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2Â¥2011-03-18 12:51:27
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robbiekean

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warlen(½ð±Ò+1): лл²ÎÓë 2011-03-18 15:54:09
¿Õ³ÇÈôÐé(½ð±Ò+40): ·Ç³£¸Ðл£¡ 2011-03-18 20:13:20
caoyuan521(½ð±Ò+2): лл²ÎÓ룡 2011-03-18 21:04:15
ÒýÓûØÌû:
Originally posted by ¿Õ³ÇÈôÐé at 2011-03-18 12:15:14:
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Fexofenadine hydrochloride
Cas number: 153439-40-8, 138452-21-8

- General description:

Fexofenadine (trade names Allegra, Telfast, Fastofen, Tilfur, Vifas, Telfexo, Allerfexo) is an antihistamine drug used in the treatment of hayfever and similar allergy symptoms. It was developed as a successor of and alternative to terfenadine (trade names include Triludan and Seldane), an antihistamine which caused QT interval prolongation, potentially leading to cardiac arrhythmia.

It has been described as both second-generation[3] and third-generation antihistamine.

The older antihistaminic agent terfenadine was found to metabolize into the related carboxylic acid, fexofenadine. Fexofenadine was found to retain all of the biological activity of its parent while giving fewer adverse reactions in patients, so terfenadine was replaced in the market by its metabolite.[8] Fexofenadine was originally synthesized in 1993 by Massachusetts-based biotechnology company Sepracor, which then sold the development rights to Hoechst Marion Roussel (now part of Sanofi-Aventis), and was later approved by the Food and Drug Administration (FDA) in 1996. AMRI holds the patents to the intermediates and production of fexofenadine HCl along with Roussel. Since that time, it has achieved blockbuster drug status with global sales of $1.87B USD in 2004 (with $1.49B USD coming from the United States). AMRI received royalty payments from Aventis that enabled the growth of AMRI.

On January 25, 2011, the FDA approved over-the-counter sales of fexofenadine in the United States, with Sanofi-Aventis' version expected to become available on March 4, 2011.


I. Originator:Aventis Pharma, Sepracor;
   Marketer:  ViroPharma;
   Reference patent: JP 1996502022; WO 9321156;



II. Main Competitors in U.S:
N021963   Yes FEXOFENADINE HYDROCHLORIDE SUSPENSION; ORAL 30MG/5ML ALLEGRA SANOFI AVENTIS US

--------------------------------------------------------------------------------

A076191  AB  No FEXOFENADINE HYDROCHLORIDE TABLET; ORAL 180MG FEXOFENADINE HYDROCHLORIDE BARR

--------------------------------------------------------------------------------

A076191  AB  No FEXOFENADINE HYDROCHLORIDE TABLET; ORAL 30MG FEXOFENADINE HYDROCHLORIDE BARR

--------------------------------------------------------------------------------

A076191  AB  No FEXOFENADINE HYDROCHLORIDE TABLET; ORAL 60MG FEXOFENADINE HYDROCHLORIDE BARR

--------------------------------------------------------------------------------

A076502  AB  No FEXOFENADINE HYDROCHLORIDE TABLET; ORAL 180MG FEXOFENADINE HYDROCHLORIDE DR REDDYS LABS LTD

--------------------------------------------------------------------------------

A076502  AB  No FEXOFENADINE HYDROCHLORIDE TABLET; ORAL 30MG FEXOFENADINE HYDROCHLORIDE DR REDDYS LABS LTD

--------------------------------------------------------------------------------

A076502  AB  No FEXOFENADINE HYDROCHLORIDE TABLET; ORAL 60MG FEXOFENADINE HYDROCHLORIDE DR REDDYS LABS LTD

--------------------------------------------------------------------------------

A077081  AB  No FEXOFENADINE HYDROCHLORIDE TABLET; ORAL 180MG FEXOFENADINE HYDROCHLORIDE MYLAN

--------------------------------------------------------------------------------

A077081  AB  No FEXOFENADINE HYDROCHLORIDE TABLET; ORAL 30MG FEXOFENADINE HYDROCHLORIDE MYLAN

--------------------------------------------------------------------------------

A077081  AB  No FEXOFENADINE HYDROCHLORIDE TABLET; ORAL 60MG FEXOFENADINE HYDROCHLORIDE MYLAN

--------------------------------------------------------------------------------

A076447  AB  No FEXOFENADINE HYDROCHLORIDE TABLET; ORAL 180MG FEXOFENADINE HYDROCHLORIDE TEVA

--------------------------------------------------------------------------------

A076447  AB  No FEXOFENADINE HYDROCHLORIDE TABLET; ORAL 30MG FEXOFENADINE HYDROCHLORIDE TEVA

--------------------------------------------------------------------------------

A076447  AB  No FEXOFENADINE HYDROCHLORIDE TABLET; ORAL 60MG FEXOFENADINE HYDROCHLORIDE TEVA

--------------------------------------------------------------------------------

A076236  AB  No FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 60MG;120MG FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE BARR

--------------------------------------------------------------------------------

A079043   No FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 180MG;240MG FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE DR REDDYS LABS LTD

--------------------------------------------------------------------------------

A076298  AB  No FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 60MG;120MG FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE IMPAX PHARMS



III. China Domestic Market
I suggest you to look through the SFDA website to get related informations. It is not difficult.



IV. The market information is not easy to acquire. I suggest you to purchase IMS data or BMI data.
3Â¥2011-03-18 13:36:14
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¿Õ³ÇÈôÐé

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4Â¥2011-03-18 20:10:17
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robbiekean

ľ³æ (ÕýʽдÊÖ)


ÒýÓûØÌû:
Originally posted by ¿Õ³ÇÈôÐé at 2011-03-18 20:10:17:
·Ç³£¸Ðл¥Éϵġ£
ÎÒÖ÷ÒªÊÇÒª²éµÄÌ«¶àÁË£¬Ê±¼ä±È½Ï½ô£¬²ÅÇóÖúµÄ¡£

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5Â¥2011-03-18 21:35:10
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