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Last Updated: October 16, 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 patent protection?

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

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

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

Drug Prices for desloratadine

See drug prices for desloratadine

Drug Sales Revenue Trends for desloratadine

See drug sales revenues for desloratadine

Recent Clinical Trials for desloratadine

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

SponsorPhase
Xiangya Hospital of Central South UniversityPhase 1/Phase 2
National Institute of Allergy and Infectious Diseases (NIAID)Phase 4
Johns Hopkins UniversityPhase 4

See all desloratadine clinical trials

Recent Litigation for desloratadine

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 desloratadine litigation

Generic filers with tentative approvals for DESLORATADINE
Applicant Application No. Strength Dosage Form
  See Pricing  See Pricing5MGTABLET; ORAL
  See Pricing  See Pricing5MGTABLET; 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 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
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
Clarinex (TN)
Clarinex RediTabs
Clarinex(R)
CPD000149358
CS-2639
CTK8B3353
D03693
D3787
DB00967
Denosin
Desalex
Descarboethoxyloratadine
Descarboethoxyoratidine
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

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   See Pricing   See Pricing   See Pricing
Dr Reddys Labs Ltd DESLORATADINE desloratadine TABLET;ORAL 078365-001 Mar 8, 2011 AB RX No No   See Pricing   See Pricing   See Pricing
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
>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 desloratadine

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

Supplementary Protection Certificates for desloratadine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1110543 C 2008 001 Romania   See Pricing 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
1110543 SPC063/2007 Ireland   See Pricing SPC063/2007: 20081105, EXPIRES: 20220729
1110543 91403 Luxembourg   See Pricing 91403, EXPIRES: 20220730
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Merck
Boehringer Ingelheim
Express Scripts
Baxter

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