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Last Updated: August 3, 2020

DrugPatentWatch Database Preview

LORATADINE - Generic Drug Details

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

Loratadine is the generic ingredient in eleven branded drugs marketed by Bayer Healthcare Llc, Bionpharma Inc, Marksans Pharma, Strides Pharma, Taro, Aurobindo Pharma Ltd, Lannett Co Inc, Perrigo, Pharm Assoc, Ranbaxy Labs Ltd, Teva, Wockhardt Bio Ag, Perrigo Pharma Intl, Sun Pharm, Glaxosmithkline, Actavis Labs Fl Inc, Sun Pharm Inds Ltd, Apotex Inc, Granules India Ltd, Guardian Drug, Mylan, Pld Acquisitions Llc, Heritage Pharma, and P And L, and is included in forty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-nine drug master file entries for loratadine. One hundred and sixteen suppliers are listed for this compound.

Drug Prices for LORATADINE

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Drug Sales Revenue Trends for LORATADINE

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Recent Clinical Trials for LORATADINE

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

SponsorPhase
Mayo ClinicPhase 2
Rutgers, The State University of New JerseyEarly Phase 1
National Cancer Institute (NCI)Early Phase 1

See all LORATADINE clinical trials

Medical Subject Heading (MeSH) Categories for LORATADINE
Paragraph IV (Patent) Challenges for LORATADINE
Tradename Dosage Ingredient NDA Submissiondate
CLARITIN HIVES RELIEF SYRUP;ORAL loratadine 020641
CLARITIN TABLET;ORAL loratadine 019658
CLARITIN HIVES RELIEF REDITAB TABLET, ORALLY DISINTEGRATING;ORAL loratadine 020704
CLARITIN HIVES RELIEF TABLET;ORAL loratadine 019658
CLARITIN REDITABS TABLET, ORALLY DISINTEGRATING;ORAL loratadine 020704
CLARITIN SYRUP;ORAL loratadine 020641

US Patents and Regulatory Information for LORATADINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan LORATADINE loratadine TABLET;ORAL 075790-001 Nov 7, 2008 DISCN No No   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
Aurobindo Pharma Ltd LORATADINE loratadine TABLET;ORAL 208314-001 Apr 16, 2018 OTC No No   Start Trial   Start Trial   Start Trial
Wockhardt Bio Ag LORATADINE loratadine SYRUP;ORAL 075815-001 Aug 20, 2004 OTC No No   Start Trial   Start Trial   Start Trial
Guardian Drug LORATADINE loratadine TABLET;ORAL 207569-001 Mar 12, 2019 OTC No No   Start Trial   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN REDITABS loratadine TABLET, ORALLY DISINTEGRATING;ORAL 021993-001 Dec 12, 2006 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd LORATADINE REDIDOSE loratadine TABLET, ORALLY DISINTEGRATING;ORAL 077153-001 Apr 11, 2007 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare Llc CLARITIN loratadine TABLET;ORAL 019658-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN loratadine SYRUP;ORAL 020641-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN loratadine SYRUP;ORAL 020641-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN REDITABS loratadine TABLET, ORALLY DISINTEGRATING;ORAL 020704-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN REDITABS loratadine TABLET, ORALLY DISINTEGRATING;ORAL 020704-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN loratadine TABLET;ORAL 019658-002 Nov 27, 2002   Start Trial   Start Trial
Bayer Healthcare Llc CLARITIN loratadine SYRUP;ORAL 020641-002 Nov 27, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Boehringer Ingelheim
Baxter
Medtronic
Merck

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