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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.
US ANDA Litigation and Generic Entry Outlook for Clarinex
Clarinex was eligible for patent challenges on December 21, 2005.
There have been thirteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for CLARINEX
| International Patents: | 73 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 5 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 102 |
| Clinical Trials: | 17 |
| Patent Applications: | 3,712 |
| Drug Prices: | Drug price information for CLARINEX |
| Drug Sales Revenues: | Drug sales revenues for CLARINEX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CLARINEX |
| DailyMed Link: | CLARINEX at DailyMed |
Recent Clinical Trials for CLARINEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| UCB Pharma | Phase 4 |
| Derm Research, PLLC | Phase 4 |
| Dr. Reddy's Laboratories Limited | Phase 1 |
Recent Litigation for CLARINEX
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 |
Pharmacology for CLARINEX
| Drug Class | Histamine-1 Receptor Antagonist |
| Mechanism of Action | Histamine H1 Receptor Antagonists |
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 | ||
| >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;ORAL | 021165-001 | Dec 21, 2001 | 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 | 021312-002 | Jul 14, 2005 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CLARINEX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 1302605 | Start Trial |
| Slovenia | 1110543 | Start Trial |
| China | 100415223 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CLARINEX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 300328 | Netherlands | Start Trial | |
| 0152897 | 2001C/013 | Belgium | Start Trial | PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
