Eli Lilly tries to halt another Cialis generic
Eli Lilly is attempting to stop a Chinese company from manufacturing a generic version of blockbuster drug Cialis (tadalafil).
Indiana-headquartered Eli Lilly sued two subsidiaries of China-based HEC Pharm at the US District Court for the District of New Jersey yesterday, April 9.
Sunshine Lake Pharma and HEC Pharm USA had filed an Abbreviated New Drug Application (ANDA) for a generic version of Cialis, a drug used to treat erectile dysfunction.
In its lawsuit, Eli Lilly claimed that the ANDA would infringe US patent number 6,943,166, called “Compositions comprising phosphodiesterase inhibitors for the treatment of sexual dysfunction”.
Eli Lilly has approval to sell tadalafil tablets in 2.5 mg, 5 mg, 10 mg and 20 mg dosage strengths—the same strength tablets that HEC Pharm is looking to make and sell.
In 2017, Cialis had worldwide sales of $2.3 billion.
Eli Lilly is seeking judgment that its patent has been infringed by the submission of the ANDA. It has also asked for injunctive relief and an order that the date of any approval of the ANDA product shall be no earlier than 30 months from the date of HEC Pharm’s notice letter to Eli Lilly.
In November last year, the English Court of Appeal ruled that patent claims protecting Cialis are invalid as obvious, handing victory to Actavis, Teva and Mylan. The court refused to grant Eli Lilly an injunction which would have stopped the trio from marketing a generic version of the drug.
A few months before, in July, Eli Lilly entered into a settlement agreement with Teva and Watson Laboratories to resolve pending patent litigation over Cialis.
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