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Last Updated: May 25, 2020

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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 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, Covis Pharma Bv, 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-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for tizanidine hydrochloride. Forty-six suppliers are listed for this compound.

Recent Clinical Trials for tizanidine hydrochloride

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

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

See all tizanidine hydrochloride clinical trials

Recent Litigation for tizanidine hydrochloride

Identify potential future generic entrants

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
Par Pharm Inc TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 207199-003 Mar 14, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Jubilant Generics TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 209605-003 Aug 4, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm Inc TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 207199-002 Mar 14, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Alkem Labs Ltd TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 212196-001 Mar 27, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 091502-003 Nov 9, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Epic Pharma Llc TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076347-002 Oct 11, 2002 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:

Moodys
Johnson and Johnson
Express Scripts
Baxter
Boehringer Ingelheim
Harvard Business School

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.