Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Dow
Baxter
McKinsey
McKesson
Express Scripts
Medtronic

Last Updated: August 15, 2022

CLARINEX Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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

< Available with Subscription >

  Try it Free

Summary for CLARINEX
Drug patent expirations by year for CLARINEX
Drug Prices for CLARINEX

See drug prices for CLARINEX

Drug Sales Revenue Trends for CLARINEX

See drug sales revenues for CLARINEX

Recent Clinical Trials for CLARINEX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
J. Uriach and CompanyPhase 1
Derm Research, PLLCPhase 4
UCB PharmaPhase 4

See all CLARINEX clinical trials

Pharmacology 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

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Organon CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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;ORAL 021165-001 Dec 21, 2001 See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005 See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001 See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001 See Plans and Pricing See Plans and Pricing
Organon CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 See Plans and Pricing See Plans and Pricing
>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
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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
McKinsey
Baxter
Mallinckrodt
Medtronic
Harvard Business School

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.