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Last Updated: June 24, 2021

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Loratadine - Generic Drug Details

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What are the generic drug 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, Fdn Consumer, Actavis Labs Fl Inc, Glaxosmithkline, Rubicon, Tenshi, Sun Pharm Inds Ltd, Apotex Inc, Granules, Guardian Drug, Mylan, Pld Acquisitions Llc, Unique Pharm, Heritage Pharma, and P And L, and is included in forty-nine 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 eighteen 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
National Cancer Institute (NCI)Early Phase 1
Rutgers, The State University of New JerseyEarly 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
Bayer Healthcare Llc CLARITIN HIVES RELIEF loratadine SYRUP;ORAL 020641-003 Nov 19, 2003 DISCN Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Pharm Assoc LORATADINE loratadine SYRUP;ORAL 075565-001 Oct 5, 2004 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Perrigo Pharma Intl LORATADINE loratadine TABLET, ORALLY DISINTEGRATING;ORAL 076011-001 Sep 29, 2003 OTC No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Perrigo Pharma Intl LORATADINE loratadine TABLET, CHEWABLE;ORAL 210033-001 Jun 12, 2019 OTC No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Wockhardt Bio Ag LORATADINE loratadine SYRUP;ORAL 075815-001 Aug 20, 2004 OTC No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Taro LORATADINE loratadine SYRUP;ORAL 076805-001 Aug 20, 2004 OTC No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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 REDITABS loratadine TABLET, ORALLY DISINTEGRATING;ORAL 020704-002 Nov 27, 2002   Try Before You Buy   Try Before You Buy
Bayer Healthcare Llc CLARITIN loratadine TABLET;ORAL 019658-002 Nov 27, 2002   Try Before You Buy   Try Before You Buy
Bayer Healthcare Llc CLARITIN loratadine TABLET;ORAL 019658-002 Nov 27, 2002   Try Before You Buy   Try Before You Buy
Bayer Healthcare Llc CLARITIN loratadine SYRUP;ORAL 020641-002 Nov 27, 2002   Try Before You Buy   Try Before You Buy
Bayer Healthcare Llc CLARITIN REDITABS loratadine TABLET, ORALLY DISINTEGRATING;ORAL 020704-002 Nov 27, 2002   Try Before You Buy   Try Before You Buy
Bayer Healthcare Llc CLARITIN loratadine SYRUP;ORAL 020641-002 Nov 27, 2002   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.