Natco Pharma on January 31 filed an abbreviated new drug application (ANDA) containing a Paragraph IV certification with the USFDA for generic the version of AbbVie's blockbuster blood cancer drug Imbruvica.
Natco joined hands with Alvogen for co-development and marketing the drug in the US in 140 mg, 280 mg, 420 mg and 560 mg strengths.
Natco said it believes the ANDA is possibly sole first-to-file based on the ANDA filing dates.
"We further believe that our ANDA may be eligible for 180 days of marketing exclusivity at the time of potential launch of the product under certain circumstances," Natco said in a statement.
In the US, Imbruvica brand is owned and marketed by Pharmacyclics
and Janssen Biotech with sales of around $2.97 billion. For calendar 2018, almost 83 percent of the sales contribution has come from the above-mentioned tablet dosage forms.
If a generic company is the first to file its ANDA with a Paragraph IV certification and subsequently prevails in a lawsuit invalidating the patents of the originator company, that generic company is granted a period of market exclusivity of 180 days in the US.
To be sure, Natco's filing of ANDA will lead to a lengthy and costly patent infringement litigation, as the patents of Imbruvica are valid and not expected to expire any time soon.
As per the USFDA's Orange Book that contains data of all approved drugs in the US, the patents of Imbruvica will start expiring only from 2026, some patents are valid all the way until 2033-2034.
But Natco isn't new for such patent battles. The company generally reduces the cost of patent litigation and the risk associated with it by partnering with other companies.
Imbruvica is a targeted therapy that works against cancerous B lymphocytes or B Cells, a type of white blood cells affected by the disease.
One bottle (90 capsules) of Imbruvica 140 mg sells anywhere between $13,094 and $13,510, according to GoodRx, a mobile app that tracks prescription drug prices in the US.
Shares of Natco Pharma rose 1.05 percent and were trading at Rs 684.40 on BSE at 12.31 pm, the benchmark Sensex gained 1.06 percent to 35,963.97 points.