Teva gains approval for generic breast cancer and anti-depressant drugs Posted 09/07/2010

The Israeli generics’ giant Teva Pharmaceuticals is racing ahead in the generics game with the announcement of the approval by the FDA of two new drugs for treatment of breast cancer and depression.

On 28 June 2010, Teva announced that it had received FDA approval, and would immediately launch its generic version of AstraZeneca’s blockbuster cancer drug, Arimidex (anastrozole). Anastrozole is indicated for treatment of breast cancer in postmenopausal women.

The patent on Arimidex was due to expire in December, but AstraZeneca was granted a six-month extension, granting paediatric exclusivity until 27 June 2010.

Loss of Arimidex earnings is clearly going to be a blow for the UK-based company. The branded product had annual sales of approximately US$916.8 million in the US, based on IMS sales data.

US-based APP Pharmaceuticals has also announced it will immediately begin marketing generic anastrozole tablets in the US.

Then on 29 June 2010, Teva announced that it had also received FDA approval for its generic version of Wyeth’s anti-depressant drug, Effexor (venlafaxine HCl). Teva expects to commence shipment of the new drug on 1 July 2010, as per the terms of the 2006 agreement with Wyeth (now part of Pfizer).

As the first company to file an Abbreviated New Drug Application containing a paragraph IV patent certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.

The branded product had annual sales of approximately US$2.75 billion in the US, based on IMS sales data.

These two drugs are just the latest in a string of generics to be launched by Teva in the US. In June alone Teva has already launched two other generics. On 1 June 2010 it launched Gianvi (drospirenone and ethinyl estradiol), a generic version of German-based Bayer Schering Pharma’s Yaz oral contraceptive. Then on 2 June 2010 a generic version of Swiss-based Galderma's Differin (adapalene 0.1%) gel, which is indicated for the treatment of acne, was launched.

(see also Bayer sues Teva over generic Yaz contraceptive and FDA ANDAs containing paragraph IV patent certifications)

References:

Teva Pharmaceuticals Press Releases, Teva Announces Launch of Generic ARIMIDEX®, 28 June 2010

Teva Pharmaceuticals Press Releases, Teva Announces Approval of Generic Effexor XR®, 29 June 2010

Comments (0)