Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Merck
Medtronic
Boehringer Ingelheim
Mallinckrodt
Colorcon
Dow

Last Updated: December 11, 2019

DrugPatentWatch Database Preview

DESLORATADINE; PSEUDOEPHEDRINE SULFATE - Generic Drug Details

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What are the generic sources for desloratadine; pseudoephedrine sulfate and what is the scope of freedom to operate?

Desloratadine; pseudoephedrine sulfate is the generic ingredient in three branded drugs marketed by Merck Sharp Dohme and Dr Reddys Labs Ltd, and is included in three NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Desloratadine; pseudoephedrine sulfate has one hundred and twenty-one patent family members in thirty-nine countries.

There are sixteen drug master file entries for desloratadine; pseudoephedrine sulfate. One supplier is listed for this compound.

Summary for DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Recent Clinical Trials for DESLORATADINE; PSEUDOEPHEDRINE SULFATE

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

SponsorPhase
Dr. Reddy's Laboratories LimitedPhase 1

See all DESLORATADINE; PSEUDOEPHEDRINE SULFATE clinical trials

Recent Litigation for DESLORATADINE; PSEUDOEPHEDRINE SULFATE

Identify potential future generic entrants

District Court Litigation
Case NameDate
MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC.2015-08-06
SCHERING CORPORATION v. SANDOZ INC.2008-04-03
Forest Laboratories Inc. v. Lupin Pharmaceuticals Inc.2008-01-10

See all DESLORATADINE; PSEUDOEPHEDRINE SULFATE litigation

Pharmacology for DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Paragraph IV (Patent) Challenges for DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Tradename Dosage Ingredient NDA Submissiondate
CLARINEX-D 12 HOUR TABLET, EXTENDED RELEASE;ORAL desloratadine; pseudoephedrine sulfate 021313 2007-06-01
CLARINEX-D 12 HOUR TABLET, EXTENDED RELEASE;ORAL desloratadine; pseudoephedrine sulfate 021313 2006-06-21

US Patents and Regulatory Information for DESLORATADINE; PSEUDOEPHEDRINE SULFATE

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   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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; PSEUDOEPHEDRINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for DESLORATADINE; PSEUDOEPHEDRINE SULFATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1110543 91403 Luxembourg   Start Trial 91403, EXPIRES: 20220730
1110543 122008000001 Germany   Start Trial PRODUCT NAME: DESLORATADIN MIT PSEUDOEPHEDRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON PSEUDOEPHEDRIN; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
1110543 318 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Dow
Moodys
Boehringer Ingelheim
AstraZeneca

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 verifification 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.