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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Questions you can ask:
- What is the 5 year forecast for CLARINEX?
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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 | 021312-002 | Jul 14, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Organon | CLARINEX | desloratadine | TABLET;ORAL | 021165-001 | Dec 21, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Organon | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-001 | Jun 26, 2002 | ⤷ 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 |
---|---|---|---|
New Zealand | 222253 | 6,11-DIHYDRO-11-(4-PIPERIDYLIDENE)-5H-BENZO C5,6,)CYCLOHEPTA C1,2-B)PYRIDINE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS | ⤷ Sign Up |
Spain | 2097155 | ⤷ Sign Up | |
China | 1935141 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CLARINEX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1110543 | SZ 1/2008 | 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 |
1110543 | C 2008 001 | Romania | ⤷ Sign Up | 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 | 318 | Finland | ⤷ Sign Up | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |