AstraZeneca Plc has filed a patent infringement case against Glenmark Pharmaceutiacals in a US court to prevent the Indian firm from applying to sell a generic version of its breast cancer drug Faslodex.
In the complaint filed in the federal court in Camden, New Jersey, AstraZeneca is seeking a court order blocking Glenmark from selling a generic copy of Faslodex, before its four patents expire in 2021.
As per a court document, a civil action for patent infringement under the patent laws of the US followed the filing by Glenmark USA of Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (USFDA) for a generic copy of Faslodex.
Glenmark had sought approval to engage in the commercial manufacture, use and sale of its 250mg/5 mL (50 mg/mL) fulvestrant injection, which is a generic version of AstraZeneca's Faslodex.
The Mumbai-based firm had notified AstraZeneca via letter dated January 14 that it has submitted to the FDA an ANDA seeking approval to engage in the manufacture and sale of its product prior to the expiration of AstraZeneca's patents.
When contacted a Glenmark Pharmaceuticals spokesperson declined to comment.
As per the document, AstraZeneca was granted patent on for Faslodex on August 10, 2004 and will expire on January 9, 2021, with an additional six months of paediatric exclusivity that will expire July 9, 2021.
Faslodex is an estrogen receptor antagonist approved by the FDA for the treatment of breast cancer in postmenopausal women.
