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Last Updated: May 25, 2020

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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, 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. Fifty-three 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 Trial30MGCAPSULE, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial15MGCAPSULE, 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-dimethylpropan-1-amine hydrochloride
3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)propyl(dimethyl)ammonium chloride
3-(dibenzo[2,1-b:1',2'-e][7]annulen-11-ylidene)-N,N-dimethylpropan-1-amine;hydrochloride
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
A14255
AC-1916
ACT06294
AK115687
AKOS015906329
Amrix
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
cyclobenzaprine-hci
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
Lisseril
LP00303
LS-60768
M-1230
MFCD00079039
Miosan
MK 130 hydrochloride
MK-130
MK-130 [AS THE BASE]
MK-130 HCl
MK-130 HYDROCHLORIDE
MK130 hydrochloride
MLS002153815
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
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
Q27106282
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
Aurobindo Pharma CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078643-002 Sep 26, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206703-002 Jul 24, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078643-001 Sep 26, 2008 AB RX No No   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   Start Trial
Actavis Labs Fl Inc CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 071611-002 Feb 3, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078722-003 May 12, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206703-001 Jul 24, 2018 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

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 017821-002 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
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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Serving leading biopharmaceutical companies globally:

Medtronic
Colorcon
Dow
Moodys
McKinsey
Mallinckrodt

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.