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Last Updated: December 13, 2019

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Amitriptyline hydrochloride - Generic Drug Details

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

Amitriptyline hydrochloride is the generic ingredient in eighteen branded drugs marketed by Roche, Watson Labs, Astrazeneca, Bristol Myers Squibb, Warner Chilcott, Accord Hlthcare, Am Therap, Ani Pharms Inc, Copley Pharm, Halsey, Lederle, Mutual Pharm, Mylan, Par Pharm, Pliva, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Inc, Superpharm, Teva, Ucb Inc, Usl Pharma, Vangard, Vintage Pharms, West Ward, Zydus Pharms, Frontida Biopharm, Heritage Pharma, Mylan Pharms Inc, Heritage Pharms Inc, Schering, Fosun Pharma, Ivax Sub Teva Pharms, Sun Pharm Industries, and New River, and is included in one hundred and seventy-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for amitriptyline hydrochloride. Thirty-four suppliers are listed for this compound.

Recent Clinical Trials for amitriptyline hydrochloride

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

SponsorPhase
Fudan UniversityN/A
All India Institute of Medical Sciences, BhubaneswarPhase 4
Yousra Hisham Abdel FattahN/A

See all amitriptyline hydrochloride clinical trials

Pharmacology for amitriptyline hydrochloride
Medical Subject Heading (MeSH) Categories for amitriptyline hydrochloride
Synonyms for amitriptyline hydrochloride
1-Propanamine, 3-(10,11-dihydro-5H-dibenzo(a,d)cyclohepten-5-ylidene)-N,N-dimethyl-, hydrochloride
1-Propanamine, 3-(10,11-dihydro-5H-dibenzo(a,d)cyclohepten-5-ylidene)-N,N-dimethyl-, hydrochloride (1:1)
1-propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-, hydrochloride
1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-, hydrochloride (1:1)
1-Propanamine,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-, hydrochloride
10,11-Dihydro-N,N-dimethyl-5H-dibenzo(a,d)cycloheptene-delta(sup 5,gamma)-propylamine hydrochloride
10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d]cycloheptene-Delta5,gamma-propylamine hydrochloride
26LUD4JO9K
3-(10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride
3-(10,11-dihydro-5H-dibenzo[a,d][7]annulen-5-ylidene)-N,N-dimethylpropan-1-amine hydrochloride
3-(10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride
3-(10,11-dihydro-5h-dibenzo[a,d]cycloheptene-5-ylidene)-n,n-dimethyl-1-propanamine hydrochloride
3-(5,6-dihydrodibenzo[2,1-b:1',2'-e][7]annulen-11-ylidene)-N,N-dimethylpropan-1-amine;hydrochloride
5-(3-(Dimethylamino)propylidene) dibenzosuberane HCl
5-(3-Dimethylaminopropylidene)dibenzo(a,d)(1,4)cycloheptadiene hydrochloride
5-(3-Dimethylaminopropylidene)dibenzo[a,4]cycloheptadiene hydrochloride
5-(3-Dimethylaminopropylidene)dibenzo[a,d][1,4]cycloheptadiene hydrochloride
5-[3-(Dimethylamino)propylidene]dibenzo[a,4]cycloheptadiene hydrochloride
50-48-6 (Parent)
549-18-8
549-18-8(hcl)
5H-Dibenzo(a,d)cycloheptene-delta(sup 5),gamma-propylamine, 10,11-dihydro-N,N-dimethyl-, hydrochloride
5H-Dibenzo(a,d)cycloheptene-delta(sup 5),gamma-propylamine, 10,11-dihydro-N,N-dimethyl-,hydrochloride
5H-Dibenzo(a,d)cycloheptene-delta5,gamma-propylamine, 10,11-dihydro-N,N-dimethyl-, hydrochloride
5H-Dibenzo(a,d)cycloheptene-delta5,gamma-propylamine, 10,11-dihydro-N,N-dimethyl-, hydrochloride (8CI)
5H-Dibenzo[a,.gamma.-propylamine, 10,11-dihydro-N,N-dimethyl-, hydrochloride
5H-Dibenzo[a,.gamma.-propylamine, 10,11-dihydro-N,N-dimethyl-,hydrochloride
5H-Dibenzo[a,d]cycloheptene-Delta(sup5),gamma-propylamine, 10,11-dihydro-N,N-dimethyl-, hydrochloride
5H-Dibenzo[a,d]cycloheptene-Delta5,gamma-propylamine, 10,11-dihydro-N,N-dimethyl-, hydrochloride (6CI,8CI)
8058-15-9
A 8404
A0908
AB0013348
AC1L1WJE
AC1Q38XC
ADT-Zimaia
AK162589
AKOS015994716
Amavil
Ami-Anelun
Amicen
Amilent
Amilit
Amineurin
Amiplin
Amiprin
Amitid
Amitrip
Amitriptyline (hydrochloride)
Amitriptyline chloride
Amitriptyline HCl
Amitriptyline Hydrochloride ,(S)
Amitriptyline hydrochloride (JP17/USP)
Amitriptyline hydrochloride [JAN]
Amitriptyline hydrochloride [USP:JAN]
Amitriptyline Hydrochloride 1.0 mg/ml in Methanol (as free base)
