cheaper options from entering the market.
Increasingly, as regards para IV filings, innovators and generic drugmakers are entering into settlements where the generic product would be launched after a particular date, usually just before the patent expires. This arrangement provides some additional time for the innovator while the generic drugmaker can hold the “first-to-file” advantage which gives it 180 days of marketing exclusivity.
The ANDA data set is also influenced by Israel’s Teva acquisitions over the years. In the time period relevant to the data set, the company bought US-based Barr Pharmaceuticals and Croatian drug major Pliva. ANDA rights also crossed international boundaries when Sandoz acquired US generic drugmakers Fougera Pharmaceuticals and Ebewe Pharma.
While the Big Pharma companies like Merck and GlaxoSmithKline keep their distance from the generic drugs market or set up a subsidiary that handles the business — for example, US-based Roxane Labs is a subsidiary of Germany’s Boehringer Ingelheim — Pfizer stands apart from its peers in the data examined. The world’s largest drug company by revenue received 16 ANDAs from January 2007 to October 2013.
On a company-wise basis, Mylan, which ranks second globally among generic drugmakers, tops the list with 207 ANDA approvals to its credit in the seven-year period. Teva has 153 approvals and ranks third.
Indian companies have faced various compliance issues in 2013 with overseas health regulators — the USFDA and the UK’s Medicines and Healthcare products Regulatory Agency — finding Indian manufacturing facilities failing to meet the good manufacturing standards laid out by them. With top Indian companies like Ranbaxy and Wockhardt under the scanner, it was assumed that approvals from the regulators would be hard to come by.
But the numbers show that despite the problems, Indian companies are still getting the USFDA nod. Since late May — when Wockhardt’s troubles first cropped up — Indian companies have received approval for 60 ANDAs, compared with 45 approvals the US companies have got.