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Serving leading biopharmaceutical companies globally:

Fuji
McKinsey
Cantor Fitzgerald
Covington
Chubb
Mallinckrodt
Daiichi Sankyo
Boehringer Ingelheim
Johnson and Johnson
Julphar

Generated: February 19, 2018

DrugPatentWatch Database Preview

Loratadine - Generic Drug Details

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

Loratadine
is the generic ingredient in eleven branded drugs marketed by Bayer Healthcare Llc, Marksans Pharma, Taro, Apotex Inc, Perrigo, Ranbaxy Labs Ltd, Silarx, Taro Pharm, Teva, Wockhardt Bio Ag, Pfizer, Actavis Labs Fl Inc, Perrigo Pharma Intl, Sun Pharm Inds Ltd, Mylan, and Pld Acquisitions Llc, and is included in thirty-six NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Loratadine has thirty-three patent family members in twenty-eight countries.

There are thirty-nine drug master file entries for loratadine. One hundred and thirty-three suppliers are listed for this compound.
Pharmacology for loratadine
Medical Subject Heading (MeSH) Categories for loratadine

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
Sun Pharm Inds Ltd LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 076557-001 Sep 22, 2004 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc LORATADINE loratadine TABLET;ORAL 076471-001 Feb 14, 2006 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ranbaxy Labs Ltd LORATADINE loratadine SYRUP;ORAL 076529-001 Aug 20, 2004 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Labs Fl Inc LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 076208-001 Jan 28, 2004 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Labs Fl Inc LORATADINE loratadine TABLET, ORALLY DISINTEGRATING;ORAL 075990-001 Nov 3, 2003 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Silarx LORATADINE loratadine SYRUP;ORAL 077421-001 Jun 29, 2006 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Perrigo LORATADINE loratadine TABLET;ORAL 021512-001 Jun 24, 2004 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer LORATADINE loratadine TABLET, ORALLY DISINTEGRATING;ORAL 075822-001 Feb 10, 2003 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva LORATADINE loratadine SYRUP;ORAL 075505-001 Nov 7, 2003 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Taro LORATADINE loratadine SUSPENSION;ORAL 021734-001 Oct 4, 2005 OTC Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for loratadine

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

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Non-Orange Book US Patents for loratadine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,514,520 Stabilized antihistamine syrup ➤ Sign Up
6,939,550 Stabilized antihistamine syrup ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for loratadine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB01/012 United Kingdom ➤ Sign Up 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
C0004 France ➤ Sign Up PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
01C/013 Belgium ➤ Sign Up PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
C/GB08/005 United Kingdom ➤ Sign Up 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.
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
QuintilesIMS
Colorcon
Covington
Moodys
Julphar
Baxter
Fish and Richardson
Daiichi Sankyo

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.

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