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Generated: February 18, 2019

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Desloratadine - Generic Drug Details

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

Desloratadine is the generic ingredient in five branded drugs marketed by Merck Sharp Dohme, Taro Pharm, Taro Pharm Inds Ltd, Reddys, Belcher Pharms, Dr Reddys Labs Ltd, Lupin Pharms, Mylan Pharms Inc, Orchid Hlthcare, Perrigo R And D, Sandoz, and Sun Pharm Inds, and is included in seventeen NDAs. There are eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Desloratadine has one hundred and five patent family members in forty-seven countries.

There are sixteen drug master file entries for desloratadine. Thirteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Pharmacology for desloratadine
Synonyms for desloratadine
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
Clarinex (TN)
Clarinex RediTabs
Clarinex(R)
CPD000149358
CS-2639
CTK8B3353
D01GBY
D03693
D3787
DB00967
delopedil
Denosin
Desalex
Descarboethoxyloratadine
descarboethoxyloratidine
Descarboethoxyoratidine
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
Tentative approvals for DESLORATADINE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial5MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial5MGTABLET; ORAL

US Patents and Regulatory Information for desloratadine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 078366-001 Apr 26, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Perrigo R And D DESLORATADINE desloratadine TABLET;ORAL 078361-001 Dec 22, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX desloratadine SOLUTION;ORAL 021300-001 Sep 1, 2004 AA RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Reddys DESLORATADINE desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 078367-001 Jul 12, 2010 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 desloratadine

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 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX desloratadine SOLUTION;ORAL 021300-001 Sep 1, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX desloratadine SOLUTION;ORAL 021300-001 Sep 1, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for desloratadine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
403 Luxembourg ➤ Try a Free Trial 91403, EXPIRES: 20220730
2008 Austria ➤ Try a Free 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
2008000001 Germany ➤ Try a Free Trial PRODUCT NAME: DESLORATADIN MIT PSEUDOEPHEDRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON PSEUDOEPHEDRIN; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
8 Finland ➤ Try a Free Trial
1/2008 Austria ➤ Try a Free Trial PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS
C0004 France ➤ Try a Free Trial PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
C/GB08/005 United Kingdom ➤ Try a Free Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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