Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
Medtronic
Merck
Boehringer Ingelheim
McKesson

Last Updated: December 8, 2019

DrugPatentWatch Database Preview

Loratadine; pseudoephedrine sulfate - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

What are the generic sources for loratadine; pseudoephedrine sulfate and what is the scope of patent protection?

Loratadine; pseudoephedrine sulfate is the generic ingredient in three branded drugs marketed by Bayer Healthcare Llc, Heritage Pharma, P And L, Perrigo Pharma Intl, and Sun Pharm Inds Ltd, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-nine drug master file entries for loratadine; pseudoephedrine sulfate. Forty-three suppliers are listed for this compound.

Recent Clinical Trials for loratadine; pseudoephedrine sulfate

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

SponsorPhase
BayerPhase 1
BayerPhase 4
Azidus BrasilPhase 3

See all loratadine; pseudoephedrine sulfate clinical trials

Recent Litigation for loratadine; pseudoephedrine sulfate

Identify potential future generic entrants

District Court Litigation
Case NameDate
MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC.2015-08-06
Simonian v. Merck & Co., Inc.2010-02-25
SCHERING CORPORATION v. SANDOZ INC.2008-04-03

See all loratadine; pseudoephedrine sulfate litigation

Paragraph IV (Patent) Challenges for LORATADINE; PSEUDOEPHEDRINE SULFATE
Tradename Dosage Ingredient NDA Submissiondate
CLARITIN-D TABLET, EXTENDED RELEASE;ORAL loratadine; pseudoephedrine sulfate 019670
CLARITIN-D 24 HOUR TABLET, EXTENDED RELEASE;ORAL loratadine; pseudoephedrine sulfate 020470

US Patents and Regulatory Information for loratadine; pseudoephedrine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo Pharma Intl LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 075989-001 Mar 4, 2004 OTC No No   Start Trial   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN-D 24 HOUR loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 020470-002 Nov 27, 2002 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Heritage Pharma LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 076208-001 Jan 28, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN-D loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 019670-002 Nov 27, 2002 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 076557-001 Sep 22, 2004 OTC No No   Start Trial   Start Trial   Start Trial
Perrigo Pharma Intl LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 076050-001 Jan 30, 2003 OTC No No   Start Trial   Start Trial   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 loratadine; pseudoephedrine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare Llc CLARITIN-D loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 019670-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN-D 24 HOUR loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 020470-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN-D 24 HOUR loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 020470-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN-D 24 HOUR loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 020470-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN-D loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 019670-002 Nov 27, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
Dow
Mallinckrodt
Boehringer Ingelheim
McKesson

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.