Amitriptyline hydrochloride solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Amitriptyline hydrochloride, >=98% (TLC), powder
Amitriptyline hydrochloride, 99%
Amitriptyline hydrochloride, British Pharmacopoeia (BP) Reference Standard
Amitriptyline hydrochloride, drug standard, 1.0 mg/mL in methanol
Amitriptyline hydrochloride, European Pharmacopoeia (EP) Reference Standard
Amitriptyline hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Amitriptyline hydrochloride, United States Pharmacopeia (USP) Reference Standard
Amitriptyline;Amitriptyline hydrochloride
Amitryptiline hydrochloride
Amitryptyline hydrochloride
Amitryptylline hydrochloride
Amyline
Amyzol
AN-23652
Anapsique
Annolytin
Annoyltin
API0001458
Apo-Amitriptyline
AX8114039
Belpax
BG0033
BI3855
C20H24ClN
CAS-549-18-8
CCG-38919
CCRIS 7092
CHEBI:2667
CHEMBL1200964
component of Etrafon
component of Triavil
CPD000058368
CS-2751
D00809
Damilen hydrochloride
Daprimen
dimethyl({3-[(2Z)-tricyclo[9.4.0.03,8]pentadeca-1(11),3,5,7,12,14-hexaen-2-ylidene]propyl})amine hydrochloride
dimethyl({3-[(2Z)-tricyclo[9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaen-2-ylidene]propyl})amine hydrochloride
Domical
DRG-0169
DSSTox_CID_13187
DSSTox_GSID_33187
DSSTox_RID_79055
DTXSID9033187
EINECS 208-964-6
Elatrol
Elatrolet
Elavil (TN)
Elavil hydrochloride
Enafon
Endep
Etrafon
Etravil
EU-0100112
Euplit
F0001-1443
FT-0662108
H905
HMS1568O09
HMS1920C13
HY-B0527A
J10484
KB-47353
KFYRPLNVJVHZGT-UHFFFAOYSA-N
KS-00000FN4
KS-1291
Kyliran
Laroxyl
Larozyl
Lentizol
Levate
LP00112
LS-60749
Maxivalet
MFCD00012537
Miketorin
Mitaptyline
MLS000028437
MLS001055393
MLS001074176
MLS002222152
MolPort-003-666-120
NC00497
NCGC00015095-09
NCGC00015095-15
NCGC00024433-03
NCGC00024433-05
NCGC00093609-01
NCGC00093609-02
NCGC00093609-03
NCGC00093609-04
NCGC00093609-05
NCGC00257393-01
NCGC00258830-01
NCGC00260797-01
NIH 10794
Nornaln
Nortriptyline Impurity F
Novoprotect
Novotriptyn
NSC 104210
NSC-104210
NSC-169910
NSC-755869
NSC104210
NSC169910
NSC755869
Oasil-M
Opera_ID_618
Pharmakon1600-01500117
Pinsanu
Pinsaun
Prestwick_20
Proheptadien monohydrochloride
PubChem21398
Rantoron
REGID_for_CID_11065
s3183
SAM002554886
Saroten
Saroten Retard
Sarotena
SCHEMBL41079
sk-Amitriptyline chloride
SMR000058368
SPECTRUM1500117
SR-01000003046
SR-01000003046-2
SR-01000003046-6
ST24045948
SW196337-3
Sylvemid
Syneudon
Teperin
Tox21_113122
Tox21_113122_1
Tox21_201278
Tox21_303612
Tox21_500112
Trepiline
Triavil
Tridep
Tripta
Triptizol
Trynol
Tryptacap hydrochloride
Tryptine
Tryptizol
Tryptizol retard
Trytomer
UNII-26LUD4JO9K
Uxen
Vanatrip
W-105596
WLN: L C676 BY&T&J BU3N1&1 &GH
Yamanouchi
ZX-AFC003121

US Patents and Regulatory Information for amitriptyline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 202446-005 Jun 4, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Vangard AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 087616-001 Feb 8, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; perphenazine TABLET;ORAL 072540-001 Feb 15, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Mutual Pharm AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 085627-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Teva AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 086854-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Roche ENDEP amitriptyline hydrochloride TABLET;ORAL 083639-004 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Par Pharm AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 088702-001 Sep 25, 1984 DISCN 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 amitriptyline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-007 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Astrazeneca ELAVIL amitriptyline hydrochloride INJECTABLE;INJECTION 012704-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-006 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-004 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-005 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-001 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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