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Last Updated: November 19, 2019

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CYCLOBENZAPRINE HYDROCHLORIDE Drug Profile

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When do Cyclobenzaprine Hydrochloride patents expire, and what generic alternatives are available?

Cyclobenzaprine Hydrochloride is a drug marketed by Apotex Inc, Twi Pharms Inc, Actavis Labs Fl Inc, Anda Repository, Aurobindo Pharma, Invagen Pharms, Jubilant Cadista, Kvk Tech, Mylan Pharms Inc, Orit Labs Llc, Oxford Pharms, Pliva, Prinston Inc, Rubicon, Sandoz, Sun Pharm Inds Ltd, Upsher Smith Labs, and Watson Labs. and is included in nineteen NDAs.

The generic ingredient in CYCLOBENZAPRINE HYDROCHLORIDE is cyclobenzaprine hydrochloride. There are sixteen drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.

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

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SponsorPhase
Centre hospitalier de l'Université de Montréal (CHUM)Phase 4
Apsen Farmaceutica S.A.Phase 3
Neurana Pharmaceuticals, Inc.Phase 1

See all CYCLOBENZAPRINE HYDROCHLORIDE clinical trials

Recent Litigation for CYCLOBENZAPRINE HYDROCHLORIDE

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District Court Litigation
Case NameDate
Adare Pharmaceuticals, Inc. v. Inventia Healthcare Limited2018-07-20
Adare Pharmaceuticals, Inc. v. Apotex, Inc.2016-09-29
Aptalis Pharmatech Inc. v. Apotex Inc.2014-08-11

See all CYCLOBENZAPRINE HYDROCHLORIDE litigation

Pharmacology for CYCLOBENZAPRINE HYDROCHLORIDE
Synonyms for CYCLOBENZAPRINE HYDROCHLORIDE
0VE05JYS2P
1-Propanamine, 3-(5H-dibenzo(a,d)cyclohepten-5-ylidene)-N,N-dimethyl-, hydrochloride
1-Propanamine,d]cyclohepten-5-ylidene)-N,N-dimethyl-, hydrochloride
10,11.delta.-Amitriptyline hydrochloride
10,11delta-Amitriptyline hydrochloride
202C239
3-(5H-Dibenzo(a,d)cyclohepten-5-ylidene)propyl(dimethyl)ammonium chloride
3-(5H-dibenzo[a,d][7]annulen-5-ylidene)-N,N-dimethylpropan-1-amine hydrochloride
3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine Hydrochloride
3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethylpropan-1-amine hydrochloride
3-(dibenzo[2,1-b:1',2'-e][7]annulen-11-ylidene)-N,N-dimethylpropan-1-amine;hydrochloride
303-53-7 (Parent)
5-(3-Dimethylaminopropylidene)-5H-dibenzo-(a,d)cycloheptene hydrochloride
5-(3-Dimethylaminopropylidene)dibenzo[a,e]cycloheptatriene hydrochloride
5-[3-(Dimethylamino)propylidene]-5H-dibenzo-[a,d]cycloheptene hydrochloride
5H-Dibenzo(a,d)cycloheptene-delta(sup 5)-gamma-propylamine, N,N-dimethyl-, hydrochloride
5H-Dibenzo(a,d)cycloheptene-delta5,gamma-propylamine, N,N-dimethyl-, hydrochloride
5H-Dibenzo(a,d)cycloheptene-delta5,gamma-propylamine, N,N-dimethyl-, hydrochloride (8CI)
5H-Dibenzo[a, N,N-dimethyl-, hydrochloride
5H-Dibenzo[a,.gamma.-propylamine, N,N-dimethyl-, hydrochloride
6202-23-9
AC-1916
AC1L2KN5
ACT06294
AKOS015906329
Amrix
AN-14454
AS-15745
BCP21781
BCP9000565
C 4542
C-19294
C20H21N.HCl
CAS-6202-23-9
CC-26027
CCG-39312
CHEBI:3997
CHEMBL1200636
Cloben
CS-2981
CTK8F8847
Cyben
Cyclobenzaprine (hydrochloride)
Cyclobenzaprine HCL
Cyclobenzaprine hydrochloride (USP)
Cyclobenzaprine hydrochloride [USAN:USP]
Cyclobenzaprine hydrochloride [USAN]
Cyclobenzaprine Hydrochloride 1.0 mg/ml in Methanol (as free base)
Cyclobenzaprine hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Cyclobenzaprine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Cycloflex
D00772
DSSTox_CID_25105
DSSTox_GSID_45105
DSSTox_RID_80672
DTXSID2045105
EINECS 228-264-4
EU-0100303
EUR-1002
Flexeril
Flexeril (TN)
Flexeril hydrochloride
Flexiban
FT-0603166
HMS1569I12
HMS1922I11
HY-B0740
KB-76226
Lisseril
LP00303
LS-60768
M-1230
MFCD00079039
Miosan
MK 130 hydrochloride
MK-130
MK-130 [AS THE BASE]
MK-130 HCl
MLS002153815
MolPort-003-666-812
Multi-Relax
N,d]cycloheptene-.delta.,5.gamma.-propylamine, hydrochloride
N,d]cycloheptene-.delta.(sup5,.gamma.)-propylamine hydrochloride
N,N-dimethyl-5H-dibenzo(a,d)cycloheptene-Delta(5,gamma)-propylamine hydrochloride
N,N-Dimethyl-5H-dibenzo(a,d)cycloheptene-delta(sup 5,gamma)-propylamine hydrochloride
NCGC00013841-01
NCGC00013841-09
NCGC00093752-01
NCGC00093752-02
NCGC00093752-03
NCGC00093752-04
NCGC00093752-05
NCGC00095017-01
NCGC00095017-02
NCGC00095017-03
NCGC00095017-04
NCGC00260988-01
Nortriptyline Impurity E
Novo-Cycloprine
NSC 169900
NSC 173379
NSC 78206
NSC-169900
NSC-173379
NSC-758414
NSC-78206
NSC169900
NSC173379
NSC758414
NSC78206
Pharmakon1600-01503207
Prestwick_790
Proheptatrien monohydrochloride
Proheptatriene hydrochloride
Proheptatriene monohydrochloride
PubChem15660
PubChem18912
Q517
s4283
SB19022
SC-18388
SCHEMBL41376
SMR000326702
SPECTRUM1503207
SR-01000075761
SR-01000075761-1
SR-01000075761-6
ST24041508
SW196928-3
Tabradol
Tensodox
TNX-102
TNX-102 SL
TNX-105
Tonmya
Tox21_110040
Tox21_110040_1
Tox21_500303
UNII-0VE05JYS2P
VXEAYBOGHINOKW-UHFFFAOYSA-N
W-105056
WLN: L C676 BHJ B3N1&1 &GH
Yurelax
Paragraph IV (Patent) Challenges for CYCLOBENZAPRINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
AMRIX CAPSULE, EXTENDED RELEASE;ORAL cyclobenzaprine hydrochloride 021777 2008-08-11
FLEXERIL TABLET;ORAL cyclobenzaprine hydrochloride 017821

US Patents and Regulatory Information for CYCLOBENZAPRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 073683-001 Feb 26, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Prinston Inc CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 077797-002 Feb 28, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078722-001 May 12, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Rubicon CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 208170-001 May 31, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206703-001 Jul 24, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Kvk Tech CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078048-002 Feb 28, 2011 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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