Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 13, 2019

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NORTRIPTYLINE HYDROCHLORIDE - Generic Drug Details

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

Nortriptyline hydrochloride is the generic ingredient in four branded drugs marketed by Lilly, Ani Pharms Inc, Aurolife Pharma Llc, Mayne Pharma, Mylan, Taro, Teva, Specgx Llc, Ranbaxy, and Pharm Assoc, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for nortriptyline hydrochloride. Twenty-three suppliers are listed for this compound.

Recent Clinical Trials for NORTRIPTYLINE HYDROCHLORIDE

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

SponsorPhase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2
Duke UniversityPhase 2
Radboud UniversityPhase 4

See all NORTRIPTYLINE HYDROCHLORIDE clinical trials

Pharmacology for NORTRIPTYLINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for NORTRIPTYLINE HYDROCHLORIDE
Synonyms for NORTRIPTYLINE HYDROCHLORIDE
(2)10,d]cycloheptene-.delta.5.gamma.-propylamine, hydrochloride
00FN6IH15D
1-Propanamine, 3-(10,11-dihydro-5H-dibenzo(a,d)cyclohepten-5-ylidene)-N-methyl-, hydrochloride
1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[ a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride
1-Propanamine,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride
10,11-Dihydro-5-(N-methyl-3-aminopropylidene)-5H-dibenzo[a,d]cycloheptene Hydrochloride
10,11-Dihydro-N-methyl-5H-dibenzo(a,d)cycloheptene-delta(sup 5,gamma)-propylamine hydrochloride
3-(10,11-2H-5H-dibenzo[a,d][7]annulen-5-ylidene)-N-methyl-1-propanaminium chloride
3-(10,11-Dihydro-5H-dibenzo[a,d]-cyclohepten-5-ylidene)-N-methyl-1-propanamine
3-(10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine Hydrochloride
3-(5,6-dihydrodibenzo[2,1-b:1',2'-e][7]annulen-11-ylidene)-N-methylpropan-1-amine;hydrochloride
37025-22-2
5-(3-(Methylamino)propylidene)dibenzo(a,e)cyclohepta(1,5)diene hydrochloride
5-(3-Methylaminopropylidene)-10,11-dihydro-5H-dibenzo(a,d)cycloheptene hydrochloride
5-[(3-(Methylamino)propylidene]-10,d]cycloheptene hydrochloride
5-[3-(Methylamino)propylidene]dibenzo[a,5]diene hydrochloride
5H-Dibenzo(a,d)cycloheptene-delta(sup 5),gamma-propylamine, 10-11-dihydro-N-methyl-, hydrochloride
5H-Dibenzo[a,.gamma.-propylamine, 10-11-dihydro-N-methyl-, hydrochloride
5H-Dibenzo[a,.gamma.-propylamine, 10,11-dihydro-N-methyl-, hydrochloride
72-69-5 (free base)
8057-32-7
894-71-3
AC1L9B17
AC1Q3BS4
Acetexa
AKOS015889095
Allegron
Altilev
AOB5370
API0003634
Ateben hydrochloride
Aventyl allegron
Aventyl hydrochloride
BG0274
C-46080
CAS-894-71-3
CCG-212718
CHEBI:7641
CHEMBL1201156
CPD000058486
CS-4913
CTK8G2012
D00816
Desmethylamitriptyline hydrochloride
DSSTox_CID_25109
DSSTox_GSID_45109
DSSTox_RID_80676
DTXSID2045109
EINECS 212-973-0
EN300-26665
EU-0100868
FT-0673146
HMS1568D10
HY-B1417
I01-17298
KS-000017PT
KS-1306
Lilly 38489
LP00868
methyl(3-{tricyclo[9.4.0.0?,?]pentadeca-1(15),3,5,7,11,13-hexaen-2-ylidene}propyl)amine hydrochloride
MFCD00058024
MLS000069673
MLS001077267
MLS002222206
MLS006010656
MolPort-003-959-040
N 7048
N 7261
N-[3-(10,11-dihydro-5H-dibenzo[a,d][7]annulen-5-ylidene)propyl]-N-methylamine hydrochloride
N0957
NC00522
NCGC00014483-01
NCGC00094192-01
NCGC00094192-02
NCGC00261553-01
NE48409
Noramitriptyline hydrochloride
Nortab hydrochloride
Nortrilen
Nortriptylene hydrochloride
Nortriptylin hydrochloride
Nortriptyline (hydrochloride)
Nortriptyline for system suitability, European Pharmacopoeia (EP) Reference Standard
Nortriptyline Hcl
Nortriptyline hdrochloride
Nortriptyline hydrochloride (JP17/USP/INN)
Nortriptyline hydrochloride [USAN:USP:JAN]
Nortriptyline Hydrochloride 1.0 mg/ml in Methanol (as free base)
Nortriptyline hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Nortriptyline hydrochloride, >=98% (TLC), powder
Nortriptyline hydrochloride, British Pharmacopoeia (BP) Reference Standard
Nortriptyline hydrochloride, European Pharmacopoeia (EP) Reference Standard
Nortriptyline hydrochloride, United States Pharmacopeia (USP) Reference Standard
Nortriptyline monohydrochloride
NORTRIPTYLINEHYDROCHLORIDE
Norzepine
NSC 169453
NSC 78248
NSC-169453
NSC-78248
NSC169453
NSC78248
Opera_ID_1915
Pamelor
Pamelor (TN)
Pamelor hydrochloride
Prestwick_366
Psychostyl
REGID_for_CID_441358
SAM002554915
SCHEMBL41329
Sensival
SHAYBENGXDALFF-UHFFFAOYSA-N
SMR000058486
SR-01000000223
SR-01000000223-2
SR-01000000223-7
Tox21_110048
Tox21_500868
UNII-00FN6IH15D
Vividyl
W-109609
WLN: L C676 BY&T&J BU3M1 &GH
Paragraph IV (Patent) Challenges for NORTRIPTYLINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
PAMELOR CAPSULE;ORAL nortriptyline hydrochloride 018013

US Patents and Regulatory Information for NORTRIPTYLINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 075520-004 May 8, 2000 AB RX No No   Start Trial   Start Trial   Start Trial
Teva NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 074132-003 Mar 27, 1995 AB RX No No   Start Trial   Start Trial   Start Trial
Aurolife Pharma Llc NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 074835-001 Jun 30, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Teva NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 073667-004 Apr 11, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Specgx Llc PAMELOR nortriptyline hydrochloride CAPSULE;ORAL 018013-004 Approved Prior to Jan 1, 1982 AB RX Yes No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 074054-003 Dec 31, 1992 DISCN No No   Start Trial   Start Trial   Start Trial
Specgx Llc PAMELOR nortriptyline hydrochloride SOLUTION;ORAL 018012-001 Approved Prior to Jan 1, 1982 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 NORTRIPTYLINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ranbaxy AVENTYL nortriptyline hydrochloride SOLUTION;ORAL 014685-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Lilly AVENTYL HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 014684-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Specgx Llc PAMELOR nortriptyline hydrochloride SOLUTION;ORAL 018012-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Specgx Llc PAMELOR nortriptyline hydrochloride CAPSULE;ORAL 018013-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Specgx Llc PAMELOR nortriptyline hydrochloride CAPSULE;ORAL 018013-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Specgx Llc PAMELOR nortriptyline hydrochloride CAPSULE;ORAL 018013-004 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Specgx Llc PAMELOR nortriptyline hydrochloride CAPSULE;ORAL 018013-001 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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