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Serving leading biopharmaceutical companies globally:

Cerilliant
Daiichi Sankyo
Merck
Colorcon
McKesson
Teva
Boehringer Ingelheim
Moodys
Chubb
Argus Health

Generated: December 12, 2017

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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 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, Pfizer, Actavis Labs Fl Inc, Perrigo Pharma Intl, Sun Pharm Inds Ltd, Mylan, and Sandoz, 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 and four supplementary protection certificates in three countries.

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

Pharmacology for loratadine

Medical Subject Heading (MeSH) Categories for loratadine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Apotex IncLORATADINEloratadineSYRUP;ORAL075565-001Oct 5, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Bayer Healthcare LlcCLARITINloratadineTABLET;ORAL019658-002Nov 27, 2002OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Bayer Healthcare LlcCLARITIN-D 24 HOURloratadine; pseudoephedrine sulfateTABLET, EXTENDED RELEASE;ORAL020470-002Nov 27, 2002OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Marksans PharmaLORATADINEloratadineCAPSULE;ORAL206214-001Sep 23, 2016OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
MylanLORATADINEloratadineTABLET;ORAL078447-001Aug 12, 2011OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
SilarxLORATADINEloratadineSYRUP;ORAL077421-001Jun 29, 2006OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
MylanLORATADINEloratadineTABLET;ORAL076154-001Aug 20, 2003OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
TaroLORATADINEloratadineSUSPENSION;ORAL021734-001Oct 4, 2005OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
PerrigoLORATADINEloratadineTABLET;ORAL076301-001Jun 25, 2004OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharm Inds LtdLORATADINEloratadineTABLET;ORAL076134-001Aug 18, 2003OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: loratadine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare LlcCLARITINloratadineSYRUP;ORAL020641-002Nov 27, 2002► Subscribe► Subscribe
Bayer Healthcare LlcCLARITINloratadineTABLET;ORAL019658-002Nov 27, 2002► Subscribe► Subscribe
Bayer Healthcare LlcCLARITIN REDITABSloratadineTABLET, ORALLY DISINTEGRATING;ORAL020704-002Nov 27, 2002► Subscribe► Subscribe
Bayer Healthcare LlcCLARITINloratadineTABLET;ORAL019658-002Nov 27, 2002► Subscribe► Subscribe
Bayer Healthcare LlcCLARITIN REDITABSloratadineTABLET, ORALLY DISINTEGRATING;ORAL020704-002Nov 27, 2002► Subscribe► Subscribe
Bayer Healthcare LlcCLARITINloratadineSYRUP;ORAL020641-002Nov 27, 2002► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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► Subscribe
6,939,550 Stabilized antihistamine syrup► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: loratadine

Country Document Number Estimated Expiration
New Zealand508037► Subscribe
Austria257705► Subscribe
Yugoslavia23599► Subscribe
Costa Rica6035► Subscribe
Portugal1082117► Subscribe
Colombia5011119► Subscribe
Australia754469► Subscribe
Japan2005015485► Subscribe
European Patent Office1082117► Subscribe
Malaysia123325► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LORATADINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/005United Kingdom► SubscribeSUPPLEMENTARY 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.
C/GB01/012United Kingdom► SubscribePRODUCT 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
C0004France► SubscribePRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
01C/013Belgium► SubscribePRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
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Serving leading biopharmaceutical companies globally:

Deloitte
Harvard Business School
Johnson and Johnson
Cerilliant
Dow
Citi
Cipla
Teva
UBS
Accenture

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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