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: October 20, 2019

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Sertraline hydrochloride - Generic Drug Details

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What are the generic sources for sertraline hydrochloride and what is the scope of freedom to operate?

Sertraline hydrochloride is the generic ingredient in two branded drugs marketed by Aci Healthcare Ltd, Aurobindo Pharma, Ranbaxy Labs Ltd, Pfizer, Accord Hlthcare, Anda Repository, Apotex Inc, Austarpharma Llc, Cadila, Chartwell Molecular, Fosun Pharma, Heritage Pharma, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan, Mylan Pharms Inc, Oxford Pharms, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Torrent Pharms, and Wockhardt, and is included in thirty-one NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sertraline hydrochloride has fifty-two patent family members in forty-five countries.

There are twenty-two drug master file entries for sertraline hydrochloride. Forty-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for sertraline hydrochloride

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

SponsorPhase
University of North Carolina, Chapel HillPhase 4
Noam SoreniPhase 3
Janssen-Cilag International NVPhase 3

See all sertraline hydrochloride clinical trials

Recent Litigation for sertraline hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Valeant International, Bermuda v. Watson Pharmaceuticals Inc.2010-02-19
Teva Pharmaceutical Industries Ltd. v. Torrent Pharmaceuticals Ltd.2007-05-25

See all sertraline hydrochloride litigation

Generic filers with tentative approvals for SERTRALINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 100MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 50MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 25MG BASETABLET;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 sertraline hydrochloride
Medical Subject Heading (MeSH) Categories for sertraline hydrochloride
Synonyms for sertraline hydrochloride
(+)-cis-(1S,4S)-1-methylamino-4-(3,4-dichlorophenyl)tetralin hydrochloride
(+)-sertraline hydrochloride
(+/-)-Sertraline Hydrochloride
(1 s-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphathalenamine hydrochloride
(1s-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphathalenamine hydrochloride
(1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride
(1S-cis)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalen-1-amine hydrochloride
(1S,4-Dichlorophenyl)-1,2,3,4-tetrahydro-1-naphthyl(methyl)amine hydrochloride
(1S,4S)-1-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-4-(methylamino)naphthalene Hydrochloride
(1S,4S)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride
(1S,4S)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine hydrochloride
(1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalen-1-amine hydrochloride
(1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalen-1-amine;hydrochloride
(1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalen-1-aminium chloride
(1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-tetralin-1-amine hydrochloride
[(1S,4S)-4-(3,4-dichlorophenyl)(1,2,3,4-tetrahydronaphthyl)]methylamine, chlor ide
1-Naphthalenamine, 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-, hydrochloride, (1S-cis)-
1-Naphthalenamine, 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-, hydrochloride,(1S-cis)-
1-naphthalenamine,1,2,3,4-tetrahydro-4-(3,4-dichlorophenyl)-N-methyl-,(1S-cis)-
559S970
79559-97-0
79617-95-1
79617-96-2 (Parent)
79617-99-5
AB07662
AC-740
AC1L1Y71
Adjuvin
AKOS005267232
AKOS015846322
AN-15588
AOB2376
Aremis
ARONIS24360
Atruline
BC216562
BLFQGGGGFNSJKA-XHXSRVRCSA-N
BR-72966
C17H17Cl2N.HCl
C17H18Cl3N
CAS-79559-97-0
CCG-39575
CHEBI:9124
CHEMBL1709
Cp 51,974-1
Cp-51,974-1
CP-51974-1
CP-5197401
CP-519741
CPD000466298
CS-2052
CS0024
CTK8E2603
D00825
DSSTox_CID_20243
DSSTox_GSID_40243
DSSTox_RID_79456
DTXSID1040243
EU-0100870
FT-0641726
Gladem
HMS1922P09
HY-B0176A
I14-16426
J10439
KB-205456
KS-00000H1Y
KS-1111
LP00870
LS-94166
Lustral
MCULE-1681469163
MFCD00895772
MLS000758929
MLS001401398
MolPort-003-666-622
NC00198
NC00726
NCGC00092386-01
NCGC00092386-03
NCGC00092386-13
NCGC00261555-01
NE57257
NSC-746308
NSC-758948
NSC746308
NSC758948
Pharmakon1600-01505262
rac-cis-Sertraline Hydrochloride
rac-Sertraline Hydrochloride ((1RS,4RS)-4-(3,4-Dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalen-1-amine Hydrochloride)
S0507
S4053
SAM001246666
SAM001247100
SAM002700175
SBB080777
SC-16255
SCHEMBL23230
Serad
Serlift
SERTALINE HYDROCHLORIDE
Sertraline (hydrochloride)
Sertraline for peak identification, European Pharmacopoeia (EP) Reference Standard
Sertraline for system suitability, European Pharmacopoeia (EP) Reference Standard
Sertraline HCl
SERTRALINE HYDRECHLORIDE
Sertraline Hydrochloride (1S-cis)-Isomer
Sertraline hydrochloride (JAN/USAN)
Sertraline hydrochloride [USAN:USP]
Sertraline hydrochloride [USAN]
Sertraline Hydrochloride 1.0 mg/ml in Methanol (as free base)
Sertraline hydrochloride racemic mixture, United States Pharmacopeia (USP) Reference Standard
Sertraline hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Sertraline hydrochloride, >=98% (HPLC)
Sertraline hydrochloride, British Pharmacopoeia (BP) Reference Standard
Sertraline hydrochloride, European Pharmacopoeia (EP) Reference Standard
Sertraline hydrochloride, United States Pharmacopeia (USP) Reference Standard
Sertraline Impurity G HCl
Sertraline, HCl
Sertraline.HCl
SMR000466298
SPECTRUM1505262
ST24031612
Tatig
TL8005382
Tox21_111199
Tox21_111199_1
Tox21_500870
TR-031501
Tresleen
UNII-UTI8907Y6X
UTI8907Y6X
Zoloft
Zoloft (TN)

US Patents and Regulatory Information for sertraline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 076882-001 Feb 6, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Invagen Pharms SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077397-003 Feb 6, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Pfizer ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-003 Dec 30, 1991 DISCN Yes No   Start Trial   Start Trial   Start Trial
Heritage Pharma SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077663-002 Feb 6, 2007 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 sertraline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-003 Dec 30, 1991   Start Trial   Start Trial
Pfizer ZOLOFT sertraline hydrochloride CONCENTRATE;ORAL 020990-001 Dec 7, 1999   Start Trial   Start Trial
Pfizer ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-004 Dec 30, 1991   Start Trial   Start Trial
Pfizer ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-001 Dec 30, 1991   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:

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Boehringer Ingelheim
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McKinsey
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Mallinckrodt

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