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Loratadine - Generic Drug Details

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Loratadine is the generic ingredient in eleven branded drugs marketed by Perrigo, Bayer Healthcare Llc, Taro, Teva, Sandoz, Perrigo Pharma Intl, Marksans Pharma, Wockhardt, Silarx, Pfizer, Ranbaxy Labs Ltd, Sun Pharm Inds Ltd, Mylan, Apotex Inc, and Actavis Labs Fl Inc, 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.

This ingredient has thirty-one patent family members in twenty-eight countries.

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

Summary for Generic Name: loratadine

Tradenames:11
Patents:1
Applicants:15
NDAs:36
Drug Master File Entries: see list39
Suppliers / Packaging: see list124
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: loratadine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Healthcare Llc
CLARITIN REDITABS
loratadine
TABLET, ORALLY DISINTEGRATING;ORAL021993-001Dec 12, 2006OTCYes► subscribe► subscribe
Sun Pharm Inds Ltd
LORATADINE AND PSEUDOEPHEDRINE SULFATE
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL076557-001Sep 22, 2004OTCNo► subscribe► subscribe
Actavis Labs Fl Inc
LORATADINE AND PSEUDOEPHEDRINE SULFATE
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL075706-001Feb 21, 2003OTCNo► 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 Llc
CLARITIN
loratadine
SYRUP;ORAL020641-002Nov 27, 20024,659,716*PED► subscribe
Bayer Healthcare Llc
CLARITIN REDITABS
loratadine
TABLET, ORALLY DISINTEGRATING;ORAL020704-002Nov 27, 20024,659,716*PED► subscribe
Bayer Healthcare Llc
CLARITIN
loratadine
TABLET;ORAL019658-002Nov 27, 20024,863,931*PED► 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
6,939,550 Stabilized antihistamine syrup► subscribe
6,514,520 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
Canada2333528► subscribe
Austria257705► subscribe
New Zealand508037► 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.
01C/013Belgium► subscribePRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
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
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