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.

Summary for desloratadine

International Patents:	73
US Patents:	7
Tradenames:	5
Applicants:	12
NDAs:	17
Drug Master File Entries:	16
Suppliers / Packagers:	10
Bulk Api Vendors:	97
Clinical Trials:	63
Patent Applications:	5,612
Drug Prices:	Drug price trends for desloratadine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for desloratadine
DailyMed Link:	desloratadine at DailyMed

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

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

See all desloratadine clinical trials

Recent Litigation for desloratadine

Identify potential future generic entrants

District Court Litigation

Case Name	Date
MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC.	2015-08-06
Purdue Pharmaceutical v. Actavis Elizabeth LLC	2015-05-13
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 Pricing	5MG	TABLET; ORAL
See Pricing	See Pricing	5MG	TABLET; 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

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

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

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Glossary

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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

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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

International Patents for desloratadine

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Country	Patent Number	Estimated Expiration
Poland	344714	See Pricing
Norway	20006503	See Pricing
Portugal	1674084	See Pricing
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for desloratadine

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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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