CLARINEX Drug Patent Profile
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When do Clarinex patents expire, and when can generic versions of Clarinex launch?
Clarinex is a drug marketed by Merck Sharp Dohme, Organon, and Organon Llc. and is included in five NDAs.
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.
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Summary for CLARINEX
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 19 |
| Patent Applications: | 4,296 |
| Drug Prices: | Drug price information for CLARINEX |
| What excipients (inactive ingredients) are in CLARINEX? | CLARINEX excipients list |
| DailyMed Link: | CLARINEX at DailyMed |
Recent Clinical Trials for CLARINEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| J. Uriach and Company | Phase 1 |
| Derm Research, PLLC | Phase 4 |
| UCB Pharma | Phase 4 |
Pharmacology for CLARINEX
| Drug Class | Histamine-1 Receptor Antagonist |
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Paragraph IV (Patent) Challenges for CLARINEX
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CLARINEX | Oral Solution | desloratadine | 0.5 mg/mL | 021300 | 1 | 2008-05-08 |
| CLARINEX | Orally Disintegrating Tablets | desloratadine | 2.5 mg and 5 mg | 021165 | 3 | 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 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Organon | CLARINEX | desloratadine | TABLET;ORAL | 021165-001 | Dec 21, 2001 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-002 | Jul 14, 2005 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 CLARINEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-001 | Jun 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-002 | Jul 14, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-002 | Jul 14, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for CLARINEX
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Actavis Group PTC ehf | Desloratadine Actavis | desloratadine | EMEA/H/C/002435 Treatment of allergic rhinitis and urticaria. |
Authorised | yes | no | no | 2012-01-13 | |
| N.V. Organon | Azomyr | desloratadine | EMEA/H/C/000310 Azomyr is indicated for the relief of symptoms associated with:allergic rhinitis (see section 5.1)urticaria (see section 5.1) |
Authorised | no | no | no | 2001-01-15 | |
| Ratiopharm GmbH | Desloratadine ratiopharm | desloratadine | EMEA/H/C/002404 Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:allergic rhinitischronic idiopathic urticaria as initially diagnosed by a physician |
Authorised | yes | no | no | 2012-01-13 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for CLARINEX
See the table below for patents covering CLARINEX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hong Kong | 1008185 | ⤷ Sign Up | |
| China | 100415223 | ⤷ Sign Up | |
| Argentina | 246520 | PROCEDIMIENTO PARA PRODUCIR 6,11-DIHIDRO-11-(4-PIPERIDILIDENO)-5H-BENZO¡5.6¿CICLOHEPTA¡1,2-B¿PIRIDINAS Y METODO PARA PREPARAR UNA COMPOSICION QUE UTILIZA EL COMPUESTO ASI OBTENIDO. (ANTIALLERGIC 6,11-DIHYDRO-11-(4-PIPERIDYLIDENE)-5H-BENZO(5,6)CYCLOHEPTA(1, 2-B)PYRIDINES) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CLARINEX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0152897 | SPC/GB01/012 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: DESLORATADINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/157/001-013 20010115; UK EU/1/00/158/001-013 20010115; UK EU/1/00/159/001-013 20010115; UK EU/1/00/160/001-013 20010115; UK EU/1/00/161/001-013 20010115 |
| 0152897 | C00152897/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH |
| 1110543 | SPC/GB08/005 | United Kingdom | ⤷ Sign Up | 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. |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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