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Generated: December 10, 2018

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CLARINEX Drug Profile

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When do Clarinex patents expire, and when can generic versions of Clarinex launch?

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

This drug has one hundred and five patent family members in forty-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
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
13-CHLORO-2-(PIPERIDIN-4-YLIDENE)-4-AZATRICYCLO[9.4.0.0(3),?]PENTADECA-1(15),3,5,7,11,13-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
Aerius (TN)
AK163520
AKOS000280921
ALBB-027276
Allex
AN-15105
ANW-42359
API0002262
Azomyr
BB_SC-2104
BBL010777
BC205533
BDBM50073179
BEN691
BG0513
C-19255
C19H19ClN2
CAS-100643-71-8
CC-26349
CCG-101162
CD0143
CHEBI:291342
CHEMBL1172
Claramax
Claramax (TN)
Clarinex (TN)
Clarinex RediTabs
Clarinex(R)
CPD000149358
CS-2639
CTK8B3353
D01GBY
D03693
D3787
DB00967
delopedil
Denosin
Desalex
Descarboethoxyloratadine
descarboethoxyloratidine
Descarboethoxyoratidine
Desloratadine
Desloratadine (JAN/USAN/INN)
Desloratadine (USAN/INN)
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
DR001310
DSSTox_CID_24196
DSSTox_GSID_44196
DSSTox_RID_80112
DTXSID1044196
Essex brand of desloratadine
FT-0602522
FVF865388R
GTPL7157
HMS2052H05
HMS2090C06
HMS2093F19
HMS3394H05
HMS3652O15
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
MLS000559042
MLS000759406
MLS001201801
MLS001424247
MolPort-000-883-875
NC00412
NCGC00159325-02
NCGC00159325-03
NCGC00159325-04
NCGC00159325-05
Neoclarityn
NeoClarityn (TN)
NSC-675447
NSC-759824
NSC675447
NSC759824
Opera_ID_1891
Opulis
Pharmakon1600-01505393
PL039437
Q-200936
R3930
RT-012269
s4012
SAM001246545
SBI-0206828.P001
SC-17296
Sch 34117
Sch-34117
SCHEMBL4425
Schering brand of desloratadine
Schering-Plough brand of desloratadine
SMR000149358
ST24046429
STK586537
TL8000065
Tox21_111574
Tox21_111574_1
UNII-FVF865388R
ZINC1261
ZX-AN025785

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

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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 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for CLARINEX
Drugname Dosage Strength RLD Date
➤ Subscribe Oral Solution 0.5 mg/mL ➤ Subscribe ➤ Sign Up
➤ Subscribe Orally Disintegrating Tablets 2.5 mg and 5 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Tablets 5mg/240mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets 5 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for CLARINEX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008 Austria ➤ Sign Up 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
8 Finland ➤ Sign Up
C063/2007 Ireland ➤ Sign Up SPC063/2007: 20081105, EXPIRES: 20220729
0328 Netherlands ➤ Sign Up
C0004 France ➤ Sign Up PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
McKinsey
Chubb
Citi
Mallinckrodt
Moodys
Fish and Richardson
Express Scripts
Julphar

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