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Desloratadine - Generic Drug Details
What are the generic drug sources for desloratadine and what is the scope of desloratadine freedom to operate?
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.There are sixteen drug master file entries for desloratadine. Twelve suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for desloratadine
| US Patents: | 8 |
| Tradenames: | 5 |
| Applicants: | 12 |
| NDAs: | 17 |
| Drug Master File Entries: | 16 |
| Suppliers / Packagers: | 12 |
| Bulk Api Vendors: | 85 |
| Clinical Trials: | 62 |
| Patent Applications: | 5,751 |
| Drug Prices: | Drug price information for desloratadine |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for desloratadine |
| DailyMed Link: | desloratadine at DailyMed |
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 |
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||
| 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 | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-002 | Jul 14, 2005 | AB | RX | Yes | No | ➤ 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 |
Expired US Patents for desloratadine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 |
| Merck Sharp Dohme | CLARINEX | desloratadine | SOLUTION;ORAL | 021300-001 | Sep 1, 2004 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for desloratadine
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 4166948 | ➤ Sign Up |
| Netherlands | 1012191 | ➤ Sign Up |
| South Africa | 200007714 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for desloratadine
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0004 | France | ➤ Sign Up | PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730 |
| 0328 | Netherlands | ➤ Sign Up | |
| 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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