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Last Updated: October 23, 2019

DrugPatentWatch Database Preview

CLARINEX Drug Profile

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Which patents cover Clarinex, and what generic alternatives are available?

Clarinex is a drug marketed by Merck Sharp Dohme and is included in five NDAs. There are seven patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-three patent family members in thirty-seven countries.

The generic ingredient in CLARINEX is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.

Drug patent expirations by year for CLARINEX
Drug Prices for CLARINEX

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Drug Sales Revenue Trends for CLARINEX

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Recent Clinical Trials for CLARINEX

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

SponsorPhase
Derm Research, PLLCPhase 4
UCB PharmaPhase 4
Dr. Reddy's Laboratories LimitedPhase 1

See all CLARINEX clinical trials

Recent Litigation for CLARINEX

Identify potential future generic entrants

District Court Litigation
Case NameDate
MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC.2015-08-06
Purdue Pharmaceutical v. Actavis Elizabeth LLC2015-05-13
Simonian v. Merck & Co., Inc.2010-02-25

See all CLARINEX litigation

Pharmacology for CLARINEX
Synonyms for CLARINEX
100643-71-8
13-chloro-2-(piperidin-4-ylidene)-4-azatricyclo[9.4.0.0;{3,8}]pentadeca-1(11),3,5,7,12,14-hexaene
4-(8-chloro-5,6-dihydro-11 H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine
4-(8-chloro-5,6-dihydro-11H-benzo-[5,6]cyclohepta(1,2-b]pyridin-11-ylidene)-piperidine
4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta [1,2-b]pyridin-11-ylidene) piperidine
4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta(1,2-b]pyridin-11-ylidene)-piperidine
4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene) piperidine
4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine
4-{8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene}-piperidine
4-{8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene}piperidine
5H-Benzo(5,6)cyclohepta(1,2-b)pyridine, 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-
5H-Benzo(5,6)cyclohepta(1,2-b)pyridine,8-chloro-6,11-dihydro-11-(4-piperidinyllidene)-
5H-Benzo[5,6]cyclohepta[1,2-b]pyridine, 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-
643D718
8-chloro-11-(4-piperidyliden)-6,11-dihydro-5H-benzo[5,6]cyclohepta [1,2-b]pyridine
8-chloro-11-(4-piperidyliden)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine
8-CHLORO-11-(4-PIPERIDYLIDENE)-6,11-DIHYDRO-5H-BENZO[5,6]CYCLOHEPTA[1,2-b]PYRIDINE
8-chloro-11-(4-piperidylidene)-6,11-dihydro-5h-benzo[5.6]cyclohepta[1,2-b]pyridine
8-chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine
8-Chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine (Descarboethoxyloratadine; Desloratadine)
8-chloro-11-piperidin-4-ylidene-5,6-dihydrobenzo[1,2]cyclohepta[2,4-b]pyridine
8-Chloro-11-piperidin-4-ylidene-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine
8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5h-benzo[5,6]cyclohepta[1,2-b]pyridine
8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H- benzo[5,6]cyclohepta[1,2,b]pyridine
8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo(5,6)cyclohepta(1,2-b)pyridine
8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine
8-chloro-6,11-dihydro-11-(4-piperidylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine
A19515
AB0012600
AB00456701_14
AB00456701_15
AB00456701-11
AB00456701-13
AC-1279
AC1L3XUD
Aerius
AK163520
AKOS000280921
ALBB-027276
Allex
AN-15105
ANW-42359
API0002262
Azomyr
BBL010777
BC205533
BCP02340
BDBM50073179
BEN691
BG0513
BRD-K82357231-001-13-4
C-19255
C19H19ClN2
CAS-100643-71-8
CC-26349
CCG-101162
CD0143
CHEBI:291342
CHEMBL1172
Claramax
Clarinex (TN)
Clarinex RediTabs
Clarinex(R)
CPD000149358
CS-2639
CTK8B3353
D03693
D3787
DB00967
Denosin
Desalex
Descarboethoxyloratadine
Descarboethoxyoratidine
Desloratadine
Desloratadine (JAN/USAN/INN)
Desloratadine [USAN:INN:BAN]
Desloratadine [USAN]
Desloratadine for system suitability, European Pharmacopoeia (EP) Reference Standard
Desloratadine, European Pharmacopoeia (EP) Reference Standard
Desloratadine, powder, >=98% (HPLC)
Desloratadine, United States Pharmacopeia (USP) Reference Standard
Desloratidine
Desloratidine, Pharmaceutical Secondary Standard; Certified Reference Material
DSSTox_CID_24196
DSSTox_GSID_44196
DSSTox_RID_80112
DTXSID1044196
FT-0602522
FVF865388R
GTPL7157
HMS2052H05
HMS2090C06
HMS2093F19
HMS3394H05
HMS3652O15
HMS3715J15
HY-B0539
I06-1866
J10309
JAUOIFJMECXRGI-UHFFFAOYSA-N
KS-00000G0C
KS-1048
L001025
Loratadine Related Compound A, United States Pharmacopeia (USP) Reference Standard
LS-181814
MCULE-2975958622
MFCD00871949
MK-4117
MLS000559042
MLS000759406
MLS001201801
MLS001424247
MolPort-000-883-875
NC00412
NCGC00159325-02
NCGC00159325-03
NCGC00159325-04
NCGC00159325-05
Neoclarityn
NSC-675447
NSC-759824
NSC675447
NSC759824
Opera_ID_1891
Opulis
Pharmakon1600-01505393
Q-200936
R3930
RT-012269
s4012
SAM001246545
SB17503
SBI-0206828.P001
SC-17296
Sch 34117
Sch-34117
SCHEMBL4425
SMR000149358
SR-01000668962
SR-01000668962-4
SR-01000668962-5
SR-01000668962-8
ST24046429
STK586537
SW197792-3
TL8000065
Tox21_111574
Tox21_111574_1
UNII-FVF865388R
ZINC1261
ZX-AN025785
Paragraph IV (Patent) Challenges for CLARINEX
Tradename Dosage Ingredient NDA Submissiondate
CLARINEX SOLUTION;ORAL desloratadine 021300 2008-05-08
CLARINEX TABLET;ORAL desloratadine 021165 2006-06-21

