Strategies for early generic launch - Atorvastatin

The major constraining patent for Atorvastaitn is EP-00247633. Patentee is Warner-Lambert company. Priority date is 30 May 1986.  SPC for EP-00247633 will expire in Nov. 2011 in number of EU countries. However, in Slovenia, Czech R., Bulgaria, Hungary, Poland and Slovakia there is no national patents with link to  EP-00247633 as primary patent.

The major constraining patent for Atorvastaitn is EP-00247633. Patentee is Warner-Lambert company. Priority date is 30 May 1986.  By acquisition of Werner-Lambert by Pfizer this become Pfizer intellectual property. As usual, the patent situation is much more complicated because Pfizer holds 58 patent families on Atorvastatin. There are numerous other companies with patents on Atorvastatin. For instance, Biocon India Group has 17 patent families on Atorvastatin.

SPC for EP-00247633 will expire in Nov. 2011 in number of EU countries. However, in Slovenia, Czech R., Bulgaria, Hungary, Poland and Slovakia there is no national patents with link to  EP-00247633 as primary patent.

Krka has noticed this opportunity and launched generic atorvastatin (Atoris) in Slovenia at 31st July 2002. After Slovenia, they launched Atoris in  Bulgaria, Czech R., Hungary and Poland.   At 09th Apr. 2004. Krka has filed patent WO-2005907742 for “Polymorphs of atorvastatin tert.-butylester and use as intermediates for the preparation of atorvastatin”.

Zentiva from Czech R. has also launched Torvacard, their generic version of atorvastatin.

Zentiva has patent WO-03068739 with priority date of 1st Feb. 2002 for “Method of manufacturing an amorphous form of the hemi-calcium salt of (3R,5R)7-[3-phenyl-4-phenylcarbamoyl-2-(4-fluorophenyl)-5-isopropyl-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid (atorvastatin)”.

On 01st  April 2005 Krka, d.d., Novo Mesto informs the interested public that it received a lawsuit from the District Court in Ljubljana, filed against Krka by the American companies Warner Lambert Company LLC and Pfizer H.C.P. Corporation in view of alleged infringement of two patents for the production of the two forms of active substance atorvastatin. The plaintiffs urge the court to render a judgment banning the use and production of atorvastatin in mentioned forms, and to order the destruction of stocks, withdrawal of the product from the market and payment of compensation at the level of one billion SIT with legitimate default interest running from August 1, 2002 until the day of payment.

Having received the patent infringement lawsuit and having examined the enclosed documentation, Krka estimates to the best of its knowledge, that the two patents mentioned by the plaintiffs, have not been infringed and that the lawsuit is not justified, which the company will demonstrate to the court. Krka will present to the court the relevant reply to the lawsuit.

• Contract Manufacturing Strategies (10/06/2008)
• Biomanufacturing Strategies (13/05/2008)
• Atorvastatin (22/08/2007)

• Relpax (24/05/2006)
• Patent Expiry Dates (01/03/2006)
• Evergreening (23/02/2006)

• IP Case - Sildenafil (22/12/2005)

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