[Pharm-policy] Aventis to investors: we will block generic Allegra (at least for a while)

[love@cptech.org]

http://www.stockhouse.com/news/news.asp?tick=AVE&newsid=825024
 
Aventis Pharmaceuticals Comments on ANDA Filing of Fexofenadine HCl 60
mg Capsules 
7/3/01 
 
Company States Generic Competition is Neither Certain nor Imminent 

BRIDGEWATER, N.J., Jul 3, 2001 /PRNewswire via COMTEX/ -- Aventis
Pharmaceuticals, the U.S. pharmaceutical business of Aventis Pharma AG,
today issued the following statement in response to an Abbreviated New
Drug Application (ANDA) filed with the U.S. Food and Drug Administration
(FDA) by Barr Laboratories, Inc. This ANDA is seeking authorization to
produce and market a generic version of fexofenadine HCl 60 mg capsules
in the US. Aventis Pharmaceuticals markets fexofenadine HCl under the
brand name Allegra(R) 
(Photo: http://www.newscom.com/cgi-bin/prnh/20000501/NYM197 ) 

Aventis Pharmaceuticals is aware that an ANDA has been filed with the
FDA for fexofenadine HCl 60 mg capsules. This filing is not a surprise
to Aventis. In fact, the possibility of such a filing has been discussed
in public for some time. At this point, the ANDA review process is just
beginning and generic competition is neither certain nor imminent. 

In the United States, Aventis holds multiple enforceable method of use,
formulation, process and composition patents with respect to Allegra.
The statutory period during which others are prevented from filing ANDAs
with the FDA, which is not related to the life of any patent, has
elapsed. The expiration of non-patent-related exclusivity does not
affect those intellectual property rights -- a generic version of
Allegra 60 mg capsules cannot be marketed lawfully in violation of
Aventis' intellectual property rights. 

Aventis is currently evaluating its legal options and intends to protect
and defend its intellectual property rights against infringement. If
litigation is pursued, marketing of an FDA-approved generic may not
commence unless and until a decision favorable to Barr Laboratories in
any related patent litigation were to occur or until 30 months (two and
a half years) have lapsed, whichever comes first. 

   [snip]