US Patents and Regulatory Information for CLARINEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme CLARINEX desloratadine SOLUTION;ORAL 021300-001 Sep 1, 2004 AA RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 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 CLARINEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX desloratadine SOLUTION;ORAL 021300-001 Sep 1, 2004   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CLARINEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1110543 318 Finland   Start Trial
1110543 300328 Netherlands   Start Trial
1110543 122008000001 Germany   Start Trial PRODUCT NAME: DESLORATADIN MIT PSEUDOEPHEDRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON PSEUDOEPHEDRIN; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
1110543 1/2008 Austria   Start Trial PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
1110543 08C0004 France   Start Trial PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
1110543 C 2008 001 Romania   Start Trial PRODUCT NAME: COMBINATIE DE DESLORATADINA, OPTIONAL SUB FORMA DE SAREACCEPTABILA FARMACEUTIC SI PSEUDOEFEDRINA OPTIONAL SUB FORMA DE SARE SAU ESTER ACCEPTABILEFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/399/001, RO EU/1/07/399/002, RO EU/1/07/399/003, RO EU/1/07/399/004, RO EU/1/07/399/005, RO EU/1/07/399/006; DATE OF NATIONAL AUTHORISATION: 20070730; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/399/001, EU/1/07/399/002, EU/1/07/399/003, EU/1/07/399/004, EU/1/07/399/005, EU/1/07/399/006; DATE OF FIRST AUTHORISATION IN EEA: 20070730
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Johnson and Johnson
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Boehringer Ingelheim
Medtronic
Dow
AstraZeneca

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