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 and Organon and is included in five NDAs. There are two patents protecting this drug and two Paragraph IV challenges.
The generic ingredient in CLARINEX is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.
DrugPatentWatch® Generic Entry Outlook for Clarinex
Clarinex was eligible for patent challenges on December 21, 2005.
There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for CLARINEX
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 5 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 122 |
Clinical Trials: | 19 |
Patent Applications: | 4,776 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for CLARINEX
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
Expired US Patents for CLARINEX
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 | |
N.V. Organon | Aerius | desloratadine | EMEA/H/C/000313 Aerius is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria. |
Authorised | no | no | no | 2001-01-15 | |
N.V. Organon | Neoclarityn | desloratadine | EMEA/H/C/000314 Neoclarityn is indicated for the relief of symptoms associated with:allergic rhinitisurticaria |
Authorised | no | no | no | 2001-01-15 | |
Teva B.V | Desloratadine Teva | desloratadine | EMEA/H/C/002419 Desloratadine Teva is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria. |
Authorised | yes | no | no | 2011-11-24 | |
Krka, d.d., Novo mesto | Dasselta | desloratadine | EMEA/H/C/002310 Dasselta is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria. |
Authorised | yes | no | no | 2011-11-28 | |
>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 |
---|---|---|---|
Czech Republic | 9702026 | See Plans and Pricing | |
Netherlands | 300042 | See Plans and Pricing | |
Hungary | T77315 | See Plans and Pricing | |
Saudi Arabia | 1490 | تركيبة جرعة تؤخذ بالفم ممتدة الانطلاق (EXTENDED RELEASE ORAL DOSAGE COMPOSITION) | See Plans and Pricing |
New Zealand | 300398 | Pharmaceutical uses of the pyridine derivative descarboethoxyloratadine (DCL) | See Plans and Pricing |
Egypt | 23908 | Stabilized antihistamine syrup | See Plans and Pricing |
Guatemala | 199900072 | JARABE ANTIHISTAMINICO ESTABILIZADO. | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CLARINEX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1110543 | 08C0004 | France | See Plans and Pricing | PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730 |
1110543 | CA 2008 00010 | Denmark | See Plans and Pricing | PRODUCT NAME: KOMBINATION OMFATTENDE DESLORATADIN OG PSEUDOEPHEDRIN, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT IFOELGE NEDENSTAENDE GRUNDPATENT, HERUNDER PSEUDOEPHEDRIN SOM SULFAT |
0152897 | SPC/GB01/012 | United Kingdom | See Plans and Pricing | 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 |
1110543 | 300328 | Netherlands | See Plans and Pricing | |
1110543 | 318 | Finland | See Plans and Pricing | |
1110543 | SZ 1/2008 | Austria | See Plans and Pricing | PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS |
1110543 | SPC/GB08/005 | United Kingdom | See Plans and Pricing | 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 |