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Last Updated: October 18, 2019

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Cyclobenzaprine hydrochloride - Generic Drug Details

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What are the generic sources for cyclobenzaprine hydrochloride and what is the scope of patent protection?

Cyclobenzaprine hydrochloride is the generic ingredient in three branded drugs marketed by Teva Pharms Intl, 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, Watson Labs, and Janssen Res And Dev, and is included in twenty-one NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cyclobenzaprine hydrochloride has one patent family member in one country.

There are sixteen drug master file entries for cyclobenzaprine hydrochloride. Sixty-eight suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for cyclobenzaprine hydrochloride

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

SponsorPhase
Centre hospitalier de l'Université de Montréal (CHUM)Phase 4
Apsen Farmaceutica S.A.Phase 3
Cognitive Research CorporationPhase 1

See all cyclobenzaprine hydrochloride clinical trials

Recent Litigation for cyclobenzaprine hydrochloride

Identify potential future generic entrants

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

See all cyclobenzaprine hydrochloride litigation

Generic filers with tentative approvals for CYCLOBENZAPRINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial15MGCAPSULE, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial30MGCAPSULE, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

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
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Orit Labs Llc CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078218-002 Jun 19, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-002 Feb 1, 2007 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-001 Feb 1, 2007 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Sun Pharm Inds Ltd CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078722-002 May 12, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Jubilant Cadista CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 077563-002 Apr 19, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-002 Feb 1, 2007 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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 cyclobenzaprine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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