tox21_501114
UNII-B53E3NMY5C
Zanaflex
Zanaflex (TN)
Zanaflex;Sirdalud
ZWUKMNZJRDGCTQ-UHFFFAOYSA-N
Paragraph IV (Patent) Challenges for TIZANIDINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ZANAFLEX CAPSULE;ORAL tizanidine hydrochloride 021447 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
Apotex TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076533-001 Jan 16, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Alkem Labs Ltd TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 211798-002 Jan 25, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076354-001 Mar 28, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Unichem Labs Ltd TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 091283-002 Nov 28, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Inc TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076286-001 Jul 3, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076354-002 Mar 28, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
Express Scripts
Baxter
Johnson and Johnson
McKinsey

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